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According to a recording obtained by �������ýҕ�l Health News, Bhattacharya at one point suggested to CDC staff that Trump could name a new leader for the agency as soon as Thursday. “But if not, I don’t think much will change,” he said.

Though his official position as acting director was set to expire Wednesday, Bhattacharya will continue to lead the agency until the top spot is filled. Meanwhile, news outlets including and reported that the administration was postponing filling the permanent director job amid the challenges of gaining Senate confirmation and other political pressures.

Bhattacharya opened the meeting by acknowledging over the past year. Workers faced waves of job losses, and a gunman attacked the CDC’s Atlanta campus in August, killing a police officer and causing significant property damage. “I want to acknowledge very honestly that I know that it has been such a difficult year for the CDC and for every single one of you here,” Bhattacharya said.

He said the agency has begun to fill its leadership gaps. During his first meeting with the agency’s top leaders, he said, “I noticed almost every single one of them is acting.”

“We’ve made progress in filling key roles across the agency,” he said. “Leadership stability is essential to delivering our mission.”

The aim, he said, is to leave the agency in “a solid, secure place” so it can do its work “without so much of the turmoil that we’ve seen the last year.”

Bhattacharya invited questions from the CDC staffers, who repeatedly asked about staffing losses, morale, and their job security, as well as Trump’s decision to withdraw from the World Health Organization.

“The politics of WHO withdrawal are above my pay grade,” Bhattacharya said. “What I do know is that without the CDC, the world will be in much worse health.”

Workforce Concerns

One employee told Bhattacharya the agency had lost a “huge amount” of “internal capacity and expertise in the past year” and it “continues to be very challenging for staff to do their jobs,” adding that “certain conditions are a bit demoralizing.”

The CDC can “function without leaders,” another speaker said. “We function without directors. And this entire team will make CDC run without you if you’re not here.”

Schedule F, an effort to reclassify certain federal employees in policy-related roles and reduce their civil service protections, drew some of the strongest statements from the staff. While it’s not fully implemented, the policy could make it easier for Trump to fire thousands of federal workers.

“What’s scaring the hell out of us right now is Schedule F,” an employee said. “We are terrified that ‘at will’ means you’re gone, you’re not here, you’re fired.”

“The Schedule F fight’s above my level,” Bhattacharya replied. He said his focus is on making sure the “work is supported.”

He said the agency should seek to “depoliticize what we do fundamentally” so that “every American sees us as working for their benefit.”

“When I say ‘depoliticize,’ I don’t mean you can’t say the hard or talk about the hard things,” he added. “I mean that you’re free to talk about the hard things without fear that you’re gonna be retaliated against.”

On hiring and operations, he pointed to ongoing efforts but acknowledged delays. The Department of Health and Human Services, which oversees the CDC, is “moving at the speed of bureaucracy,” he said, adding that he’s trying his best. “We have to move past the last year, and I think we now have an opportunity really to do that.”

Vaccine Policy

On vaccines, Bhattacharya said one of the first things he did in his role as acting CDC director was to record a video “strongly encouraging parents to vaccinate their kids from measles.”

He said rebuilding trust requires engagement. That means working with communities without denigrating them, and respecting how “they think and their values,” he said.

Bhattacharya said he would like the NIH and CDC to coordinate more, particularly on HIV prevention. He described his approach as “an implementation science strategy so that we can use these two pieces of the HIV tool kit to actually end the HIV pandemic.”

The search for a permanent CDC director is being led by HHS officials on behalf of the White House and Health and Human Services Secretary Robert F. Kennedy Jr.

Bhattacharya said he’s friends with Kennedy and called “the caricature of him that I’ve seen in the press” unfair. Kennedy “really does have a deep desire to make America healthy,” he said.

For now, Bhattacharya said, he expects to stay in place at the CDC, as “either acting director or acting in the capacity of the director, whatever the heck that means.”

He joked about the ambiguity: “It’s like an Office episode, you know?”

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Raven’s case reveals a little-known gap in the U.S. donation system: There is no clear, nationally binding way to opt out — or to ensure a later “no” overrides an earlier “yes” in a different state.

This gap, along with a range of other issues related to the organ procurement system, has become a point of bipartisan congressional concern. Late last year, the House Ways and Means subcommittee on oversight examining what members described as shortcomings, including alleged consent failures.

The panel’s scrutiny of organ procurement organizations, or OPOs, and their consent practices is a first step toward a more meaningful accountability plan that could help maintain trust across the system, according to some committee staff members.

The trust in our organ procurement and transplant system “has been eroded,” said Rep. Terri Sewell of Alabama, the panel’s senior Democrat, calling for stronger transparency and oversight to rebuild public confidence.

“Respect for autonomy — our ability to make our own decisions (self-determination) — allows for both ‘yes’ and ‘no’ decisions and for changing one’s mind,” Margaret McLean, a bioethicist at Santa Clara University, said in an email.

“Medical decision-making is not well served in a context of ambiguity,” she said.

And if a donor revokes consent, she added, “revocation by that person should carry the same ethical and procedural weight as the initial authorization, perhaps more.”

Raven Kinser Changed Her Mind

Raven was 25 when she died. Her parents, Jeff and Jaime Kinser, were at home in Michigan when they received the phone call that shattered their world. They drove through the night to the Newport News hospital, where they learned Raven’s disposition had been referred to LifeNet Health, the region’s federally designated OPO. LifeNet a failing OPO by the Centers for Medicare & Medicaid Services, meaning it doesn’t meet the government’s standards for how well it finds donors and recovers usable organs for transplant compared with other organizations.

Under federal law, hospitals are required to refer deaths and imminent deaths to OPOs, which take responsibility for donation-related decisions and discussions.

OPOs occupy a hybrid position in the health care system, as private nonprofit entities that hold exclusive, federally authorized contracts to recover organs within defined regions. They are regulated by CMS and overseen by the Health Resources and Services Administration, but that oversight occurs primarily through certification standards, performance metrics, and periodic audits rather than routine public disclosure requirements. With donor registries largely managed at the state level and no unified federal reporting requirement for removals, comprehensive national data on revocations is elusive.

OPOs are meant to separate bedside care from organ procurement decisions — to help prevent conflicts of interest and preserve the trust that decisions about life-sustaining treatment are made solely in the dying patient’s interest. But the , leaving families unsure who is in control if and when conflicts arise.

The Kinsers, for instance, felt their daughter would not have wanted to go through the donation process, but, at the time, had no evidence. Jaime remembers telling her husband that Raven would have been mad at them for letting it happen. In an effort to stop it, Jaime inquired about whether she would be asked to sign a consent form. But a LifeNet staff member told her that wasn’t an option because donation was Raven’s “living will,” Jaime said. Meanwhile, Raven’s parents said, her personal effects, including her Virginia driver’s license, which bore no donor designation, had not yet been turned over to the family, leaving them no meaningful way to challenge LifeNet’s determination in real time.

Jaime struggled with this outcome, even mentioning in Raven’s obituary that she was an organ donor. “How would you try to make peace with something that you felt was so wrong but had no proof?” Jaime said.

Two months passed before the Kinsers gained possession of the license, which, as they had expected, showed that Raven had not opted to be an organ donor.

According to the Kinsers, LifeNet staff told them that Raven’s status as a registered donor was established by her designation on her older Michigan license.

An emailed statement attributed to Douglas Wilson, LifeNet executive vice president, said the OPO follows federal law on organ donation, the , and queries applicable state donor registries, relying on time stamps and governing law to determine the , legally valid expression of intent. Under that framework, a prior donor authorization remains enforceable unless a valid revocation is recorded in the regional OPO’s donor registry.

Because of privacy laws, Wilson said, LifeNet could not comment on the specifics of any individual case.

Raven Kinser’s choice not to be a donor when she applied for a Virginia license in July 2024 was not reflected in the registry LifeNet consulted, according to her parents, who said that is what the organization told them. According to Lara Malbon, executive director of Donate Life Virginia, which manages the state’s organ donor registry, if someone changes their donor status while completing a Virginia driver’s license or ID transaction, “that information is sent to our registry, and the registry is updated daily to reflect those changes.” Malbon also said Virginia’s registry includes only people who have “affirmatively said ‘yes’ to becoming an organ, eye, and tissue donor, and it retains records solely for those who have made that decision.”

The Kinsers said they were never told why Raven’s Virginia DMV record was insufficient, or how an older yes from Michigan could outweigh a newer no in Virginia.

In December, the Kinsers filed a complaint with the Health Resources and Services Administration, urging federal regulators to investigate LifeNet’s actions and require OPOs to provide families with documented proof of the donor’s current status at the time of referral. They also called for OPOs, which operate as federally designated regional monopolies but are structured as private nonprofits, to be made subject to public records laws.

When Opting Out Doesn’t Stick

Such confusion is not unique to the Kinser family. It is a consequence of the organ donation consent process in the United States.

“I have also wondered that: why there’s not just one” registry for organ donation, Jaime said. If you go to get a firearm, you have one federal registry, she said.

Here’s how the system works: Americans typically register their organ donation intentions when they apply for driver’s licenses through state DMVs, and that decision remains governed largely by state law. That has led to 50 different sets of rules and very little federal regulation of what has become an in the U.S.

In some states, a donor checkbox is a binding legal document. In other states, the same choice may have different rules about when it takes effect, what it covers, and how it can be revoked.

Those differences can be big. State rules determine whether a person’s “gift” is limited to transplantation or also includes research and education. They determine whether the donation authorization includes tissue. And they can determine what counts as a valid revocation and when it is legally recognized.

Because of the system’s fragmentation, though, signals can cross when someone changes their mind, like Raven; it’s not always reflected from one state system to another.

Under state versions of the Uniform Anatomical Gift Act, a donor’s most recent legally valid expression of intent is meant to control.

“Personal autonomy is paramount to everything,” said Adam Schiavi, a neurointensivist who studies end-of-life decision-making. “If I say I want to be a donor, or if I say I don’t want to be a donor, that has to take precedence over everything else.”

But states differ in how revocation must be recorded and which registry is considered authoritative if someone has lived in more than one state. Those inconsistencies can create uncertainty when records conflict across jurisdictions.

“It has to be the most recent expression, not the most recent yes,” Schiavi said.

In Michigan, a change to someone’s donor status is reflected immediately in the secretary of state’s system, but only affirmative “yes” registrations appear in the registry. Removal information remains in internal motor vehicle records. In Virginia, the state registry includes only those who have affirmatively said “yes,” retaining records solely of donors, creating potential gaps if someone believes a DMV change alone is sufficient.

Elsewhere, processes and volumes differ sharply. New Mexico updates driver records in real time but does not transmit status changes to its donor registry. Instead, donor services receive restricted search access. The state logged nearly 15,000 removals in late 2021 and almost 30,000 in 2022. Florida, which maintains formal removal records through weekly DMV data files, reported 356,161 removals in 2020, more than 1.5 million in 2023, and over 1.2 million in 2025. Kentucky processed 847,371 donor registrations from 2020 to 2025, but only 16,043 icon removals, with registry withdrawal handled separately. In 2025, more than 570,000 Texans opted into the registry, while over 31,000 individuals requested removal.

According to a federal official who asked not to be identified for fear of professional repercussions, OPOs have been highly effective at lobbying states to broaden the definition of consent and authorization — shaping how those terms are applied, whether those statuses must be renewed, and how easy or difficult it is for someone to opt out.

In subsequent correspondence with federal officials, the Kinsers have urged reforms to prevent OPOs from relying on older registry entries when a more recent state DMV record exists, and they have called for criminal penalties in cases in which consent is knowingly misrepresented. Federal regulators have not indicated whether such proposals are under consideration.

Congress Takes a Closer Look

Ethicists have long cautioned that consent must be more than a checkbox and must remain grounded in respect for the donor-patient. In an October on organ transplantation, the American College of Physicians emphasized that clinicians’ primary duty is to the patient in their care, and that maintaining trust requires transparency and safeguards to prevent conflicts of interest from blurring that “bright line.”

Advocates say those steps leave unresolved the core problem raised by the Kinser family: the lack of a clear, legally binding way for people to say “no” and for that decision to follow them across state lines.

The said it “supports strengthening donor registries and enhancing registry interoperability to ensure that an individual’s documented donation decision is honored.” But OPOs have also argued that current policies protect donation as a legally enforceable gift and prevent families from overriding a loved one’s “yes” in the midst of grief. They argue that stronger, more durable consent helps reduce missed donations and saves lives.

Congress and federal regulators are considering changes to the nation’s organ donation system, including how consent is recorded and what should happen when a donor changes their mind.

Sen. Ron Wyden (D-Ore.) last year to create new federal standards for patient safety, transparency, and oversight of organ transplants, including a formal authorization for hospital or OPO staff to pause harvesting if there is any “clinical sign of life.”

HHS press secretary Emily Hilliard said the agency is “committed to holding organ procurement organizations accountable” and to “restoring integrity and transparency” to organ donation policy, calling reforms essential to informed consent and protecting donor rights. CMS issued related March 11, but it does not address the problems highlighted by the Kinsers’ case.

Critics of the organ transplant system say it is difficult for families to obtain documentation or independently verify how consent determinations were made in disputed cases.

HRSA has launched a sweeping modernization of the Organ Procurement and Transplantation Network, the national system that oversees organ allocation and transplant policy. Federal officials have described the overhaul as the most significant restructuring of the transplant system in decades, aimed at breaking up a long-standing contractor monopoly, strengthening patient safety oversight, and replacing aging technology infrastructure.

Central to that effort is modernizing the OPTN’s data systems: improving interoperability, audit trails, and transparency in how decisions are documented and reviewed. A more modern federal data architecture could make it easier to trace which registry was queried, what time stamp controlled, and how a consent determination was reached in disputed donations that span multiple states. But the modernization effort would not change the underlying state-by-state legal framework for donor authorization and what counts as a valid “no.”

Meanwhile, Donate Life America, a national nonprofit that supports state donor registries, also runs the , a central database that allows people to sign up as organ donors directly. Unlike many DMV systems, the national registry lets people log in at any time to view, update, or remove their registration and print proof of their decision. The group is also starting a project to let participating states send registrations directly into the national system, creating one place to track donor sign-ups and removals across state lines.

Each of the proposals comes with trade-offs, and both advocates and OPOs have raised concerns about how they would work in practice.

“Just doing a dump truck dump of information is not going to do much unless you really apply it through checking and auditing,” said Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine. “It could be like the IRS. They don’t have to audit everybody. Just do a spot audit once in a while.”

The Kinsers aren’t opposed to organ donation itself. They celebrated Raven’s donation in her obituary, and in their complaint to federal regulators, they wrote, “We are NOT anti-organ donation, and we will never take away the gift of life our oldest daughter gave to others. However, that was not LifeNet’s choice to make.”

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Engineered quartz countertops have surged in popularity in the home renovation market, with industry analysts estimating the global engineered stone market at . It’s continuing to expand as quartz surfaces replace natural stone in kitchens in the United States and worldwide.

When González was working, the dust that rose from his saw didn’t look extraordinary. It settled on his clothes, in his hair, across the shop floor. In a small countertop fabrication shop, he cut marble and granite before shifting to engineered stone after the 2008-09 recession, when demand for cheaper quartz countertops surged.

But the crystalline silica released while the engineered stone was cut and polished also settled into his lungs, scarring them beyond repair. What began as breathlessness hardened into silicosis, an irreversible disease that stiffens the lungs until even ordinary movement becomes effort.

A lung transplant was his path forward. The procedure can extend survival, but it redraws the boundaries of a life: anti-rejection drugs every day, constant monitoring, vulnerability to infection, the knowledge that breathing depends on the fragile acceptance of another person’s donated organ.

González, who was diagnosed with silicosis in 2023, is not alone in dealing with a disease that once was associated with miners at the end of long careers. It’s now prevalent among the much younger, often Hispanic men who work in this industry, physicians and public health officials say.

In the United States, cases are appearing in countertop fabrication shops from California to Texas, Florida, and the Northeast. Because silicosis is not a nationally reportable disease and surveillance varies by state, no comprehensive national count exists. But clinicians who treat occupational lung disease say the number of workers — often men in their 30s and 40s — diagnosed after cutting engineered stone has risen sharply over the past decade.

As of , California had identified 519 confirmed cases of engineered-stone-associated silicosis and 29 deaths since 2019. The median age at diagnosis is 46; at death, 49.

Doctors don’t debate whether working with engineered stone can scar lungs.

Manufacturers argue, though, that proper ventilation, wet cutting, and respirators can make fabrication safe. Workers, physicians, and plaintiffs’ attorneys counter that a material composed almost entirely of crystalline silica may be impossible to handle safely at scale.

“This is comparable to the tobacco industry saying cigarettes are safe,” said epidemiologist David Michaels, an assistant labor secretary under President Barack Obama who led the Occupational Safety and Health Administration.

More than 370 lawsuits have been filed by workers who say engineered stone manufacturers failed to warn employees about the risks or sold a product that cannot be fabricated safely. At the same time, members of Congress are that would largely shield manufacturers from liability in those cases, turning a workplace health crisis into a national debate over regulation, responsibility, and the limits of civil litigation.

Gustavo Reyes, 36, is part of that debate. Like González, he spent the early years of his career cutting marble and granite before shifting to engineered stone, a quartz-based material that can contain up to 95% silica and generates far more hazardous dust when cut.

In the shop, he said, cutting was done with water to control the dust. But finishing work — sanding and shaping — generated heavy dust. He said he wore disposable respirator masks or a reusable elastomeric respirator with filters. A door was kept open. Fans ran overhead.

When he was diagnosed in 2021, he did not know what silicosis meant. The doctor told him that there was no medication and that he had three to five years to live. He received a lung transplant in 2023.

Asked who he believes is responsible, Reyes answered: “The industries who created the artificial stone, the product.” Manufacturers dispute that characterization. Major companies say engineered stone can be fabricated safely when employers follow OSHA dust controls, including wet cutting, ventilation, and respirator use.

An Old Disease, Reengineered

Silicosis is not new. It was synonymous with mining disasters and sandblasting, most notoriously in the , when hundreds of workers drilling through silica-rich rock in West Virginia in the early 1930s developed acute silicosis after months of unprotected exposure to dust. In 1938, advised that the disease could be prevented if dust controls were conscientiously applied.

What is new is the industry in which it has resurfaced.

Engineered stone, often marketed as “quartz,” is typically composed of crushed quartz bound with resins and pigments. Unlike marble, which contains little crystalline silica, engineered slabs contain very high levels of the substance.

Cutting changes the material.

“When you grind it, when you cut it, you’re pulverizing it,” said Robert Blink, an occupational and environmental medicine specialist who treats patients with advanced silicosis in Chicago and is a member of the Western Occupational and Environmental Medical Association. “You’re weaponizing the silica.”

Power tools fracture the surface into respirable particles small enough to lodge deep in the lungs. Repeated exposure triggers inflammation and fibrosis. Once scarring begins, it doesn’t reverse.

What Happens When You Look for It

In California, physicians say the pattern emerged gradually.

Robert Harrison, an occupational medicine physician at the University of California-San Francisco, helped identify the of engineered stone silicosis cases in California in 2019 after several workers from the same countertop fabrication shop died or were diagnosed with the disease. He described the crisis as “the largest outbreak of silicosis in decades.” What initially appeared as isolated cases of unexplained lung scarring in young men resolved into a recognizable occupational epidemic once work histories were examined.

Jane Fazio, a pulmonologist at UCLA, recalls seeing advanced fibrosis in otherwise healthy workers. “They have families. They were working full-time,” she said. Some experienced respiratory failure within a few years.

When doctors compared work histories, the pattern became unmistakable: Many of the men had worked in small shops cutting and polishing engineered stone countertops.

Sheiphali Gandhi, an occupational and environmental pulmonologist at UCSF, warned that the true burden remains uncertain. “We’re missing cases,” she said. “There’s no national surveillance system for this.”

California designated silicosis a reportable disease . Since 2019, statewide surveillance has identified hundreds of cases linked to engineered stone. The numbers probably underestimate the toll, though makes the illness visible.

Outside California, there is no comparable tracking.

Early Warnings

California was not the first place this happened.

The earliest modern alarm came from Israel. Caesarstone, a company founded on a kibbutz in the late 1980s, helped popularize quartz countertops globally.

Israeli physicians began in young countertop workers as early as 1997.

“We had never seen this before,” said Mordechai Kramer, a retired pulmonologist who previously worked at Rabin Medical Center in Israel. “In classic silicosis, you expect long exposure, decades. Here, it was much shorter.”

Several patients required lung transplantation.

Despite the warning signs, the market continued to expand.

Australia confronted the same pattern in the late 2010s.

Rather than wait for sporadic diagnoses, Australian regulators launched systematic CT-based screening of artificial-stone workers. Disease prevalence was far higher than anticipated.

Ryan Hoy, a respiratory physician and occupational health researcher at Australia’s Monash University, described severe disease in workers with relatively short exposures.

Authorities examined whether wet cutting, ventilation, and respirators could reduce exposure sufficiently. They ultimately concluded that even with controls, fabrication of high-silica engineered stone posed unacceptable risk.

In 2024, Australia prohibited the manufacture, supply, and installation of engineered stone containing high levels of crystalline silica. Manufacturers pivoted toward lower- and zero-silica formulations.

In the United States: Who’s To Blame?

Fabrication in the U.S. continues under OSHA’s silica standard, which relies on exposure limits, wet cutting, ventilation, and respiratory protection. Manufacturers argue that compliance works and that the problem lies with shops that fail to follow the rules.

OSHA first adopted silica limits based on research from mining, quarrying, and foundry work. Although the agency updated the rule , it regulates crystalline silica broadly and does not distinguish between natural stone and high-silica engineered quartz.

The regulatory debate has now spilled into Congress. , introduced in September by Rep. Tom McClintock (R-Calif.), would largely shield manufacturers and distributors of engineered stone from civil lawsuits arising from the manufacture or sale of their products. McClintock’s office did not respond to a request for comment.

The bill was the subject of a January .

Supporters of the measure argue that manufacturers should not be held liable for injuries caused by employers who fail to follow OSHA standards. Opponents warn that removing litigation pressure would eliminate one of the few mechanisms capable of driving product reform if the material itself cannot be safely handled.

Michaels, the former OSHA official, sees the stakes as historical. “Litigation drives change,” he said, pointing to past battles over asbestos and tobacco.

Plaintiffs’ attorneys argue that compliance with the OSHA silica standard does not eliminate risk.

“It’s not a few bad actors,” said Raphael Metzger, a product liability attorney who has filed roughly 200 silicosis-related injury cases and a class action seeking medical monitoring. He said the issue is the product’s composition, not isolated regulatory noncompliance.

James Nevin, a tort attorney representing workers in silicosis cases, framed the congressional debate as a fight over accountability. “When it comes to causation, there’s no question,” he said, arguing that the wave of cases explains why manufacturers are now seeking what he calls “a manufacturer bailout.”

In mid-2025, Caesarstone US introduced its first products containing less than 1% silica. In response to questions, Irene Williams, a spokesperson for Caesarstone, said, “The company is not responding as these are matters of pending litigation.”

The U.S. engineered stone market is dominated by a handful of large brands — including Caesarstone, Spain-based Cosentino, and U.S.-based Cambria — while the volume of slabs imported from Asian manufacturers is growing.

Cosentino, too, is moving to low-silica products: “One third of the portfolio, including most new collections, contain less than 10% of crystalline silica,” said Kamela Kettles, a Cosentino spokesperson. “Cosentino will not be providing additional commentary at this time,” she said.

Commenting on behalf of Cambria, Mark Duffy, a communications consultant for the company, wrote, “Reckless employers are criminally violating the law, exposing workers to deadly working conditions.” He added that engineering and administrative controls, when properly used, are effective in reducing exposures below OSHA limits and said Cambria maintains exposures below the OSHA Action Level in its own facilities.

While Caesarstone and Cosentino are headquartered overseas, Cambria is based in Minnesota. Its chief executive, Marty Davis, has been a major Republican political donor, to President Donald Trump’s election campaigns as well as to other Republican candidates and political action committees, according to federal campaign finance records. Davis has also contributed to the campaign of Rep. Brad Finstad (R-Minn.), a co-sponsor of the legislation. Finstad’s office did not respond to a request for comment.

Nevin, the attorney, said the bill would give manufacturers “free rein” from civil liability.

He also questions whether regulatory enforcement alone can address the problem. Even before the Trump administration’s funding and staffing cuts, “you had a better chance of being struck by lightning than being visited by OSHA,” he said, arguing that inspections are too infrequent to prevent disease in an industry composed largely of small shops.

Breathing on Borrowed Time

For González, the debate arrives after the fact. The dust he inhaled has already reshaped his life.

And Reyes’ transplanted lungs may last years, but not decades. The median survival time for transplanted lungs is about eight years, UCSF’s Gandhi said.

Reyes said he hopes people shopping for countertops understand that buying artificial stone “will harm the worker. The one who cuts it, the one who manufactures it.”

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They wrote that the claims and policy changes in the memo from Vinay Prasad, the head of the FDA’s Center for Biologics Evaluation and Research, pose “a threat to evidence-based vaccine policy and public health security” and break sharply from long-standing scientific norms.

What is unfolding inside the FDA is not a narrow dispute over covid vaccines. It is an attempt, according to critics and vaccine scientists, to rewrite the rules governing the entire U.S. vaccine system — how risks are weighed, how benefits are proved, and how quickly lifesaving shots reach the public. Former agency leaders warn that if these changes take hold, the consequences could be lasting: fewer vaccines, slower updates, weakened public trust, and more preventable outbreaks.

Prasad made clear he sees the moment as corrective. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it,” he wrote, telling employees the agency’s mission, and its “worldview,” would change.

Prasad’s email reopened old arguments about covid vaccines, using what is generally considered weak and misleading science in the peer-reviewed research community. He claimed that FDA staff had found “at least 10” deaths in children that happened “after and because of” covid vaccination, using reports from the .

The VAERS system is notoriously crowdsourced, meaning anyone can contribute, and scientists say it serves only as a clearinghouse for reports. For example, a person could file a report saying that after getting a flu shot, their hair turned purple. Though that report would remain in the database until it was reviewed, it cannot prove the cause of medical events. But Prasad argued that the true number of deaths was likely higher because many cases go unreported.

On Substack, that Prasad used incomplete information and that a Dec. 5 internal FDA memo set the pediatric death toll from covid shots somewhere between zero and seven. Department of Health and Human Services spokesperson Emily Hilliard wrote, “The FDA’s investigation into deaths caused by Covid vaccines is still ongoing and there’s no final count yet of those deaths.”

Prasad also accused the FDA and the Centers for Disease Control and Prevention of downplaying the risk of heart inflammation, called myocarditis, in young men; criticized the agency for approving shots for teenagers; and suggested that school and workplace vaccine mandates may have “harmed more children than we saved,” adding that “we do not know if we saved lives on balance.”

By comparison, died of covid itself since the pandemic began, the CDC reported.

Based on his erroneous and misleading claims about covid vaccines, Prasad proposed a major overhaul of how vaccines are approved. He said the FDA should stop relying on immune markers to establish the efficacy of shots, such as antibody levels, and instead require large placebo-controlled randomized trials that track hospitalizations and deaths before approving most new vaccines.

Many immunologists and vaccine experts say it’s unethical to test vaccines known to be effective against disease with a control group that would receive a placebo, exposing them to infection.

“There is a rock-solid principle in bioethics that it is unethical to test any drug or vaccine against a placebo if it is known to be safe and effective. The reason is that such placebo-controlled trials would effectively deny patients access to a vaccine that could prevent a dangerous infectious disease,” said Lawrence Gostin, a professor of global health law at Georgetown University.

Prasad called the current flu vaccine system an “evidence-based catastrophe,” questioned the approval of vaccines for pregnant women based on immune response alone, and raised concerns about giving multiple vaccines at once. He told staff to rewrite FDA guidelines to match his new “worldview” and said anyone who disagreed with his “core principles” should resign.

The former FDA leaders expressed alarm in the NEJM article. They said Prasad is exploiting public frustration over the federal response to covid to spark doubt about the entire childhood vaccine system, which could undo decades of success in protecting children from deadly diseases.

“This is really different. And it’s really dangerous. And people will be hurt, particularly by the vaccine decisions,” former FDA commissioner Robert Califf said in an interview. He also warned that Prasad’s proposed policies — which he noted echo positions on vaccines held by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist — could shake the entire vaccine market.

“The goal of RFK seems to be to make it impossible for vaccines to be available in the U.S.,” he said. If the proposals advance, he added, “it won’t be a viable business.”

Hilliard pushed back sharply on those concerns, writing: “The American people deserve evidence-based science. Prasad’s email lays out a philosophical framework that points us toward that higher standard. We will soon release documents laying out that framework and data confirming how the COVID vaccine resulted in children’s deaths that previous leadership failed to properly investigate.”

For generations, the childhood vaccine program has depended on clear rules, strong safety systems, and public trust. Experts say Prasad’s ideas, based on claims they argue are not supported by real evidence, could make it much harder to test, approve, and deliver vaccines to families.

Fueling Parental Doubt

Prasad’s memo indicates he considers VAERS reports as proof that vaccines caused children’s deaths. The system, though, is designed to be only an “” for potential safety issues with vaccines that can be investigated further.

“VAERS signals should never be taken as proof of true vaccine risks without careful, confirmatory studies,” said Katherine Yih, an epidemiologist and longtime investigator with the Vaccine Safety Datalink, a CDC program.

Doing so, scientists say, directly feeds public fear at a time when many parents are already unsure whom to trust.

“Causation requires converging evidence, not just one report or coincidence,” said Robert Hopkins, medical director of the National Foundation for Infectious Diseases.

Prasad’s framework, however, treats uncertainty as a reason to halt development entirely.

Experts fear this doubt won’t stay limited to covid vaccines. Once parents start to question the FDA’s honesty, they may begin doubting long-standing vaccines for measles, polio, or whooping cough — shots that have protected children for decades.

“Science must be transparent,” Gostin said. If families believe the FDA is misusing data or silencing experts, confidence in the entire vaccine system can collapse, he said. “There’s a public narrative that people have lost trust in science, but that’s not true. The vast majority want the FDA to make decisions based on the best scientific evidence. Once they believe that the agency is marginalizing scientists and cherry-picking evidence, their trust will plummet.”

Delicate Vaccine Pipeline

Prasad’s new framework will likely make it far harder for companies to produce or update vaccines. The 12 former FDA commissioners warned that requiring clinical trials for all new or updated shots would slow vaccine improvements and leave people unprotected. His plan, they wrote, “would impede the ability to update vaccines in a timely fashion, especially for respiratory viruses.”

For fast-changing viruses like flu and covid, this could be disastrous. There’s simply not enough time to run full clinical trials every time a virus mutates.

There are also major business effects. Vaccine development is costly, and companies may decide the U.S. is no longer worth the risk. If companies slow down or leave the market, families could face shortages, fewer innovations, and fewer protections for their kids.

‘Checks and Balances’

Science depends on open and public debate. Prasad’s memo warned his employees against it. In addition to demanding that FDA staff members who disagree with him resign, he said their disputes should stay private and called leaks “unethical” and “illegal.”

Susan Ellenberg, a former director of the FDA’s Office of Biostatistics and Epidemiology, warned that Prasad risks destroying the process that makes science credible. “If disagreement is treated as disloyalty, you lose the only mechanism that keeps science honest,” she said.

Without strong internal debate, safety reviews become weaker. “You lose the checks and balances that make vaccine safety science credible,” said Kathryn Edwards, a pediatric infectious disease specialist at Vanderbilt University Medical Center who served on the Clinical Immunization Safety Assessment Network during the covid pandemic.

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“I was 18, healthy, in college,” she said. “And suddenly I had a chronic illness I didn’t even know about.”

Born in Florida in 1975, Wang grew up before the hepatitis B vaccine was routinely given to newborns. For years, she assumed she had been infected by her mother, only to discover later that both her parents were negative. “It turns out my grandparents, who cared for me after birth, probably passed it to me,” she said. “That’s how easy this virus spreads — not from some exotic risk factor, just family.”

Today, Wang is the medical director for viral hepatitis programs at RWJBarnabas Health in New Jersey. Her story now sits at the center of a historic turning point in public health.

On Dec. 5, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to end the universal U.S. recommendation for the newborn dose of the hepatitis B vaccine, instead adopting a policy urging individual-based decision-making.

Under the new approach, only infants born to mothers who test positive for hepatitis B will automatically receive a dose of the vaccine and hepatitis B antibodies shortly after birth. For everyone else, if the parents choose to vaccinate, the birth dose can be delayed until 2 months of age.

All the committee members were appointed by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist. In an 8-to-3 vote, the panel decided that since most pregnant women now receive hepatitis B testing, administering the vaccine at birth should be reserved for infants whose mothers test positive. They framed the shift as a way to reduce interventions deemed unnecessary, align vaccination with test results, and give parents more control over timing. Supporters of the decision described it as a move toward parental choice rather than a reflection of changing epidemiology.

But to many clinicians and epidemiologists, the change represents a dangerous rollback that could reverse three decades of progress toward eliminating a disease that still infects as many as 2.4 million Americans and kills tens of thousands each year. They see echoes of the 1980s, when risk-based vaccination left entire generations unprotected, and worry the country is about to repeat that mistake.

Moreover, the panel’s move on hepatitis B — in the face of overwhelming data that shows the birth dose is effective and safe — portends further upheaval for the nation’s childhood vaccine schedule, a cornerstone of public health.

“They’re not just trying to change one vaccine,” said Angela Rasmussen, a virologist and an editor of the scientific journal Vaccine. “They’re trying to dismantle how vaccine policy is made.” 

Department of Health and Human Services spokesperson Emily Hilliard responded: “ACIP reviews all evidence presented and issues recommendations based on evidence and sound judgment to best protect America’s children.”

The authors of a by the Vaccine Integrity Project, which evaluated more than 400 studies and reports, warned in a that delaying the birth dose “would reduce protection for infants and increase the risk of avoidable HBV infections, undermining decades of progress” toward eliminating the hepatitis B virus. The review was led by researchers at the University of Minnesota’s Center for Infectious Disease Research and Policy, which created the Vaccine Integrity Project in response to what it regards as Trump administration actions that “,” and it was vetted by outside experts.

“We fought hard for that universal birth dose because targeted approaches missed too many babies,” Wang said. “We know what happens when you wait.”

What’s unfolding now is not just a technical policy update but a fundamental test of the systems meant to protect the most vulnerable. The debate turns on a few critical questions — whether testing is reliable enough to replace universal safeguards, how infectious hepatitis B truly is, why past strategies failed, and what the CDC’s internal shake-ups mean for vaccine policy writ large.

The Limits of Testing

Hepatitis B testing sits at the center of the new ACIP recommendation, but even the CDC acknowledges that testing alone can’t guarantee protection. Pregnant women may test negative if the virus was acquired late in pregnancy or during the “window period,” before hepatitis B surface antigens become detectable. False negatives happen. No testing system, no matter how well designed, can catch every infection. That’s why universal vaccination was created in the first place.

If a mother’s status is unknown at delivery, hospitals are supposed to give the newborn a hepatitis B vaccine within 12 hours, adding hepatitis B antibodies for premature infants or if the mother later tests positive. But in real clinical settings, these safeguards routinely break down. Results take time. Nurses miss or misread labs. Pharmacies delay deliveries. Documentation gets lost.

“Every step you add increases the chance that something falls through the cracks,” Wang said. “Delaying the vaccine just adds another.”

ACIP’s vote shows how that logic is being challenged.

Some committee members suggested dropping the third hepatitis B shot if antibody levels look high after the second. 

But Brian McMahon, a liver disease specialist who has spent decades treating hepatitis B, told the panelists that the data doesn’t support that idea. “Only maybe 20% to 30%” of infants have an adequate antibody level after the first dose, he said.

“You need two doses to really reach a high level of protection,” he said, with the third shot giving a stronger, longer-lasting response.

He said the overall message coming from the committee seemed designed to “discourage the birth dose.”

“They’re making it more and more difficult,” McMahon said.

In a second vote, ACIP also encouraged parents and clinicians to order post-vaccine serology tests — blood tests that measure protective antibody levels — after the second or third dose. The tests, ACIP said, should be covered by insurance.

More Infectious Than HIV or Hepatitis C

Hepatitis B can survive on toothbrushes, razors, and household surfaces for a week. It spreads not just from mother to child but also through ordinary family contact: shared items, open sores, small blood exposures. In the 1980s, researchers found that about half of infections in American children came not from mothers but from other household members.

That’s why state health departments continue to insist that every newborn be vaccinated within 24 hours of delivery, regardless of maternal status. “Delaying vaccination misses a crucial period of potential exposure,” warned this year. The vaccine, it noted, is 80% to 100% effective when given on time.

The Vaccine Integrity Project report underscores the stakes. Since the universal birth dose was introduced in 1991, pediatric hepatitis B infections in the U.S. have dropped by more than 99%. A estimated that the current schedule has prevented more than 6 million hepatitis B infections and nearly 1 million hospitalizations.

The benefits are lifelong. Infants vaccinated at birth are shielded not just from hepatitis B but also from the liver failure and cancer it can cause decades later. Yet because the disease unfolds slowly, the consequences of policy shifts may not surface for 20 or 30 years.

Trieu Pham, a California physician, doesn’t need to imagine those consequences. Born in Vietnam in 1976, he probably contracted the virus at birth. “If the vaccine had existed then, I wouldn’t have gone through what I did,” he said. Diagnosed in his 20s, he developed cirrhosis by 40. At 47, he was coughing blood from ruptured esophageal veins. Eventually, he required a liver transplant to survive.

“You live with this constant fatigue and fear,” he said. “And the saddest part is it was preventable.”

His three children, all vaccinated within hours of birth, are free of hepatitis B. “That’s the difference a day can make,” Pham said.

A Lesson Already Learned

In 1982, ACIP recommended the new hepatitis B vaccine only for adults at high risk: health care workers, injection drug users, and men who have sex with men. But by the late 1980s, it was clear that risk-based vaccination couldn’t contain transmission. Many newly infected adults didn’t fit any defined risk group. Identifying high-risk people proved imperfect, stigmatizing, and ultimately ineffective.

Meanwhile, infants infected during or shortly after birth had a of developing chronic infection, compared with in adults. Yet public health officials repeated the same targeted strategy, this time with newborns. In 1988, the CDC recommended universal prenatal screening and linked an infant’s vaccination to the mother’s test result, again basing protection on a risk marker instead of vaccinating all infants.

As before, it failed. Many infected mothers weren’t correctly identified. Some were never tested, some were tested too early, and others had results that were misread or never communicated. Too many infants slipped through the cracks, proof that another targeted approach couldn’t reliably protect them.

In 1991, the CDC issued its landmark guidance recommending that all infants, regardless of their mother’s infection status, receive a hepatitis B vaccine at birth, followed by two additional doses in infancy. By 2005, the policy was fully embedded in the routine immunization schedule, then reaffirmed in 2018. This evolution was based on data showing that a universal strategy, rather than a targeted one, was the most effective in preventing infections.

A Matter of Trust

The CDC’s new hepatitis B policy rests on the premise that moving the decision to parents will strengthen trust in the vaccine system. Supporters frame it as an empowerment shift — a way to give families more control.

In 1999, when it was last recommended to postpone the first dose of hepatitis B vaccine for infants born to uninfected mothers, vaccination rates among infants born to those who were infected.

“Opt-in policies sound patient-centered,” Wang said, “but in practice they’re inequitable. They leave behind the very families who need protection most” — the ones most likely to miss prenatal care and testing, have infections that go undetected or arise after testing, or slip through gaps in hospital care, as well as infants who can be exposed and infected by other caregivers and household members.

Those are often immigrant families, including from Asian and Pacific Islander communities in which hepatitis B remains endemic. “We already underdiagnose and undertreat these populations,” Wang said. “This change would deepen that gap.”

The United States is now the only country to abandon a universal hepatitis B birth dose recommendation. Though it will take decades to gather outcomes data, predict that delaying the first dose of hepatitis B vaccine to 2 months of age could result in over 1,400 preventable infections and about 300 cases of liver cancer per year.

“We don’t get to choose what we inherit,” Wang said. “But we do get to choose what we pass on.”

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Kennedy, a longtime anti-vaccine activist before seeking public office, are neurotoxic and tied to autism, asthma, autoimmune disease, and .

But science and medicine advances a different view. Strong recommendations that parents introduce peanut-containing foods to infants early, for instance, have led to in the incidence rate of peanut allergies.

Since taking office, Kennedy has ordered reviews of vaccine ingredients, citing aluminum as a top concern. A discussion of “adjuvants and contaminants” is on the vaccine advisory panel’s .

A that for years has assured the public vaccines do not cause autism was updated Nov. 19 with new language stating that studies have not definitively ruled out a link between vaccines and autism.

He has also targeted scientists who have published studies showing aluminum adjuvants are safe. In August, Kennedy denounced finding no link between aluminum in vaccines and childhood disease, calling it a “” and demanding its retraction. The Annals of Internal Medicine rejected the claim and refused to retract the study.

And, regarding the upcoming advisory panel meeting, HHS spokesperson Emily HIlliard said ACIP “is independently reviewing the full body of evidence on adjuvants and other vaccine components to ensure the highest safety standards.”

The stakes are high because Kennedy’s push to cast doubt on aluminum isn’t just about the ingredient itself. It’s part of a broader strategy to foster uncertainty about vaccine safety and lay the groundwork to challenge the , which drug manufacturers say is essential to ensure a stable market for shots.

But researchers across infectious diseases, immunology, pediatrics, and epidemiology say the data is clear: Aluminum adjuvants are safe.

“Aluminum is the third most common element on the Earth’s surface,” said Paul Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “So we’re all exposed to aluminum all the time. The water that we drink has aluminum in it. The food that we eat has aluminum in it.”

Vaccines add only a tiny amount of aluminum to the body — a combined total of about 8 milligrams — after the schedule of childhood vaccines is complete. Offit said that over the first 18 years of life, people naturally take in about 400 milligrams of aluminum from everyday sources.

“I don’t know why there is so much concern,” said Rajesh Gupta, a former FDA vaccine scientist. “Aluminum gets distributed in the body everywhere. It is ultimately excreted by the kidneys in the urine. So, it is not that aluminum stays in the body.”

How They Work

The aluminum in vaccines isn’t foil or metal. It’s a compound of aluminum salts, such as aluminum hydroxide or aluminum phosphate, that help the vaccine work better.

It’s a bit like zinc in cold tablets: Patients don’t swallow chunks of metal, instead ingesting a zinc salt that dissolves safely in the body.

In vaccines, these aluminum salts give the immune system an extra nudge so it learns to recognize the target germ more effectively.

When injected, the vaccine stays near the injection site and causes mild, short-lived inflammation that summons immune cells. Those cells pick up the vaccine antigen, a harmless piece of a virus or bacterium, and carry it to nearby lymph nodes. There, the adjuvants show it around like a wanted poster so the body can identify and destroy the germ quickly.

Harm HogenEsch, a professor of immunopathology at the Purdue University College of Veterinary Medicine, said that aluminum adjuvants work only when they’re injected in the same spot as the vaccine ingredient they’re meant to boost, to help nearby immune cells learn to recognize the germ. If the two shots are given in different places, he said, “you don’t see that effect.”

In response to Kennedy’s claims, scientists say that anything that acts as an adjuvant can, in principle, also boost an allergic response. But that doesn’t mean aluminum-adjuvanted vaccines are turning children into food-allergic time bombs. Antigens in vaccines such as the hepatitis B surface antigen or HPV proteins are not allergens, and no food proteins are put into vaccines.

Animal Experiments

Animal studies form the basis of Kennedy’s claim that aluminum adjuvants in vaccines can create allergies. In these experiments, scientists deliberately sensitize rats or mice by injecting them with a food protein mixed with aluminum. The aluminum strengthens the immune response, but it does not cause an allergy by itself.

“That’s the basis for a lot of the experimental mouse models, where you inject a food allergen with an aluminum adjuvant to sensitize the mice,” HogenEsch said. “I’m not aware of any food antigen being included in vaccines, and so I don’t really see a way by which this could happen.”

Ross Kedl, a professor of immunology and microbiology at the University of Colorado Anschutz School of Medicine, went further, noting that there is no plausible route for vaccines to create a peanut allergy out of thin air. “Someone would have had to mix peanut proteins in with the actual vaccine prior to injection.”

Stefan H. E. Kaufmann, director emeritus at the Max Planck Institute for Infection Biology in Berlin, said results from mice often don’t match what happens in people, because “mice are much easier to push into allergic reactions than humans.” In other words, what looks dramatic in a rodent study doesn’t automatically apply to human immune systems.

And in this case, it’s “important to distinguish between how aluminum behaves in lab animals versus people,” Kaufmann said.

Human Studies

Beyond animal models and theoretical scenarios, scientists have looked hard for signals of harm in large human datasets.

In 2023, by the Vaccine Safety Datalink, a collaboration coordinated by the CDC, reported a slight increase in asthma among children with higher aluminum exposure before age 2, but the association disappeared in further analyses.

“That paper was roundly criticized,” Offit said. “When they controlled for breastfeeding, the association between asthma and receipt of aluminum-adjuvant-containing vaccines disappeared.”

“It should have never been published,” he said.

Kathy Edwards, professor emerita of pediatrics at Vanderbilt University, said that false signals are common when large databases are mined for dozens of outcomes.

“When you look at a hundred different things, just by the law of percentages, some of those may look like there is a signal,” she said. “The whole RFK Jr. assessment is really prone to cherry-picking,” she said, adding that “there does need to be some kind of basic understanding of statistics for people to interpret this.”

Soon after the 2023 U.S. findings drew attention, scientists at the CDC contacted Anders Hviid, head of epidemiology research at the Statens Serum Institut in Copenhagen, Denmark, to see whether his team could replicate the work.

“It makes perfect sense to try to replicate findings of any kind in different data sources,” Hviid said.

followed 1.2 million children over two decades, using linked national health registries that record every vaccination and diagnosis.

“Our health care system is quite egalitarian. It’s free, and there’s universal access. And everyone is in these nationwide registers,” he said. Their findings: no increased risk of these conditions associated with increasing amounts of aluminum received through the vaccines.

Rare Bumps

Doctors have documented one genuine reaction to aluminum adjuvants: itchy nodules at the injection site, called “pruritic granulomas.” These small bumps are so rare that most allergists and pediatricians will never see a single case.

This reaction “doesn’t lead to something bad, and it really isn’t associated with anything other than that local irritation,” Edwards said.

Researchers believe these bumps represent a localized immune response — meaning only in the area of the injection, not a body-wide allergy — that is very different from the kind of immediate allergic reaction people treat with antihistamines. These include the reactions driven by food or beestings, when histamine, the body’s own alarm signal, floods the system within minutes and causes hives, swelling, or breathing trouble. Kedl said that distinction often gets lost in public debate.

Eliminating Aluminum Adjuvants

For many experts, the real issue is not just whether aluminum is safe but what happens to the entire vaccine program if aluminum adjuvants are stripped out. For many modern vaccines that rely on a single purified protein — such as those for diphtheria and tetanus toxoids, hepatitis B, and HPV — adjuvants are crucial.

Edwards said that simply swapping in a different adjuvant isn’t realistic.

“They’re kind of all built on one another,” she said. Once a vaccine has been proved to work and become the standard of care, new or updated versions are generally no longer tested against a placebo in people who should be getting that vaccine. Instead, they’re tested against the existing product, which means each approval rests on the one before it.

Core childhood vaccines would probably have to be reformulated, and large clinical trials would have to be repeated to prove the new products are safe and effective. Meanwhile, production gaps and shortages would have to be managed, potentially for years, while manufacturers and regulators start over — all while diseases such as whooping cough, hepatitis B, and HPV-related cancers gain more room to spread.

“The aluminum adjuvants have sort of hit the sweet spot in terms of being effective at inducing a robust antibody response that is protective for those vaccines in which they’re being used and being very safe,” HogenEsch said. “It would be quite frankly foolish to try to eliminate them.”

A Century of Safe Use

The DTaP, hepatitis B, and HPV vaccines all contain aluminum adjuvants and have been in use for nearly a century. Large-scale studies show no link between aluminum and systemic allergic disease.

“We have had aluminum adjuvants in vaccines for decades,” Edwards said. “I have grandchildren. My grandchildren have received all of their vaccines. And I do not worry about the safety of them.”

If aluminum is falsely cast as the villain and vaccine uptake falls, experts warn, the consequences will not be theoretical: more measles in schools, more meningitis in college dorms, and more young adults dying of cancers that HPV shots could have prevented.

In their view, the real danger isn’t the trace amounts of a metal that children already encounter every day. It’s rolling back the protection aluminum-adjuvanted vaccines have provided for generations.

That’s the trade-off Offit hopes parents will see. “A choice not to get a vaccine is not a risk-free choice,” he said. “It’s just a choice to take a different risk.”

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The outbreaks are fueled by falling vaccination rates, fading immunity, and delays in public health tracking systems, according to interviews with state and federal health officials. Babies too young to be fully vaccinated are most at risk.

“Pertussis cases increase in a cyclical fashion driven by waning immunity, but the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk,” said Demetre Daskalakis, a former head of the Centers for Disease Control and Prevention’s immunization program, who resigned in August.

Before the first pertussis vaccine became available in the , whooping cough was one of the most common childhood diseases and a in the United States. Today, children get a series of DTaP shots (full-dose version) starting at 2 months old, and teens and adults receive a Tdap booster (lower-dose version) every 10 years. (Both vaccines target diphtheria and tetanus in addition to pertussis.)

Until recently, had received four doses of the DTaP vaccine by age 2, and case rates were controlled. But vaccine coverage has declined since the covid pandemic and increases in state nonmedical exemptions have widened immunity gaps, which is when the proportion of individuals who are immune falls below the level needed to contain spread.

Texas logged in 2024. By October 2025, the state had . National numbers are just as stark: In the first three months of 2025, the U.S. tallied — four times last year’s pace and 25 times 2023’s. Several states are posting their highest case totals in a decade, and outbreaks from Louisiana to South Dakota to Idaho make clear this surge isn’t regional. It’s everywhere.

Key Factors Behind These Numbers

Texas lawmakers recently passed a law that for parents to claim nonmedical exemptions from school vaccine requirements by allowing them to download exemption forms online. These forms now go straight to schools, not health departments, making the exemptions harder to track.

Dallas County Health and Human Services Director Phil Huang said the full impact of the new exemption rule is not yet known because it began this school year, but he expects it will make school-level vaccination rates fall even more.

He’s already noted a dramatic drop in vaccinations. Normally, during back-to-school season, “our whole front downstairs area is packed,” he said. “We did not see that this year.”

Huang believes fear of immigration enforcement may be keeping at least some families, especially Hispanic families, from getting vaccinated. Dallas County is about 40% Hispanic. “We think that a lot of them are deterred by the ICE activity,” he said, referring to Immigration and Customs Enforcement.

More complications: These vaccines protect against severe disease, but protection against infection fades over time, as is the case with the covid and influenza vaccines.

The U.S. switched in the 1990s from whole-cell pertussis vaccines to “acellular” ones, which cause fewer side effects but do not last as long. Because more adults today than in the past received the acellular vaccine as children, many have lost immunity over time and may unknowingly pass the infection to babies.

Babies Face the Greatest Risk

Whooping cough is especially dangerous for infants under a year old. Some stop breathing during coughing fits. Many need hospital care, about of whom develop pneumonia, and about 1% of whom die.

Because of this high risk, the CDC urges pregnant women to get a . This allows the mother’s antibodies to pass to the baby before birth.

Health officials once promoted “cocooning,” vaccinating all family members and caregivers around the baby, but that strategy was hard to carry out in real life and is . Vaccination of pregnant women and babies at 2 months of age remains the strongest protection.

Better Testing Finds More Cases

Modern is also than in the past. Many clinics now routinely use this lab-based technology to test for several respiratory infections at once, including pertussis. Ten years ago, these panels were uncommon.

CDC experts say this explains part of the rise in case counts. But the large number of infant hospitalizations and the size of state outbreaks show that true transmission has also increased.

A Growing Worry: Antibiotic Resistance

Doctors normally treat pertussis with , such as erythromycin, azithromycin, and clarithromycin. These drugs work best early in the illness and help stop spread. Another drug, trimethoprim-sulfamethoxazole, is an option for some older infants and adults.

But has become common abroad, especially in China, and recent reports show resistance rising in Peru. In the U.S., resistant cases have been rare.

CDC officials warn that resistant strains could spread more easily through international travel. Because treatment options are limited, especially for very young infants, health workers are watching this closely.

Huang said macrolide resistance has not been seen yet in Dallas County. But he is aware of the national concern.

What Happens Now

The resurgence of whooping cough has no single cause. Instead, several problems are occurring at once: falling vaccine coverage, only of pregnant women receiving Tdap, waning immunity, improved testing, and early signs of antibiotic resistance.

Health experts say solutions must match the problem’s complexity.

Across the nation, clinicians are being told to have a higher suspicion for pertussis when they see patients, especially children or caregivers of newborns with a persistent cough or coughing fits followed by vomiting. Babies who stop breathing or turn blue need immediate care.

Obstetricians are encouraged to discuss Tdap during every pregnancy. Pediatricians and family doctors are urged to check booster status for teens and adults.

Several states have issued health advisories over the past two years, including , which has in both 2024 and 2025 urging clinicians to stay vigilant.

Huang said Dallas County is trying to rebuild public health outreach programs that were cut when covid funding ended. But staffing is still limited. “There’s just a lot of different things that are making it more difficult,” he said.

He also noted that Dallas County now receives immunization registry data only once a month, rather than daily, making it harder to track vaccine coverage. “We don’t have that yet. … It’s not real time,” he said.

Protecting the Youngest

As the holiday season approaches, experts urge families with newborns to take extra care:

• Ensure infants and children are up to date with their childhood vaccines and that everyone in the family is up to date with their vaccines for influenza, covid, and RSV, or respiratory syncytial virus.
• Keep sick visitors away.
• Seek care quickly if an infant has a cough or pauses breathing.

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The massive study, which was conducted in Sweden and tracked more than 2 million teenage girls and women under age 50 for more than a decade, found that hormonal contraception remains safe overall, but also found small differences in breast cancer risk based on the hormones used in the formulation. In addition, the researchers observed a small, short-term rise in breast cancer diagnoses among current or recent users. Those findings are consistent with prior large studies, including a and a .

It was published online Oct. 30 in .

Doctors say these study results won’t change how they advise patients and that women should not stop using their birth control.

Still, TikTok is flooded with factually incomplete warnings that contraceptives cause cancer and are as dangerous as smoking. Reproductive health advocates warn that studies like this online and be reduced to a single alarming number.

Case in point: reported that women who had used hormonal birth control had about a 24% higher rate of breast cancer than women who hadn’t. But because breast cancer is still uncommon in younger women, that works out to an increase from roughly 54 to 67 breast cancer cases per 100,000 women per year — about 13 extra cases per 100,000 women, or about one extra case per 7,800 users of hormonal contraceptives per year.

Co-authors Åsa Johansson and Fatemeh Hadizadeh, epidemiologists at , said the rise is modest and short-term, with risk highest during current use and fading within five to 10 years after stopping.

Rachel Fey — interim co-CEO of Power to Decide, a group whose mission is to provide accurate information on sexual health and contraceptive methods — said that kind of nuance is exactly what tends to disappear on social media. “I get really angry at this because it’s designed to scare people like me away from birth control, which has made my life so much better in so many ways,” she said. “It’s really frustrating … especially when it’s given without context. And then in this era of social media, it can just take off without anybody who knows what they’re talking about providing that context.”

The researchers also found the risk was slightly higher with certain progestins such as desogestrel — found in combined oral contraceptives like Cyred EQ, Reclipsen, Azurette, and Pimtrea — but did not increase with others, such as medroxyprogesterone acetate injections, sold under the brand name Depo‑Provera.

How To Interpret the Findings

Some experts say the results should be viewed with care because the study counted both invasive breast cancers and early, noninvasive lesions known as in situ tumors, growths that may never become life-threatening. Including these precancerous cases could make the overall risk of clinically significant disease appear higher than it is.

“A substantial proportion of the ‘cases’ would never have progressed to invasive breast cancer,” said Lina S. Mørch, a senior researcher and team leader at the Danish Cancer Institute. Mørch was not associated with the Swedish study. She added that experts should wait for more data separating early-stage and advanced cancers before making new rules or warnings about specific hormones.

The Doctor-Patient Conversation

Even as scientists debate how to interpret the finer points of the data, physicians emphasize that for most patients, the study reinforces what they already discuss in the exam room: that hormonal birth control is broadly safe, and decisions should be tailored to each woman’s needs and values.

Katharine White, chief of Obstetrics and Gynecology at Boston Medical Center, said this study won’t change how she talks to her patients.

“When counseling patients about their contraceptive options, I focus on their past experiences with birth control, their medical history, and what’s important to them about their birth control method and pregnancy planning (if applicable),” White wrote in an email. “Side effects and risks of methods are already a key part of my counseling about both hormonal and non-hormonal methods.”

Other doctors noted there are other contraceptive options.

Eleanor Bimla Schwarz, chief of General Internal Medicine at Zuckerberg San Francisco General Hospital, said, “For those who prefer hormone-free contraception, the copper IUD offers safe, convenient, highly effective contraception for over a decade after placement, and is rapidly reversible when pregnancy is desired,” referring to a type of long-acting intrauterine device.

Mary Rosser, director of Integrated Women’s Health at Columbia University Irving Medical Center, said this was a large, high-quality study that looked at many types of hormones over many years. But she added that doctors shouldn’t change their advice yet.

Johansson and Hadizadeh stressed that the results should guide shared decision-making, not cause alarm. “It may be reasonable to consider formulations associated with lower observed risk in our data,” they said. They noted that products containing medroxyprogesterone acetate, drospirenone, or levonorgestrel were linked to lower risk, while long-term use of desogestrel-only contraceptives might be best avoided when other options fit.

Keeping the Risk in Perspective

Hormonal birth control provides many health benefits beyond pregnancy prevention. It can lighten heavy periods, ease pain from endometriosis, and lower the risk of ovarian and uterine cancers for years after stopping. Mørch noted that even small risks are worth discussing but said decisions should be guided by women’s “values and preferences.”

White said it’s important to see the big picture. “The risk of an unintended pregnancy is 85% for people who do not use contraception—so any risks of birth control need to be weighed against the risk of an unexpected pregnancy,” she wrote.

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The increase in risk was small for any one child, but because millions of women were pregnant during the pandemic, even a small increase matters. The study doesn’t prove that covid infection during pregnancy causes autism or other brain conditions in the fetus, but it suggests that infections and inflammation during pregnancy can affect how a baby’s brain grows, something scientists have seen before with other illnesses. It’s a reason to help pregnant women avoid covid and to keep a close eye on children who were exposed in the womb.

What the Study Found

Researchers at Massachusetts General Hospital examined medical records from more than 18,000 mothers and their children born from March 2020 through May 2021, before vaccines were widely available to pregnant women. Because everyone giving birth during that period was tested for covid, the team could clearly see which pregnancies were exposed to the virus causing it.

About 5% of those mothers had covid while pregnant. Their children were modestly more likely to be diagnosed with a neurodevelopmental condition by age 3 than those whose mothers weren’t infected, even after accounting for differences in maternal age, race, insurance status, and preterm birth.

The link appeared strongest among boys and when infection occurred in their mother’s third trimester. Still, most children in both groups showed typical development.

“This was a very clean group to follow,” said Andrea Edlow, a maternal-fetal medicine specialist at Mass General and one of the study’s authors. “Because of universal testing early in the pandemic, we knew who had covid and who didn’t.”

Independent authorities say covid, which causes a powerful immune response in some people, fits the biological pattern seen with other infections in pregnancy. Alan Brown, a professor of psychiatry and epidemiology at Columbia University who studies maternal infection and brain development and was not involved in this research, explained, “Covid would be a very strong candidate for it to happen because the amount of inflammation is very extreme.”

How Might Infection Affect Brain Development?

Scientists are still piecing together how various infections during pregnancy can affect fetal development. Severe illness can cause inflammation that or can , which carries its own risks.

“There’s a long history of evidence showing that maternal infection can slightly raise the risk for many neurodevelopmental disorders,” said Roy Perlis, the vice chair for research in psychiatry at Massachusetts General Hospital and co-author of the new study.

Edlow’s lab is investigating how infection and inflammation may interfere with brain development. In a healthy brain, immune cells help shape developing neural circuits by trimming away extra or unnecessary connections, a process known as “synaptic pruning,” which sculpts the brain’s wiring. When a mother’s immune system is activated by infection, inflammatory molecules can reach the fetal brain and alter the pruning process.

support Edlow’s hypothesis. When scientists trigger inflammation in pregnant mice, their offspring often show changes in how brain cells grow and connect, changes that can alter learning and behavior.

Why Late Pregnancy and Why Boys?

In Edlow and Perlis’ study, the link between covid and developmental delays was strongest when infection occurred late in pregnancy, during the third trimester. That’s also when the fetal brain is growing most rapidly, forming and refining millions of neural connections.

“When we think of organ development, we think earlier in pregnancy, but the brain is an exception in this regard, where there’s a massive amount of brain development in the third trimester. And that continues after birth,” Perlis said. “It is entirely plausible that the third trimester is a period of vulnerability specifically for brain development.”

But not all researchers agree that the third trimester is uniquely vulnerable. Brian Lee, a professor of epidemiology at Drexel University, cautioned that because most mothers in the study were tested at delivery, there were simply more late-pregnancy infections to analyze. “That gives the study more power to find a difference in the third trimester,” he said. “It doesn’t prove earlier infections aren’t important.”

The study also found stronger effects in boys. That pattern is familiar: Boys are generally more likely than girls to have speech or motor delays and to be diagnosed with autism. Researchers suspect that male fetuses may be more susceptible to stress and inflammation, though the biology isn’t fully understood.

What the Study Can and Can’t Show

Edlow and Perlis are careful to say the study shows an association, not proof that covid infection in pregnancy causes developmental problems. could explain the correlation.

Mothers who get sick with covid may have other health issues, such as obesity, diabetes, or mental health conditions, that increase the risk of developmental delays in children. “Persons with are much more likely to get covid. Women with mental disorders are much ,” Lee said. “Mothers with are also at higher risk of having children with neurodevelopmental problems.”

Lee’s research has shown that , suggesting that shared genetics or environment, rather than the infection itself, could be at play. That’s why experts say much larger, longer studies are needed to understand the extent of any risk from the infection.

Edlow, Perlis, and their team plan to follow the children in their study as they grow older to see whether early differences persist or fade. They’re also studying how inflammation during pregnancy affects the placenta and fetal brain, and how to counteract these effects.

What About Vaccination?

Because this study followed pregnancies from early in the pandemic, it doesn’t answer whether vaccination changes the risk. But other research offers reassurance.

A large national study in Scotland between children whose mothers were vaccinated and those who weren’t. Another study in the U.S. : no link between prenatal covid vaccination and developmental delays through 18 months. Both align with decades of data showing that vaccination during pregnancy is safe for both the mother and the baby.

“Vaccination is a short spike … your immune system revs up, then it goes back to normal,” Edlow said. “Covid [infection] is much more prolonged, unpredictable, and people can get … a dysregulated immune phenomenon that really doesn’t exist in vaccine responses.”

What This Means for Parents and Clinicians

Since late 2020, there’s been widespread confusion and misinformation about the safety of covid vaccination during pregnancy. Some women have hesitated to get vaccinated out of fear it might harm their baby. But the evidence since then has been clear: Covid vaccines are safe in pregnancy. The American College of Obstetricians and Gynecologists to protect .

Experts say the broader lesson is that pregnancy is a period of vulnerability, and prevention matters, not only , but other infections as well.

Janet Currie, a professor of economics at Yale University, said these risks remain “underappreciated,” despite decades of evidence. “Even though the flu vaccine is recommended for pregnant women, very few pregnant women get it,” she said. “Physicians seem to be reluctant to vaccinate pregnant women.”

As Gil Mor, scientific director of the C.S. Mott Center for Human Growth and Development at Wayne State University in Detroit, put it, “Protecting the mother is protecting the long-term health of the offspring. … The best intervention is vaccination.”

A Century-Old Echo

The idea that what happens in the womb can shape life after birth took root with studies of famine, like the Dutch “Hunger Winter” in the final months of World War II. In 1944 and 1945, as German forces blockaded the western Netherlands, rations fell to just a few hundred calories a day. Thousands died of starvation, and women pregnant during that period gave birth to babies who later faced higher risks of , , and . The episode became a cornerstone of the “” idea, that deprivation or stress in pregnancy can have lifelong effects.

The broadened that idea to infection. Babies exposed to influenza in utero later showed small but lasting , a sign that illness during pregnancy could affect brain development. Researchers in , , , , and found similar consequences. Some argued that those findings reflected the disruptions of World War I, not the flu itself. But , including those from the and , have strengthened the case for a biological effect, reinforcing that the infection itself, not wartime upheaval, was the key driver.

“It isn’t simply influenza that can alter fetal neurodevelopment,” Kristina Adams Waldorf, a professor of obstetrics and gynecology at the University of Washington, explained. “Many types of infections … in the mother can be transmitted as a signal to the fetus, which can alter its brain development.”

A century later, the same question has returned with covid: Could infection during pregnancy subtly shape how children grow and learn? The new Massachusetts General Hospital study offers an early look at an answer.

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According to new data from the Centers for Disease Control and Prevention, there were 3.6 million births in 2025, a from 2024. The fertility rate dropped to 53.1 births per 1,000 women ages 15 to 44, down 23% since 2007.

The Trump administration has said it wants to reverse this trend. President Donald Trump has called for “a new baby boom,” and aides have solicited proposals from outside advocates and policy groups ranging from baby bonuses to expanded fertility planning. The administration is also the federal government’s only dedicated family planning program: Title X.

For more than five decades, Title X has been geared — with bipartisan support — toward giving low-income women access to contraception, screening for sexually transmitted infections, and reproductive health care regardless of ability to pay. At its peak, the served more than 5 million patients a year. Title X clients have reported the program as their sole source of health care in a given year.

In early April, the Department of Health and Human Services for Title X grants for fiscal year 2027, which begins in October. The 67-page Notice of Funding Opportunity included only one mention of contraception — describing it as overprescribed, associated with negative side effects, and part of a broader “overreliance on pharmaceutical and surgical treatments.”

The grant notification reshapes the program from its traditional public health intervention efforts to focus on fertility, family formation, and reproductive health conditions such as polycystic ovary syndrome, endometriosis, low testosterone, and erectile dysfunction.

While Title X will continue to help women “achieve healthy pregnancies,” the grant document does not explicitly reference preventing unintended pregnancies — a long-standing goal of the program.

Jessica Marcella, who oversaw the Title X program as a senior official in the Biden administration, said the new funding notice amounts to a wholesale redefinition of family planning.

“What we’re seeing is trying to use our nation’s family planning as a Trojan horse for an entirely different agenda,” Marcella said, noting that Trump eliminating Title X altogether.

Birth Rates and Fertility Trends

The administration is overhauling Title X in the context of declining birth rates. But researchers who study fertility trends say the decline is driven by forces that have little to do with contraception access and that restricting it is unlikely to produce more births.

The most important factors, according to demographer Alison Gemmill of UCLA, are timing-related. “Childbearing is increasingly delayed as part of a broader shift toward later adult milestones, including stable employment, leaving the parental home, and marriage,” she said.

Most American women, she said, still complete their childbearing years with an average of two children, suggesting a shift toward smaller families rather than an increase in childlessness.

“Having children has become more contingent and more planned,” she said.

Much of the decline since 2007 reflects women postponing births rather than forgoing them.

“The average number of babies women are having in their whole lives has not fallen. It’s still more than 2.0 for women aged 45,” said Philip Cohen, a professor of sociology at the University of Maryland.

Phillip Levine, an economist at Wellesley College, said the birth rate has declined due to shifts in how women approach work, leisure, and parenting. “Efforts to reverse those patterns would be more successful if they can make childbearing more desirable, not make it harder to prevent a pregnancy,” he said.

Asked about the role of contraception in reducing maternal mortality and how the new funding notice advances that goal, HHS press secretary Emily Hilliard said in a statement: “Applicants for the 2027 Title X funding cycle will be expected to align with the administration’s stated priorities in the released Notice of Funding Opportunity. HHS, under the leadership of Secretary Kennedy and President Trump, will continue to support policies that support life, family well-being, maternal health, and address the chronic disease epidemic. HHS remains focused on improving maternal outcomes and ensuring programs are administered consistent with applicable law.”

Marcella said the new funding notice is the product of two converging forces: the Make America Healthy Again movement, with its skepticism of conventional medicine and emphasis on lifestyle and behavioral interventions, and a pronatalist agenda that seeks to boost birth rates by steering policy toward family formation.

The document’s language reflects both: It repeatedly invokes “optimal health” and “chronic disease” while sidelining the contraceptive services that have defined Title X for .

Clare Coleman, president and CEO of the National Family Planning & Reproductive Health Association, which represents health professionals focused on family planning, said tying Title X to birth-rate goals replaces individual decision-making with a government objective. The program “is designed to facilitate access to family planning services, including services to achieve and prevent pregnancy,” she said.

Title X’s New Focus

The administration’s changes have been welcomed on the right.

Emma Waters, a senior policy analyst at the conservative Heritage Foundation, who has advocated for what she calls “restorative reproductive medicine,” said the new funding notice reflects overdue attention to neglected aspects of women’s health.

“I was particularly encouraged to see language that spoke to the delays in diagnosis for conditions like endometriosis, the need for women to practically understand how their cycle and fertility works, and to ensure that real root-cause was promoted through Title X,” Waters said.

She described the notice as an expansion, not a narrowing, of the program’s mission: “I see this iteration of Title X as the fulfillment of its purpose. The goal was never just ‘more contraception’ but a wholesale empowerment of women to govern their own fertility.”

Waters also argued that untreated reproductive health problems may contribute to lower birth rates.

“One of the interesting aspects of this debate, and one that is often overlooked, is the degree to which painful and unaddressed reproductive health problems may suppress or create ambivalence around a woman’s desire to have kids,” she said, pointing to endometriosis.

An estimated of reproductive age have endometriosis, and of those, . Scientifically speaking, the relationship is an association, not a proven cause. Women aren’t screened for endometriosis if they don’t have symptoms, and the condition may be more prevalent than is recognized. Researchers still do not fully understand why some women with endometriosis struggle to conceive while others do not, and treating the disease does not reliably restore fertility.

Infertility rates in the U.S., meanwhile, have not risen. An found them essentially flat between 1995 and 2019, even as the national birth rate fell sharply — a divergence that points away from untreated reproductive disease as an explanation.

Meanwhile, in February, the American College of Obstetricians and Gynecologists enabling earlier diagnosis of endometriosis without surgery, a step toward addressing the delays Waters described. But the first-line treatment ACOG recommends is hormonal therapy, part of the same category of care the funding notice dismisses as part of an “overreliance on pharmaceutical and surgical treatments.” The effect, reproductive health experts say, is a contradiction: Title X is now prioritizing diagnosis of endometriosis while deemphasizing the drugs clinicians use to treat it.

Treatments that have been shown to improve fertility in women with endometriosis, such as laparoscopic surgery and in vitro fertilization, are . When President Richard Nixon signed Title X into law in 1970, as a way to expand access to family planning services — helping women determine the number and spacing of their children by making contraception and related preventive care more widely available, particularly for those who could not afford it. , not Title X, is the primary government health insurance program covering health care for low-income women, but, like many commercial insurance plans, it .

Many of the conditions prioritized in the funding notice deserve attention, said Liz Romer, a former chief clinical adviser for the HHS Office of Population Affairs who helped write updated guidelines for the family planning program. But they fall outside the scope of what Title X can realistically provide.

“There’s not even enough funding to support the core premise of contraception,” Romer said. “And so, if you want to expand Title X funding, you can expand the scope, but you can’t move away from the foundation.”

The emergence of an anticontraception ideology within federal health policy is striking, she said, given how broadly the public supports access to birth control. Eight in 10 women of childbearing age surveyed by KFF in 2024 reported having in the previous 12 months.

Laura Lindberg, director of the Concentration in Sexual and Reproductive Health, Rights and Justice at Rutgers School of Public Health, said, “If contraception is sidelined in Title X, it won’t just change language on paper but will show up as fewer options and more barriers for patients.” Funding could move away from providers who offer a full range of contraceptive care, she added, “toward organizations that are ideologically opposed to contraception and don’t deliver the same standard of health care services.”

The Stakes Are High

The United States already has one of the highest maternal mortality rates among wealthy nations — as of 2024. According to the CDC, in the U.S. may be preventable. Medical research shows that pregnancy carries substantially higher risks of blood clots, stroke, and cardiovascular complications than hormonal contraception.

And since the Supreme Court’s Dobbs decision in 2022, which overturned the constitutional right to abortion established by Roe v. Wade, access to abortion has been significantly curtailed across much of the country. While national abortion numbers have risen, driven largely by telehealth and interstate access, research shows births have increased in states with bans, with an estimated , disproportionately among young women and women of color.

Dr. Christine Dehlendorf, who directs the Person-Centered Reproductive Health Program at the University of California-San Francisco, said “there is absolutely no evidence for any positive outcome of restricting access to contraception.” Restrictions would instead increase demand for abortion care and make it harder for women to prevent high-risk pregnancies.

Since Trump returned to office, more than a dozen Title X grantees have had their grants frozen, forcing some health centers to stop delivering services, lay off staff, or close. During the first Trump administration, regulatory changes led to a decline in Title X participation from more than . The program grew slowly under the Biden administration, reaching about 3 million clients, before the current round of disruptions began.

The second Trump administration’s overhaul of the program, Marcella said, “directly undermines the public health intent of our nation’s family planning program and will potentially exclude millions of individuals from getting the care they have relied on for decades. It’s bad policy.”

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According to a recording obtained by �������ýҕ�l Health News, Bhattacharya at one point suggested to CDC staff that Trump could name a new leader for the agency as soon as Thursday. “But if not, I don’t think much will change,” he said.

Though his official position as acting director was set to expire Wednesday, Bhattacharya will continue to lead the agency until the top spot is filled. Meanwhile, news outlets including and reported that the administration was postponing filling the permanent director job amid the challenges of gaining Senate confirmation and other political pressures.

Bhattacharya opened the meeting by acknowledging over the past year. Workers faced waves of job losses, and a gunman attacked the CDC’s Atlanta campus in August, killing a police officer and causing significant property damage. “I want to acknowledge very honestly that I know that it has been such a difficult year for the CDC and for every single one of you here,” Bhattacharya said.

He said the agency has begun to fill its leadership gaps. During his first meeting with the agency’s top leaders, he said, “I noticed almost every single one of them is acting.”

“We’ve made progress in filling key roles across the agency,” he said. “Leadership stability is essential to delivering our mission.”

The aim, he said, is to leave the agency in “a solid, secure place” so it can do its work “without so much of the turmoil that we’ve seen the last year.”

Bhattacharya invited questions from the CDC staffers, who repeatedly asked about staffing losses, morale, and their job security, as well as Trump’s decision to withdraw from the World Health Organization.

“The politics of WHO withdrawal are above my pay grade,” Bhattacharya said. “What I do know is that without the CDC, the world will be in much worse health.”

Workforce Concerns

One employee told Bhattacharya the agency had lost a “huge amount” of “internal capacity and expertise in the past year” and it “continues to be very challenging for staff to do their jobs,” adding that “certain conditions are a bit demoralizing.”

The CDC can “function without leaders,” another speaker said. “We function without directors. And this entire team will make CDC run without you if you’re not here.”

Schedule F, an effort to reclassify certain federal employees in policy-related roles and reduce their civil service protections, drew some of the strongest statements from the staff. While it’s not fully implemented, the policy could make it easier for Trump to fire thousands of federal workers.

“What’s scaring the hell out of us right now is Schedule F,” an employee said. “We are terrified that ‘at will’ means you’re gone, you’re not here, you’re fired.”

“The Schedule F fight’s above my level,” Bhattacharya replied. He said his focus is on making sure the “work is supported.”

He said the agency should seek to “depoliticize what we do fundamentally” so that “every American sees us as working for their benefit.”

“When I say ‘depoliticize,’ I don’t mean you can’t say the hard or talk about the hard things,” he added. “I mean that you’re free to talk about the hard things without fear that you’re gonna be retaliated against.”

On hiring and operations, he pointed to ongoing efforts but acknowledged delays. The Department of Health and Human Services, which oversees the CDC, is “moving at the speed of bureaucracy,” he said, adding that he’s trying his best. “We have to move past the last year, and I think we now have an opportunity really to do that.”

Vaccine Policy

On vaccines, Bhattacharya said one of the first things he did in his role as acting CDC director was to record a video “strongly encouraging parents to vaccinate their kids from measles.”

He said rebuilding trust requires engagement. That means working with communities without denigrating them, and respecting how “they think and their values,” he said.

Bhattacharya said he would like the NIH and CDC to coordinate more, particularly on HIV prevention. He described his approach as “an implementation science strategy so that we can use these two pieces of the HIV tool kit to actually end the HIV pandemic.”

The search for a permanent CDC director is being led by HHS officials on behalf of the White House and Health and Human Services Secretary Robert F. Kennedy Jr.

Bhattacharya said he’s friends with Kennedy and called “the caricature of him that I’ve seen in the press” unfair. Kennedy “really does have a deep desire to make America healthy,” he said.

For now, Bhattacharya said, he expects to stay in place at the CDC, as “either acting director or acting in the capacity of the director, whatever the heck that means.”

He joked about the ambiguity: “It’s like an Office episode, you know?”

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Raven’s case reveals a little-known gap in the U.S. donation system: There is no clear, nationally binding way to opt out — or to ensure a later “no” overrides an earlier “yes” in a different state.

This gap, along with a range of other issues related to the organ procurement system, has become a point of bipartisan congressional concern. Late last year, the House Ways and Means subcommittee on oversight examining what members described as shortcomings, including alleged consent failures.

The panel’s scrutiny of organ procurement organizations, or OPOs, and their consent practices is a first step toward a more meaningful accountability plan that could help maintain trust across the system, according to some committee staff members.

The trust in our organ procurement and transplant system “has been eroded,” said Rep. Terri Sewell of Alabama, the panel’s senior Democrat, calling for stronger transparency and oversight to rebuild public confidence.

“Respect for autonomy — our ability to make our own decisions (self-determination) — allows for both ‘yes’ and ‘no’ decisions and for changing one’s mind,” Margaret McLean, a bioethicist at Santa Clara University, said in an email.

“Medical decision-making is not well served in a context of ambiguity,” she said.

And if a donor revokes consent, she added, “revocation by that person should carry the same ethical and procedural weight as the initial authorization, perhaps more.”

Raven Kinser Changed Her Mind

Raven was 25 when she died. Her parents, Jeff and Jaime Kinser, were at home in Michigan when they received the phone call that shattered their world. They drove through the night to the Newport News hospital, where they learned Raven’s disposition had been referred to LifeNet Health, the region’s federally designated OPO. LifeNet a failing OPO by the Centers for Medicare & Medicaid Services, meaning it doesn’t meet the government’s standards for how well it finds donors and recovers usable organs for transplant compared with other organizations.

Under federal law, hospitals are required to refer deaths and imminent deaths to OPOs, which take responsibility for donation-related decisions and discussions.

OPOs occupy a hybrid position in the health care system, as private nonprofit entities that hold exclusive, federally authorized contracts to recover organs within defined regions. They are regulated by CMS and overseen by the Health Resources and Services Administration, but that oversight occurs primarily through certification standards, performance metrics, and periodic audits rather than routine public disclosure requirements. With donor registries largely managed at the state level and no unified federal reporting requirement for removals, comprehensive national data on revocations is elusive.

OPOs are meant to separate bedside care from organ procurement decisions — to help prevent conflicts of interest and preserve the trust that decisions about life-sustaining treatment are made solely in the dying patient’s interest. But the , leaving families unsure who is in control if and when conflicts arise.

The Kinsers, for instance, felt their daughter would not have wanted to go through the donation process, but, at the time, had no evidence. Jaime remembers telling her husband that Raven would have been mad at them for letting it happen. In an effort to stop it, Jaime inquired about whether she would be asked to sign a consent form. But a LifeNet staff member told her that wasn’t an option because donation was Raven’s “living will,” Jaime said. Meanwhile, Raven’s parents said, her personal effects, including her Virginia driver’s license, which bore no donor designation, had not yet been turned over to the family, leaving them no meaningful way to challenge LifeNet’s determination in real time.

Jaime struggled with this outcome, even mentioning in Raven’s obituary that she was an organ donor. “How would you try to make peace with something that you felt was so wrong but had no proof?” Jaime said.

Two months passed before the Kinsers gained possession of the license, which, as they had expected, showed that Raven had not opted to be an organ donor.

According to the Kinsers, LifeNet staff told them that Raven’s status as a registered donor was established by her designation on her older Michigan license.

An emailed statement attributed to Douglas Wilson, LifeNet executive vice president, said the OPO follows federal law on organ donation, the , and queries applicable state donor registries, relying on time stamps and governing law to determine the , legally valid expression of intent. Under that framework, a prior donor authorization remains enforceable unless a valid revocation is recorded in the regional OPO’s donor registry.

Because of privacy laws, Wilson said, LifeNet could not comment on the specifics of any individual case.

Raven Kinser’s choice not to be a donor when she applied for a Virginia license in July 2024 was not reflected in the registry LifeNet consulted, according to her parents, who said that is what the organization told them. According to Lara Malbon, executive director of Donate Life Virginia, which manages the state’s organ donor registry, if someone changes their donor status while completing a Virginia driver’s license or ID transaction, “that information is sent to our registry, and the registry is updated daily to reflect those changes.” Malbon also said Virginia’s registry includes only people who have “affirmatively said ‘yes’ to becoming an organ, eye, and tissue donor, and it retains records solely for those who have made that decision.”

The Kinsers said they were never told why Raven’s Virginia DMV record was insufficient, or how an older yes from Michigan could outweigh a newer no in Virginia.

In December, the Kinsers filed a complaint with the Health Resources and Services Administration, urging federal regulators to investigate LifeNet’s actions and require OPOs to provide families with documented proof of the donor’s current status at the time of referral. They also called for OPOs, which operate as federally designated regional monopolies but are structured as private nonprofits, to be made subject to public records laws.

When Opting Out Doesn’t Stick

Such confusion is not unique to the Kinser family. It is a consequence of the organ donation consent process in the United States.

“I have also wondered that: why there’s not just one” registry for organ donation, Jaime said. If you go to get a firearm, you have one federal registry, she said.

Here’s how the system works: Americans typically register their organ donation intentions when they apply for driver’s licenses through state DMVs, and that decision remains governed largely by state law. That has led to 50 different sets of rules and very little federal regulation of what has become an in the U.S.

In some states, a donor checkbox is a binding legal document. In other states, the same choice may have different rules about when it takes effect, what it covers, and how it can be revoked.

Those differences can be big. State rules determine whether a person’s “gift” is limited to transplantation or also includes research and education. They determine whether the donation authorization includes tissue. And they can determine what counts as a valid revocation and when it is legally recognized.

Because of the system’s fragmentation, though, signals can cross when someone changes their mind, like Raven; it’s not always reflected from one state system to another.

Under state versions of the Uniform Anatomical Gift Act, a donor’s most recent legally valid expression of intent is meant to control.

“Personal autonomy is paramount to everything,” said Adam Schiavi, a neurointensivist who studies end-of-life decision-making. “If I say I want to be a donor, or if I say I don’t want to be a donor, that has to take precedence over everything else.”

But states differ in how revocation must be recorded and which registry is considered authoritative if someone has lived in more than one state. Those inconsistencies can create uncertainty when records conflict across jurisdictions.

“It has to be the most recent expression, not the most recent yes,” Schiavi said.

In Michigan, a change to someone’s donor status is reflected immediately in the secretary of state’s system, but only affirmative “yes” registrations appear in the registry. Removal information remains in internal motor vehicle records. In Virginia, the state registry includes only those who have affirmatively said “yes,” retaining records solely of donors, creating potential gaps if someone believes a DMV change alone is sufficient.

Elsewhere, processes and volumes differ sharply. New Mexico updates driver records in real time but does not transmit status changes to its donor registry. Instead, donor services receive restricted search access. The state logged nearly 15,000 removals in late 2021 and almost 30,000 in 2022. Florida, which maintains formal removal records through weekly DMV data files, reported 356,161 removals in 2020, more than 1.5 million in 2023, and over 1.2 million in 2025. Kentucky processed 847,371 donor registrations from 2020 to 2025, but only 16,043 icon removals, with registry withdrawal handled separately. In 2025, more than 570,000 Texans opted into the registry, while over 31,000 individuals requested removal.

According to a federal official who asked not to be identified for fear of professional repercussions, OPOs have been highly effective at lobbying states to broaden the definition of consent and authorization — shaping how those terms are applied, whether those statuses must be renewed, and how easy or difficult it is for someone to opt out.

In subsequent correspondence with federal officials, the Kinsers have urged reforms to prevent OPOs from relying on older registry entries when a more recent state DMV record exists, and they have called for criminal penalties in cases in which consent is knowingly misrepresented. Federal regulators have not indicated whether such proposals are under consideration.

Congress Takes a Closer Look

Ethicists have long cautioned that consent must be more than a checkbox and must remain grounded in respect for the donor-patient. In an October on organ transplantation, the American College of Physicians emphasized that clinicians’ primary duty is to the patient in their care, and that maintaining trust requires transparency and safeguards to prevent conflicts of interest from blurring that “bright line.”

Advocates say those steps leave unresolved the core problem raised by the Kinser family: the lack of a clear, legally binding way for people to say “no” and for that decision to follow them across state lines.

The said it “supports strengthening donor registries and enhancing registry interoperability to ensure that an individual’s documented donation decision is honored.” But OPOs have also argued that current policies protect donation as a legally enforceable gift and prevent families from overriding a loved one’s “yes” in the midst of grief. They argue that stronger, more durable consent helps reduce missed donations and saves lives.

Congress and federal regulators are considering changes to the nation’s organ donation system, including how consent is recorded and what should happen when a donor changes their mind.

Sen. Ron Wyden (D-Ore.) last year to create new federal standards for patient safety, transparency, and oversight of organ transplants, including a formal authorization for hospital or OPO staff to pause harvesting if there is any “clinical sign of life.”

HHS press secretary Emily Hilliard said the agency is “committed to holding organ procurement organizations accountable” and to “restoring integrity and transparency” to organ donation policy, calling reforms essential to informed consent and protecting donor rights. CMS issued related March 11, but it does not address the problems highlighted by the Kinsers’ case.

Critics of the organ transplant system say it is difficult for families to obtain documentation or independently verify how consent determinations were made in disputed cases.

HRSA has launched a sweeping modernization of the Organ Procurement and Transplantation Network, the national system that oversees organ allocation and transplant policy. Federal officials have described the overhaul as the most significant restructuring of the transplant system in decades, aimed at breaking up a long-standing contractor monopoly, strengthening patient safety oversight, and replacing aging technology infrastructure.

Central to that effort is modernizing the OPTN’s data systems: improving interoperability, audit trails, and transparency in how decisions are documented and reviewed. A more modern federal data architecture could make it easier to trace which registry was queried, what time stamp controlled, and how a consent determination was reached in disputed donations that span multiple states. But the modernization effort would not change the underlying state-by-state legal framework for donor authorization and what counts as a valid “no.”

Meanwhile, Donate Life America, a national nonprofit that supports state donor registries, also runs the , a central database that allows people to sign up as organ donors directly. Unlike many DMV systems, the national registry lets people log in at any time to view, update, or remove their registration and print proof of their decision. The group is also starting a project to let participating states send registrations directly into the national system, creating one place to track donor sign-ups and removals across state lines.

Each of the proposals comes with trade-offs, and both advocates and OPOs have raised concerns about how they would work in practice.

“Just doing a dump truck dump of information is not going to do much unless you really apply it through checking and auditing,” said Arthur Caplan, a professor of bioethics at New York University’s Grossman School of Medicine. “It could be like the IRS. They don’t have to audit everybody. Just do a spot audit once in a while.”

The Kinsers aren’t opposed to organ donation itself. They celebrated Raven’s donation in her obituary, and in their complaint to federal regulators, they wrote, “We are NOT anti-organ donation, and we will never take away the gift of life our oldest daughter gave to others. However, that was not LifeNet’s choice to make.”

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Engineered quartz countertops have surged in popularity in the home renovation market, with industry analysts estimating the global engineered stone market at . It’s continuing to expand as quartz surfaces replace natural stone in kitchens in the United States and worldwide.

When González was working, the dust that rose from his saw didn’t look extraordinary. It settled on his clothes, in his hair, across the shop floor. In a small countertop fabrication shop, he cut marble and granite before shifting to engineered stone after the 2008-09 recession, when demand for cheaper quartz countertops surged.

But the crystalline silica released while the engineered stone was cut and polished also settled into his lungs, scarring them beyond repair. What began as breathlessness hardened into silicosis, an irreversible disease that stiffens the lungs until even ordinary movement becomes effort.

A lung transplant was his path forward. The procedure can extend survival, but it redraws the boundaries of a life: anti-rejection drugs every day, constant monitoring, vulnerability to infection, the knowledge that breathing depends on the fragile acceptance of another person’s donated organ.

González, who was diagnosed with silicosis in 2023, is not alone in dealing with a disease that once was associated with miners at the end of long careers. It’s now prevalent among the much younger, often Hispanic men who work in this industry, physicians and public health officials say.

In the United States, cases are appearing in countertop fabrication shops from California to Texas, Florida, and the Northeast. Because silicosis is not a nationally reportable disease and surveillance varies by state, no comprehensive national count exists. But clinicians who treat occupational lung disease say the number of workers — often men in their 30s and 40s — diagnosed after cutting engineered stone has risen sharply over the past decade.

As of , California had identified 519 confirmed cases of engineered-stone-associated silicosis and 29 deaths since 2019. The median age at diagnosis is 46; at death, 49.

Doctors don’t debate whether working with engineered stone can scar lungs.

Manufacturers argue, though, that proper ventilation, wet cutting, and respirators can make fabrication safe. Workers, physicians, and plaintiffs’ attorneys counter that a material composed almost entirely of crystalline silica may be impossible to handle safely at scale.

“This is comparable to the tobacco industry saying cigarettes are safe,” said epidemiologist David Michaels, an assistant labor secretary under President Barack Obama who led the Occupational Safety and Health Administration.

More than 370 lawsuits have been filed by workers who say engineered stone manufacturers failed to warn employees about the risks or sold a product that cannot be fabricated safely. At the same time, members of Congress are that would largely shield manufacturers from liability in those cases, turning a workplace health crisis into a national debate over regulation, responsibility, and the limits of civil litigation.

Gustavo Reyes, 36, is part of that debate. Like González, he spent the early years of his career cutting marble and granite before shifting to engineered stone, a quartz-based material that can contain up to 95% silica and generates far more hazardous dust when cut.

In the shop, he said, cutting was done with water to control the dust. But finishing work — sanding and shaping — generated heavy dust. He said he wore disposable respirator masks or a reusable elastomeric respirator with filters. A door was kept open. Fans ran overhead.

When he was diagnosed in 2021, he did not know what silicosis meant. The doctor told him that there was no medication and that he had three to five years to live. He received a lung transplant in 2023.

Asked who he believes is responsible, Reyes answered: “The industries who created the artificial stone, the product.” Manufacturers dispute that characterization. Major companies say engineered stone can be fabricated safely when employers follow OSHA dust controls, including wet cutting, ventilation, and respirator use.

An Old Disease, Reengineered

Silicosis is not new. It was synonymous with mining disasters and sandblasting, most notoriously in the , when hundreds of workers drilling through silica-rich rock in West Virginia in the early 1930s developed acute silicosis after months of unprotected exposure to dust. In 1938, advised that the disease could be prevented if dust controls were conscientiously applied.

What is new is the industry in which it has resurfaced.

Engineered stone, often marketed as “quartz,” is typically composed of crushed quartz bound with resins and pigments. Unlike marble, which contains little crystalline silica, engineered slabs contain very high levels of the substance.

Cutting changes the material.

“When you grind it, when you cut it, you’re pulverizing it,” said Robert Blink, an occupational and environmental medicine specialist who treats patients with advanced silicosis in Chicago and is a member of the Western Occupational and Environmental Medical Association. “You’re weaponizing the silica.”

Power tools fracture the surface into respirable particles small enough to lodge deep in the lungs. Repeated exposure triggers inflammation and fibrosis. Once scarring begins, it doesn’t reverse.

What Happens When You Look for It

In California, physicians say the pattern emerged gradually.

Robert Harrison, an occupational medicine physician at the University of California-San Francisco, helped identify the of engineered stone silicosis cases in California in 2019 after several workers from the same countertop fabrication shop died or were diagnosed with the disease. He described the crisis as “the largest outbreak of silicosis in decades.” What initially appeared as isolated cases of unexplained lung scarring in young men resolved into a recognizable occupational epidemic once work histories were examined.

Jane Fazio, a pulmonologist at UCLA, recalls seeing advanced fibrosis in otherwise healthy workers. “They have families. They were working full-time,” she said. Some experienced respiratory failure within a few years.

When doctors compared work histories, the pattern became unmistakable: Many of the men had worked in small shops cutting and polishing engineered stone countertops.

Sheiphali Gandhi, an occupational and environmental pulmonologist at UCSF, warned that the true burden remains uncertain. “We’re missing cases,” she said. “There’s no national surveillance system for this.”

California designated silicosis a reportable disease . Since 2019, statewide surveillance has identified hundreds of cases linked to engineered stone. The numbers probably underestimate the toll, though makes the illness visible.

Outside California, there is no comparable tracking.

Early Warnings

California was not the first place this happened.

The earliest modern alarm came from Israel. Caesarstone, a company founded on a kibbutz in the late 1980s, helped popularize quartz countertops globally.

Israeli physicians began in young countertop workers as early as 1997.

“We had never seen this before,” said Mordechai Kramer, a retired pulmonologist who previously worked at Rabin Medical Center in Israel. “In classic silicosis, you expect long exposure, decades. Here, it was much shorter.”

Several patients required lung transplantation.

Despite the warning signs, the market continued to expand.

Australia confronted the same pattern in the late 2010s.

Rather than wait for sporadic diagnoses, Australian regulators launched systematic CT-based screening of artificial-stone workers. Disease prevalence was far higher than anticipated.

Ryan Hoy, a respiratory physician and occupational health researcher at Australia’s Monash University, described severe disease in workers with relatively short exposures.

Authorities examined whether wet cutting, ventilation, and respirators could reduce exposure sufficiently. They ultimately concluded that even with controls, fabrication of high-silica engineered stone posed unacceptable risk.

In 2024, Australia prohibited the manufacture, supply, and installation of engineered stone containing high levels of crystalline silica. Manufacturers pivoted toward lower- and zero-silica formulations.

In the United States: Who’s To Blame?

Fabrication in the U.S. continues under OSHA’s silica standard, which relies on exposure limits, wet cutting, ventilation, and respiratory protection. Manufacturers argue that compliance works and that the problem lies with shops that fail to follow the rules.

OSHA first adopted silica limits based on research from mining, quarrying, and foundry work. Although the agency updated the rule , it regulates crystalline silica broadly and does not distinguish between natural stone and high-silica engineered quartz.

The regulatory debate has now spilled into Congress. , introduced in September by Rep. Tom McClintock (R-Calif.), would largely shield manufacturers and distributors of engineered stone from civil lawsuits arising from the manufacture or sale of their products. McClintock’s office did not respond to a request for comment.

The bill was the subject of a January .

Supporters of the measure argue that manufacturers should not be held liable for injuries caused by employers who fail to follow OSHA standards. Opponents warn that removing litigation pressure would eliminate one of the few mechanisms capable of driving product reform if the material itself cannot be safely handled.

Michaels, the former OSHA official, sees the stakes as historical. “Litigation drives change,” he said, pointing to past battles over asbestos and tobacco.

Plaintiffs’ attorneys argue that compliance with the OSHA silica standard does not eliminate risk.

“It’s not a few bad actors,” said Raphael Metzger, a product liability attorney who has filed roughly 200 silicosis-related injury cases and a class action seeking medical monitoring. He said the issue is the product’s composition, not isolated regulatory noncompliance.

James Nevin, a tort attorney representing workers in silicosis cases, framed the congressional debate as a fight over accountability. “When it comes to causation, there’s no question,” he said, arguing that the wave of cases explains why manufacturers are now seeking what he calls “a manufacturer bailout.”

In mid-2025, Caesarstone US introduced its first products containing less than 1% silica. In response to questions, Irene Williams, a spokesperson for Caesarstone, said, “The company is not responding as these are matters of pending litigation.”

The U.S. engineered stone market is dominated by a handful of large brands — including Caesarstone, Spain-based Cosentino, and U.S.-based Cambria — while the volume of slabs imported from Asian manufacturers is growing.

Cosentino, too, is moving to low-silica products: “One third of the portfolio, including most new collections, contain less than 10% of crystalline silica,” said Kamela Kettles, a Cosentino spokesperson. “Cosentino will not be providing additional commentary at this time,” she said.

Commenting on behalf of Cambria, Mark Duffy, a communications consultant for the company, wrote, “Reckless employers are criminally violating the law, exposing workers to deadly working conditions.” He added that engineering and administrative controls, when properly used, are effective in reducing exposures below OSHA limits and said Cambria maintains exposures below the OSHA Action Level in its own facilities.

While Caesarstone and Cosentino are headquartered overseas, Cambria is based in Minnesota. Its chief executive, Marty Davis, has been a major Republican political donor, to President Donald Trump’s election campaigns as well as to other Republican candidates and political action committees, according to federal campaign finance records. Davis has also contributed to the campaign of Rep. Brad Finstad (R-Minn.), a co-sponsor of the legislation. Finstad’s office did not respond to a request for comment.

Nevin, the attorney, said the bill would give manufacturers “free rein” from civil liability.

He also questions whether regulatory enforcement alone can address the problem. Even before the Trump administration’s funding and staffing cuts, “you had a better chance of being struck by lightning than being visited by OSHA,” he said, arguing that inspections are too infrequent to prevent disease in an industry composed largely of small shops.

Breathing on Borrowed Time

For González, the debate arrives after the fact. The dust he inhaled has already reshaped his life.

And Reyes’ transplanted lungs may last years, but not decades. The median survival time for transplanted lungs is about eight years, UCSF’s Gandhi said.

Reyes said he hopes people shopping for countertops understand that buying artificial stone “will harm the worker. The one who cuts it, the one who manufactures it.”

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They wrote that the claims and policy changes in the memo from Vinay Prasad, the head of the FDA’s Center for Biologics Evaluation and Research, pose “a threat to evidence-based vaccine policy and public health security” and break sharply from long-standing scientific norms.

What is unfolding inside the FDA is not a narrow dispute over covid vaccines. It is an attempt, according to critics and vaccine scientists, to rewrite the rules governing the entire U.S. vaccine system — how risks are weighed, how benefits are proved, and how quickly lifesaving shots reach the public. Former agency leaders warn that if these changes take hold, the consequences could be lasting: fewer vaccines, slower updates, weakened public trust, and more preventable outbreaks.

Prasad made clear he sees the moment as corrective. “Never again will the US FDA commissioner have to himself find deaths in children for staff to identify it,” he wrote, telling employees the agency’s mission, and its “worldview,” would change.

Prasad’s email reopened old arguments about covid vaccines, using what is generally considered weak and misleading science in the peer-reviewed research community. He claimed that FDA staff had found “at least 10” deaths in children that happened “after and because of” covid vaccination, using reports from the .

The VAERS system is notoriously crowdsourced, meaning anyone can contribute, and scientists say it serves only as a clearinghouse for reports. For example, a person could file a report saying that after getting a flu shot, their hair turned purple. Though that report would remain in the database until it was reviewed, it cannot prove the cause of medical events. But Prasad argued that the true number of deaths was likely higher because many cases go unreported.

On Substack, that Prasad used incomplete information and that a Dec. 5 internal FDA memo set the pediatric death toll from covid shots somewhere between zero and seven. Department of Health and Human Services spokesperson Emily Hilliard wrote, “The FDA’s investigation into deaths caused by Covid vaccines is still ongoing and there’s no final count yet of those deaths.”

Prasad also accused the FDA and the Centers for Disease Control and Prevention of downplaying the risk of heart inflammation, called myocarditis, in young men; criticized the agency for approving shots for teenagers; and suggested that school and workplace vaccine mandates may have “harmed more children than we saved,” adding that “we do not know if we saved lives on balance.”

By comparison, died of covid itself since the pandemic began, the CDC reported.

Based on his erroneous and misleading claims about covid vaccines, Prasad proposed a major overhaul of how vaccines are approved. He said the FDA should stop relying on immune markers to establish the efficacy of shots, such as antibody levels, and instead require large placebo-controlled randomized trials that track hospitalizations and deaths before approving most new vaccines.

Many immunologists and vaccine experts say it’s unethical to test vaccines known to be effective against disease with a control group that would receive a placebo, exposing them to infection.

“There is a rock-solid principle in bioethics that it is unethical to test any drug or vaccine against a placebo if it is known to be safe and effective. The reason is that such placebo-controlled trials would effectively deny patients access to a vaccine that could prevent a dangerous infectious disease,” said Lawrence Gostin, a professor of global health law at Georgetown University.

Prasad called the current flu vaccine system an “evidence-based catastrophe,” questioned the approval of vaccines for pregnant women based on immune response alone, and raised concerns about giving multiple vaccines at once. He told staff to rewrite FDA guidelines to match his new “worldview” and said anyone who disagreed with his “core principles” should resign.

The former FDA leaders expressed alarm in the NEJM article. They said Prasad is exploiting public frustration over the federal response to covid to spark doubt about the entire childhood vaccine system, which could undo decades of success in protecting children from deadly diseases.

“This is really different. And it’s really dangerous. And people will be hurt, particularly by the vaccine decisions,” former FDA commissioner Robert Califf said in an interview. He also warned that Prasad’s proposed policies — which he noted echo positions on vaccines held by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist — could shake the entire vaccine market.

“The goal of RFK seems to be to make it impossible for vaccines to be available in the U.S.,” he said. If the proposals advance, he added, “it won’t be a viable business.”

Hilliard pushed back sharply on those concerns, writing: “The American people deserve evidence-based science. Prasad’s email lays out a philosophical framework that points us toward that higher standard. We will soon release documents laying out that framework and data confirming how the COVID vaccine resulted in children’s deaths that previous leadership failed to properly investigate.”

For generations, the childhood vaccine program has depended on clear rules, strong safety systems, and public trust. Experts say Prasad’s ideas, based on claims they argue are not supported by real evidence, could make it much harder to test, approve, and deliver vaccines to families.

Fueling Parental Doubt

Prasad’s memo indicates he considers VAERS reports as proof that vaccines caused children’s deaths. The system, though, is designed to be only an “” for potential safety issues with vaccines that can be investigated further.

“VAERS signals should never be taken as proof of true vaccine risks without careful, confirmatory studies,” said Katherine Yih, an epidemiologist and longtime investigator with the Vaccine Safety Datalink, a CDC program.

Doing so, scientists say, directly feeds public fear at a time when many parents are already unsure whom to trust.

“Causation requires converging evidence, not just one report or coincidence,” said Robert Hopkins, medical director of the National Foundation for Infectious Diseases.

Prasad’s framework, however, treats uncertainty as a reason to halt development entirely.

Experts fear this doubt won’t stay limited to covid vaccines. Once parents start to question the FDA’s honesty, they may begin doubting long-standing vaccines for measles, polio, or whooping cough — shots that have protected children for decades.

“Science must be transparent,” Gostin said. If families believe the FDA is misusing data or silencing experts, confidence in the entire vaccine system can collapse, he said. “There’s a public narrative that people have lost trust in science, but that’s not true. The vast majority want the FDA to make decisions based on the best scientific evidence. Once they believe that the agency is marginalizing scientists and cherry-picking evidence, their trust will plummet.”

Delicate Vaccine Pipeline

Prasad’s new framework will likely make it far harder for companies to produce or update vaccines. The 12 former FDA commissioners warned that requiring clinical trials for all new or updated shots would slow vaccine improvements and leave people unprotected. His plan, they wrote, “would impede the ability to update vaccines in a timely fashion, especially for respiratory viruses.”

For fast-changing viruses like flu and covid, this could be disastrous. There’s simply not enough time to run full clinical trials every time a virus mutates.

There are also major business effects. Vaccine development is costly, and companies may decide the U.S. is no longer worth the risk. If companies slow down or leave the market, families could face shortages, fewer innovations, and fewer protections for their kids.

‘Checks and Balances’

Science depends on open and public debate. Prasad’s memo warned his employees against it. In addition to demanding that FDA staff members who disagree with him resign, he said their disputes should stay private and called leaks “unethical” and “illegal.”

Susan Ellenberg, a former director of the FDA’s Office of Biostatistics and Epidemiology, warned that Prasad risks destroying the process that makes science credible. “If disagreement is treated as disloyalty, you lose the only mechanism that keeps science honest,” she said.

Without strong internal debate, safety reviews become weaker. “You lose the checks and balances that make vaccine safety science credible,” said Kathryn Edwards, a pediatric infectious disease specialist at Vanderbilt University Medical Center who served on the Clinical Immunization Safety Assessment Network during the covid pandemic.

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“I was 18, healthy, in college,” she said. “And suddenly I had a chronic illness I didn’t even know about.”

Born in Florida in 1975, Wang grew up before the hepatitis B vaccine was routinely given to newborns. For years, she assumed she had been infected by her mother, only to discover later that both her parents were negative. “It turns out my grandparents, who cared for me after birth, probably passed it to me,” she said. “That’s how easy this virus spreads — not from some exotic risk factor, just family.”

Today, Wang is the medical director for viral hepatitis programs at RWJBarnabas Health in New Jersey. Her story now sits at the center of a historic turning point in public health.

On Dec. 5, the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices voted to end the universal U.S. recommendation for the newborn dose of the hepatitis B vaccine, instead adopting a policy urging individual-based decision-making.

Under the new approach, only infants born to mothers who test positive for hepatitis B will automatically receive a dose of the vaccine and hepatitis B antibodies shortly after birth. For everyone else, if the parents choose to vaccinate, the birth dose can be delayed until 2 months of age.

All the committee members were appointed by Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine activist. In an 8-to-3 vote, the panel decided that since most pregnant women now receive hepatitis B testing, administering the vaccine at birth should be reserved for infants whose mothers test positive. They framed the shift as a way to reduce interventions deemed unnecessary, align vaccination with test results, and give parents more control over timing. Supporters of the decision described it as a move toward parental choice rather than a reflection of changing epidemiology.

But to many clinicians and epidemiologists, the change represents a dangerous rollback that could reverse three decades of progress toward eliminating a disease that still infects as many as 2.4 million Americans and kills tens of thousands each year. They see echoes of the 1980s, when risk-based vaccination left entire generations unprotected, and worry the country is about to repeat that mistake.

Moreover, the panel’s move on hepatitis B — in the face of overwhelming data that shows the birth dose is effective and safe — portends further upheaval for the nation’s childhood vaccine schedule, a cornerstone of public health.

“They’re not just trying to change one vaccine,” said Angela Rasmussen, a virologist and an editor of the scientific journal Vaccine. “They’re trying to dismantle how vaccine policy is made.” 

Department of Health and Human Services spokesperson Emily Hilliard responded: “ACIP reviews all evidence presented and issues recommendations based on evidence and sound judgment to best protect America’s children.”

The authors of a by the Vaccine Integrity Project, which evaluated more than 400 studies and reports, warned in a that delaying the birth dose “would reduce protection for infants and increase the risk of avoidable HBV infections, undermining decades of progress” toward eliminating the hepatitis B virus. The review was led by researchers at the University of Minnesota’s Center for Infectious Disease Research and Policy, which created the Vaccine Integrity Project in response to what it regards as Trump administration actions that “,” and it was vetted by outside experts.

“We fought hard for that universal birth dose because targeted approaches missed too many babies,” Wang said. “We know what happens when you wait.”

What’s unfolding now is not just a technical policy update but a fundamental test of the systems meant to protect the most vulnerable. The debate turns on a few critical questions — whether testing is reliable enough to replace universal safeguards, how infectious hepatitis B truly is, why past strategies failed, and what the CDC’s internal shake-ups mean for vaccine policy writ large.

The Limits of Testing

Hepatitis B testing sits at the center of the new ACIP recommendation, but even the CDC acknowledges that testing alone can’t guarantee protection. Pregnant women may test negative if the virus was acquired late in pregnancy or during the “window period,” before hepatitis B surface antigens become detectable. False negatives happen. No testing system, no matter how well designed, can catch every infection. That’s why universal vaccination was created in the first place.

If a mother’s status is unknown at delivery, hospitals are supposed to give the newborn a hepatitis B vaccine within 12 hours, adding hepatitis B antibodies for premature infants or if the mother later tests positive. But in real clinical settings, these safeguards routinely break down. Results take time. Nurses miss or misread labs. Pharmacies delay deliveries. Documentation gets lost.

“Every step you add increases the chance that something falls through the cracks,” Wang said. “Delaying the vaccine just adds another.”

ACIP’s vote shows how that logic is being challenged.

Some committee members suggested dropping the third hepatitis B shot if antibody levels look high after the second. 

But Brian McMahon, a liver disease specialist who has spent decades treating hepatitis B, told the panelists that the data doesn’t support that idea. “Only maybe 20% to 30%” of infants have an adequate antibody level after the first dose, he said.

“You need two doses to really reach a high level of protection,” he said, with the third shot giving a stronger, longer-lasting response.

He said the overall message coming from the committee seemed designed to “discourage the birth dose.”

“They’re making it more and more difficult,” McMahon said.

In a second vote, ACIP also encouraged parents and clinicians to order post-vaccine serology tests — blood tests that measure protective antibody levels — after the second or third dose. The tests, ACIP said, should be covered by insurance.

More Infectious Than HIV or Hepatitis C

Hepatitis B can survive on toothbrushes, razors, and household surfaces for a week. It spreads not just from mother to child but also through ordinary family contact: shared items, open sores, small blood exposures. In the 1980s, researchers found that about half of infections in American children came not from mothers but from other household members.

That’s why state health departments continue to insist that every newborn be vaccinated within 24 hours of delivery, regardless of maternal status. “Delaying vaccination misses a crucial period of potential exposure,” warned this year. The vaccine, it noted, is 80% to 100% effective when given on time.

The Vaccine Integrity Project report underscores the stakes. Since the universal birth dose was introduced in 1991, pediatric hepatitis B infections in the U.S. have dropped by more than 99%. A estimated that the current schedule has prevented more than 6 million hepatitis B infections and nearly 1 million hospitalizations.

The benefits are lifelong. Infants vaccinated at birth are shielded not just from hepatitis B but also from the liver failure and cancer it can cause decades later. Yet because the disease unfolds slowly, the consequences of policy shifts may not surface for 20 or 30 years.

Trieu Pham, a California physician, doesn’t need to imagine those consequences. Born in Vietnam in 1976, he probably contracted the virus at birth. “If the vaccine had existed then, I wouldn’t have gone through what I did,” he said. Diagnosed in his 20s, he developed cirrhosis by 40. At 47, he was coughing blood from ruptured esophageal veins. Eventually, he required a liver transplant to survive.

“You live with this constant fatigue and fear,” he said. “And the saddest part is it was preventable.”

His three children, all vaccinated within hours of birth, are free of hepatitis B. “That’s the difference a day can make,” Pham said.

A Lesson Already Learned

In 1982, ACIP recommended the new hepatitis B vaccine only for adults at high risk: health care workers, injection drug users, and men who have sex with men. But by the late 1980s, it was clear that risk-based vaccination couldn’t contain transmission. Many newly infected adults didn’t fit any defined risk group. Identifying high-risk people proved imperfect, stigmatizing, and ultimately ineffective.

Meanwhile, infants infected during or shortly after birth had a of developing chronic infection, compared with in adults. Yet public health officials repeated the same targeted strategy, this time with newborns. In 1988, the CDC recommended universal prenatal screening and linked an infant’s vaccination to the mother’s test result, again basing protection on a risk marker instead of vaccinating all infants.

As before, it failed. Many infected mothers weren’t correctly identified. Some were never tested, some were tested too early, and others had results that were misread or never communicated. Too many infants slipped through the cracks, proof that another targeted approach couldn’t reliably protect them.

In 1991, the CDC issued its landmark guidance recommending that all infants, regardless of their mother’s infection status, receive a hepatitis B vaccine at birth, followed by two additional doses in infancy. By 2005, the policy was fully embedded in the routine immunization schedule, then reaffirmed in 2018. This evolution was based on data showing that a universal strategy, rather than a targeted one, was the most effective in preventing infections.

A Matter of Trust

The CDC’s new hepatitis B policy rests on the premise that moving the decision to parents will strengthen trust in the vaccine system. Supporters frame it as an empowerment shift — a way to give families more control.

In 1999, when it was last recommended to postpone the first dose of hepatitis B vaccine for infants born to uninfected mothers, vaccination rates among infants born to those who were infected.

“Opt-in policies sound patient-centered,” Wang said, “but in practice they’re inequitable. They leave behind the very families who need protection most” — the ones most likely to miss prenatal care and testing, have infections that go undetected or arise after testing, or slip through gaps in hospital care, as well as infants who can be exposed and infected by other caregivers and household members.

Those are often immigrant families, including from Asian and Pacific Islander communities in which hepatitis B remains endemic. “We already underdiagnose and undertreat these populations,” Wang said. “This change would deepen that gap.”

The United States is now the only country to abandon a universal hepatitis B birth dose recommendation. Though it will take decades to gather outcomes data, predict that delaying the first dose of hepatitis B vaccine to 2 months of age could result in over 1,400 preventable infections and about 300 cases of liver cancer per year.

“We don’t get to choose what we inherit,” Wang said. “But we do get to choose what we pass on.”

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Kennedy, a longtime anti-vaccine activist before seeking public office, are neurotoxic and tied to autism, asthma, autoimmune disease, and .

But science and medicine advances a different view. Strong recommendations that parents introduce peanut-containing foods to infants early, for instance, have led to in the incidence rate of peanut allergies.

Since taking office, Kennedy has ordered reviews of vaccine ingredients, citing aluminum as a top concern. A discussion of “adjuvants and contaminants” is on the vaccine advisory panel’s .

A that for years has assured the public vaccines do not cause autism was updated Nov. 19 with new language stating that studies have not definitively ruled out a link between vaccines and autism.

He has also targeted scientists who have published studies showing aluminum adjuvants are safe. In August, Kennedy denounced finding no link between aluminum in vaccines and childhood disease, calling it a “” and demanding its retraction. The Annals of Internal Medicine rejected the claim and refused to retract the study.

And, regarding the upcoming advisory panel meeting, HHS spokesperson Emily HIlliard said ACIP “is independently reviewing the full body of evidence on adjuvants and other vaccine components to ensure the highest safety standards.”

The stakes are high because Kennedy’s push to cast doubt on aluminum isn’t just about the ingredient itself. It’s part of a broader strategy to foster uncertainty about vaccine safety and lay the groundwork to challenge the , which drug manufacturers say is essential to ensure a stable market for shots.

But researchers across infectious diseases, immunology, pediatrics, and epidemiology say the data is clear: Aluminum adjuvants are safe.

“Aluminum is the third most common element on the Earth’s surface,” said Paul Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia. “So we’re all exposed to aluminum all the time. The water that we drink has aluminum in it. The food that we eat has aluminum in it.”

Vaccines add only a tiny amount of aluminum to the body — a combined total of about 8 milligrams — after the schedule of childhood vaccines is complete. Offit said that over the first 18 years of life, people naturally take in about 400 milligrams of aluminum from everyday sources.

“I don’t know why there is so much concern,” said Rajesh Gupta, a former FDA vaccine scientist. “Aluminum gets distributed in the body everywhere. It is ultimately excreted by the kidneys in the urine. So, it is not that aluminum stays in the body.”

How They Work

The aluminum in vaccines isn’t foil or metal. It’s a compound of aluminum salts, such as aluminum hydroxide or aluminum phosphate, that help the vaccine work better.

It’s a bit like zinc in cold tablets: Patients don’t swallow chunks of metal, instead ingesting a zinc salt that dissolves safely in the body.

In vaccines, these aluminum salts give the immune system an extra nudge so it learns to recognize the target germ more effectively.

When injected, the vaccine stays near the injection site and causes mild, short-lived inflammation that summons immune cells. Those cells pick up the vaccine antigen, a harmless piece of a virus or bacterium, and carry it to nearby lymph nodes. There, the adjuvants show it around like a wanted poster so the body can identify and destroy the germ quickly.

Harm HogenEsch, a professor of immunopathology at the Purdue University College of Veterinary Medicine, said that aluminum adjuvants work only when they’re injected in the same spot as the vaccine ingredient they’re meant to boost, to help nearby immune cells learn to recognize the germ. If the two shots are given in different places, he said, “you don’t see that effect.”

In response to Kennedy’s claims, scientists say that anything that acts as an adjuvant can, in principle, also boost an allergic response. But that doesn’t mean aluminum-adjuvanted vaccines are turning children into food-allergic time bombs. Antigens in vaccines such as the hepatitis B surface antigen or HPV proteins are not allergens, and no food proteins are put into vaccines.

Animal Experiments

Animal studies form the basis of Kennedy’s claim that aluminum adjuvants in vaccines can create allergies. In these experiments, scientists deliberately sensitize rats or mice by injecting them with a food protein mixed with aluminum. The aluminum strengthens the immune response, but it does not cause an allergy by itself.

“That’s the basis for a lot of the experimental mouse models, where you inject a food allergen with an aluminum adjuvant to sensitize the mice,” HogenEsch said. “I’m not aware of any food antigen being included in vaccines, and so I don’t really see a way by which this could happen.”

Ross Kedl, a professor of immunology and microbiology at the University of Colorado Anschutz School of Medicine, went further, noting that there is no plausible route for vaccines to create a peanut allergy out of thin air. “Someone would have had to mix peanut proteins in with the actual vaccine prior to injection.”

Stefan H. E. Kaufmann, director emeritus at the Max Planck Institute for Infection Biology in Berlin, said results from mice often don’t match what happens in people, because “mice are much easier to push into allergic reactions than humans.” In other words, what looks dramatic in a rodent study doesn’t automatically apply to human immune systems.

And in this case, it’s “important to distinguish between how aluminum behaves in lab animals versus people,” Kaufmann said.

Human Studies

Beyond animal models and theoretical scenarios, scientists have looked hard for signals of harm in large human datasets.

In 2023, by the Vaccine Safety Datalink, a collaboration coordinated by the CDC, reported a slight increase in asthma among children with higher aluminum exposure before age 2, but the association disappeared in further analyses.

“That paper was roundly criticized,” Offit said. “When they controlled for breastfeeding, the association between asthma and receipt of aluminum-adjuvant-containing vaccines disappeared.”

“It should have never been published,” he said.

Kathy Edwards, professor emerita of pediatrics at Vanderbilt University, said that false signals are common when large databases are mined for dozens of outcomes.

“When you look at a hundred different things, just by the law of percentages, some of those may look like there is a signal,” she said. “The whole RFK Jr. assessment is really prone to cherry-picking,” she said, adding that “there does need to be some kind of basic understanding of statistics for people to interpret this.”

Soon after the 2023 U.S. findings drew attention, scientists at the CDC contacted Anders Hviid, head of epidemiology research at the Statens Serum Institut in Copenhagen, Denmark, to see whether his team could replicate the work.

“It makes perfect sense to try to replicate findings of any kind in different data sources,” Hviid said.

followed 1.2 million children over two decades, using linked national health registries that record every vaccination and diagnosis.

“Our health care system is quite egalitarian. It’s free, and there’s universal access. And everyone is in these nationwide registers,” he said. Their findings: no increased risk of these conditions associated with increasing amounts of aluminum received through the vaccines.

Rare Bumps

Doctors have documented one genuine reaction to aluminum adjuvants: itchy nodules at the injection site, called “pruritic granulomas.” These small bumps are so rare that most allergists and pediatricians will never see a single case.

This reaction “doesn’t lead to something bad, and it really isn’t associated with anything other than that local irritation,” Edwards said.

Researchers believe these bumps represent a localized immune response — meaning only in the area of the injection, not a body-wide allergy — that is very different from the kind of immediate allergic reaction people treat with antihistamines. These include the reactions driven by food or beestings, when histamine, the body’s own alarm signal, floods the system within minutes and causes hives, swelling, or breathing trouble. Kedl said that distinction often gets lost in public debate.

Eliminating Aluminum Adjuvants

For many experts, the real issue is not just whether aluminum is safe but what happens to the entire vaccine program if aluminum adjuvants are stripped out. For many modern vaccines that rely on a single purified protein — such as those for diphtheria and tetanus toxoids, hepatitis B, and HPV — adjuvants are crucial.

Edwards said that simply swapping in a different adjuvant isn’t realistic.

“They’re kind of all built on one another,” she said. Once a vaccine has been proved to work and become the standard of care, new or updated versions are generally no longer tested against a placebo in people who should be getting that vaccine. Instead, they’re tested against the existing product, which means each approval rests on the one before it.

Core childhood vaccines would probably have to be reformulated, and large clinical trials would have to be repeated to prove the new products are safe and effective. Meanwhile, production gaps and shortages would have to be managed, potentially for years, while manufacturers and regulators start over — all while diseases such as whooping cough, hepatitis B, and HPV-related cancers gain more room to spread.

“The aluminum adjuvants have sort of hit the sweet spot in terms of being effective at inducing a robust antibody response that is protective for those vaccines in which they’re being used and being very safe,” HogenEsch said. “It would be quite frankly foolish to try to eliminate them.”

A Century of Safe Use

The DTaP, hepatitis B, and HPV vaccines all contain aluminum adjuvants and have been in use for nearly a century. Large-scale studies show no link between aluminum and systemic allergic disease.

“We have had aluminum adjuvants in vaccines for decades,” Edwards said. “I have grandchildren. My grandchildren have received all of their vaccines. And I do not worry about the safety of them.”

If aluminum is falsely cast as the villain and vaccine uptake falls, experts warn, the consequences will not be theoretical: more measles in schools, more meningitis in college dorms, and more young adults dying of cancers that HPV shots could have prevented.

In their view, the real danger isn’t the trace amounts of a metal that children already encounter every day. It’s rolling back the protection aluminum-adjuvanted vaccines have provided for generations.

That’s the trade-off Offit hopes parents will see. “A choice not to get a vaccine is not a risk-free choice,” he said. “It’s just a choice to take a different risk.”

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The outbreaks are fueled by falling vaccination rates, fading immunity, and delays in public health tracking systems, according to interviews with state and federal health officials. Babies too young to be fully vaccinated are most at risk.

“Pertussis cases increase in a cyclical fashion driven by waning immunity, but the size of the outbreak and the potential for severe outcomes in children who cannot be vaccinated can be mitigated by high coverage and good communication to folks at risk,” said Demetre Daskalakis, a former head of the Centers for Disease Control and Prevention’s immunization program, who resigned in August.

Before the first pertussis vaccine became available in the , whooping cough was one of the most common childhood diseases and a in the United States. Today, children get a series of DTaP shots (full-dose version) starting at 2 months old, and teens and adults receive a Tdap booster (lower-dose version) every 10 years. (Both vaccines target diphtheria and tetanus in addition to pertussis.)

Until recently, had received four doses of the DTaP vaccine by age 2, and case rates were controlled. But vaccine coverage has declined since the covid pandemic and increases in state nonmedical exemptions have widened immunity gaps, which is when the proportion of individuals who are immune falls below the level needed to contain spread.

Texas logged in 2024. By October 2025, the state had . National numbers are just as stark: In the first three months of 2025, the U.S. tallied — four times last year’s pace and 25 times 2023’s. Several states are posting their highest case totals in a decade, and outbreaks from Louisiana to South Dakota to Idaho make clear this surge isn’t regional. It’s everywhere.

Key Factors Behind These Numbers

Texas lawmakers recently passed a law that for parents to claim nonmedical exemptions from school vaccine requirements by allowing them to download exemption forms online. These forms now go straight to schools, not health departments, making the exemptions harder to track.

Dallas County Health and Human Services Director Phil Huang said the full impact of the new exemption rule is not yet known because it began this school year, but he expects it will make school-level vaccination rates fall even more.

He’s already noted a dramatic drop in vaccinations. Normally, during back-to-school season, “our whole front downstairs area is packed,” he said. “We did not see that this year.”

Huang believes fear of immigration enforcement may be keeping at least some families, especially Hispanic families, from getting vaccinated. Dallas County is about 40% Hispanic. “We think that a lot of them are deterred by the ICE activity,” he said, referring to Immigration and Customs Enforcement.

More complications: These vaccines protect against severe disease, but protection against infection fades over time, as is the case with the covid and influenza vaccines.

The U.S. switched in the 1990s from whole-cell pertussis vaccines to “acellular” ones, which cause fewer side effects but do not last as long. Because more adults today than in the past received the acellular vaccine as children, many have lost immunity over time and may unknowingly pass the infection to babies.

Babies Face the Greatest Risk

Whooping cough is especially dangerous for infants under a year old. Some stop breathing during coughing fits. Many need hospital care, about of whom develop pneumonia, and about 1% of whom die.

Because of this high risk, the CDC urges pregnant women to get a . This allows the mother’s antibodies to pass to the baby before birth.

Health officials once promoted “cocooning,” vaccinating all family members and caregivers around the baby, but that strategy was hard to carry out in real life and is . Vaccination of pregnant women and babies at 2 months of age remains the strongest protection.

Better Testing Finds More Cases

Modern is also than in the past. Many clinics now routinely use this lab-based technology to test for several respiratory infections at once, including pertussis. Ten years ago, these panels were uncommon.

CDC experts say this explains part of the rise in case counts. But the large number of infant hospitalizations and the size of state outbreaks show that true transmission has also increased.

A Growing Worry: Antibiotic Resistance

Doctors normally treat pertussis with , such as erythromycin, azithromycin, and clarithromycin. These drugs work best early in the illness and help stop spread. Another drug, trimethoprim-sulfamethoxazole, is an option for some older infants and adults.

But has become common abroad, especially in China, and recent reports show resistance rising in Peru. In the U.S., resistant cases have been rare.

CDC officials warn that resistant strains could spread more easily through international travel. Because treatment options are limited, especially for very young infants, health workers are watching this closely.

Huang said macrolide resistance has not been seen yet in Dallas County. But he is aware of the national concern.

What Happens Now

The resurgence of whooping cough has no single cause. Instead, several problems are occurring at once: falling vaccine coverage, only of pregnant women receiving Tdap, waning immunity, improved testing, and early signs of antibiotic resistance.

Health experts say solutions must match the problem’s complexity.

Across the nation, clinicians are being told to have a higher suspicion for pertussis when they see patients, especially children or caregivers of newborns with a persistent cough or coughing fits followed by vomiting. Babies who stop breathing or turn blue need immediate care.

Obstetricians are encouraged to discuss Tdap during every pregnancy. Pediatricians and family doctors are urged to check booster status for teens and adults.

Several states have issued health advisories over the past two years, including , which has in both 2024 and 2025 urging clinicians to stay vigilant.

Huang said Dallas County is trying to rebuild public health outreach programs that were cut when covid funding ended. But staffing is still limited. “There’s just a lot of different things that are making it more difficult,” he said.

He also noted that Dallas County now receives immunization registry data only once a month, rather than daily, making it harder to track vaccine coverage. “We don’t have that yet. … It’s not real time,” he said.

Protecting the Youngest

As the holiday season approaches, experts urge families with newborns to take extra care:

• Ensure infants and children are up to date with their childhood vaccines and that everyone in the family is up to date with their vaccines for influenza, covid, and RSV, or respiratory syncytial virus.
• Keep sick visitors away.
• Seek care quickly if an infant has a cough or pauses breathing.

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The massive study, which was conducted in Sweden and tracked more than 2 million teenage girls and women under age 50 for more than a decade, found that hormonal contraception remains safe overall, but also found small differences in breast cancer risk based on the hormones used in the formulation. In addition, the researchers observed a small, short-term rise in breast cancer diagnoses among current or recent users. Those findings are consistent with prior large studies, including a and a .

It was published online Oct. 30 in .

Doctors say these study results won’t change how they advise patients and that women should not stop using their birth control.

Still, TikTok is flooded with factually incomplete warnings that contraceptives cause cancer and are as dangerous as smoking. Reproductive health advocates warn that studies like this online and be reduced to a single alarming number.

Case in point: reported that women who had used hormonal birth control had about a 24% higher rate of breast cancer than women who hadn’t. But because breast cancer is still uncommon in younger women, that works out to an increase from roughly 54 to 67 breast cancer cases per 100,000 women per year — about 13 extra cases per 100,000 women, or about one extra case per 7,800 users of hormonal contraceptives per year.

Co-authors Åsa Johansson and Fatemeh Hadizadeh, epidemiologists at , said the rise is modest and short-term, with risk highest during current use and fading within five to 10 years after stopping.

Rachel Fey — interim co-CEO of Power to Decide, a group whose mission is to provide accurate information on sexual health and contraceptive methods — said that kind of nuance is exactly what tends to disappear on social media. “I get really angry at this because it’s designed to scare people like me away from birth control, which has made my life so much better in so many ways,” she said. “It’s really frustrating … especially when it’s given without context. And then in this era of social media, it can just take off without anybody who knows what they’re talking about providing that context.”

The researchers also found the risk was slightly higher with certain progestins such as desogestrel — found in combined oral contraceptives like Cyred EQ, Reclipsen, Azurette, and Pimtrea — but did not increase with others, such as medroxyprogesterone acetate injections, sold under the brand name Depo‑Provera.

How To Interpret the Findings

Some experts say the results should be viewed with care because the study counted both invasive breast cancers and early, noninvasive lesions known as in situ tumors, growths that may never become life-threatening. Including these precancerous cases could make the overall risk of clinically significant disease appear higher than it is.

“A substantial proportion of the ‘cases’ would never have progressed to invasive breast cancer,” said Lina S. Mørch, a senior researcher and team leader at the Danish Cancer Institute. Mørch was not associated with the Swedish study. She added that experts should wait for more data separating early-stage and advanced cancers before making new rules or warnings about specific hormones.

The Doctor-Patient Conversation

Even as scientists debate how to interpret the finer points of the data, physicians emphasize that for most patients, the study reinforces what they already discuss in the exam room: that hormonal birth control is broadly safe, and decisions should be tailored to each woman’s needs and values.

Katharine White, chief of Obstetrics and Gynecology at Boston Medical Center, said this study won’t change how she talks to her patients.

“When counseling patients about their contraceptive options, I focus on their past experiences with birth control, their medical history, and what’s important to them about their birth control method and pregnancy planning (if applicable),” White wrote in an email. “Side effects and risks of methods are already a key part of my counseling about both hormonal and non-hormonal methods.”

Other doctors noted there are other contraceptive options.

Eleanor Bimla Schwarz, chief of General Internal Medicine at Zuckerberg San Francisco General Hospital, said, “For those who prefer hormone-free contraception, the copper IUD offers safe, convenient, highly effective contraception for over a decade after placement, and is rapidly reversible when pregnancy is desired,” referring to a type of long-acting intrauterine device.

Mary Rosser, director of Integrated Women’s Health at Columbia University Irving Medical Center, said this was a large, high-quality study that looked at many types of hormones over many years. But she added that doctors shouldn’t change their advice yet.

Johansson and Hadizadeh stressed that the results should guide shared decision-making, not cause alarm. “It may be reasonable to consider formulations associated with lower observed risk in our data,” they said. They noted that products containing medroxyprogesterone acetate, drospirenone, or levonorgestrel were linked to lower risk, while long-term use of desogestrel-only contraceptives might be best avoided when other options fit.

Keeping the Risk in Perspective

Hormonal birth control provides many health benefits beyond pregnancy prevention. It can lighten heavy periods, ease pain from endometriosis, and lower the risk of ovarian and uterine cancers for years after stopping. Mørch noted that even small risks are worth discussing but said decisions should be guided by women’s “values and preferences.”

White said it’s important to see the big picture. “The risk of an unintended pregnancy is 85% for people who do not use contraception—so any risks of birth control need to be weighed against the risk of an unexpected pregnancy,” she wrote.

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The increase in risk was small for any one child, but because millions of women were pregnant during the pandemic, even a small increase matters. The study doesn’t prove that covid infection during pregnancy causes autism or other brain conditions in the fetus, but it suggests that infections and inflammation during pregnancy can affect how a baby’s brain grows, something scientists have seen before with other illnesses. It’s a reason to help pregnant women avoid covid and to keep a close eye on children who were exposed in the womb.

What the Study Found

Researchers at Massachusetts General Hospital examined medical records from more than 18,000 mothers and their children born from March 2020 through May 2021, before vaccines were widely available to pregnant women. Because everyone giving birth during that period was tested for covid, the team could clearly see which pregnancies were exposed to the virus causing it.

About 5% of those mothers had covid while pregnant. Their children were modestly more likely to be diagnosed with a neurodevelopmental condition by age 3 than those whose mothers weren’t infected, even after accounting for differences in maternal age, race, insurance status, and preterm birth.

The link appeared strongest among boys and when infection occurred in their mother’s third trimester. Still, most children in both groups showed typical development.

“This was a very clean group to follow,” said Andrea Edlow, a maternal-fetal medicine specialist at Mass General and one of the study’s authors. “Because of universal testing early in the pandemic, we knew who had covid and who didn’t.”

Independent authorities say covid, which causes a powerful immune response in some people, fits the biological pattern seen with other infections in pregnancy. Alan Brown, a professor of psychiatry and epidemiology at Columbia University who studies maternal infection and brain development and was not involved in this research, explained, “Covid would be a very strong candidate for it to happen because the amount of inflammation is very extreme.”

How Might Infection Affect Brain Development?

Scientists are still piecing together how various infections during pregnancy can affect fetal development. Severe illness can cause inflammation that or can , which carries its own risks.

“There’s a long history of evidence showing that maternal infection can slightly raise the risk for many neurodevelopmental disorders,” said Roy Perlis, the vice chair for research in psychiatry at Massachusetts General Hospital and co-author of the new study.

Edlow’s lab is investigating how infection and inflammation may interfere with brain development. In a healthy brain, immune cells help shape developing neural circuits by trimming away extra or unnecessary connections, a process known as “synaptic pruning,” which sculpts the brain’s wiring. When a mother’s immune system is activated by infection, inflammatory molecules can reach the fetal brain and alter the pruning process.

support Edlow’s hypothesis. When scientists trigger inflammation in pregnant mice, their offspring often show changes in how brain cells grow and connect, changes that can alter learning and behavior.

Why Late Pregnancy and Why Boys?

In Edlow and Perlis’ study, the link between covid and developmental delays was strongest when infection occurred late in pregnancy, during the third trimester. That’s also when the fetal brain is growing most rapidly, forming and refining millions of neural connections.

“When we think of organ development, we think earlier in pregnancy, but the brain is an exception in this regard, where there’s a massive amount of brain development in the third trimester. And that continues after birth,” Perlis said. “It is entirely plausible that the third trimester is a period of vulnerability specifically for brain development.”

But not all researchers agree that the third trimester is uniquely vulnerable. Brian Lee, a professor of epidemiology at Drexel University, cautioned that because most mothers in the study were tested at delivery, there were simply more late-pregnancy infections to analyze. “That gives the study more power to find a difference in the third trimester,” he said. “It doesn’t prove earlier infections aren’t important.”

The study also found stronger effects in boys. That pattern is familiar: Boys are generally more likely than girls to have speech or motor delays and to be diagnosed with autism. Researchers suspect that male fetuses may be more susceptible to stress and inflammation, though the biology isn’t fully understood.

What the Study Can and Can’t Show

Edlow and Perlis are careful to say the study shows an association, not proof that covid infection in pregnancy causes developmental problems. could explain the correlation.

Mothers who get sick with covid may have other health issues, such as obesity, diabetes, or mental health conditions, that increase the risk of developmental delays in children. “Persons with are much more likely to get covid. Women with mental disorders are much ,” Lee said. “Mothers with are also at higher risk of having children with neurodevelopmental problems.”

Lee’s research has shown that , suggesting that shared genetics or environment, rather than the infection itself, could be at play. That’s why experts say much larger, longer studies are needed to understand the extent of any risk from the infection.

Edlow, Perlis, and their team plan to follow the children in their study as they grow older to see whether early differences persist or fade. They’re also studying how inflammation during pregnancy affects the placenta and fetal brain, and how to counteract these effects.

What About Vaccination?

Because this study followed pregnancies from early in the pandemic, it doesn’t answer whether vaccination changes the risk. But other research offers reassurance.

A large national study in Scotland between children whose mothers were vaccinated and those who weren’t. Another study in the U.S. : no link between prenatal covid vaccination and developmental delays through 18 months. Both align with decades of data showing that vaccination during pregnancy is safe for both the mother and the baby.

“Vaccination is a short spike … your immune system revs up, then it goes back to normal,” Edlow said. “Covid [infection] is much more prolonged, unpredictable, and people can get … a dysregulated immune phenomenon that really doesn’t exist in vaccine responses.”

What This Means for Parents and Clinicians

Since late 2020, there’s been widespread confusion and misinformation about the safety of covid vaccination during pregnancy. Some women have hesitated to get vaccinated out of fear it might harm their baby. But the evidence since then has been clear: Covid vaccines are safe in pregnancy. The American College of Obstetricians and Gynecologists to protect .

Experts say the broader lesson is that pregnancy is a period of vulnerability, and prevention matters, not only , but other infections as well.

Janet Currie, a professor of economics at Yale University, said these risks remain “underappreciated,” despite decades of evidence. “Even though the flu vaccine is recommended for pregnant women, very few pregnant women get it,” she said. “Physicians seem to be reluctant to vaccinate pregnant women.”

As Gil Mor, scientific director of the C.S. Mott Center for Human Growth and Development at Wayne State University in Detroit, put it, “Protecting the mother is protecting the long-term health of the offspring. … The best intervention is vaccination.”

A Century-Old Echo

The idea that what happens in the womb can shape life after birth took root with studies of famine, like the Dutch “Hunger Winter” in the final months of World War II. In 1944 and 1945, as German forces blockaded the western Netherlands, rations fell to just a few hundred calories a day. Thousands died of starvation, and women pregnant during that period gave birth to babies who later faced higher risks of , , and . The episode became a cornerstone of the “” idea, that deprivation or stress in pregnancy can have lifelong effects.

The broadened that idea to infection. Babies exposed to influenza in utero later showed small but lasting , a sign that illness during pregnancy could affect brain development. Researchers in , , , , and found similar consequences. Some argued that those findings reflected the disruptions of World War I, not the flu itself. But , including those from the and , have strengthened the case for a biological effect, reinforcing that the infection itself, not wartime upheaval, was the key driver.

“It isn’t simply influenza that can alter fetal neurodevelopment,” Kristina Adams Waldorf, a professor of obstetrics and gynecology at the University of Washington, explained. “Many types of infections … in the mother can be transmitted as a signal to the fetus, which can alter its brain development.”

A century later, the same question has returned with covid: Could infection during pregnancy subtly shape how children grow and learn? The new Massachusetts General Hospital study offers an early look at an answer.

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