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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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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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Either move, experts warn, would unleash a flood of claims, threatening the program’s financial stability and handing vaccine opponents a powerful new talking point.

Legally, HHS “is required to undergo notice and comment rulemaking to revise the table,” said Richard Hughes, a law firm partner who teaches at George Washington University. The that the U.S. government accepts as presumed to be caused by a vaccine if those injuries occur within a certain time window. If someone can show they meet the criteria, they have a simpler path to securing compensation without having to prove fault. Autism is not in the table because a link between vaccines and autism has been .

If autism is added, Hughes explained, the VICP could face “an exorbitant number of claims that would threaten the viability of the program.”

Asked about its possible plans, an HHS spokesperson told CBS News the agency does not comment on future or potential policy decisions.

Carole Johnson, former administrator of the Health Resources and Services Administration, which oversees VICP, cautioned that the system is already overburdened: “The backlog is not just a function of management, it’s built into the statute itself. That’s important context for any conversation about adding new categories of claims.”

Dorit Reiss, a law professor at the University of California College of the Law-San Francisco, said that any such : “This can, and likely will, be used to cast doubt on vaccines.”

Compensation Without Causation

The Vaccine Injury Compensation Program was born of crisis. In 1982, “,” a television documentary, aired nationwide, alleging routine childhood shots were causing seizures, brain damage, and even sudden infant death. The program alarmed parents and triggered a surge of lawsuits against vaccine makers.

“That led to a flood of litigation against vaccine makers,” recalled Paul Offit, a pediatric infectious disease specialist and vaccine inventor at the University of Pennsylvania. “I mean, to the point that it drove them out of the business. … By the mid-1980s, there were $3.2 billion worth of lawsuits against these companies.”

Were it not for the VICP, Offit said, “We wouldn’t have vaccines for American children. The companies — it wasn’t worth it for them.”

The National Childhood Vaccine Injury Act of 1986 created a no-fault system. Families who believed a vaccine caused harm could file a claim; if the injury appeared on the table within a set time frame, compensation was automatic. If not, claimants could present medical evidence. The system had two purposes: provide compensation and protect the vaccine supply.

From the beginning, the table was understood not as a scientific document but as a legal tool.

“It’s a legal document and things can be included for policy reasons even if the causation evidence is weak,” Reiss said. She explained, “The program is designed to be generous, to compensate in cases of doubt.”

But, she said, “autism is not in that category. The science is clear. Adding it would be pure politics.”

This tension — between law, science, and public perception — has defined the program for nearly four decades.

What Expansion Would Mean in Practice

Since 1988, shows more than 25,000 petitions to the VICP have been adjudicated; of those, 12,019 were granted compensation and 13,007 were dismissed. About 60% of compensated cases involved negotiated settlements in which HHS drew no conclusion about the cause. Over the same period, billions of vaccine doses were safely administered to millions of Americans.

Adding autism to the VICP table would change that picture overnight.

Federal estimates suggest up to 48,000 children could qualify immediately under a “profound autism” standard, with potential payouts averaging $2 million per case, at an initial cost of nearly $100 billion, followed by annual totals of about $30 billion a year — , a new analysis finds.

“Any case where the symptoms appeared in the past eight years and the parents blame vaccines,” Reiss said. “I don’t know how many that would be. The fund has a surplus of over $4 billion. One seriously disabled child’s care can cost millions, so a significant number, say 100,000 compensations, might exhaust it.”

Furthermore, with only eight special masters handling cases, the system would also be paralyzed by backlogs.

The stakes are not just fiscal. If the fund collapses under the weight of autism claims, vaccine makers may question whether producing vaccines for the U.S. market is worth the risk. That would mirror the crisis of the 1980s, which led to the establishment of the VICP.

Autism and the Courts

In the late 1990s and early 2000s, Andrew Wakefield’s now-retracted paper alleging a link between the MMR vaccine and autism fueled a surge of VICP claims. By 2002, the VICP was swamped with petitions alleging vaccines had caused autism. The court consolidated thousands of cases into the Omnibus Autism Proceedings, selecting a handful of test cases to decide them all.

After years of hearings and expert testimony, the conclusion was unequivocal: vaccines do not cause autism. In 2010, the court ruled against petitioners on every theory of causation. The U.S. Court of Federal Claims affirmed, and the Court of Appeals upheld, the decision.

“That precedent is binding,” said Richard Hughes, a vaccine law expert at George Washington University and former VICP legal counsel. “Autism was litigated thoroughly and rejected. That still carries weight in the court today.”

The Ghost of Hannah Poling

Yet, the vaccine-autism debate has never quite faded. In 2008, the government conceded a case involving Hannah Poling, a girl with a rare mitochondrial disorder who developed autism-like symptoms after vaccination. Officials stressed the concession was specific to her condition, not evidence of a general link. But headlines told another story: “.”

The Poling case fueled years of confusion.

Autism Science Today

The science is clearer than ever. Autism begins early in pregnancy, not in toddlerhood when most vaccines are given.

“Vaccinations … happened around the time families were recognizing symptoms of autism in their children,” said Catherine Lord, a UCLA clinical psychologist and specialist in autism diagnosis. “However, we now know that autism begins much earlier, likely as the fetus develops during pregnancy, so it cannot be an explanation.”

Peter Hotez, a pediatric infectious disease specialist and vaccine scientist at the Baylor College of Medicine who is also the father of a young adult with autism, underscores that point: “The drivers of autism are genetics and, in rare cases, environmental exposures during pregnancy, not vaccines. We’ve been over this ground for decades, and the evidence is overwhelming.”

Sarah Despres, former legal counsel to the secretary of Health and Human Services in the Biden administration and now a consultant to nonprofit organizations on immunization policy, adds that the compensation program itself is often misunderstood.

“The table was originally written as a political document,” she said. “The purpose of the program was to be swift, generous, and fair. … There would be cases that may not be caused by the vaccine but would be compensated if you went through this table injury scheme, where you don’t have to prove causation.”

What’s at risk: Harm From the Diseases Themselves

The stakes are not abstract. Measles, one of the on Earth, spreads so efficiently that one infected child can transmit it to 90% of susceptible contacts. Before vaccinations began in the 1960s, annually in the U.S., killing hundreds and causing thousands of cases of encephalitis and lifelong disability. Complications included pneumonia, brain swelling, and, in rare cases, a fatal degenerative brain disorder called subacute sclerosing panencephalitis, or SSPE, that can strike years later. This year, a after contracting measles in infancy, before being eligible for vaccination.

Mumps was once a near-universal childhood illness. Though often dismissed as mild, it can cause sterility in men, meningitis, and permanent hearing loss. Outbreaks on college campuses, as recently as the 2000s, showed how quickly it can return when vaccination rates slip.

Rubella, also known as German measles, is mild in most children, but can be devastating during pregnancy. Congenital Rubella Syndrome, or CRS, caused waves of tragedy before the development of the vaccine: Thousands of babies each year were born blind, deaf, with heart defects, or with intellectual disabilities. In medical texts, autism itself is listed as one of CRS’ sequelae, or possible consequences — proof that rubella infection, not vaccination, can contribute to developmental disorders.

Measles, mumps, and rubella “are not trivial,” said Walt Orenstein, former head of the Centers for Disease Control and Prevention’s immunization program. “Fever, high fever, is common … and they have frequent complications.”

And yet, as these diseases fade from living memory, a counternarrative has gained traction. On Sept. 29, the nonprofit Physicians for Informed Consent, a group that disputes the scientific consensus on vaccines, announced it had mailed its “Silver Booklet” on vaccine safety to every member of Congress, as well as to President Donald Trump and Vice President JD Vance. The book claims that “vaccines are not proven to be safer than the diseases they intend to prevent,” and calls on federal leaders to punish states that restrict vaccine exemptions. (The booklet isn’t free. The group sells copies for $25 on Amazon.)

Scientists say this framing misrepresents the basic math of risk. “Measles is one of the most important infectious diseases in human history,” notes “,” the field’s authoritative textbook. “The widespread use of measles vaccines in the late 20th and early 21st centuries led to a further marked reduction in measles deaths. Measles vaccination averted an estimated 31.7 million deaths from 2000 to 2020.”

Kennedy’s possible move to expand the Vaccine Injury Compensation Program hinges on casting doubt — on suggesting that science is unsettled, that vaccines may be riskier than diseases.

“One tactic used to argue that vaccines cause autism is the use of compensation decisions from the National Vaccine Injury Compensation Program to claim such a link,” said Reiss of UC Law-San Francisco. “Even the cases that most closely address the question of vaccines and autism do not show the link that opponents claim exists, and many of the cases used are misrepresented and misused.”

Offit underscores the danger on the perception side. “When people see the Vaccine Injury Compensation program, they assume that any money that is given is because there was a vaccine injury,” he said.

Kathryn Edwards, an expert in pediatric infectious diseases and vaccine safety at Vanderbilt University, said, “Expanding compensation for issues that are not clearly related to vaccines … suggests that these conditions are related to vaccines when they are not.” She compared it to the , a preservative dropped from most childhood vaccines to ease public fears, despite no evidence of harm. “Now, we are still suffering from that action.”

Public health experts stress that such narratives invert reality. The very diseases being downplayed once killed or disabled tens of thousands of American children each year. As pediatrician, psychiatrist, and medical historian Howard Markel put it: “Back a hundred years ago, everybody lost a kid or knew a kid who died of one of these diseases. … We never conquer germs, we wrestle them to a draw. That’s the best we do. And so this is a real … handicap to the other side, the microbes who live to infect.”

Families and the Future

The hardest voices to reckon with are . Parents of autistic children often feel abandoned — unsupported by disability programs, exhausted by care needs, searching for answers. Kennedy’s appeal to them is emotional, not scientific.

Reiss noted that families deserve far more support but argues that it shouldn’t come through VICP.

“The program is to award compensation to those injured by vaccines,” she said. “We should have more direct support — disability funding, disability aid. Kennedy has been taking HHS in the opposite direction, cutting services where we need more.”

Despres made the same point: “The goal of the program really was if there’s a close call, we’re going to err on the side of compensation. … And it’s really important that everyone understands that compensation does not mean that the vaccine actually caused the injury. … And I think we have seen statistics around the compensation program misused by those who would want to sow distrust in vaccines, to say vaccines are unsafe, when in fact … that’s not what this is.”

UCLA’s Lord urged a shift in focus. “For the last 50 years, science has focused on the biological causes of autism, which has led to great progress, especially in genetics,” she said. Of Secretary Kennedy, she said, “He could help more by acknowledging the value of science, but also the need to better attend to the actual lives of autistic people and their families.”

What Comes Next?

If Kennedy decides to move forward with such a plan, HHS would need to draft a rule, open it to public comment, and then defend the change in court. The pushback will be fierce: from scientists, from public health leaders, and from families who fear being misled yet again.

The debate over adding autism to the Vaccine Injury Table is not just a policy debate. The program was built on the principle of compensation without causation, a fragile balance designed to sustain both trust and supply. Adding autism could collapse that distinction entirely.

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Caroline Connor’s concerns about her son’s development began around his 1st birthday, when she noticed he wasn’t talking or using any words. Their pediatrician didn’t seem worried, but the speech delay persisted. At 2½, Mason was .

The Connors went on a mission, searching for anything that would help.

“We just started researching on our own. And that’s when my husband Joe came across Dr. Frye in a research study he was doing,” Caroline said.

Richard Frye, a pediatric neurologist, is one of many doctors searching for treatments that can help . He’s studying leucovorin, an inexpensive, generic drug derived from folic acid, also known as folate or vitamin B9. Leucovorin is currently prescribed to ease the side effects of cancer chemotherapy. Pregnant women are prescribed multivitamins with folic acid to prevent neural tube defects. The neural tube develops into the brain and spinal cord.

Leucovorin isn’t a cure for autism, but “it could really have a substantial impact on a very good percentage of children with autism,” Frye said.

This week, the FDA began the process of approving leucovorin as a treatment for autism, despite a lack of any large, phase 3 clinical trials.

“We do have some good preliminary evidence that leucovorin helps,” Frye said. “But normally, the FDA would want to see at least a couple of large phase 3, placebo-controlled, randomized clinical trials. Right now, we only have phase 2B studies, and more research is needed to answer key questions, like how to dose it correctly, when to start, and which children will benefit most.”

The theory behind the drug’s use for autism postulates that some children have a blockage in the transport of folic acid into the brain that potentially contributes to some of the neurological problems associated with the disorder. Leucovorin bypasses that blockage and can help some autistic kids improve their ability to speak. Three randomized controlled trials of leucovorin to treat autism have shown positive effects on speech.

Frye cited five blinded controlled studies to date, all positive, although at different doses and in different populations. Still, he said, “the evidence isn’t yet where it would normally be for a drug.”

Frye said he was “disappointed” that his group had not received funding from the National Institutes of Health’s new and that he was not consulted on the design of upcoming leucovorin trials. “It’s strange, because I’ve been leading this work for decades,” he noted.

The Science of Cerebral Folate Deficiency

Cerebral folate deficiency, or a deficiency of folate in the brain, was . Ramaekers found that some kids with neurodevelopmental disorders had normal levels of folic acid in the blood, but low levels in their spinal fluid. He then teamed up with researcher Edward Quadros, who had been studying how an autoimmune disorder might lead to a blockage of folic acid transport into the brain. Ramaekers and Quadros found that autoantibodies against the folate receptor alpha (FR⍺), which transports folic acid from the blood into the brain and the placenta, might cause abnormal fetal brain development and some autism spectrum disorders.

One study found that over 75% of children with autism spectrum disorder , compared with 10%-15% of healthy kids. There is evidence of a for developing FR⍺ autoantibodies. While environmental and immune system dysregulation may also play a role, there’s no evidence to suggest that vaccines cause the development of FR⍺ autoantibodies.

The brain has a backup system to the FR⍺ known as the reduced folate carrier, or RFC. The RFC isn’t as efficient a transporter as the FR⍺, but it can transport leucovorin, also known as folinic acid, into the brain. Enzymes in the brain convert leucovorin into the active form of folate.

Treatment with leucovorin in kids with cerebral folate deficiency, or CFD. In one study led by Frye, one-third of such kids in their speech and other behavior when treated with leucovorin. Two randomized trials conducted in France and India showed similar results. A is available to help may most likely respond to leucovorin treatment.

Frye’s team has also identified new potential biomarkers, such as the soluble folate receptor protein, that could predict which children require higher doses.

Frye noted that there are many nuances to treating CFD with leucovorin, including the addition of adjunctive treatments to optimize mitochondrial function.

The side effects associated with leucovorin are mild. Some children experience hyperactivity during the first few weeks of treatment, but that typically subsides within a month or two. A similar pattern is seen with other B vitamins.

Mason’s ‘Little Bottle of Hope’

Mason Connor’s first words came just three days after he started taking leucovorin at age 3, his parents say.

Doctors can currently prescribe the drug only for autism off-label, which means repurposing a drug approved for one condition to treat another.

“We’ve done the science, and the next step is that we want to get more funding so we can actually get it FDA-approved,” Frye said.

He welcomed the but cautioned that it “may have been a little premature,” given the gaps in knowledge and the need for physician education on how to prescribe leucovorin correctly in autism.

There’s one big problem. “Leucovorin’s an old drug, and you can get it for a very low price. So nobody is going to make a lot of money on it. So there’s no reason for them to invest,” Frye said.

Compounding the challenge: supply and quality vary. “Leucovorin is a generic, and different manufacturers use different additives,” Frye explained. “Some formulations children with autism don’t tolerate well.”

Frye used to recommend that patients use the generic form of leucovorin manufactured by West-Ward Pharmaceuticals, a U.S. subsidiary of Hikma, but, he said, “it ran out early this year. Right now, the only reliable source is through a high-quality compounding pharmacy that knows how to make it for kids with autism.” Frye is in the process of establishing a for-profit company to manufacture the right form of leucovorin for kids with autism.

An estimated 20%-30% of all prescriptions in the U.S. are off-label, according to the nonprofit . This is often done as there are more than 14,000 known human diseases with no FDA-approved drugs to treat them. Drugs like leucovorin are frequently used off-label because doctors believe that the benefits outweigh the risks. However, there is often limited awareness about these treatments, so they may go unused.

, Every Cure’s co-founder and president, said he’s “literally alive today from a repurposed drug” after he was diagnosed with a rare cancer-like disease that almost killed him. His research into his disease led to a drug meant for another condition.

“It’s heartbreaking to think about drugs being on the pharmacy shelf while someone suffers from a disease,” Fajgenbaum said.

Every Cure uses AI to scour available medical data on diseases and treatments to uncover potential matches. the work of Frye, Ramaekers, Quadros, and others on leucovorin in the treatment of autism.

“I think our system is just flawed and there’s this major gap where drug companies are great at developing new drugs for new diseases, and we as a system are really lousy at looking for new diseases for old drugs. That’s why we started Every Cure — to unlock these hidden cures,” Fajgenbaum said.

Mason is now 5, and the plan is for him to start mainstream kindergarten this fall — helped toward a new path by an old medicine.

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Céline Gounder, �������ýҕ�l Health News’ editor-at-large for public health, appeared on CBS News’ “Face the Nation With Margaret Brennan” on Aug. 31 to discuss leadership changes at the Centers for Disease Control and Prevention and vaccine policy concerns. Gounder noted that the departures of top officials and confusion over how to get vaccines affect the public health of Americans. She pointed out that Americans may want to get vaccinated and stay healthy to avoid having to miss work or school.

She recently explored these issues in her article “Senior CDC Officials Resign After Monarez’s Ouster, Citing Concerns Over Scientific Independence.”

on CBS News and to read the transcript.

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