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 disrupts brain growth or can trigger preterm birth, 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.

Animal studies 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. Many other factors 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 mental disorders are much more likely to get covid. Women with mental disorders are much more likely to have kids with neurodevelopmental problems,” Lee said. “Mothers with worse physical health are also at higher risk of having children with neurodevelopmental problems.”

Lee’s research has shown that even infections before or after pregnancy can be linked to autism, 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 found no difference in early developmental outcomes between children whose mothers were vaccinated and those who weren’t. Another study in the U.S. found the same: 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 strongly recommends covid vaccination to protect both mother and child.

Experts say the broader lesson is that pregnancy is a period of vulnerability, and prevention matters, not only for covid, 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 heart disease, diabetes, and schizophrenia. The episode became a cornerstone of the “fetal origins” idea, that deprivation or stress in pregnancy can have lifelong effects.

The 1918 flu pandemic broadened that idea to infection. Babies exposed to influenza in utero later showed small but lasting differences in education and earnings, a sign that illness during pregnancy could affect brain development. Researchers in Taiwan, Sweden, Switzerland, Brazil, and Japan found similar consequences. Some argued that those findings reflected the disruptions of World War I, not the flu itself. But later studies, including those from the United Kingdom and Finland, 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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“People don’t realize how much these clinics hold together the local health system until they’re gone,” said George Hill, the group’s president and CEO. “For thousands of patients, that was their doctor, their lab, and their lifeline.”

Maine Family Planning’s closures are among the first visible signs of what health leaders call the biggest setback to reproductive care in half a century. The U.S. Department of Health and Human Services’ Office of Population Affairs, which administers the Title X family planning program, has been effectively shut down. At the same time, Medicaid cuts, the potential lapse of Affordable Care Act subsidies, as well as cuts across programs in the Health Resources and Services Administration and Centers for Disease Control and Prevention are eroding the broader safety net.

“When you cut OPA, HRSA, and Medicaid together, you’re removing every backup we have,” said Clare Coleman, president of the National Family Planning and Reproductive Health Association. “It’s like taking EMTs off the road while closing the emergency rooms.”

Asked about the cutbacks, HHS press secretary Emily G. Hilliard said, “HHS will continue to carry out all of OPA’s statutory functions.”

How the Safety Net Frays

For more than 50 years, Title X has underwritten a national network of clinics, now numbering over 4,000, that provide contraception, pregnancy testing, testing and treatment for sexually transmitted infections, cancer screening, and other primary and preventive care to nearly 3 million low-income or uninsured patients annually. OPA managed nearly $400 million in grants, issued clinical guidance, and ensured compliance.

In mid-October, OPA’s operations went dark amid federal layoffs that also affected hundreds of CDC staffers. “Under the Biden administration, HHS became a bloated bureaucracy — expanding its budget by 38% and its workforce by 17%,” a spokesperson for the department said at the time, adding, “HHS continues to eliminate wasteful and duplicative entities, including those inconsistent with the Trump administration’s Make America Healthy Again agenda.”

According to Jessica Marcella, who led OPA under the Biden administration, the office was previously staffed by 40 to 50 people. Now, she says, only one U.S. Public Health Service Commissioned Corps officer remains.

“The structure to run the nation’s family planning program disappeared overnight,” said Liz Romer, OPA’s former chief clinical adviser.

“This isn’t just about government jobs,” Coleman said. “It’s a patient care crisis. Every safety net program that touches reproductive health is being weakened.”

A Policy Linking Health, Autonomy, and Opportunity

Created in 1970 under President Richard Nixon and rooted in President Lyndon Johnson’s War on Poverty, Title X was designed as a cornerstone of preventive public health, not a partisan cause. Nixon called family planning assistance key to a “national commitment to provide a healthful and stimulating environment for all children,” and Congress agreed overwhelmingly across party lines.

Sara Rosenbaum, a professor of health law at George Washington University, said the program reflected a pivotal shift in how policymakers understood health itself.

“By the late 1960s, there was a deep appreciation that the ability to time and space pregnancies was absolutely essential to women’s and children’s health,” she said. “Title X represented the idea that reproductive care wasn’t a privilege or a moral issue. It was basic health care.”

UCLA economist Martha Bailey later found that children born after the first federally funded family planning programs were 7% less likely to live in poverty, and had household incomes 3% higher, than those born before. Research by Bailey just published by the National Bureau of Economic Research showed that when low-income women can access free birth control, unintended pregnancies drop by 16% and abortions drop by 12% within two years.

Those findings underscore what Rosenbaum calls “one of the great public health achievements of the 20th century — a program that linked economic opportunity to health and autonomy.”

That bipartisan foundation and evidence-based mission, Rosenbaum said, make today’s unraveling especially striking.

“What was once common sense, that access to family planning is essential to a functioning health system, has become politically fragile,” she noted. “Title X was built for continuity, but it’s being undone by neglect.”

The Hidden Health Risks Behind Unplanned Pregnancies

Family planning is central to maternal and infant health because it gives women the time to optimize medical conditions like high blood pressure, diabetes, and heart disease before pregnancy, and allows them to safely space out their births.

“Pregnancy is the ultimate stress test,” said Andra James, a maternal-fetal medicine specialist who advised the CDC on its contraceptive guidelines. “It increases the heart’s workload by up to 50%. For people with heart disease, diabetes, or hypertension, that stress can be dangerous.”

Brianna Henderson, a Texas mother, learned this firsthand. Weeks after delivery, she developed peripartum cardiomyopathy, a form of heart failure that can occur during or after pregnancy. She survived. Her sister, who had the same undiagnosed condition, died three months after giving birth to her second child. Those kids are now 12 and 16, and they’re growing up without a mom. Their dad and his mother look after the kids now.

“Contraception has been a lifesaving option for me,” Henderson said.

James and other specialists warn that without CDC-informed guidance on contraceptive safety for complex conditions, clinicians and patients are left without clear, current standards.

What History and the Data Predict Happens Next

Title X clinics provide millions of STI tests each year and are often the only cancer screening sites for uninsured women. Cuts to Medicaid and ACA subsidies will make it even harder for people to afford preventive visits.

“If these clinics close, we’ll see more infections, more unplanned pregnancies, and more maternal deaths, especially among Black, Indigenous, and rural communities,” said Whitney Rice, an expert on reproductive health at Emory University.

And the geographic gaps are large already. Power to Decide, a nonprofit reproductive rights group, counts more than 19 million women living in “contraceptive deserts,” where there’s no reasonable access to publicly supported birth control. 

“These are places where the nearest clinic might be 60 or 100 miles away,” said Power to Decide interim co-CEO Rachel Fey. “For many families, that distance might as well be impossible.”

The High Price of Short-Term Savings

Each pregnancy averted through Title X saves about $15,000 in public spending on medical and social services, according to an analysis by Power to Decide. And an analysis by the Guttmacher Institute shows that every $1 invested in publicly funded family planning programs saves roughly $7 in Medicaid costs.

Cutting federal funding for reproductive health services “isn’t saving money. It’s wasting it,” said Brittni Frederiksen, an associate director with KFF’s Women’s Health Policy program and a former OPA health scientist. “We’ll spend far more fixing the problems these cuts create.” KFF is a health information nonprofit that includes KFF Health News.

Supporters of cuts argue federal spending must be reduced and states should set their own priorities.

Strain on the Ground

Affirm, Arizona’s Title X grantee, oversees a statewide network of clinics that provide family planning services to more than 33,000 patients each year.

Affirm CEO Bré Thomas said the state could lose $6.1 million in Title X funding if federal appropriations expire after March 31. It’s a cut that would reduce access to care across the network. “That’s $6.1 million for Arizona,” she said. “That means over 33,000 patients in our state could lose access to services.”

Thomas noted that two consecutive funding reductions, combined with 11 years of flat federal support and rising health care costs, have already strained operations. Without new funding, she warned, clinics may be forced to limit contraceptive options to cheaper methods, reduce preventive care, and lay off staff, especially in rural communities. “We’re talking about impacts to people’s jobs and their ability to access the care they need,” she said.

Megan Kavanaugh, a scientist at the Guttmacher Institute, underscored those limits.

“Federally Qualified Health Centers do not have the capacity to absorb the number of patients who will lose care,” she said, referring to federally funded community-based clinics for underserved populations. “Some people may find another clinic, but a large share simply won’t, and we’ll see that reflected in higher rates of unintended pregnancy, untreated infections, and later-stage disease.”

Hospitals are beginning to absorb the spillover.

“The safety net is shrinking, and hospitals can’t absorb everyone,” said Sonya Borrero, a reproductive health expert at the University of Pittsburgh School of Medicine and a former chief medical and scientific adviser at OPA. “Wait times will get longer, and preventable problems will rise.”

Funding Frozen, Oversight Halted

With OPA offline, Title X dollars already awarded can be spent, but no new funds are moving.

“Most programs can hang on for a few months,” Romer said. “By spring, many won’t have enough money to stay open.”

The halt also suspends compliance reviews and technical assistance tied to CDC-aligned guidelines.

Marcella, the former OPA leader, warned of a “backdoor dismantling.”

“If there aren’t people to administer the grants, then the administration can later argue the program isn’t working and redirect the funds elsewhere,” she said. “This is a functional elimination, done quietly.”

Kavanaugh called the moment “one more step toward dismantling the public health infrastructure that has supported people’s reproductive health for decades.”

Without staff to move money and guidance, she said, “that’s how a system collapses.”

What Can Still Be Done

According to the National Association of Community Health Centers, Federally Qualified Health Centers can still use HRSA money that was already approved, even during the government shutdown. But no new funding is being released, similar to the freeze on Title X funds. At the same time, HRSA has stopped first-quarter payments for its Title V Maternal and Child Health program, which limits how states can provide preventive care and services for children and young people with special health needs.

Some states — California, New Mexico, Washington — are plugging holes with state dollars, and health systems are expanding telehealth, but most jurisdictions cannot replace federal support at scale.

“Private donors can’t replace the federal government,” said Hill, of Maine Family Planning. “You can’t crowdfund your way to a working health system.”

Congress could restore Title X and rebuild OPA’s staffing, but without administrators in place, money can’t reach clinics quickly. States have a short window to bridge care by stabilizing Medicaid coverage, shoring up community health centers, and protecting contraceptive access.

“This isn’t a political debate,” Romer said. “It’s women showing up for care and finding the doors locked.”

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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 “table” is a list of specific injuries 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 thoroughly debunked.

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 change would be exploited: “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, “Vaccine Roulette,” 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, federal data 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 — dwarfing the current $4 billion trust, 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: “Family to Receive $1.5 Million in First-Ever Vaccine Autism Court Award.”

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 most contagious pathogens on Earth, spreads so efficiently that one infected child can transmit it to 90% of susceptible contacts. Before vaccinations began in the 1960s, measles sickened hundreds of thousands 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 school-age child in Los Angeles County died of SSPE 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 “Plotkin’s Vaccines,” 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 removal of thimerosal, 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 those of families. 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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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 kids with autism. 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 Autism Data Science Initiative 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 first described by physician-researcher Vincent Ramaekers. 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 had FR⍺ autoantibodies, compared with 10%-15% of healthy kids. There is evidence of a familial or genetic predisposition 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 increases brain levels of folate in kids with cerebral folate deficiency, or CFD. In one study led by Frye, one-third of such kids experienced improvement in their speech and other behavior when treated with leucovorin. Two randomized trials conducted in France and India showed similar results. A folate receptor autoantibody test (FRAT) is available to help identify which children 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 FDA’s recent interest 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 Every Cure. 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.

David Fajgenbaum, 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. Every Cure brought to light 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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Members admitted they didn’t know what they were voting on, first rejecting a combined measles-mumps-rubella-chickenpox vaccine for young toddlers, then voting to keep it funded minutes later. The next day, they reversed themselves on the funding.

Now Jim O’Neill, the deputy health and human services secretary and the Centers for Disease Control and Prevention’s acting director (a lawyer, not a doctor), must sign off. The panel’s recommendations matter, because insurers and federal programs rely on them, but they are not binding. States can follow the recommendations, or not.

In the West, California, Oregon, Washington, and Hawaii have joined forces in the West Coast Health Alliance. Their first move was to issue joint recommendations on covid, flu, and RSV vaccines, going further than ACIP.

“Public health should never be a patchwork of politics,” said Sejal Hathi, Oregon’s state health director.

California’s health director, Erica Pan, described the goal as “demonstrating unity around science and values” while reducing public confusion.

The bloc is also exploring coordinated lab testing, data sharing, and even group purchasing. “Our intent is to restore trust in science and safeguard people’s freedom to protect themselves and their families without endless barriers,” Hathi said.

In the Northeast, New York and its neighbors created the Northeast Public Health Collaborative. Democratic Gov. Kathy Hochul called it a rebuke to Washington, D.C.’s retreat from science.

“Every resident will have access to the COVID vaccine, no exceptions,” she said in a statement.

The group has already gone beyond vaccines. After the CDC disbanded its infection-control advisory body, the Northeast states created their own return-to-work rules. Work groups now span vaccines, labs, emergency preparedness, and surveillance.

“Infectious diseases don’t respect borders,” said Connecticut’s health commissioner, Manisha Juthani. “We had to move in the same direction to protect our residents.”

The two blocs are in regular contact. “We communicate every day,” Hathi said.

“We can’t just sit by while federal agencies are hollowed out,” said acting New York City health commissioner Michelle Morse. “Public health is local, and we have to act like it.”

State leaders describe their coalitions as filling a vacuum left by Washington, D.C.

“You would think emerging from a pandemic, we would be embracing public health, but the federal government was heading in the opposite direction,” said James McDonald, New York state health commissioner.

Massachusetts commissioner Robbie Goldstein added: “The federal government has historically been the entity that held us all together. In January of this year, that tradition seemed to be going away.”

Boston University law professor Matt Motta summarized the dilemma: “States are taking matters into their own hands, sometimes to expand access to vaccines, sometimes to roll it back. That’s technically how the system works, but it risks inefficiency and confusion.”

Public health law has long tilted toward the states.

“If there was a public health issue, we’d say it’s for the states,” said Wendy Parmet of the Northeastern University School of Law.

States have mandated vaccines since the 1800s. Federal agencies can approve vaccines and fund programs, but they cannot force mandates except in very specific circumstances (e.g., federal employees).

UC Law-San Francisco’s Dorit Reiss agreed with Parmet: “Public health authority resides primarily with the states. Recommendations are recommendations.”

ACIP’s votes matter for coverage rules and insurance mandates, but states are free to diverge.

That divergence is already widening. Florida, led by Surgeon General Joseph Ladapo, is moving to eliminate childhood vaccine requirements altogether — a first-in-the-nation step. Georgetown Law’s Larry Gostin warned this could reopen century-old battles dating to Jacobson v. Massachusetts (1905), when the Supreme Court upheld state vaccine mandates for public safety.

Health leaders warn that competing systems risk causing confusion and costing lives. “Federal silence creates a vacuum, and states either step up together or splinter apart,” Hathi said.

Pan added that “without federal credibility, we’re left improvising.”

McDonald cautioned that partisan divides could grow sharper.

And Morse said that “blue and red states could each go their own way, leaving the public even more divided.”

Gostin put it bluntly: “That risks confusion, inefficiency, and ultimately lives.”

This state-by-state tug-of-war is not new. In the 1800s, local boards of health fought cholera with sewers and sanitation when federal authority was absent. In the 1950s, states organized mass polio clinics, with uneven uptake until federal funding smoothed disparities.

During the covid pandemic, Trump White House response coordinator Deborah Birx saw firsthand the limits of federal power. She visited 44 states, urging governors to adopt masks, closures, and vaccines.

“I was trying to get them to tailor responses to their populations, not just follow generic federal guidance,” she later recalled.

Supreme Court Justice Louis Brandeis once said that states are “laboratories of democracy,” where leaders could test out new ideas without putting the whole country at risk. But diseases don’t follow state lines. A virus that starts in Tallahassee could spread to Times Square by the next morning.

Today, states have become laboratories of public health. Each state is experimenting — some expanding protections, others cutting them back. And those choices could, for better or worse, affect us all.

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

Click here to watch Gounder on CBS News and click here to read the transcript.

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Two of them — Debra Houry, the CDC’s chief science and medical officer, and Demetre Daskalakis, who led the National Center for Immunization and Respiratory Diseases — stepped down on Aug. 27, hours after the White House announced the firing of CDC Director Susan Monarez.

Monarez, confirmed by the Senate in late July, was removed less than a month into her tenure. White House spokesperson Kush Desai said Monarez “was not aligned with the President’s agenda of Making America Healthy Again.” Monarez’s attorneys argue the dismissal is unlawful, asserting that only the president can remove a Senate-confirmed director.

On Aug. 28, Jim O’Neill, the deputy secretary of the Department of Health and Human Services, was chosen to serve as acting CDC director, several White House officials confirmed to CBS News and KFF Health News. And in an internal email sent to CDC staffers that evening, HHS Secretary Robert F. Kennedy Jr. confirmed O’Neill as the acting CDC director without addressing Monarez’s departure. 

“I am committed to working with you to restore trust, transparency, and credibility to the CDC,” Kennedy told CDC employees, later writing that “President Trump and I are aligned on the commonsense vision for the CDC: Strengthen the public health infrastructure by returning to its core mission of protecting Americans from communicable diseases by investing in innovation to prevent, detect and respond to future threats.”

Houry and Daskalakis said they had become increasingly uneasy about how vaccine policy was being handled. Both pointed to preparations for the Advisory Committee on Immunization Practices meeting, which recommends vaccine schedules.

Houry said they feared “some decisions had been made before there was even the data or the science to support those. We are scientists, and that was concerning to us.”

Daskalakis added that he was “very concerned that there’s going to be an attempt to relitigate vaccines that have already had clear recommendations with science that has been vetted,” which he warned could undermine public trust. “If you can’t attack access, then why not attack trust? And that’s what I think the playbook is,” he said.

Both officials cited instances in which evidence reviews were altered or withdrawn. A CDC analysis of thimerosal, a vaccine preservative, was briefly posted before being taken down at the HHS’ direction. “If there’s something that doesn’t line up with the recommendations, then that information will be taken down, and it’s not there for the public to see for openness and transparency,” Houry said.

The two also criticized what they described as a lack of direct communication between CDC scientists and HHS leadership. Daskalakis said his team was never invited to brief Kennedy on topics ranging from measles to covid-19.

When asked about Kennedy’s calls for “radical transparency,” Houry and Daskalakis described learning about changes to the covid vaccine schedule for children not through internal channels but via social media.

“The radical transparency manifested itself by a Twitter post, which is how Dr. Houry and I learned that the secretary had mandated the change in the children’s vaccine schedule for covid,” Daskalakis recalled. “What is the background that led to that decision? And we were denied access to that information. So, I don’t think that that’s radically transparent,” Daskalakis said.

CBS News and KFF Health News reached out to HHS for comment on some of the allegations made by Houry and Daskalakis but did not immediately hear back.

Both officials said they had no jobs lined up when they resigned. Houry described the decision as an effort to raise the alarm about the direction of the agency.

“For us, this was really sending out a bat signal,” Houry said. “We were the very senior scientists and career leaders at CDC. We thought this was the time to stand together and try to do what we could to raise the alarm around public health in our country.”

Daskalakis said remaining at the CDC under current conditions would have made them complicit in what he called the “weaponization” of public health.

“The safety has already been compromised. … We are flying blind in the U.S. already. If we continued … we would be complicit and would be facilitating the ability to go from flying blind to actively harming people,” he said.

Houry emphasized the severity of the moment by noting that she left without a backup plan.

“My leaving without a job was really just showing how dire the circumstances had become,” Houry said.

Daskalakis said his decision was also shaped by his medical oath.

“As a physician, I take the Hippocratic oath: First, do no harm. I am seeing ideology permeating science in a way that is going to harm children and adults. … I think we are seeing things that are happening that are making our country less prepared to be able to respond to the everyday pathogens … but also … to the next big thing.”

Both also expressed concerns about their personal safety in the current climate.

“The environment we live in … stoked by misinformation, especially from people considered by some to be health authorities, makes me worried for all of us in public health,” Daskalakis said. “I am concerned, but that’s part of our job … to be brave and continue to speak the truth even when we are outside of the CDC.”

The resignations came weeks after a shooting outside the CDC’s Atlanta headquarters, which law enforcement linked to covid misinformation.

Houry said the White House response to the shooting was muted. Kennedy toured the site but later gave an interview expressing distrust of experts. “That was after the attack. It was based on covid misinformation. So this is when we were trying to build trust,” she said.

Daskalakis added that while Kennedy later described mass shootings as a public health crisis, he believed the secretary should address misinformation as a root cause. “The misinformation about the covid vaccine — that has been documented by the Georgia Bureau of Investigation” as the reason for the CDC shooting. “I would really recommend that the secretary actually do take his own advice and actually address the core problem that led to that shooting as well,” he said.

He also noted that the CDC’s gun violence prevention programs had been sharply reduced. “We talk about violence as a public health problem. It is, and there’s things we can do to prevent it. Unfortunately, the majority of that program, the staff are terminated,” he said.

The firings and resignations have sparked calls for oversight. Independent Sen. Bernie Sanders of Vermont called for a bipartisan investigation, Democratic Sen. Patty Murray of Washington urged Kennedy’s removal, and Republican Sen. Bill Cassidy of Louisiana — who voted to confirm Kennedy’s appointment as HHS secretary — said the developments would “require oversight.”

The events come as the FDA narrowed eligibility for updated covid vaccines to older adults and people with risk factors for severe covid.

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Notifications that the funding would not be extended were relayed May 30 to researchers, who were told by National Institutes of Health officials that the Department of Health and Human Services had elected “to go with currently available approaches to eliminate HIV” instead.

The cuts will shutter two major HIV vaccine research efforts first funded by the NIH in 2012 at the Duke Human Vaccine Institute and the Scripps Research Institute, scientists said. A Moderna spokesperson said the vaccine manufacturer’s clinical trials through the NIH’s HIV Vaccine Trials Network have also been put on pause.

One senior NIH official said the HHS had instructed the agency not to issue any more funding in the next fiscal year for HIV vaccine research, with only a handful of exceptions. 

A budgetary rule change specifically targeted at HIV vaccine research is also expected to lead to another cut to the NIH’s awards for studies initiated by scientists, an official said.

The change, to be finalized shortly, inflates the accounting for the upfront cost of studies into HIV vaccines funded by the agency. Instead of the cost of a five-year grant being spread over five years, the NIH plans to make HIV vaccine dollars from multiyear grants all count toward a single year, the official said, making it harder for them to get funded.

A spokesperson for HHS told CBS News that “complex and duplicative health programs have resulted in serious duplication of efforts,” saying that “27 separate programs that address HIV/AIDS” had spent $7.5 billion.

“The Administration believes the United States should have the best medical research in the world. To that end, we are advancing policies to maximize the impact of every federal taxpayer dollar and ensure proper oversight of this funding,” HHS spokesperson Emily Hilliard said.

Hilliard claimed “critical HIV/AIDS programs will continue” under the new agency that Health and Human Services Secretary Robert F. Kennedy Jr. has proposed creating, dubbed the Administration for a Healthy America.

“For HIV vaccine design and development, we’ve begun to see light at the end of the tunnel after many years of research. This is a terrible time to cut it off. We’re beginning to get close. We’re getting good results out of clinical trials,” said Dennis Burton, an immunology professor at Scripps Research.

Burton warned that his institution’s HIV vaccine research could not simply be turned back on, even if a future administration decided to change course on HIV funding. He said that ongoing experiments would be shuttered and that researchers assembled to study the issue would be forced to refocus their careers on other topics.

“This is a decision with consequences that will linger. This is a setback of probably a decade for HIV vaccine research,” Burton said.

The cancellation of the funds comes weeks ahead of the FDA’s June 19 deadline for deciding on approval of lenacapavir, a twice-yearly injectable drug to prevent HIV.

The drug, which is being brought to the commercial market by drugmaker Gilead Sciences, builds on NIH-backed research into earlier HIV medications. The drug’s availability could lead to a significant drop in HIV cases worldwide, since a study found it was 100% effective in preventing transmission.

An NIH official, who was not authorized to speak publicly, rebuked the claim that the effectiveness of current HIV prevention strategies meant a vaccine was no longer needed. “The only way of ending the HIV epidemic in the U.S. and AIDS pandemic worldwide” is with a vaccine, the official said.

Developing an effective HIV vaccine has been an elusive target for researchers, though scientists have hailed recent breakthroughs in the field.

“HIV has established roadblocks to us fighting it off, which are unparalleled in vaccinology. We’ve had to learn what each of the roadblocks are and to devise ways to overcome it. This virus mutates so quickly,” said Duke professor of medicine Barton Ford Haynes, who is part of the Duke Human Vaccine Institute.

Haynes said his institute’s work was essentially combining different vaccines as part of a strategy to design an effective HIV vaccine.

He praised lenacapavir as a “wonderful development for the field” but said there was still a need for a vaccine. Lenacapavir requires injections every six months to remain effective, a challenging proposition even before steep cuts to the Centers for Disease Control and Prevention’s domestic HIV programs and U.S.-backed HIV/AIDS foreign aid programs.

“The hope was that adding an HIV vaccine to all the preventive measures that we have would finally allow us to end the pandemic,” Haynes said.

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Céline Gounder, the editor-at-large for public health at KFF Health News and a CBS News medical contributor, answers questions below about the role Kennedy has been tapped to take on and some of the ideas in the sweeping “Make America Healthy Again” platform he may try to push through.

Q: What is the role of the Department of Health and Human Services, and how much power does the HHS secretary have over its work?

A: The U.S. Department of Health and Human Services comprises several agencies and offices including the National Institutes of Health, the Centers for Disease Control and Prevention, the Food and Drug Administration, the Centers for Medicare & Medicaid Services, the Office of the Surgeon General, and much more.

There is a big difference between political appointees and career civil servants. Political appointees set strategic priorities and align their department or agency’s policies with the current administration’s objectives. Civil servants have the institutional knowledge to know how to get things done and have specialized scientific or technical expertise. Scientific questions require specialized expertise. This is why there are career scientists who advise the HHS secretary, NIH director, CDC director, and FDA commissioner.

The HHS secretary has the authority to establish regulations that govern health, including food and drug safety, public health, and health care quality. The HHS secretary can declare public health emergencies and coordinate federal responses to health crises, such as disease outbreaks or natural disasters. The secretary wields significant influence over the department’s policies and its constituent agencies, which include the CDC, FDA, NIH, and others.

The HHS secretary is also in a position to shape public opinion if given a platform to do so by the media. Absent media attention, their influence on public opinion is more limited. We in the media have a responsibility to fact-check their statements and hold those in power accountable — regardless of who is in power.

Q: One of Kennedy’s most controversial stances is his criticism of vaccines, promoting the idea that they cause autism, among other conditions, and claiming “there’s no vaccine that is safe and effective.” What is the reality?

A: Extensive research has conclusively shown that vaccines do not cause autism. The “research” behind these claims was retracted due to ethical violations and sloppy work. The doctor who originally made those claims lost his medical license as a result of his professional misconduct.

For parents whose kids have autism or people who have autism, this matters. For too long, claims about the safety of vaccines have not only put people at unnecessary risk of getting illnesses that vaccines can prevent, but have also been a red herring, distracting people from the real causes of autism and how to diagnose them and treat them. That distraction is unproductive and harmful.

Secondly, nothing in this world is 100% safe and effective. It’s all about weighing risks, the pros and cons. Is one choice more beneficial or more risky? Do the pros of wearing a seat belt in the car outweigh the risks? Do the pros of exercising regularly outweigh the risks of not exercising? You could get injured while exercising. Do the pros of vaccinating instead of allowing infectious diseases to spread in the community outweigh the cons? Yes, yes, and yes.

Q: Kennedy has said he wants to leave it up to individuals to decide whether to vaccinate themselves or their children. What impact could that have?

A: Increasingly, people are formulating opinions about vaccines based not on science but on Google searches, social media, what family and friends think, and personal observation. That is not research. Research is formulating a hypothesis and trying to disprove that hypothesis. It means you understand how to differentiate correlation from causation. And it means doing repeated experiments to show consistency, not just a chance or random result.

This isn’t a question of whether people are smart or not. But most people don’t have the training, experience, and context to objectively assess the pros and cons of vaccination. You wouldn’t want me repairing your car’s transmission or brake system. I’m not stupid, but I have no training or experience in this.

The risk of leaving these decisions to untrained individuals is that these decisions won’t be made on science. They will be made based on emotion and confirmation bias, which is to say, Google searches looking for opinions that line up with your preexisting beliefs or inclinations. This will put kids at risk, and because vaccines protect against transmissible infectious diseases this will put others in the community at risk, especially other kids and people who are immunocompromised.

Q: Kennedy has also said chemicals in food are tied to autism as well as psychotic episodes and depression. What do we know about the connection between food and mental health?

A: He’s not wrong that there is a relationship between diet and autism as well as diet and mental health. These are areas of ongoing research. No diet has been proven to cure or universally improve autism or mental health symptoms, but certain dietary interventions improve symptoms in some people. These dietary changes may include elimination of ultraprocessed foods, eliminating gluten, and avoiding certain food additives or preservatives. 

Q: Kennedy has said one of the Trump administration’s first acts will be to work to remove fluoride from drinking water, arguing it’s connected to cancer, IQ loss, thyroid disease, and other health problems. Why is fluoride in drinking water, and is it safe?

A: Fluoride is put in the water to reduce the risk of cavities, especially in kids.

As with many things, fluoride safety is all about dose. Drinking a few glasses of water a day is healthy. Drinking from a fire hydrant all day would land you in the hospital. The level of fluoride in U.S. water is safe and protects against tooth decay.

When municipalities stopped putting fluoride in the water, cavity rates went up. This was observed, for example, in Calgary, Canada, and in Juneau, Alaska.

There are parts of the world, including India, China, and East Africa, where fluoride levels 30 to 40 times higher than levels in the U.S. have been found to be harmful. But we don’t have anywhere near those levels of fluoride in our water.

But Kennedy’s statement demonstrates a common misunderstanding about public health authorities in the U.S. We are the United States of America — public health powers reside at the state level. The federal government has the authority to tax and spend and to regulate commerce across state lines, and federal government authorities derive from that.

The CDC provides scientific guidance to help state and local authorities to make informed decisions. The CDC does not mandate fluoridation. The EPA sets the maximum allowable fluoride concentration in public water systems. But states have the authority to mandate fluoridation or can leave it up to local jurisdictions. 

Q: Kennedy has criticized multiple public health agencies he could now lead. He has said the FDA’s “war on public health is about to end,” claiming the agency suppresses anything that “advances human health and can’t be patented” by pharmaceutical companies. What do you make of these criticisms?

A: This again demonstrates a misunderstanding of federal agency authority. Congress has passed laws that give the FDA specific authority to regulate drugs, supplements, and food, and those laws grant the FDA different powers over drugs, supplements, and food.

If anything, given the Supreme Court’s “major questions doctrine,” the courts can determine that agencies may not make regulations on issues of significant economic or political importance unless Congress has clearly authorized such actions. For example, in the case FDA v. Brown & Williamson Tobacco Corp. (2000), the Supreme Court concluded that the FDA lacked the power to regulate tobacco. In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, granting the FDA the authority to regulate tobacco.

Drugs require FDA approval before they can be marketed. Under the law, drugs are defined as substances used to diagnose, treat, or prevent disease.

Supplements don’t need FDA approval before they are sold. The FDA monitors dietary supplements once they are on the market and can take action if they are unsafe or if they make claims about diagnosis, treatment, or prevention of disease.

Dietary supplement manufacturers often choose not to seek FDA approval to market their products as drugs because:

• There are less stringent requirements on dietary supplements than on drugs.
• The FDA approval process is expensive and lengthy. Clinical trials take years to conduct and cost millions of dollars. Manufacturers foot the bill for clinical trials.
• Dietary supplements can be sold directly to consumers without a prescription.

The manufacturer decides whether it wants to seek FDA approval for a drug or if it wants to market a product as a dietary supplement — and that decision typically comes down to time and money. Pharmaceutical companies are less inclined to invest millions of dollars in clinical trials of unpatented treatments due to the lack of exclusive marketing rights (in other words, a time-limited monopoly), which can affect profitability.

The FDA often goes after supplement brands that test this line when it sees companies marketing products with claims that amount to what should be regulated as a drug. This is why supplements often carry a disclaimer that they aren’t being sold to “diagnose, treat, cure, or prevent any disease.” Kennedy has praised the supplement industry for “fighting back,” following a court action over an anti-aging supplement that the FDA argued should be regulated as a drug. 

Finally, the FDA doesn’t grant patents. That’s the job of the U.S. Patent and Trademark Office. 

Q: Trump has said Kennedy will “end the Chronic Disease epidemic.” What are some of the positive actions he could take if he becomes HHS secretary to reduce chronic disease in the U.S.?

A: Kennedy has called for greater regulation of food additives and ultraprocessed foods. Ultraprocessed foods in American diets have led to an explosion in obesity, diabetes, high blood pressure, and other chronic disease.

However, it’s unclear which factions within Trump’s orbit will prevail. Congress may have to give the FDA the authority to regulate more aggressively and the funding to enforce those regulations. Historically, the Republican Party has been opposed to regulation. Trump’s chief of staff pick, Susie Wiles, is a longtime lobbyist who has worked on behalf of the food, insurance, and tobacco industries.

The Heritage Foundation’s Project 2025 — which involved a number of former Trump advisers, but which Trump has tried to distance himself from — would roll back dietary guidelines, making it harder to fight ultraprocessed foods.

Alexander Tin contributed to this report.

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