WASHINGTON — Robert F. Kennedy Jr. clinched the political support needed to become the nation's top health official by pledging to work within the decades-old federal system for approval and use of vaccines. Yet his regulators are promising big changes that cloud the outlook for what shots might even be available.
The Food and Drug Administration will soon "unleash a massive framework" for how vaccines are tested and approved, according to Commissioner Marty Makary. Details aren't yet public but the plan is being overseen by the agency's new vaccine chief, Dr. Vinay Prasad, an outspoken critic of FDA's handling of COVID-19 boosters.
Makary and other Trump administration officials already took unprecedented steps that raise uncertainty about next fall's COVID-19 vaccinations, including delaying FDA scientists' full approval of Novavax's shot — and then restricting its use to people at higher risk from the virus. They also suggested seasonal tweaks to match the latest circulating virus strains are new products requiring extra testing.
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Secretary of Health and Human Services Robert F. Kennedy Jr. appears Wednesday before a Senate committee on Health, Education, Labor and Pensions hearing at the U.S. Capitol on in Washington.
The changes cross multiple health agencies.
The Centers for Disease Control and Prevention hasn't yet acted on an influential advisory panel's recent recommendations on use of a new meningitis shot or broader RSV vaccination.
A meeting of Kennedy's "Make America Healthy Again" allies was recently told to expect an end to COVID-19 booster recommendations for children — something that vaccine advisory panel was supposed to debate in June. Researchers around the country lost National Institutes of Health funding to study vaccine hesitancy.
"I think you have to assume that RFK Jr.'s intention is to make it harder for vaccines to come to market," said Dr. Amesh Adalja, a vaccine expert at Johns Hopkins University. The changes are "looked at suspiciously because this is someone with a proven track record of evading the value of vaccines."
Food and Drug Administration commissioner Marty Makary speaks during a news conference April 22 at the Hubert Humphrey Building Auditorium in Washington.
Raising doubts about vaccines
In a Senate health committee hearing last week, Kennedy incorrectly claimed that the only vaccines tested against a placebo, or dummy shot, were for COVID-19.
Sen. Bill Cassidy, a Louisiana Republican and physician who chairs the committee, briefly interrupted the hearing to say, "For the record, that's not true" — pointing to placebo-controlled studies of the rotavirus, measles and HPV vaccines.Â
Concerned by rhetoric about how vaccines are tested, a group of doctors recently compiled a list of more than 120 vaccine clinical trials spanning decades, most of them placebo-controlled, including for shots against polio, hepatitis B, mumps and tetanus.
"It directly debunks the claim that vaccines were never tested against placebo," said Dr. Jake Scott, a Stanford University infectious disease physician who's helping lead the project.
Antivaccine groups claim some substances scientists call a placebo may not really qualify, though the list shows simple saline shots are common.
Dr. Sydney Sewall fills a syringe with the COVID-19 vaccine Dec. 21, 2021, in Augusta, Maine.
Trump officials held up decision
The administration's promise of a new vaccine framework comes ahead of a Thursday meeting where FDA advisers will discuss updating COVID-19 shots for this fall and winter.
The FDA's credibility has long rested on the independence of its scientific decisions. While the agency is led by a handful of political appointees, approval decisions are almost always handled by career scientists.
That standard appears to be shifting. FDA staffers were poised to approve Novavax's vaccine early last month but administration officials, including Makary, delayed the decision, according to two people with direct knowledge of the situation who spoke on condition of anonymity. The shot was approved late Friday with unusual restrictions.
Dr. Tracy Beth Hoeg — a political appointee serving as Makary's special assistant — was involved in the unprecedented demand that Novavax conduct a new clinical trial of its shot after approval, according to the people. The requirement came shortly after the agency's longtime vaccine chief, Dr. Peter Marks, was forced to resign.
Hoeg — along with Makary and Prasad — spent much of the COVID-19 pandemic criticizing the FDA's handling of booster shots, particularly in children and young adults. All three were co-authors of a 2022 paper stating that requiring booster shots in young people would cause more harm than benefit.
Booster critics in control
As the FDA's top official overseeing vaccines, Prasad is now in position to reverse what he recently called "a number of missteps" in how the FDA assessed the benefits and risks of COVID-19 boosters.
He questioned how much benefit yearly vaccinations continue to offer. In a podcast shortly before assuming his FDA job, Prasad suggested companies could study about 20,000 older adults in August or September to show if an updated vaccine prevented COVID-related hospitalizations.
There is "legitimate debate about who should be boosted, how frequently they should be boosted and the value of boosting low-risk individuals," said Hopkins' Adalja. But he stressed that CDC's Advisory Committee on Immunization Practices has the proper expertise to be making those decisions.
Other experts say simply updating the strain that a COVID-19 vaccine targets doesn't make it a new product — and real-world data shows each fall's update has offered benefit.
"The data are clear and compelling" that vaccination reduces seniors' risk of hospitalization and serious illness for four to six months, said Michael Osterholm, a University of Minnesota infectious disease researcher.
Nor could that kind of study be accomplished quickly enough to get millions of people vaccinated before the yearly winter surge, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
"You'd always be doing clinical trials and you'd never have a vaccine that was up to date," he said.
For families with sick kids, the rise of vaccine hesitancy could be life-threatening
For families with sick kids, the rise of vaccine hesitancy could be life-threatening
Colleen Thomas' son was born missing a part of his immune system. The Indiana mother didn't know that immediately, but there were signs. The little boy was always sick—constant congestion and respiratory infections. Thomas had to hold a breathing mask over her son's face as he slept and wheezed.
"That was just for a cold," Thomas recalled. "It was horrible."
Thomas' son was 3 when he was diagnosed with an immunodeficiency that made him susceptible to severe illness if he was exposed to respiratory infections.
"Once he was diagnosed by an immunologist, it all became very clear that he'd been really lucky, that he had only caught mild viruses and colds—even though it wasn't mild for him," she said. "He's very lucky he didn't come into contact with something like or ."
"There was a point at which the doctor looked at me and said, 'I don't know if he would survive those,'" Thomas added. "That is scary."
Even before his diagnosis, Thomas' son got all his childhood vaccinations, reports. Now, with the news of —coupled with Robert F. Kennedy Jr., an anti-vaccine activist, of the nation's health department—Thomas worries about the future of vaccine research, messaging and hesitancy in the country.
For parents of kids and adult children with immunocompromised systems, the consequences of fewer people vaccinating themselves and their children could be life-threatening—particularly for young children, children and adults with medically complex needs and disabilities, and older Americans. Often the people advocating most on their behalf are parents, or members of the sandwich generation who have young children and also care for aging parents. Many of them are women, who are credited with making family health decisions.
Thomas' son, who is now 12 and much healthier, for a long time relied on the chance that enough people around him—at places like school, the park, and even the grocery store—were vaccinated. High rates of vaccination can achieve herd immunity, the indirect protection of a community from an infectious disease. It can also be achieved through natural infection, but it leads to .
Medical experts worry about the impact on herd immunity if more people decline vaccinations. The percentage of people who need to be immune from a disease varies, but herd immunity .
"The good news is that the vast majority of adults in the U.S. are vaccinated," said Dr. Elizabeth Jacobs, a cancer and nutritional epidemiologist who has studied vaccine hesitancy, in an email. "Over time, however, as vaccination coverage continues to drop, we can expect to see more outbreaks of diseases that are preventable."
Herd immunity protects not just people with weakened immune systems, but also people who can't get vaccinated yet like newborns.Â
"These are already issues that we've been working to address by creating herd immunity, so it protects those people that need this most because of whatever reasons they can't get a vaccine," said Dr. Regina Davis Moss, who advocates for equitable health outcomes through . She previously worked for the federal health department, Kaiser Health and the American Public Health Association.Â
"The beauty of living in the United States is that we do have freedom, we do have choice," she said. "But that doesn't mean it doesn't have consequences—that doesn't mean that other people don't get hurt."
Concerns about vaccine hesitancy come as are declining, and there is a rise in the so-called "medical freedom" movement, which essentially rejects government interference in health choices.
"I feel like what gets lost in this discussion is parents who also want to make sure that their communities and their child's school are healthy," said Rekha Lakshmanan, chief strategic officer at , a Texas-based nonprofit that educates the public and state lawmakers on the importance of vaccinations. "Those parents, too, have a right to make sure that we're living in a society and in a community that is free from disease. Their rights are getting lost in all this discussion."
Thomas said the population of people who are anti-vaccine—meaning they will not accept medical science on the safety of vaccines—is smaller than people realize.
"Most people are not that way," she said. "But that tiny group is very loud, and so I have to be the counter voice."
Pennsylvania resident Erica Finkelstein-Parker's adult son, Djino, was diagnosed with liver cancer in 2021 at the age of 15. He received oncology treatments for a year, which culminated with a liver transplant. Today, the 19-year-old is on immunosuppressant medication that has weakened his immune system and makes him more susceptible to severe illness.
Finkelstein-Parker makes sure her family is up to date on vaccines. But it won't be enough for her son if there are increasing instances of widespread infection among unvaccinated people. The measles outbreak in Texas—among mostly children—is in a county with one of the lowest vaccination rates in the state."
"I can't tell you how angry I get when I hear people say, 'It's my right to not vaccinate,'" she said. "It's not somebody's right to endanger somebody else."
Childhood vaccination rates have been declining since around the start of the pandemic, a period of rising disinformation and misinformation about vaccine safety about vaccines. (The nation's vaccines .)
"Refusing vaccines is withdrawing from the community health bank without depositing anything back into it," Jacobs said. "A lot of people think that choosing not to vaccinate will only affect their own children, but this is not true."
During the pandemic, an anti-vaccine nonprofit that Kennedy founded was linked to widespread messaging against the COVID-19 vaccines, . At the height of the pandemic, the same group asked the federal government , claiming the health risks outweighed the benefits.
People who are anti-vaccine consciously challenge the safety of vaccines despite research that confirms they are safe. Then there are people who lack enough information about existing vaccine safety data, but are willing to change their minds. Lakshmanan said that the public should not equate these groups as the same, since the latter is open to changing their minds.
"They're just genuinely trying to decipher and swim through the vast amount of information to help inform them as to how they want to approach vaccines for their children," she said.
Keesha Middlemass is a political science professor at Howard University who has examined the history of racist medical research, misinformation and its impact on vaccine hesitancy among Black people. Middlemass said it's important to acknowledge that American society is facing a fractured media ecosystem that will make vaccine education more difficult moving forward.
"People don't trust government," she said. "The lack of trust in government, plus the disinformation in this echo chamber of information, leads to vaccine hesitancy."
During his Senate confirmation hearings, Kennedy was repeatedly asked about his history of . He refused to say that vaccines don't cause autism. (.) Kennedy also claimed support for the measles vaccine and the polio vaccine. During one of his first remarks as secretary, Kennedy indicated an interest in .
As HHS secretary, Kennedy oversees the research and approval of vaccines but does not have authority to revoke vaccine mandates that were put in place by statehouses around the country. But some legislatures and state officials have begun to dismantle that safety net.
In Louisiana, the surgeon general there announced this month that . Lawmakers in several states have filed bills aimed at expanding the types of reasons that parents can use to exempt their children from vaccines.
Now with RFK Jr. as HHS secretary, Lakshmanan said she won't be surprised if vaccine hesitancy gets more air time on social media and other mediums.
"That's going to just create even more confusion for parents," she said.
Lakshmanan said it's important that people call out bad faith messaging on vaccines, including from medical professionals and doctors within the halls of state legislatures.Â
"We should hold lawmakers, policymakers and decisionmakers accountable when they try to normalize misinformation about vaccines," she said. "At the end of the day, it's about protecting kids and putting kids over the politics around this issue."
Middlemass said the way forward will be a vaccine education, but it can't be a one-size-fits-all approach.
"Vaccine education needs to be culturally relevant. A single campaign for everybody is not appropriate," she said. "There's got to be a huge push for vaccine education through a public health lens that connects with different communities. You need credible messengers. You need to be able to approach parents where they are, versus telling them what they must do."
Finkelstein-Parker is observing all of this with frustration. She promotes vaccines through a social media account, writes to her congressional leaders and plans on getting more politically involved locally. For her, it's personal.Â
She adopted a child, a daughter named Emmalee, in 2005. Emmalee died in 2011 at age 8 from complications related to a measles infection she contracted prior to her adoption, in her home country of India. Finkelstein-Parker's daughter's case was rare, but emerging measles outbreaks in the United States shows what's at stake for other families.
"I am a vaccine advocate because for people walking around unvaccinated, if they get measles as an adult, they're going to be really sorry. If their kids get it, they land in the hospital," she said.
Today, Thomas said her son is thriving after years of surgeries and treatment. She volunteers for an Indiana vaccine advocacy organization that does outreach to parents and lawmakers. Thomas wonders about the families and friends in her community whose children are as vulnerable as her son was as a toddler and young child. She implored mothers in particular to seek science-based information.
"If they're not going to take the time to go to the doctor and really listen and ask questions, then they're going to run with this misinformation," she said. "And they're not doing it because they're trying to be negligent or hurt their kids. They're trying to do the very best they can for their kids, and we're just victims of this manipulation."
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