Robert F. Kennedy Jr., awaiting confirmation to become secretary of health and human services, has repeatedly claimed that vaccines are not tested rigorously enough and has called for an alternative type of testing that medical experts say would be unethical, according to a Washington Post review of his public statements from recent years.
In at least 34 appearances, Kennedy called for placebo-controlled studies for vaccines that have already been approved for use, The Post found in a review of more than 400 of Kennedy’s podcast appearances, interviews and public speeches since 2020. In his push for vaccine safety, Kennedy has repeatedly falsely linked vaccines to deaths without evidence, saying “that’s the danger of not having placebo-controlled trials.”
But experts say placebo-controlled trials - where one group of people gets a medicine or treatment and the other does not - would be irresponsible to apply to most vaccines because it could deprive people of immunizations already proved to prevent infectious disease. In practice, that could mean several thousand children in Chicago, for instance, would not get childhood vaccinations, while their neighbors did.
In an interview with a health and wellness influencer in January 2024 while he was mounting his campaign for president, Kennedy vowed that if he won the presidency, he would “reorient” National Institutes of Health research efforts to focus on vaccine safety, saying “none of the childhood (vaccines) have ever been studied” and “we ought to evaluate the risk profile realistically over long periods of time.” In a separate 2023 interview, he promised to “immediately do placebo-controlled trials.”
Kennedy’s insistence that vaccines are not regulated adequately fits a broad pattern of his disparagement of them despite overwhelming scientific evidence, a previous Post examination found. Public health leaders fear that if Kennedy is confirmed to run the Department of Health and Human Services, his views will seep into the nation’s vaccine policy, delay the development of lifesaving shots and further intensify vaccine hesitancy.
“He’s going to do everything he can to weaken the infrastructure of vaccines,” said Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
Requests for comment to Kennedy went unanswered. If Democrats collectively rally against Kennedy during his confirmation vote, which is widely expected to take place this week, he can afford to lose only three Republican senators to secure the nomination.
In his Senate hearing in front of the health committee, Kennedy said: “News reports and many in the hearing yesterday have claimed that I’m anti-vaccine and anti-industry. Well, I’m neither. I’m pro-safety. I’m pro-good science.”
But Kennedy’s previous comments about vaccine testing appeared concerning enough that he had to promise Sen. Bill Cassidy (R-Louisiana) that he would not establish a separate system of testing immunizations, the senator said in a floor speech Feb. 4 explaining why he had decided to cast a pivotal vote for Trump’s nominee.
It is unclear whether Kennedy would call for additional placebo trials or other testing mechanisms. Regardless, Kennedy would have the powerful bully pulpit as HHS secretary, said Amesh Adalja, an infectious-disease physician and senior scholar at the Johns Hopkins Center for Health Security.
“He doesn’t have to create a parallel system, he just has to open his mouth,” Adalja said.
Unpacking placebo-controlled trials
Kennedy often makes the misleading argument that without placebo-controlled trials, Americans cannot know if vaccines are having long-term side effects.
“Vaccines are the only medication that are exempt from pre-licensing placebo-controlled trials,” he said in a Rumble interview with Glenn Greenwald in 2023. “So the only way that you get that information … is if you test a large cohort of people who are vaccinated and measure them against a large cohort that are unvaccinated and then watch them for about five years.”
Placebo-controlled trials are considered the scientific gold standard in testing medicines and vaccines. A group that receives treatment and a group that does not are measured for the outcomes over a period of time to ensure the treatment is safe and effective.
Newly developed vaccines for diseases that do not have an existing one undergo such placebo-controlled trials - such as the first iterations of the coronavirus vaccine. But for diseases where a vaccine exists, the medical community considers it unethical to deprive children or adults of an effective vaccine that could protect them from harmful and potentially deadly pathogens.
Thus those new variations of those vaccines undergo clinical trials, in which the control group receives the prior vaccine that is considered the standard of care, and its outcomes are monitored against the group that receives the newly formulated vaccine.
What Kennedy repeatedly suggests - running placebo-control trials on previously approved vaccines - flies in the face of medical ethics, Adalja said.
“No doctor is going to risk a malpractice lawsuit for not giving somebody a vaccine that works,” he said.
Kennedy’s argument that the vaccines are not fully tested also overlooks those who could suffer if placed in the placebo group, Offit said, pointing to the “casual cruelty” of the U.S. polio vaccine trial organized by the nonprofit health organization March of Dimes. In 1954, a polio vaccine created by Jonas Salk was tested against a placebo group of hundreds of thousands of children against his wishes, as Salk believed it was probably effective against the disease and thought giving them a placebo would be immoral.
While 420,000 U.S. children were given Salk’s inactivated polio vaccine, 200,000 were inoculated with salt water. The 16 children who died were all in the placebo group, and 34 were paralyzed, Offit said, according to research he had done for a book.
That kind of trade-off is unacceptable when there already are vaccines that are known to prevent infectious disease, Offit said.
Vaccine safety testing
Kennedy has repeatedly claimed that vaccines are not tested as much as medicines when he makes his pitch for placebo-controlled studies.
“They’re the only medicine or medical product that are exempt from pre-licensing safety trials,” Kennedy said in an interview with Piers Morgan in 2023.
Experts say his claim that vaccines do not undergo pre-licensing safety trials is not true - vaccines go through several stages of clinical trials before approval. Thousands of people are studied along the way to determine vaccines’ safety and effectiveness before they are rolled out to the public. And after vaccines are in use, companies, health-care providers and the federal government monitor for additional adverse events.
Kennedy’s claims that vaccines aren’t tested as much as medicines are also false, said David Gorski, a Wayne State University School of Medicine professor of surgery and oncology and managing editor of Science-Based Medicine, which debunks misinformation in medicine.
“It’s exactly the opposite, they’re tested way more rigorously than medicines,” he said, noting that while medicines are given to treat a condition, vaccines are given to healthy people, so the tolerance for risk of adverse events is much lower.
Offit said there is no government-led system to monitor drugs after they’re rolled out as rigorous as the Vaccine Safety Datalink, which monitors electronic health record data to “assess vaccine safety and detect adverse events in near-real time,” according to the Centers for Disease Control and Prevention.
Kennedy, however, often falsely links the growing vaccine schedule - which has grown along with scientific breakthroughs - to autism, food allergies and chronic disease.
“Not one of those 72 vaccines has ever had a pre-licensing safety study, which means nobody can tell you whether that product is going to have heard more problems than it causes,” Kennedy said in an appearance on Chris Cuomo’s NewsNation show last year.
Arguing that not a single childhood vaccine was ever studied before it was licensed is false, experts say. Additionally, it’s a claim that ignores the safety systems set up to catch vaccine injuries and safety signals, experts said, allowing vaccines to be pulled off the market if they are found to be unsafe. That process was on display when the government’s extensive monitoring system for adverse events linked the Johnson & Johnson coronavirus vaccine to a rare side effect - blood clots that resulted in nine patient deaths in the United States. That vaccine was pulled.
Kennedy’s long history of throwing out scientific-sounding statements should not disguise the truth of the robust vaccine monitoring that takes place in the United States, said Richard Hughes IV, a former vice president of public policy at Moderna who teaches vaccine law at the George Washington University Law School.
“What (Kennedy) does is he repeats this and it sounds important, it sounds like why would we not develop the safety data?” Hughes said. “And lawmakers sometimes buy into that and say ‘Well, why shouldn’t we have the safety data?’ But the fact is we already have the safety data. And we have these robust systems for continuously monitoring vaccines.”