Health and Human Services Secretary Robert F. Kennedy Jr., a longtime anti-vaccine conspiracy theorist, will now require placebo testing for “all new vaccines.”
“All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure — a radical departure from past practices,” an HHS spokesperson said in a statement first reported by The Washington Post on Thursday.
A placebo is an inert substance that does not contain the vaccine. And while vaccines for new pathogens are often tested using a placebo, it’s unclear if HHS would require the same testing for already well-researched vaccines, including the MMR vaccine, which protects against measles, mumps and rubella.
In its statement to publications, the HHS said Kennedy is “pro-transparency,” but did not provide basic clarifying details on when the changes would take place and what vaccines could be affected. A spokesperson for the HHS did not immediately respond to a request for comment.
Although COVID vaccines aren’t mentioned in the statement, it did suggest any updates to the vaccines could put it in the category of “new vaccines,” which would require placebo testing.
“As we’ve said before, trials from four years ago conducted in people without natural immunity no longer suffice,” the statement said. “A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years.”
Health officials warn that the changes could seriously delay a vaccine’s release and lead to making vaccines less accessible. It could also create situations in which someone needing a life-saving vaccine could instead receive a placebo.
“You are watching the gradual dissolution of the vaccine infrastructure in this country,” Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, told The Washington Post. “The goal is to make vaccines less available and less affordable.”
Peter Lurie, a former official with the Food and Drug Administration (FDA), told the BBC that the proposed change is “treading in ethically dubious territory.”
Lurie said, “But, broadly, if they mean that every modification to an existing vaccine would require a new placebo-controlled trial, they are treading in ethically dubious territory and likely to deny Americans life-saving vaccines at some point.”
Kennedy, a longtime anti-vaccine conspiracy theorist, has made several false claims about measles and the MMR vaccine, even as measles cases in the U.S. near 1,000. Three people have died, including two Texas children.
“It’s not unusual,” Kennedy said in February when asked about the measles death of a 6-year-old Texas boy. “We have measles outbreaks every year.”
Kennedy slightly walked back his comments after attending the funeral of an 8-year-old Texas girl who died from measles at the start of April.
“The most effective way to prevent the spread of measles is the MMR vaccine,” he posted on X.
Of the current measles cases, 96% of those infected were either unvaccinated or their vaccination status was unknown.
On Monday, on Merit TV’s “Dr. Phil Primetime,” Kennedy told parents to “do your own research.”
“I would say that we live in a democracy, and part of the responsibility of being a parent is to do your own research,” Kennedy said in response to a question regarding vaccine safety. “You research the baby stroller, you research the foods that they’re getting, and you need to research the medicines that they’re taking as well.”
Kennedy did not specify any sources parents should look at.