RFK Jr. to require placebo-controlled studies for new vaccines
The Trump administration plans to impose a new testing requirement for new vaccines — a demand that could delay the availability of the next round of COVID-19 vaccines and complicate the approval of other vaccines.
The administration will require all new vaccines to be tested against an inert substance known as a placebo before they can be made available, which is a “radical departure from past practices,” according to a statement from Andrew Nixon, a spokesman for Robert F. Kennedy Jr., the secretary of Health and Human Services.
The latest statement triggered alarm among vaccine experts that this may be another step by Kennedy to undermine the confidence in and availability of vaccines.
“I think it is the interest of Robert F. Kennedy Jr. to make vaccines more expensive, less available and more feared,” said Dr. Paul Offit, a University of Pennsylvania vaccine expert. “He’s an anti-vaccine activist, a science denialist who is going to do everything he can to tear down the infrastructure in this country of vaccines. Robert F. Kennedy Jr is a dangerous man.”
The administration maintains this new requirement is aimed at ensuring vaccines are safe. But vaccine experts dispute the claim that key vaccines weren’t tested against a placebo. They also take issue with the definition of what constitutes a new vaccine. The ingredients in some vaccines, such as the COVID shots, have been updated regularly to better match the strains of the SARS-CoV-2 virus in circulation, without fundamentally changing the vaccines themselves. That has long been the case with flu vaccines, too.
“Secretary Kennedy’s HHS has pledged radical transparency to the American public. This means being honest and straightforward about what we know — and what we don’t know — about medical products, including vaccines,” Nixon said.
He also claimed that “except for the COVID vaccine, none of the vaccines on the CDC’s childhood recommended schedule was tested against an inert placebo, meaning we know very little about the actual risk profiles of these products.”
Nixon also questioned the reliability of existing vaccine monitoring programs, which he described as “regulatory malpractice.”
Change in standard could delay future COVID shots
While the administration didn’t specifically name the COVID vaccines, Nixon indicated any update to the COVID vaccines could make them new vaccines that would require this testing.
“As we’ve said before, trials from four years ago conducted in people without natural immunity no longer suffice. A four-year-old trial is also not
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