Health and Human Services Secretary Robert F. Kennedy Jr. is changing the way vaccines are tested.
The department will now require all new vaccines to undergo safety testing in placebo-controlled trials, meaning some people will receive the vaccine while others will get an inert substance like saline to test the vaccine’s efficacy.
The Department Health and Human Services (HHS) called the change a “radical departure from past practices” that will increase transparency about medical products and vaccines.
An HHS spokesperson did not clarify how the policy will be implemented and said the department will “evaluate the data as companies submit their applications.” The spokesperson did define what the department considers to be a new vaccine.
Vaccines for new diseases are sometimes tested against a placebo, but the revised method could make little sense for well-researched diseases like polio and measles, public health experts told The Washington Post.
COVID-19 booster shots are one exception to this and have been authorized without human trials to target quickly evolving new strains of the virus.
“As we’ve said before, trials from four years ago conducted in people without natural immunity no longer suffice. A 4-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,” an HHS spokesperson told The Hill. “The public deserves transparency and gold-standard science — especially with evolving products.”
Kennedy has a long history of vaccine skepticism and has said they aren’t tested enough. He has called for placebo-controlled studies of vaccines multiple times.
Nathaniel Weixel contributed to this report.
