RFK Jr. changing new vaccine testing to include placebo

Health and Human Services Secretary Robert F. Kennedy Jr. Is changing the way vaccines are tested and will now require all new vaccines to undergo safety testing in placebo-controlled trials, meaning that some people will receive the vaccine while others get an inert substance like saline to test the vaccine’s efficacy.  

HHS called the change a “radical departure from past practices” that will increase transparency about medical products and vaccines.  

HHS added in its release that none of the vaccines on the Centers for Disease Control and Prevention’s childhood recommended schedule were tested against an inert placebo, but health experts say this is false.  

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 often tested against a placebo, like saline or another inert substance, to test their safety and efficacy. But in some cases, using a traditional placebo is not necessary, according to health experts.  

“You need a comparison group, but it doesn’t always have to be a placebo, in a way I think they are defining,” William Moss, executive director of the International Vaccine Access Center at Johns Hopkins University.  

Moss added that it could be unethical to use a placebo when an existing and well-established vaccine is available that health experts know is safe and effective, like the current measles, mumps, and rubella vaccine.  

Sometimes, during vaccine trials, participants in a comparison group are not given a placebo but another type of vaccine so that they can still receive some benefit from the study, Moss said.

“That was done in studies of malaria vaccines in sub-Saharan Africa, they gave children another vaccine to compare.”  

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 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,” 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 that they are tested enough.  He has called for placebo-controlled studies of vaccines multiple times.  

Updated at 4:20 p.m. EDT