Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has proposed changes to vaccine testing, a shift that the agency said intends to increase transparency by providing the highest standards of safety and efficacy testing. The pending changes will require all new vaccines to undergo placebo testing, an experiment where some people receive the vaccine while others are given an inert substance, and then scientists compare the results.
"All new vaccines will undergo safety testing in placebo-controlled trials prior to licensure - a radical departure from past practices," an HHS spokesperson told The Washington Post, who made it clear that "Secretary Kennedy is not anti-vaccine - he is pro-safety, pro-transparency, and pro-accountability."
HHS did not clarify which new vaccines will be subjected to the testing. However, the agency stated that the changes will not apply to the flu vaccines, explaining that such vaccines have been "tried and tested for more than 80 years."
Secretary Kennedy has a lengthy history of advocating for enhanced vaccine safety testing, including placebo testing for vaccinations that have been approved for use. He has also advocated for longer vaccine testing studies, saying in a 2021 interview, "A lot of the injuries that come from medication are autoimmune injuries and allergic injuries and neurodevelopmental injuries that have long diagnostic horizons or long incubation periods, so you can do the study and you will not see the injury for five years."
The HHS and the National Institutes of Health (NIH) has also announced "the development of the next-generation, universal vaccine platform, Generation Gold Standard" for vaccines intended to treat pandemic-prone diseases.
"Our commitment is clear: every innovation in vaccine development must be grounded in gold standard science and transparency, and subjected to the highest standards of safety and efficacy testing," said RFK Jr. in a press release.
HHS said that Generation Gold Standard, developed by NIH's National Institute of Allergy and Infectious Diseases (NIAID), will recalibrate America's pandemic preparedness, utilize government-led research to ensure transparency, accountability, and freedom from commercial conflicts of interest, and mark the future of vaccine development for proactive pandemic prevention.
"Generation Gold Standard is a paradigm shift," said NIH Director Dr. Jay Bhattacharya. "It extends vaccine protection beyond strain-specific limits and prepares for flu viral threats - not just today's, but tomorrow's as well - using traditional vaccine technology brought into the 21st century."