United States: New methods in vaccine safety examinations approved by HHS generate concerns about increased regulatory hurdles, which may limit the availability of COVID-19 and additional viral vaccines.
Under Secretary Robert F. Kennedy Jr.‘s leadership, HHS might utilize a prolonged process for new vaccine technology assessment, which violates fundamental medical and scientific measures to verify vaccine safety.
More about the news
As per Richard Hughes, a partner at law firm Epstein, Becker & Green and former vice president of public policy at Moderna, “It’s going to do some damage to the speed at which we get new vaccines, and just the basic availability of new vaccines to prevent diseases,” axios.com reported.
The HHS requires new vaccines to demonstrate safety performance by conducting clinical trials using placebos.
RFK Jr.'s latest vaccine plan threatens future of shots, experts say https://t.co/Ho50VHzAER
— Axios (@axios) May 1, 2025
The HHS has not specified its requirements when defining what qualifies as a new vaccine.
FDA vaccine advisory committee member Paul Offit since 2018 states that new vaccines historically need testing against placebos, according to his position as director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
The existing flu vaccine retains its safety status without continuous placebo testing since its basic structure has already proved its safety.
Each year, a vaccine produces fresh updates by using the currently existing virus strain.
What are the critics stating?
According to critics mentioned in the Washington Post’s initial report, the new policy may create vaccine doubts among people, which could result in slow development of new inoculations at higher development costs.
RFK Jr. intends to shift the way vaccines are tested, a move HHS says will up transparency but medical experts fear could limit access to vaccines & undermine the public’s trust in immunization depending on its implementation
— Lauren Weber (@LaurenWeberHP) May 1, 2025
Our latest @washingtonpost https://t.co/IojyoeadY0
The analysis matches the beliefs of former President Kennedy based on Offit’s examination of Axios.
“That’s who he is. That’s who our head of Health and Human Services is. It is a dangerous time for America’s children,” he added.
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