Despite warnings from an FDA adviser of a lack of sufficient safety and efficacy data, the FDA on Wednesday authorized COVID-19 boosters of the updated bivalent vaccine for children 5 years of age and older.
The agency amended its emergency use authorization of the Moderna and Pfizer-BioNTech bivalent vaccines to include children, allowing it to be administered at least two months after completion of primary or booster vaccination.
The FDA adviser who issued the warning, Dr. Paul Offit, was one of two members of the agency’s vaccine advisory panel to vote against recommending the booster shot, which was modified to target omicron variants. Offit, the co-inventor of a rotavirus vaccine, argued that the testing was limited to only eight mice, with no human participation.
“I don’t ever think you should ever ask tens of millions of people to get a vaccine based on mouse data,” he said in a video interview.
Offit – a specialist in infectious diseases, vaccines, immunology and virology – directs the Vaccine Education Center at Children’s Hospital of Philadelphia, where he is an attending physician in the Division of Infectious Diseases.
He said the only reason he voted against recommending the new booster in the June advisory panel meeting – there were 19 yes votes – was “because ‘hell no’ was not a choice.”
“It just surprised me that we were willing to go forward with such scant evidence of benefit,” he said.
Offit added that he “just felt sort of like the fix was in a little bit here – maybe that’s not the right phrase – but it was something that they wanted.”
“I felt like we were being led here, with a critical lack of information.”
One year ago, several members of the FDA’s vaccine advisory panel said they were reluctantly recommending approval of the Pfizer vaccine for children ages 5-11 despite a lack of safety data.
A panel member, Dr. Eric Rubin, editor of the New England Journal of Medicine, famously said during the hearing, “We’re never going to learn about how safe the vaccine is unless we start giving it – that’s just the way it goes.”
The FDA’s top vaccine adviser, Dr. Peter Marks, was at the center of the resignations of the two top FDA scientists in 2021 over alleged government interference in the approval of the COVID vaccines.
See Offit’s remarks:
“I don’t ever think you should ever ask tens of millions of people to get a vaccine based on mouse data“ https://t.co/GNfL5TiRzO
— Marty Makary MD, MPH (@MartyMakary) October 12, 2022
The FDA said in a statement Wednesday that the bivalent COVID-19 vaccines “include an mRNA component of the original strain to provide an immune response that is broadly protective against COVID-19 and an mRNA component in common between the omicron variant BA.4 and BA.5 lineages to provide better protection against COVID-19 caused by the omicron variant.”
Marks, director of FDA’s Center for Biologics Evaluation and Research, argued in the FDA statement that with children back at school in person “and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19.”
“Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” he said.
In March, a former adviser to the FDA commissioner who continues to serve in an oversight role said the agency is ignoring its requirement to disclose clear safety and efficacy problems with the COVID-19 vaccines.
Also in March, an Army flight surgeon testified in federal court that she was ordered by high-level command not to discuss the controversy over Department of Defense data indicating a massive spike in serious injuries and illnesses among military personnel when the vaccines were rolled out in 2021.
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