Two days after CBS News broke the informal media blackout of COVID-19 vaccine “safety signals” suppressed by the Biden administration’s Food and Drug Administration, the outside advisers to the Trump administration’s FDA voted to recommend updated COVID vaccines despite receiving no safety data, as one adviser had requested.It’s déjà vu all over again for the Vaccines and Related Biological Products Advisory Committee, which similarly complained about the prior administration hiding data sought by advisers to make informed decisions about COVID vaccine recommendations.
The committee recommended targeting the “JN.1-lineage XFG” of SARS-CoV-2 in next season’s vaccines at its six-and-a-half hour May 28 virtual meeting. The FDA’s summary said advisers reviewed data on manufacturing, circulation of variants, current vaccine effectiveness and both human and animal “immunogenicity data,” not mentioning safety.
Sanofi and Novavax are already making non-mRNA versions of the new formulation, and Moderna says it will have mRNA jabs ready by mid-August.
Vaccine injury lawyer Aaron Siri trashed the advisers for “shamelessly” recommending a new vaccine, “ignoring its incredible trail of harm,” after giving a three-minute comment asking the committee to make an “evidenced-based and not belief-based decision.” Siri’s new book Vaccines, Amen portrays jabs as a religion shielded from scientific scrutiny.
“The COVID cartel’s cover-up continues,” Senate Permanent Subcommittee on Investigations Chair Ron Johnson, R-Wis., said after the vote, sharing Siri’s testimony.
His subcommittee exposed the Biden FDA silencing whistleblower Ana Szarfman when the data-mining expert told officials including Peter Marks, then-director of the Center for Biologics Evaluation and Research, that its surveillance was “masking” dozens of “statistically significant safety signals for adverse events” following COVID vaccination as early as March 2021.
Johnson is convening medical experts from around the world at a Wednesday hearing to share “plausible mechanisms” by which COVID jabs are “causing” cancer.
‘FDA keeps the lane narrow’ and early warning system ‘effectively disabled’
Former FDA regulatory review officer Jessica Adams and CEO David Wiseman of Synechion, which specializes in “products for preventing postsurgical adhesions,” separately observed that safety wasn’t even on the VRBPAC agenda and that only member Hayley Gans, a Stanford pediatrics professor, asked for “continued safety data” for the committee to review.
“I think that there is some misinformation in the public, and it would be nice actually to see those” data, whether provided by the Centers for Disease Control and Prevention or the vaccine makers, Gans said, according to Adams’ transcript of the exchange.
CDC representative Natalie Thornburg responded with an apologetic “non-answer.” The Immunization Safety Office collects that data, but it didn’t send a rep to the virtual meeting, and it has not presented to VRBPAC “in years past,” Thornburg said.
“Even if safety was not formally part of today’s agenda, is it really asking too much for CDC to have someone present who can speak to ongoing vaccine safety questions if committee members raise them?” Adams wrote on X.
Unlike flu vaccines, COVID vaccines are “newer products with ongoing” post-marketing requirements and conditions, “evolving risk-benefit discussions, and an entirely different level of public attention and controversy,” she said. The FDA should “make room elsewhere” to address safety if it wants to limit these meetings to “strain selection.”
Adams elaborated on the limitations in the committee’s mandate, which was “not re-approving the vaccines,” yet some members have nonetheless “spent years raising broader questions beyond a purely narrow strain-selection role,” including safety surveillance, new safety signals and requests for “underlying data” on the “overall benefit-risk profile.”
“FDA keeps the lane narrow,” she lamented. “There is no established annual committee process for a comprehensive benefit-risk reassessment here.”
