Featured Image: yourNEWS Media Illustration
A federal vaccine advisory panel backed next season’s COVID-19 formulation after a member asked to review ongoing safety data, but CDC officials said no safety office representative was present.
By yourNEWS Media Newsroom
A federal vaccine advisory committee recommended an updated COVID-19 vaccine formulation for the 2026-27 season after a member asked to review ongoing safety data and was told the Centers for Disease Control and Prevention’s Immunization Safety Office was not represented at the meeting, according to a Just the News report.
The vote by the Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee came two days after CBS News reported on COVID-19 vaccine “safety signals” that were allegedly suppressed during the Biden administration’s FDA. Critics said the latest meeting repeated concerns that outside advisers have not received the full data they need when weighing updated COVID vaccine recommendations.
The committee met virtually for six and a half hours on May 28 and recommended that next season’s vaccines target the JN.1-lineage XFG strain of SARS-CoV-2. The FDA’s summary of the meeting said advisers reviewed data on manufacturing, variant circulation, current vaccine effectiveness and human and animal immunogenicity data. The summary did not mention safety.
Sanofi and Novavax are already producing non-mRNA versions of the new formulation, while Moderna has said its mRNA shots will be ready by mid-August, according to Pharmaceutical Executive.
The meeting drew criticism from vaccine injury lawyer Aaron Siri, who gave a three-minute public comment urging advisers to make an “evidenced-based and not belief-based decision.” Siri later criticized the committee, accusing advisers of “shamelessly” recommending another vaccine while “ignoring its incredible trail of harm.” His book, Vaccines, Amen, argues that vaccines are treated like a religion shielded from scientific scrutiny.
Sen. Ron Johnson, R-Wis., chairman of the Senate Permanent Subcommittee on Investigations, also criticized the vote and shared Siri’s testimony.
“The COVID cartel’s cover-up continues,” Johnson said.
Johnson’s subcommittee previously accused the Biden FDA of silencing whistleblower Ana Szarfman, a data-mining expert who told officials, including then-Center for Biologics Evaluation and Research Director Peter Marks, that FDA surveillance was “masking” dozens of “statistically significant safety signals for adverse events” after COVID vaccination as early as March 2021.
Johnson is also convening a Wednesday hearing featuring medical experts from around the world to discuss “plausible mechanisms” by which COVID shots are “causing” cancer.
Several observers focused on what they said was missing from the May 28 advisory meeting. Former FDA regulatory review officer Jessica Adams and David Wiseman, CEO of Synechion, separately noted that safety was not on the VRBPAC agenda. Synechion specializes in products for preventing postsurgical adhesions.
Only committee member Hayley Gans, a Stanford pediatrics professor listed in an FDA committee roster, asked for “continued safety data” for advisers to examine.
“I think that there is some misinformation in the public, and it would be nice actually to see those” data, Gans said, referring to information that could be provided by the CDC or vaccine manufacturers, according to Adams’ transcript of the exchange.
CDC representative Natalie Thornburg responded that the Immunization Safety Office collects such data, but did not send a representative to the virtual meeting and has not presented to VRBPAC “in years past,” according to the account.
“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.
Adams argued that COVID vaccines differ from seasonal flu shots because they are “newer products with ongoing” post-marketing requirements and conditions, changing risk-benefit questions and greater public scrutiny. She said the FDA should “make room elsewhere” for safety questions if it wants these advisory meetings limited to strain selection.
In a separate analysis, Adams said the committee was not “re-approving the vaccines,” but said members have repeatedly raised questions beyond strain selection, including safety surveillance, emerging safety signals and requests for underlying data on the overall benefit-risk profile.
“FDA keeps the lane narrow,” she wrote. “There is no established annual committee process for a comprehensive benefit-risk reassessment here.”
Wiseman said advisers should have been told that “the US early vaccine safety warning system is effectively disabled because safety signals for all vaccines are masked by COVID-19 vaccine reports” in the Vaccine Adverse Event Reporting System, according to a short paper he wrote before the meeting.
Wiseman urged VRBPAC to ask Health and Human Services Secretary Robert F. Kennedy Jr. for a “corrective action plan within 30 days,” including an explanation of why VRBPAC and the CDC’s Advisory Committee on Immunization Practices were not informed of alleged “safety signal imbalances” and why the FDA did not disclose that it knew of the masking issues.
Johnson amplified Wiseman’s concerns, accusing federal health officials of continuing to use what he described as the FDA’s “flawed algorithm,” which he said was exposed by Szarfman and was “apparently […] to hide all vaccine injury safety signals.”
TrialSiteNews also criticized the scope of the meeting.
“No dedicated vaccine safety presentation occurred. No CDC Immunization Safety Office representative appeared. No Vaccine Safety Datalink update was presented. No V-safe [survey-based safety surveillance] review was conducted. No detailed discussion of post-marketing safety surveillance occurred,” TrialSiteNews summarized.
The CDC asked Just the News for “a few days” to examine why it did not send anyone with safety data to the May 28 VRBPAC meeting, why it has not historically done so and whether it had previously been asked to provide safety data for such meetings.
The recommendation for the updated COVID vaccine came one day before President Donald Trump issued an executive order directing the CDC and its advisers to “realign” the U.S. childhood vaccine schedule with those used in other developed countries. Those nations generally recommend fewer vaccines and doses and rely more on “public trust and education” than mandates, according to the report.
Former acting Center for Drug Evaluation and Research Director Tracy Beth Hoeg said Trump’s order formally adopted an HHS scientific assessment as a “guiding resource” for federal agencies.
“Nice to have our vaccine report recognized by” the president, Hoeg wrote Monday night.
“Less nice to have just been fired […] & not know why or who fired me,” she added, linking to a lengthy essay describing her FDA work, her accomplishments at CDER and what she called a “lack of transparency about the details behind my firing.” Her firing closely followed Commissioner Marty Makary’s resignation.
Hoeg told medical scientist-turned-journalist Maryanne Demasi that two FDA officials told her to choose between resignation and termination, and that she refused to resign.
During ACIP meetings, Hoeg had highlighted what she called a “safety signal that has largely escaped public attention,” involving post-flu vaccine febrile seizures in children ages 6 months through 4 years.
In his testimony to VRBPAC, Siri questioned whether some committee members could “objectively consider the data and evidence regarding these products,” citing “the prior statements made by some members of this committee.”
He asked the panel not to dismiss the “tens of thousands of individuals” who contacted his law firm about what they described as “serious” COVID vaccine injuries, the 40,000 members of the React19 vaccine injury group and litigation involving CDC and FDA data that, he argued, suggests vaccine injuries are more common than federal surveillance reflects.
Siri also said Pfizer’s COVID vaccine trial had more deaths in the vaccinated group even though the placebo group was larger. He argued that alleged victims “have been abandoned” because of the PREP Act liability shield and because the Countermeasures Injury Compensation Program was “designed to deny compensation” and remains underfunded.
“Until this immunity is lifted and the harms actually accounted for, this committee should decline to recommend any further Covid-19 vaccines,” Siri said.
Siri, counsel to the Informed Consent Action Network, has also been involved in transparency litigation that exposed the CDC’s inability to substantiate claims about COVID vaccine ingredients and hidden “checkbox” and “free-text” V-safe vaccine injury reports.
A month before the VRBPAC meeting, Siri asked Kennedy and National Institutes of Health Director Jay Bhattacharya, on behalf of ICAN, to revise CDC guidance on contraindications and precautions to make medical exemptions to vaccination easier to obtain. The request concerned the CDC’s Contraindications and Precautions page.
The proposed revisions would add adverse events listed in a vaccine package insert to the CDC’s contraindications and precautions list when there is “some basis to believe there is a causal relationship between the drug and the occurrence.”
Siri called the request a “truly minimum step toward protecting the public from vaccine harms” one day after VRBPAC recommended the updated COVID vaccine. HHS and NIH did not respond to Just the News requests for comment on ICAN’s proposal.
Original article
Comments