by Greg Piper
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.”
VRBPAC 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 government’s Vaccine Adverse Event Reporting System, Wiseman wrote in a short paper prior to the meeting based on the absence of safety in the agenda.
The committee should ask Health and Human Services Secretary Robert F. Kennedy Jr. for a “corrective action plan within 30 days” that includes why VRBPAC and the CDC’s Advisory Committee on Immunization Practices weren’t informed of the “safety signal imbalances” and why the FDA didn’t tell them “it was aware of the masking issues,” he wrote.
Wiseman’s recommendations got a boost from Sen. Johnson, who accused federal health officials of still using the FDA’s “flawed algorithm,” as exposed by whistleblower Szarfman, “apparently […] to hide all vaccine injury safety signals.”
“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 look into why it didn’t send anyone with safety data to the May 28 VRBPAC meeting and has not historically sent anyone, and whether it was ever previously asked to provide safety data for the meetings.
The recommendation of updated COVID vaccines came a day before President Trump’s executive order to the CDC and its advisers to “realign” the U.S. childhood vaccine schedule with those of developed peer nations, which generally recommend far fewer vaccines and doses and use “public trust and education” more than mandates.
“Nice to have our vaccine report recognized by” the president, former acting Center for Drug Evaluation and Research Director Tracy Beth Hoeg wrote Monday night, referring to the HHS scientific assessment now formally adopted as a “guiding resource” for the feds.
“Less nice to have just been fired […] & not know why or who fired me,” she wrote, sharing a lengthy essay on her accomplishments in the agency and CDER specifically and the “lack of transparency about the details behind my firing,” which closely followed Commissioner Marty Makary’s resignation.
Hoeg told medical scientist-turned-journalist Maryanne Demasi that two FDA officials ordered her to choose between resignation and termination and that Hoeg refused resignation.
As a participant in ACIP meetings, Hoeg highlighted a “safety signal that has largely escaped public attention,” post-flu vaccine febrile seizures in ages 6 months through 4 years.
Siri adopted a cynical note in his testimony to VRBPAC, citing “the prior statements made by some members of this committee” as reasons to wonder if they can “objectively consider the data and evidence regarding these products.”
He urged members not to ignore the “tens of thousands of individuals” contacting his law firm about what they said were their “serious” COVID vaccine injuries, the 40,000 injured in the widely censored victim group React19, and the legal fights by the CDC and FDA to hide data suggesting COVID vaccine injury is far more common than their surveillance suggests.
Pfizer’s COVID vaccine trial had more deaths in the vaccinated group despite the placebo group being larger, and victims “have been abandoned” because of the liability shield in the PREP Act and the Countermeasures Injury Compensation Program having been “designed to deny compensation” and grossly underfunded in any case, he said.
“Until this immunity is lifted and the harms actually accounted for, this committee should decline to recommend any further Covid-19 vaccines,” Siri said.
As counsel to the Informed Consent Action Network, whose transparency litigation has exposed the CDC’s inability to vouch for its claims about COVID vaccine ingredients and hidden “checkbox” and “free-text” V-safe vaccine injury reports, Siri has thrown several pots of spaghetti against the regulatory wall to see what sticks.
A month ago, he asked Kennedy and National Institutes of Health Director Jay Bhattacharya, on behalf of ICAN, to make several revisions to the CDC’s Contraindications and Precautions page, to make medical exemptions to vaccinations easier to get.
The proposed revisions would add adverse events from a given vaccine’s package insert, which are limited to those with “some basis to believe there is a causal relationship between the drug and the occurrence,” to the CDC’s contraindications and precautions list.
Siri called it a “truly minimum step toward protecting the public from vaccine harms” the day after VRBPAC recommended the updated COVID vaccine. HHS and NIH didn’t answer Just the News queries for their response to the ICAN request.
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Greg Piper is a reporter for Just the News.
Photo “CDC Building” by Raed Mansour. CC BY 2.0.
