by Megan Redshaw, Childrens Health Defense:
In a move Children’s Health Defense President Mary Holland called “head-spinning,” the U.S. Food and Drug Administration on Friday granted full approval of Pfizer-BioNTech’s Comirnaty COVID-19 vaccine for adolescents 12 through 15 years old.
In an FDA press release, the agency said full approval of Comirnaty follows a “rigorous analysis and evaluation of the safety and effectiveness data,” and the Pfizer-BioNTech vaccine “has been, and will continue to be authorized for emergency use in this age group since May 2021.”
Pfizer’s press release announcing the approval said the Comirnaty vaccine has been available under Emergency Use Authorization (EUA) since May 2021 for the adolescent age group.
Yet, Comirnaty is not available in the U.S for any age group and is not the same formula as the Pfizer-BioNTech vaccine currently authorized under EUA and being distributed as a “fully approved” vaccine.
“The approval of Comirnaty for adolescents 12 to 15 is head-spinning,” said Mary Holland, president and general counsel for Children’s Health Defense.
“The FDA failed to convene an expert committee and failed to appropriately weigh the risk-benefit profile of this vaccine for this age group. Even Vaccine cheerleader Dr. Paul Offit acknowledged FDA decisions are being made based on political pressure, not science when, in commenting on the agency’s vote last week to allow reformulated booster shots, he said it felt like ‘the fix was in.’”
Holland said that at base, “this is a move by pharma to ensure liability protection” under the National Childhood Vaccine Injury Act of 1986. Some states likely will attempt to put Comirnaty on the childhood vaccine schedule, despite the myriad known and unknown risks, Holland said.
“Pfizer‘s fraud and collusion with government is becoming more evident by the day,” Holland said. “CHD, already challenging the authorizations for those six months through age 11, will be at the forefront of challenging this approval for teenagers.”
Efficacy claims based on old analysis of 16- to 25-year-olds — before Delta, Omicron variants
Pfizer said Friday’s approval is based on data from a Phase 3 clinical trial of 2,260 participants ages 12 through 15.
About half of the participants, “elicited SARS-CoV-2–neutralizing antibody geometric mean titers (GMTs)” demonstrating “strong immunogenicity in a subset of adolescents one month after the second dose,” Pfizer said.
It is unknown what happened to antibody levels after one month, but peer-reviewed research suggests vaccine protection conferred by second and third doses of Pfizer’s COVID-19 vaccine wanes rapidly against the Omicron variant.
“Our study found a rapid decline in Omicron-specific serum neutralizing antibody titers only a few weeks after the second and third doses of [the Pfizer-BioNTech] BNT162b2,” said the authors of a May 13 study published in JAMA.
To further support its claim that Comirnaty is effective in the 12 to 15 age group, Pfizer used an old analysis of 16- to 25-year-olds conducted before the Delta and Omicron surges.
“The efficacy analysis was conducted between November 2020 and May 2021, which was before the Delta and Omicron surges,” and the “only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was Alpha,” Pfizer said in its press release.
FDA experts question neutralizing antibodies as standard for vaccine effectiveness
During a June 28 meeting of the FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC), vaccine experts raised concerns that neutralizing antibodies did not correlate to clinical protection — noting Moderna’s COVID-19 vaccine had a two-fold increase in neutralizing antibody levels compared with Pfizer’s vaccine during clinical trials, but it did not translate into a clinically significant difference in terms of protection against severe disease.
Dr. Ofer Levy, VRBPAC member and infectious disease physician at Boston Children’s Hospital, said during the meeting there is still “no established correlate of protection,” referring to the level of antibodies needed to confer protection.
“You have a lot of data now,” Levy told Pfizer. “What is your relative protection?”
“I would say there is no established correlate of protection,” Kena Swanson, Ph.D., vice president of viral vaccines at Pfizer, told Levy.
“I would like to hear from FDA what their overall approach will be around improving our understanding of correlate protection. We spend a good amount of time reviewing antibody data. We have no doubt antibody data is important. We don’t have a level of antibody that anybody is comfortable stating is correlated [with] protection.
Levy, who said antibodies are important, but T cells are more important, called for federal leadership to establish a “standardization of the T-cell assay and encourage or in fact require the sponsors to gather that information.”
“So what is the effort to standardize the pre-clinical assays?” Levy asked. “This is an effort that’s critical not just now but for future cycles of vaccine revision. If we aren’t able to define a standard for correlate protection we are fighting with one arm behind our back.”
Dr. Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, acknowledged the importance of Levy’s question and said they are “having conversations” with colleagues at the National Institutes of Health and throughout government about how they might move forward, but it is something they “don’t have an answer to yet.”
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