The Food and Drug Administration (FDA) has granted full approval to Pfizer’s Comirnaty Wuhan coronavirus (COVID-19) vaccine for children ages 12 to 15 years old.
In a press release, the FDA said the approval followed a “rigorous analysis and evaluation of the safety and effectiveness data,” and that the vaccine “has been, and will continue to be, authorized for emergency use in this age group since May 2021.”
However, the vaccine is not yet available in the U.S. for any age group as it is not the same formula as the Pfizer vaccine that has been authorized for use under the EUA and distributed as “fully approved.”
Mary Holland, the president and general counsel for Children’s Health Defense, said the approval of Comirnaty for adolescents as young as 12 is “head-spinning.” (Related: Pfizer, FDA knew their COVID vaccine causes immunosuppression, ADE, VAED.)
“The FDA failed to convene an expert committee and failed to appropriately weigh the risk-benefit profile of this vaccine for this age group,” Holland noted. “Even vaccine cheerleader Dr. Paul Offit acknowledged FDA decisions are being made based on political pressure, not science. When commenting on the agency’s vote last week to allow reformulated booster shots, he said it felt like ‘the fix was in.'”
Some states will also likely attempt to put the vaccine on the childhood vaccine schedule despite unknown risks.
While the Comirnaty vaccine can be mandated, it has no liability shield, which means that vials of the branded product that say Comirnaty on the label are subject to the same product liability laws as other U.S. products. Only vaccines distributed under EUA have liability protection under the 2005 Public Readiness and Preparedness Act (PREP).
But Comirnaty can receive liability protection when it is fully approved for children and added to the CDC’s immunization schedule, bringing it under the National Vaccine Injury Compensation Program.
Holland said Pfizer’s fraud and collusion with the government are becoming more evident: CHD is already challenging the EUA for children ages six months to 11, and will also be at the forefront of challenging this same authorization for adolescents and teens.
For its part, Pfizer said the approval is based on data from a Phase 3 clinical trial of 2,260 participants ages 12 through 15, and about half of the participants elicited neutralizing antibody geometric mean titers (GMTs) that demonstrate “strong immunogenicity in a subset of adolescents one month after the second dose.”
It is yet unknown what happens to antibody levels after one month, but peer-reviewed research suggests that protection after second and third doses of the vaccine wanes rapidly against the omicron variant.
Pfizer used an old analysis of 16 to 25-year-olds conducted before the delta and omicron surges, with an efficacy analysis conducted between November 2020 and May 2021.
The company admitted in its own press release that “only SARS-CoV-2 variant of concern identified from the confirmed COVID-19 cases in this age group was alpha.”
Meanwhile, FDA’s Vaccine and Related Biological Products Advisory Committee (VRBPAC) said in its June 28 meeting that vaccine experts raised concerns that neutralizing antibodies did not correlate to clinical protection, noting that Moderna’s COVID-19 vaccine had a twofold increase in neutralizing antibody levels compared to that of Pfizer’s during the trials, but it still did not translate into a clinically significant difference in terms of protection against severe diseases.
Watch the video below exposing how the vaccine advisory committee lied to get FDA approval for babies.
This video is from The Prisoner channel on Brighteon.com.
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