Following Briefing, Clyburn Vows To Hold FDA To Its Commitment To Review Coronavirus Vaccines For Young Children As Expeditiously As Science Allows (goalposts moved-50+% efficacy not required!)

Washington, D.C. (May 9, 2022) – Today, Rep. James E. Clyburn, Chairman of the Select Subcommittee on the Coronavirus Crisis, issued the following statement after a staff briefing by Dr. Peter Marks, Director for the Center of Biologics Evaluation and Research at the Food and Drug Administration (FDA), on the status of coronavirus vaccine candidates for young children that took place on the afternoon of May 6. The briefing followed Chairman Clyburn’s April 25 letter to FDA Commissioner Dr. Robert M. Califf after reports emerged that the agency was considering delaying its review of the first coronavirus vaccine for children under six years old.

Dr. Marks explained that ...FDA has to take a “very close look” at the side effect profile of vaccines for young children because common side effects from vaccinations—such as fevers—that are not typically associated with adverse outcomes in adults can, in rare cases, cause severe conditions in young children.

Dr. Marks also said that the emergence of new variants—including Delta and Omicron—has made the process of reviewing vaccines more complex and time consuming. He acknowledged that it “was a little simpler for the original submissions in late 2020 when we didn’t have the variants and tons of immunogenicity data to go through,” which has made review and authorization of the vaccines for young kids “reasonably complicated.”

Dr. Marks explained that FDA would not withhold authorization for a pediatric vaccine solely because it did not reach a 50% efficacy threshold at blocking symptomatic infection—a requirement that had been previously listed in FDA guidance.(emphasis added) The vaccines currently authorized in the United States have proven to be less effective at preventing symptomatic infection from the Omicron variant—as compared to the original strain—but still remain effective at reducing the risk of severe disease.

GOALPOST MOVING ALERT

Per the FDA in June 2020, the FDA would expect that a COVID-19 vaccine would prevent disease or decrease its severity in at least 50% of people who are vaccinated.

This is where words become REALLY important. In the US, the basis of approval EUA and the only "approved" Vaccine, was for PREVENTION...NOT for decreased severity. Indeed, look at the actual FDA and Pfizer-BioNTech info.

Per the FDA's website,

On August 23, 2021, the FDA approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.(emphasis added)

Per the Comernity Insert,

--------------------------- INDICATIONS AND USAGE----------------------------

COMIRNATY is a vaccine indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. (1)(emphasis added)

Per the Summary Basis for Regulatory Action, under "Indication"

Active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older. (Emphasis added)

Clearly, the vaccine is for PREVENTION. Nothing else. All of the clinical trials (limited as they were) and statistical confidence intervals were focused on VE with regard to PREVENTION...not hospitalization, not ER visits, not fatalies, and not symptoms. Accordingly, THAT is the basis upon which approval and Efficacy should be based.

THIS is why people are peeved... If we follow their "rules of science" and these shots don't not have VE above 50% (With Omicron, we saw VE being zero in Norway and Denmark and of course the US.), then they absolutely deserve ridicule and revocation.

And yet, even 50% isn't good enough for kids.

“The powers not delegated to the United States by the Constitution, nor prohibited by it to the States, are reserved to the States respectively, or to the people.” Amendment 10
Good luck with forcing people in “the Several States” into taking a dangerous and experimental vaccine for them or their kids for preventing sniffles and a headache. All the dumb and gullible ones have already been vaxxed and boostered leaving everyone else with common sense standing along the sidelines watching it all play out.

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