By  Megan Redshaw

The U.S. Food and Drug Administration’s top vaccine official told a congressional committee on Friday that COVID-19 vaccines for kids under 6 will not have to meet the agency’s 50% efficacy threshold required to obtain Emergency Use Authorization.

The FDA is reviewing data from Moderna’s two-shot vaccine for infants and toddlers 6 months to 2 years old, and for children 2 to 6 years old.

The agency is awaiting data on Pfizer and BioNTech’s three-dose regimen for children under age 5 after two doses of its pediatric vaccine failed to trigger an immune response in 2-, 3- and 4-year-olds comparable to the response generated in teens and adults.

According to Endpoints News, Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, told the House Select Subcommittee on the Coronavirus Crisis the agency would not withhold authorization of a pediatric vaccine if it fails to meet the agency’s 50% efficacy threshold for blocking symptomatic infections.

COVID-19 vaccines for adolescents, teens and adults had to meet the requirement.

“If these vaccines seem to be mirroring efficacy in adults and just seem to be less effective against Omicron like they are for adults, we will probably still authorize,” Marks said.

The FDA on June 30, 2020, issued guidance that in order for an experimental COVID-19 vaccine to obtain EUA, it must “prevent disease or decrease its severity in at least 50 percent of people who are vaccinated.”

The guidelines were issued during a briefing with the Senate Committee on Health, Education, Labor and Pensions, during which senators sought assurances from former FDA Commissioner Stephen Hahn, Dr. Anthony Fauci and other top health officials that the expedited speed of development of COVID-19 vaccines wouldn’t compromise the integrity of the final product.

All previously authorized COVID-19 vaccines and boosters for all age groups were required to meet the FDA’s 50% requirement prior to obtaining EUA.

Vinay Prasad, a hematologist-oncologist and associate professor of Epidemiology and Biostatistics at the University of California, San Francisco posted a video responding to the news the FDA would bypass its own standard to authorize pediatric COVID-19 vaccines for kids.

Vasad said:

“Peter Marks from the FDA — he’s the defacto regulator-in-chief when it comes to vaccines — is saying that kids’ vaccines don’t need to hit the target. They don’t need to hit the 50% vaccine efficacy against symptomatic SARS-CoV-2 target. That was the target that the FDA themselves came up with in the original pandemic.

“They came up with this target 50% point estimate above, and the lower bound to the 95% confidence interval has to be above 30%. That was their minimum efficacy standard for vaccination. That was the standard they themselves set and that was the standard initial vaccine trials did clear for adults.

“But the pediatric vaccine trials — both the Pfizer and Moderna — appear not to have cleared that bar, and Peter Marks is talking to congressional officials and he is saying that it’s okay, we’ll probably authorize it anyway.

Vasad said it was “incredible” that Marks would sign off on a pediatric vaccine if it seems to be mirroring efficacy in adults but is less effective against Omicron.

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Via https://childrenshealthdefense.org/defender/covid-vaccines-kids-efficacy-standard-fda/