US FDA lowers the efficacy bar for Covid vaccine EUA for toddlers to 6
Head shaking report at Children's Health Defense regarding the Emergency Use Authorization Pfizer and Moderna so desperately seek, as a gateway to landing on the CDC Pediatric vaccine schedule, which means guaranteed customers from 2 to eternity. Can you imagine lowering the bar for efficacy, and subjecting toddlers to a vaccine that could be virtually ineffective yet have all of the risk? And parents will cheer for the ability to dose their kids, thinking they are protecting them. Remember how that felt, so many years ago? I do.
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COVID Vaccines for Kids Under 6 Won’t Have to Meet 50% Efficacy Standard, FDA Official Says
The U.S. Food and Drug Administration’s (FDA) 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 (EUA).
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. Read more at COVID Vaccines for Kids Under 6 Won’t Have to Meet 50% Efficacy Standard, FDA Official Says
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