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FDA’s Top Vaccine Official Tells Congress COVID-19 Jab for Youngest Children Won’t Need to Hit 50% Efficacy Threshold


“The FDA’s top vaccine leader told a congressional committee on Friday afternoon that although the adult vaccines had to meet a 50% threshold for efficacy against Covid-19 infections, that same standard will not need to be met for the vaccines for the youngest group of children, for which a vaccine is not yet available,” Endpoints News reports.

From Endpoints News:

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The agency is currently reviewing data from Moderna’s two-shot vaccine for this youngest group as it awaits further data from Pfizer on its potential three-dose shot. The agency previously scheduled and then canceled an adcomm to review data on two doses of Pfizer’s vaccine for children under the age of 5.

According to a readout of the meeting from the House select subcommittee on the coronavirus crisis, Marks explained that the FDA would not withhold authorization — despite previous guidance — for a pediatric vaccine solely because it did not reach a 50% efficacy threshold at blocking symptomatic infections. All of the other adult and children’s vaccines currently authorized in the US have lost significant amounts of efficacy due to the Omicron variant, but they still remain effective at reducing the risk of severe disease, hospitalization and death.

“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.

Meanwhile, Marks directly addressed concerns that the agency might slow-play the Moderna application and wait to review both applications together, saying that the VRBPAC meetings set for next month will be moved up if necessary.

“Obviously if we get through reviews faster, then we will send them to committees sooner,” Marks said, according to Rep. Jim Clyburn’s account of the meeting. Marks also told Clyburn and his staff that VRBPAC members have reserved earlier dates, enabling FDA to potentially “move dates up even by a week for any of these reviews.”

The Defender added:

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 published this response to the FDA bypassing this standard to authorize pediatric COVID-19 injections for young children.


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