Lawmakers ask FDA to lay out plans for reviewing COVID vaccines for young children

Even though most people in the U.S. have been eligible for COVID-19 vaccines and boosters for quite some time, children under 5 still don't have vaccine options. Now, lawmakers are asking the FDA to lay out its plans in this age group⁠—and address a perceived delay for Moderna's product.

Yesterday, Congress’s Select Subcommittee on the Coronavirus Crisis sent a letter (PDF) to FDA Commissioner Robert Califf, M.D., requesting a briefing on the status of COVID-19 vaccines for the under 5 age group.

The letter comes after U.S. chief medical adviser Anthony Fauci, M.D., indicated on CNN that the FDA is considering holding off on reviewing Moderna’s vaccine candidate in order to authorize it at the same time as Pfizer’s to “not confuse people” with a staggered rollout, the lawmakers wrote. That could lead to a potential delay of several weeks for Moderna's shot, they said.

Moderna reportedly plans to submit its vaccine for the under-5 age group by the end of April. Pfizer, for its part, is prepping a filing for June, the lawmakers wrote.

In February, Pfizer extended its rolling FDA submission to wait for data for a potential third dose. Moderna’s trials for its children’s vaccine showed the shot was 43.7% effective in children 6 months to 2 years old and 37.5% effective in the 2 to under 6 years old group.

The reported timing of the reviews prompted the congressional committee to request a staff briefing by May 9 to gather more information. Rep. James Clyburn, the committee chairman who signed the letter, reminded Califf that up to 1.5% of all child COVID-19 cases result in hospitalization.

Congress is hopeful that the FDA briefing requested would provide scientific rationale for the potential Moderna delay.