Drugmaker Pfizer on Monday said the third dose of its COVID-19 vaccine produced a strong immune response in children ages 6 months to under 5 years and should meet the criteria for emergency authorization.
The three-dose regimen appeared to have an 80% efficacy based on symptomatic infections counted in a subset of a trial involving 1,678 children, though the release did not say how many children were in that smaller group.
“We are pleased that our formulation for the youngest children, which we carefully selected to be one-tenth of the dose strength for adults, was well tolerated and produced a strong immune response,” Pfizer CEO Albert Bourla said.
Roughly 18 million children in the U.S. remain ineligible for a COVID-19 vaccine even as older Americans seek out their fourth shots.
Young children tend to see far milder outcomes from COVID-19 than older persons, though some parents are clamoring to give their children some protection.
The Food and Drug Administration plans to gather outside advisers to discuss and debate vaccines being presented for children under 5.
Moderna has offered data on a two-shot regimen that is a quarter of its adult dose, though hasn’t submitted third-shot data yet.
FDA regulators seemed poised to approve a two-shot regimen from Pfizer earlier this year but decided to wait until the third-shot data rolled in from the study. Pfizer said its Monday data on efficacy was preliminary and it would offer more final data “once available.”
The twin applications from Pfizer and Moderna raised fears the FDA would let the process drag out and evaluate the drugmakers at the same time, although Dr. Peter Marks, a key official, said the FDA won’t allow unnecessary delays.
For more information, visit The Washington Times COVID-19 resource page.