FDA sets aside June for possible decisions on vaccines

The Food and Drug Administration on Friday laid out a tentative timetable for deciding whether to authorize a coronavirus vaccine for America’s youngest children, announcing that June 8 is the earliest date that it will present data to its outside advisers for a recommendation.

The nation’s 18 million children younger than 5 are the only group not yet eligible for vaccination against the coronavirus.

The agency said it understood the urgency of protecting that group and that it would act quickly “if the data support a clear path forward following our evaluation.”

The FDA laid out a packed June schedule, setting aside three days for its outside advisory committee to consider the pediatric vaccine applications from Moderna and PfizerBiontech, and another day to debate and presumably vote on proposals to update existing vaccines so they work better against a range of coronavirus variants.

The agency’s release of a schedule came after some critics raised concerns that it was delaying action on Moderna’s application in order to compare it with data from Pfizer, which is not expected in full until June. The FDA commissioner, Robert Califf, said that was not the case Thursday and Friday.

Moderna said Thursday that it had asked the FDA to authorize its vaccine for children 6 months to 6 years old, saying its clinical trial showed the vaccine was safe and produced an antibody response comparable to that of adults ages 18-25. That met the trial’s criterion for success. It said the vaccine appeared to be 51% effective against symptomatic infection among those younger than 2, and 37% effective among those ages 2-5.

Moderna said it would finish submitting its data to the FDA by May 9. Pfizer and Biontech are expected to complete their application in June. The vaccine regimens are different: Moderna is proposing two doses, using one-fourth the strength of an adult dose. Pfizer and Biontech are working on a three-dose regimen, at one-tenth the strength of the adult dose.

Pfizer’s vaccine is already authorized for everyone 5 years and older, while Moderna’s shots are limited to adults.