FDA Supports Expanded EUAs for Pfizer-BioNTech and Moderna Pediatric COVID-19 Vaccines

In a briefing document issued ahead of a two-day meeting by its vaccines advisory committee that begins today, the FDA indicated its support for Emergency Use Authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine for children age six months through four years.

Pfizer submitted its request on May 27 for an amended EUA for a three-dose COVID-19 vaccine primary series.

The company also submitted new data from a phase 2/3 study, including data from 1,776 children from age six through 23 months, and data from 2,750 children age two years through four years.

Overall, the vaccine’s efficacy was estimated to be 80.4 percent, the agency said, ranging from 75.6 percent in the six-months to 23-months age group to 82.4 percent in the two-years to four-years age group.

The FDA also released a briefing document on Moderna’s EUA amendment for its COVID-19 vaccine, Spikevax, for children age six months through 17 years. Currently, Spikevax is only authorized for use in people who are 18 years and older.

In its EUA amendment request, Moderna is seeking authorization for three different pediatric age groups: children between 12 and 17 years old, six through 11 years old and six months through five years old.

The Vaccines and Related Biological Products Advisory Committee will consider the Moderna vaccine on June 14 and 15 and the Pfizer-BioNTech vaccine on June 15. — Selma Khenissi