Pfizer plans to request Emergency Use Authorization from the FDA based on data from its phase 2/3 trial for children ages 5 to 11, as experts question the company’s data and need for kids to be vaccinated against COVID.
Pfizer said Monday a phase 2/3 trial showed its COVID vaccine was safe and generated a “robust” antibody response in children ages 5 to 11, but experts warn Pfizer’s data is misleading, and some question the need for kids to be vaccinated in the first place.
These are the first results released for this age group for a COVID vaccine, and the data has not yet been peer-reviewed or published, CNN reported.
Pfizer said it plans to request Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) soon. FDA officials said once data is submitted, the agency could authorize a vaccine for younger children in a matter of weeks.
In a statement, Pfizer CEO Albert Bourla said:
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the Delta variant and the substantial threat it poses to children.”
The trial included 2,268 participants ages 5 to 11, and used a two-dose regimen of the vaccine administered 21 days apart. The trial used a 10-microgram dose — smaller than the 30-microgram dose used for those 12 and older.