Pfizer today said it will delay applying for Emergency Use Authorization (EUA) of its COVID vaccine for infants and children 6 months to 4 years old stating there’s not enough data on the efficiency of a third dose.
The U.S. Food and Drug Administration (FDA) in response postponed a meeting that had been scheduled for Feb. 15 to review Pfizer’s application for the pediatric vaccine.
Two separate clinical trials of Pfizer-BioNTech’s COVID vaccine for the younger age group are in progress: one involving children between the ages of 6 months to 2 years old, the other involving children between ages 2 and 4.
CNBC last month reported two shots did not induce an adequate immune response in children 2 to 4 years old in Pfizer’s clinical trials, leading Dr. Anthony Fauci to predict children in that age group would need a three-dose regimen of the vaccine.
In what the New York Times described as a “highly unusual move,” the FDA urged Pfizer to apply for EUA of the vaccine, even though two doses failed to produce the hoped-for immune response among children 2 to 4 years old and the vaccine maker did not yet have data on the efficacy of a third shot.
Pfizer had planned to submit its application to the FDA next week, then provide additional data in the coming weeks on a third dose, NBC reported.
The FDA did not say when the Feb. 15 meeting would be rescheduled, and Pfizer did not indicate when it would submit the application.