Pfizer has officially submitted its request to the Food and Drug Administration (FDA) to clear its COVID-19 vaccine for emergency use in children under the age of five.
The pharmaceutical giant, along with BioNTech SE, finalized their application with the FDA for emergency use authorization (EUA) of their vaccine in children aged six months to four years. In a statement on Wednesday, the companies said that they began the submission process in February.
Pfizer announced in May that a three-shot regimen was highly effective and prompted a robust immune response in children under age 5. Pfizer’s data was based on early results from a highly anticipated trial that is likely to pave the way for infants and toddlers to be immunized.
Early testing found that the vaccine was 80.3% effective in preventing COVID infections among young children, with ten infections occurring among all study participants. According to the company, the final results will be determined once 21 children enrolled in the study have been infected.
In February, Pfizer launched a rolling review of data from the trial of 1,678 children under the age of 5. The three-dose vaccine regimen was well-tolerated, with a safety profile similar to that of the placebo, and most side effects were mild or moderate.
The complete submission includes data on the product’s safety, efficacy, and ability to prompt an appropriate immune response in recipients.
Children under the age of 5 were given three doses; each dose contained three micrograms or one-tenth of the adult dosage.
Attention will now turn to an upcoming FDA advisory committee meeting set for June 15. During the scheduled meeting, the experts will discuss the dangers and advantages of the Pfizer-BioNTech and Moderna vaccines for young children. After the session, the panel will recommend to the FDA whether they should be cleared for emergency use.