FDA panel overwhelmingly recommends Moderna, Pfizer vaccines for children 6 months to 5 years

The youngest population can soon be vaccinated against COVID-19 after an independent advisory panel voted 21-0 that both the Moderna and Pfizer COVID-19 vaccines for children are safe and effective. 

Moderna's vaccine is for 6-month- to 5-year-olds and Pfizer's is for 6-month- to 4-year-olds. 

The FDA said June 10 that Moderna's two-dose vaccine, which is 25 micrograms each, is "safe and effective" after finding an efficacy rate of 51 percent in 6-month- to 2-year-olds and 37 percent in 2- to 5-year-olds, according to The Washington Post. The dosage is one-fourth of the adult vaccine. 

During the deliberation, parents had three minutes each to urge the panel to approve both vaccines, many citing that the timeline would allow for children to be fully vaccinated before the 2022-23 school year starts. 

Pfizer is on Moderna's heels with its three-dose vaccine. Some on the panel worried about Pfizer's low dosage, which is 3 micrograms per shot for children younger than 4. According to an early analysis, the vaccine may be up to 80 percent effective against symptomatic illness.

Others cautioned the probability of children getting more than two jabs, while many panelists said they were surprised by the low efficacy rate before the third shot. Despite these concerns, the committee agreed that the benefits outweighed the risks. 

The panel's votes move each vaccine's approval and authorization process to the FDA commissioner and the CDC, which is expected in the coming weeks. If authorized, the nation stands ready with 100 hospitals to roll out the vaccine for the youngest population as early as June 21.

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars