FDA Committee Recommends Two Covid-19 Vaccines For Young Children
By Jaimy Lee
The Food and Drug Administration is now expected to authorize two COVID-19 vaccines for children as young as 6 months old.
The Food and Drug Administration is now expected to authorize two COVID-19 vaccines for the nation’s youngest children in a move that will provide a choice to parents who have had few protective options for their children during the pandemic.
An FDA advisory committee on Wednesday voted 21-0 that the benefits of Moderna’s MRNA, -5.80% two-dose vaccine for children between the ages of 6 months old and 5 years old outweigh the risks.
The committee also voted 21-0 in favor of BioNTech BNTX, -6.41% and Pfizer’s PFE, -2.12% three-dose COVID-19 vaccine for children between the ages of 6 months old and 4 years old.
(The dosing for both vaccines is different than it is for adults.)
The FDA is not required to follow the advice of the advisory committee but it often does. Once the regulator makes its decision on both vaccines, the next step in the regulatory process is getting an OK from the Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices and then a final sign-off from CDC director Dr. Rochelle Walensky.
The White House has already said it expects vaccinations for this age group to begin the week of June 20.
Moderna’s stock gained 5.7% in trading on Wednesday after the vote was announced. Pfizer’s stock was up 1.2%.