FDA post­pones ad­comm for Pfiz­er's Covid-19 vac­cine for the youngest age group

The FDA on Fri­day af­ter­noon said it’s no longer mov­ing for­ward with its plan to au­tho­rize two dos­es (while wait­ing for da­ta on a third dose) of Pfiz­er’s Covid-19 vac­cine for the youngest group of chil­dren, from 6 months through 4 years of age.

“Based on the agency’s pre­lim­i­nary as­sess­ment, and to al­low more time to eval­u­ate ad­di­tion­al da­ta, we be­lieve ad­di­tion­al in­for­ma­tion re­gard­ing the on­go­ing eval­u­a­tion of a third dose should be con­sid­ered as part of our de­ci­sion-mak­ing for po­ten­tial au­tho­riza­tion,” FDA’s top vac­cine of­fi­cial Pe­ter Marks and act­ing FDA com­mis­sion­er Janet Wood­cock said in a state­ment while an­nounc­ing that next week’s VRB­PAC meet­ing would be de­layed.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER