RAPS

FDA authorizes Pfizer COVID vaccine for younger kids

The first US emergency use authorization (EUA) for younger children to receive a COVID-19 vaccine has been issued, the US Food and Drug Administration (FDA) announced Friday afternoon. The mRNA ...
RAPS

This Week at FDA: Senate committee to vote on Califf’s nomination; FDA ordered to speed release of Pfizer vaccine documents

Welcome back to This Week at FDA! There’s lots of big news to cover in this week’s installment, including some items from before the holidays, updates on COVID-19 vaccines and Robert Califf’s ...
abc7NY

Pfizer and BioNTech begin application for full FDA approval of their COVID-19 vaccine

Pfizer/BioNTech has initiated its application to the US Food and Drug Administration for full FDA approval of its Covid-19 vaccine for people ages 16 and older, the companies said Friday. This is the ...
fox17online

FDA approves Pfizer vaccine booster shot for kids as young as 12

The Food and Drug Administration has issued approval for a booster shot of Pfizer's COVID-19 vaccine for children as young as 12. The Pfizer vaccine is the first booster shot to receive emergency ...
The Southern Illinoisan

Pfizer's COVID Vaccine for Kids Under 5 Moves Closer to FDA Approval

Pfizer's COVID Vaccine for Kids Under 5 , Moves Closer to FDA Approval . Pfizer announced on June 1 that its application to the Food and Drug Administration (FDA) for the vaccine was complete. Pfizer ...
Nasdaq

Pfizer and BioNTech’s COMIRNATY® Receives U.S. FDA Approval for Adults 65 and Older and Individuals Ages 5 through 64 at Increased Risk for Severe COVID-19

The 2025-2026 COVID-19 vaccine formulation targets the SARS-CoV-2 sublineage LP.8.1, in line with FDA guidance to more closely match circulating strains1 Shipping of the LP.8.1-adapted vaccine will ...