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 ...

The US Food and Drug Administration has issued emergency use authorization (EUA) for the Covid-19 vaccine developed by Pfizer and BioNTech. After months of development, emergency use was authorized ...

PHILADELPHIA -- Pfizer and BioNTech said Tuesday they have submitted Covid-19 vaccine data on children ages 5 to 11 to the US Food and Drug Administration for initial review, but are not yet seeking ...

The Food and Drug Administration will likely authorize Pfizer's COVID-19 booster shot for adolescents aged 12 to 15 by next week, The Washington Post and The New York Times reported on Thursday. The ...

Last week, the Food and Drug Administration's top vaccine regulator told staff that "at least" 10 children died "after and because of" COVID-19 vaccinations and that the agency was preparing to raise ...