Pfizer/BioNTech seeks full FDA approval for its Covid-19 vaccine, which is currently available through an emergency use authorization
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 first Covid-19 vaccine in the United States to be assessed for full approval from the FDA.
Pfizer's mRNA two-shot vaccine is currently being used in the US under emergency use authorization from the FDA. The companies say 170 million doses of the vaccine have been distributed across the US to date.FDA to authorize Pfizer's Covid-19 vaccine for 12-to-15-year-olds by early next week, official says"We are proud of the tremendous progress we've made since December in delivering vaccines to millions of Americans, in collaboration with the U.S.
Clinical trials and recently published real-word data show the vaccine is up to 95% effective at preventing infection, severe illness and hospitalization. Pfizer/BioNTech reported last month that trial results show the vaccine remains more than 91% effective against disease with any symptoms for six months.Recent research suggests the vaccine is effective against some worrying virus variants, and Pfizer/BioNtech is currently testing booster and variant-specific vaccines.
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