Infectious Disease
FDA sets deadline until 2022 to decide on full approval of the Pfizer BioNTech vaccine
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The FDA has set a deadline of January 2022 to decide on full approval of the Pfizer-BioNTech COVID-19 vaccine, the companies said on Friday.
Pfizer and BioNTech announced that the FDA has granted priority review to BNT162 – the company’s messenger RNA vaccine – for the prevention of COVID-19 in people 16 years and older.
Pfizer and BioNTech’s COVID-19 vaccine has received priority review by the FDA.
Source: Adobe Stock.
Companies began filing for full FDA approval for the vaccine in May, using data from a Phase 3 clinical trial that showed that up to 6 months after a second dose was administered, the vaccine was more than 91% effective. was effective and almost 95% against severe COVID. effective was -19.
The vaccine has been approved for emergency use in people aged 16 and over since last December.
In May, the FDA expanded the emergency vaccine approval to patients ages 12-15. Pfizer and BioNTech have announced that they will apply for full approval for this age group as soon as the 6-month data is available.
The companies recently said that amid growing concerns about the Delta variant of SARS-CoV-2, they would also seek approval for a booster dose of the mRNA vaccine, but officials from the CDC and NIH said booster doses of the COVID-19 – Vaccine not yet available.
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