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Pfizer-BioNTech COVID-19 vaccine gains full U.S. regulatory approval

Pfizer-BioNTech COVID-19 vaccine gains full U.S. regulatory approval

14 Sept 04:37 Key points summarised by AI
  • The U.S. Food and Drug Administration (FDA) granted full regulatory approval to the Pfizer-BioNTech COVID-19 vaccine for individuals aged 16 and older, making it the first vaccine to achieve this status in the U.S.
  • President Joe Biden urged unvaccinated Americans to get the shot, anticipating that the full approval would boost public confidence and lead to more vaccine mandates from employers, states, and the military.
  • Based on updated clinical trial data, the FDA's decision affirms the vaccine's efficacy and safety profile, while also extending its shelf life and potentially simplifying off-label use for third doses in certain populations.
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