Pfizer and BioNTech will request full approval from the FDA for the vaccine.
At the moment, all three vaccines used in the United States (Pfizer, Moderna, Johnson & Johnson) have an emergency-use authorization from the U.S. Food and Drug Administration (FDA).
For full approval, things look a little bit different. The company will have to file a Biologics License Application, using data of at least six months, proving that its vaccine is safe and effective long-term.
A spokesperson for Pfizer-BioNTech confirmed that the two companies will file a Biologics License Application at the beginning of summer 2021, but they’re very optimistic thanks to their recent study.
Make sure to also check: Why Is The AstraZeneca Vaccine Controversial?
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