Dr Robert Hess speaks about the FDA grants full approval to the Pfizer/BioNTech COVID-19 vaccine
Update: 2021-09-06
Description
What exactly does full FDA approval of a vaccine mean?
The Pfizer/BioNTech COVID-19 vaccine first received Emergency Use Authorization (EUA) from the U.S. authorities in mid-December 2020 for administration to persons aged 16 and older. On Monday, the FDA announced that it has now granted full approval. The vaccine has thus become the first to receive FDA approval for use against coronavirus. More are expected to follow in the coming weeks and months.
Emergency Use Authorization continues to apply for use on adolescents aged 12 to 15 years and for administration as a third booster dose to immunocompromised individuals.
Further monitoring of the vaccine’s safety and efficacy remains mandatory, even after approval, and will be carried out assiduously.
The Pfizer/BioNTech COVID-19 vaccine first received Emergency Use Authorization (EUA) from the U.S. authorities in mid-December 2020 for administration to persons aged 16 and older. On Monday, the FDA announced that it has now granted full approval. The vaccine has thus become the first to receive FDA approval for use against coronavirus. More are expected to follow in the coming weeks and months.
Emergency Use Authorization continues to apply for use on adolescents aged 12 to 15 years and for administration as a third booster dose to immunocompromised individuals.
Further monitoring of the vaccine’s safety and efficacy remains mandatory, even after approval, and will be carried out assiduously.
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