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US authorization of first COVID vaccine marks new phase in safety monitoring

The FDA has issued an emergency-use authorization for the Pfizer–BioNTech vaccine. Regulators are gearing up to look for side effects.
  1. Heidi Ledford
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The US Food and Drug Administration (FDA) has granted an emergency-use authorization for the country’s first COVID-19 vaccine. The vaccine, made by Pfizer of New York City and BioNTech of Mainz, Germany, can now be administered in the United States outside a clinical trial.

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Nature 588, 377-378 (2020)

doi: https://doi.org/10.1038/d41586-020-03542-4

Updates & Corrections

  • Update 12 December 2020: On 12 December, the story was updated with the US FDA's decision to issue an emergency use authorization for the Pfizer–BioNTech vaccine.

References

  1. Polack, F. P. et al. N. Engl. J. Med. https://doi.org/10.1056/NEJMoa2034577 (2020).

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