Pfizer-BioNTech COVID-19 vaccine authorized for emergency use

U.S. FDA staff have recommended monitoring individuals who get the Pfizer or Moderna vaccine shots for possible cases of Bell’s palsy.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the Food and Drug Administration (FDA), but it has been authorized for emergency use under an Emergency Use Authorization (EUA) “to prevent COVID-19 infection in individuals 16 years of age and older.”1

The EUA came soon after the vaccine received the green light from the Vaccines and Related Biological Products Advisory Committee on Dec. 10, 2020.

For more coverage, check out our sister publication, Drug Topics®.

U.S. FDA staff have recommended monitoring individuals who get the Pfizer or Moderna vaccine shots for possible cases of Bell’s palsy. A staff report released Tuesday stated that Pfizer’s vaccine trial had 4 reported cases of Bell’s palsy in approximately 43,000 participants, and that all four cases received the vaccine and not the placebo.2

Check back with Contemporary OB/GYN® for more vaccine coverage.

__

References

  1. One of the world's premier biopharmaceutical companies. https://www.pfizer.com/. Published 2020. Accessed December 16, 2020.
  2. Higgins-Dunn N. FDA staff recommends watching for Bell's palsy in Moderna and Pfizer vaccine recipients. CNBC. https://www.cnbc.com/2020/12/15/fda-staff-recommends-watching-for-bells-palsy-in-moderna-and-pfizer-vaccine-recipients.html. Published December 15, 2020. Accessed December 16, 2020.