Pfizer COVID-19 vaccine FDA report released ahead of emergency use meeting

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COVID-19 VACCINE infographic

COVID-19 Vaccine infographic. (Danielle Alred / NEWS10)

ALBANY, N.Y. (NEWS10)- On December 10 the U.S. Food and Drug Administration (FDA) will meet to approve the emergency use of the Pfizer-BioNTech COVID-19 vaccine. The suggested vaccination schedule for the vaccine is two doses given 21 days apart.

Pfizer’s vaccine has proven to be 95% effective and would be approved for people over the age of 16, according to the FDA’s briefing document. The FDA said the vaccine provided protection from COVID-19 and severe complications after one dose but the data to support a “firm conclusion” did not exist.

Approximately 38,000 individuals over 16 years old participated in the vaccine clinical trial and were followed for two months after receiving the second dose. The three most commonly reported side effects were injection site reaction, fatigue, and headache.

Most commonly reported side effects

  • Injection site reaction- 84.1%
  • Fatigue- 62.9%
  • Headache- 55.1%
  • Muscle pain- 38.3%
  • Chills- 31.9%
  • Joint pain- 23.6%
  • Fever- 14.2

*Severe reactions were reported in up to 4.6% of individuals and were more likely after the second dose.

The FDA said a COVID-19 vaccine would have to have a minimum effective rate of 50% in order to gain approval. Public support could play a role in the number of Americans who are actually on board to get the vaccine.

For herd immunity to be achieved, 70% of the population would either have had to become infected or get the vaccine, according to the Mayo Clinic.

There may not be enough public support to achieve herd immunity. However, the Pfizer vaccine may receive less resistance from wary Americans who said they would be more likely to support a vaccine made in the states, according to a report released by Cornell University in October.

Electronic comments on the FDA’s approval for the emergency use of the vaccine will be accepted through 11:59 p.m. eastern time on December 9. Comments can be submitted on Regulations.gov.

Copyright 2021 Nexstar Media Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.

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