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Pfizer-BioNTech Vaccine Granted Full FDA Approval

August 23, 2021

The U.S. Food and Drug Administration (FDA) today issued a full approval of the Pfizer-BioNTech COVID-19 vaccine, marking another public health milestone during the pandemic. 

U.S. public health officials said the approval comes after a thorough review of clinical trial data showing the safety and effectiveness of the vaccine.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” Acting FDA Commissioner Janet Woodcock, said in a statement  “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.” 

Here are the key facts about the FDA approval:

  • Effectiveness:  The clinical trials included 22,000 vaccine and 22,000 placebo recipients 16 and older. The trials indicated the vaccine was 91 percent effective in preventing COVID-19
  • What it means:  Full approval comes after review of additional data and allows the vaccine to be used after the pandemic ends
  • How the vaccine works:  The vaccine contains messenger RNA (mRNA), which teaches the immune system to react defensively to the virus that causes COVID-19. The mRNA from the vaccine is only present in the body for a short time and does not alter an individual’s genetic material
  • About the name:  The vaccine has been approved with the name, “Comirnaty,” which combines community, immunity, mRNA, and COVID

The Pfizer-BioNTech vaccine is now fully approved for people 16 and older. The vaccine also has been approved under an emergency use authorization for people between 12 and 15. The vaccine is administered in two doses scheduled three weeks apart.

“The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S," said Peter Marks, director of FDA’s Center for Biologics Evaluation and Research.

A recent survey from the Kaiser Family Foundation indicated that more than three in ten unvaccinated individuals said they would be more likely to get a vaccine after it received full FDA approval. All vaccines reviewed by the FDA must undergo the agency’s standard process, which includes:

  • A review of the quality, safety, and effectiveness of medical products
  • Oversight of the vaccine’s manufacturing process and vaccine testing results to ensure vaccine quality
  • Inspections of the sites where the vaccine is made

HAP continues to encourage anyone who is eligible to receive the COVID-19 vaccine to contact their health care provider for more information. The vaccines are free, safe, and effective, and are widely available in your community.

For more information, contact Robert Shipp III, PhD, BSN, RN, NEA-BC, HAP’s vice president, population health and clinical affairs.