Full Approval for Pfizer

The FDA has now issued full approval of the Pfizer vaccine

National Geographic

The FDA has now issued full approval of the Pfizer vaccine

Emma Larkin, Staff Writer

Monday, August 23, will be known as a historic day as the FDA gave their official full approval for the Pfizer/BioNTech COVID-19 vaccine. The vaccine was originally released to the general public on December 11, 2020, with an Emergency Use Authorization (EUA) approval.

Out of the three different coronavirus vaccines, Pfizer’s is the first to receive full approval from the FDA. The Moderna vaccine is still under review and the request for full approval on the single shot Johnson & Johnson vaccine has yet to be submitted to the FDA.

The vaccine now is officially approved for people 16 years of age or older. However, for children ages 12 to 15, the vaccine continues to be authorized under the EUA approval.

“The initial Pfizer studies were done in those age groups of 16 and above. Those are the data that were submitted for full approval. The vaccine is authorized under the EUA for kids ages 12 to 15. There just hasn’t been enough time for the vaccine in this age group to receive full approval,” medical analyst Dr. Leana Wen said.

Full FDA approval differs from EUA in that it is an entirely different approval process. The FDA approval generally requires a minimum of six months of intensive studies and tests on the product before it can receive the stamps of approval. In contrast, the EUA approval for the Pfizer vaccine was given after only two months of data collecting. This was due to the state of emergency that was in effect during the time.

Currently 52.2% of Americans are fully vaccinated with Pfizer being the most common vaccine out of the three. This evidence was crucial for the FDA to have in order to fully approve Pfizer’s vaccine.

With this approval on Pfizer and the incoming approval of the other vaccines, this long, and seemingly unending pandemic might finally come to an end.