FDA Grants Priority Review For Pfizer's Vaccine, Decision Expected In 2022
By Bill Galluccio
July 16, 2021
The Food and Drug Administration has granted a priority review for the coronavirus vaccine created by Pfizer and BioNTech. The decision on whether to grant full approval for the vaccine is expected to be made by January 2022.
Pfizer submitted the application in late May. It included six months of data from an extensive study of fully vaccinated individuals who were over 16-years-old.
The two-dose vaccine has been granted an emergency use authorization for anybody over the age of 12. It is the most widely administered vaccine in the United States. Over 186 million doses have been given out, compared to 136 million of Moderna's vaccine and 12 million of Johnson & Johnson's single-dose vaccine.
Overall, 56.5% of people over the age of 12 are fully vaccinated against COVID-19.
The FDA is also reviewing whether to grant an emergency use authorization for both Pfzifer and Moderna's vaccine in children under the age of 12. That decision is expected to come before the end of the year.
The decision comes as several states are dealing with another surge in cases due to the Delta variant and low vaccination rates. Health officials hope that more people will be willing to get inoculated once the FDA grants full approval for the vaccine.