Pfizer COVID-19 shot to get FDA priority review

The FDA has granted Pfizer's COVID-19 vaccine priority review designation for use in people ages 16 and older, the drugmaker said July 16. 

The deadline for the FDA to make a decision on granting full approval to the vaccine is January 2022, though the agency said it intends to make a decision "far in advance" of that date. An FDA official told CNN July 16 that a decision on full approval will likely come within two months. 

Pfizer completed the rolling submission of its application for use of its COVID-19 shot in people ages 16 and older in May, and said it will submit a second application for use in people as young as 12 years once it has six months of data following the second dose for that age group.

Some experts have said full approval of a COVID-19 vaccine may increase uptake from those who have hesitated due to the belief that the vaccines are too new and not thoroughly tested. A Kaiser Family Foundation survey of US adults released July 13 found that among the one-third of U.S. adults surveyed who are not yet vaccinated, 16 percent said the vaccines were too new, too unknown or not tested enough.

 

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars

>