FDA prioritizing review for Pfizer-BioNTech COVID-19 vaccine approval, companies say

The Food and Drug Administration has granted priority review for the approval of the Pfizer-BioNTech COVID-19 shots for people aged 16 years and older, the vaccine makers said Friday.

The FDA is striving to make a decision in January, according to Pfizer and BioNTech.

Although the goal is set for next year, the FDA said it does not mean approval will not occur sooner, noting the review for licensure is “among the highest priorities of the agency, and the agency intends to complete the review far in advance” of the targeted deadline.

The companies said they completed the rolling submission of the Biologics License Application for their two-dose mRNA vaccine in May. Data from phase three clinical trials of the vaccine, in which the shot’s efficacy and safety were observed for up to six months after the second dose, were included in the application.

The COVID-19 vaccine has not been granted full approval or license by the FDA, but authorized for emergency use during the pandemic.

In May, the FDA expanded the vaccine’s emergency use authorization to include adolescents 12 to 15 years old. Pfizer and BioNTech noted they plan to submit additional documentation for licensing of the vaccine for this age group once data are collected for six months after the second vaccine dose.

The Pfizer-BioNTech vaccine is the most highly administered in the U.S., with more than 186 million doses given as of Thursday, data from the Centers for Disease Control and Prevention shows.