FDA Reportedly Nears Full Approval for Pfizer-BioNTech Vaccine
The Food and Drug Administration is close to granting Pfizer (PFE) – Get Report and BioNTech’s (BNTX) – Get Report COVID-19 vaccine full approval in coming days, according to a published report Friday.
The move could clear the path for government and private entities to require the vaccine which currently only has emergency use authorization.
The two-shot vaccine is one of three inoculations to have won provisional approval in the United States following a rapid development effort over the first year of the COVID-19 pandemic.
Granting the vaccine full approval could give impetus to more vaccinations in the U.S., the New York Times reported.
However, the timing of full approval remains unclear, according to the report. FDA officials had hoped to complete paperwork by Friday, but that goal could slip to Monday or later, the report said.
After surging in spring and early summer, U.S. vaccination rates stalled, leaving about 30% of the country without protection as the fast-moving delta variant of COVID-19 took hold.
In recent days, vaccination rates in the U.S. have risen as the surge in delta variant cases has sent hospitalization and death rates higher in states with low vaccination rates, including Florida, Alabama, Mississippi, Louisiana and Arkansas. An overwhelming percentage of those who are hospitalized and die from the new variant are unvaccinated, according to the Centers for Disease Control.
Shares of Pfizer rose $1.63, or 3.4%, to $50.35 in after-hours trading on Friday. The stock traded little changed in the regular session.
Shares of BioNTech jumped $22.82, or 6.5%, to $371.50 in after-hours trading. The stock gained 5% in the regular session.
