Full FDA approval for Pfizer vaccine could come next week: reports

Full FDA approval for Pfizer vaccine could come next week: reports
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The Food and Drug Administration’s (FDA) long-awaited full approval for the Pfizer-BioNTech COVID-19 vaccine could come as soon as next week, The New York Times and Politico reported on Friday, potentially expediting more decisions about mandates.

The federal agency is reportedly aiming to grant the full license to Pfizer and its German partner BioNTech on Monday, the Times reported, citing people familiar with the agency’s planning. 

The Times reported that FDA regulators were trying to get the approval by Friday but more paperwork and negotiations needed to be completed. Sources warned that the authorization could be delayed past Monday. 


The new timeline represents an acceleration from the plan to reach full approval for the Pfizer vaccine by Labor Day, as reported by The New York Times earlier this month. 

Politico first reported that three people with knowledge of the matter said the agency is on course to give full authorization for the Pfizer-BioNTech shot as soon as next week. 

The FDA declined to comment, and The Hill has reached out to the White House. 

All three vaccines currently available in the U.S. were authorized under an emergency use authorization, meaning they would only be available as long as the country had a declared public health emergency. But the COVID-19 vaccines are widely considered safe and effective under the FDA’s current authorization.

The expectation for a COVID-19 vaccine’s full authorization has ignited hope within the Biden administration and among outside experts that more people will get vaccinated, something crucial given the delta variant's hold on the nation.

More vaccine mandates are expected following the full license as several organizations and employers wanted to wait for the complete endorsement from the FDA before announcing requirements.


The FDA’s total approval could also influence people who are hesitant to get the jab after a Kaiser Family Foundation poll found about 30 percent of unvaccinated people say they would be more willing to get the vaccine with the full authorization. 

Starting in mid-April, vaccinations fell dramatically before starting to tick up again in July amid the recent surge in cases, hospitalizations and deaths. 

Slightly more than half of the U.S.’s total population is considered fully vaccinated against the virus. Out of the eligible population aged 12 and older, almost 60 percent are fully vaccinated, according to data from the Centers for Disease Control and Prevention. 

Nine months ago, the Pfizer-BioNTech vaccine was the first vaccine authorized for emergency use in the U.S., followed shortly after by Moderna. Pfizer and BioNTech applied for full FDA approval more than three months ago. 

This week, the administration announced it will make booster shots available by Sept. 20. Biden has also instituted vaccination requirements for federal workers.