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What Would Full FDA Approval Mean for the Pfizer Vaccine?

By Cory Renauer - Updated May 7, 2021 at 3:45PM

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Pfizer and BioNTech have submitted an application for full FDA approval of their COVID-19 vaccine.

Pfizer (PFE 3.77%) and BioNTech (BNTX 1.11%) submitted an application on Friday to the Food and Drug Administration for full approval of their coronavirus vaccine. If you're wondering how a full approval would be any different from the status quo, you aren't alone.

There are a few important ways a full FDA approval could differ from the Emergency Use Authorization (EUA) that allows Americans to access the partners' vaccine now. If approved, one of the biggest changes most people will notice will be slick advertisements goading hesitant Americans into requesting Pfizer's vaccine by name. The big change behind the scenes, though, will be increased scrutiny of the vaccine's manufacturing process.

A smiling pharmacist

Image source: Getty Images.

Pfizer's COVID-19 vaccine hasn't been the subject of any manufacturing debacle so far. If approved, it's extremely unlikely we'll see one. The FDA does not pull punches when it comes to biologics manufacturing, and industry veterans know it. Getting an initial green light to manufacture a vaccine is such a challenge that facility operators generally fight tooth and nail to maintain their credibility.

Plenty of organizations are still sticking to strict mandates that prevent their uptake of Pfizer's COVID-19 vaccine until it's fully approved by the FDA. Finally, full approval could go a long way to combat general vaccine hesitancy.

Pfizer has requested a shortened six-month review instead of the standard 10-month-long process. The agency has two months to begin a review or ask for more information. 

On Tuesday, Pfizer reported first-quarter revenue figures that outperformed expectations thanks in large part to surging COVID-19 vaccine sales. In response to additional supply agreements, the company raised its outlook for 2021 revenue related to the vaccine from $15 billion to a mind-boggling $26 billion. 

Cory Renauer has no position in any of the stocks mentioned. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy.

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Stocks Mentioned

Pfizer Inc. Stock Quote
Pfizer Inc.
PFE
$50.11 (3.77%) $1.82
BioNTech SE Stock Quote
BioNTech SE
BNTX
$160.35 (1.11%) $1.76

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