Aug 23, 2021
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About this Deal
Eight months after first authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the United States, the Food and Drug Administration has issued its full stamp of approval.
Now that the companies' detailed, so-called biologics license application has been granted, it's expected vaccination will be required by many companies, schools and other entities.
The FDA decision also clears the way for the companies to market their vaccine, which is not permitted without full licensure. And it may launch a race for booster shots, allowing doctors to prescribe extra Pfizer-BioNTech shots "off label" to anyone they think should get one.
The FDA confirmed late last year through a more streamlined evaluation process that the vaccine, from pharmaceutical giant Pfizer and its partner German startup BioNTech, was safe, effective and could be reliably produced.
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