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FDA Grants Final Approval to Pfizer Vaccine

(Washington, D.C.) - Eight months after authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the USA, the Food and Drug Administration issued its full stamp of approval.


Now that the companies' so-called biologics license application has been granted, it's likely that vaccination will be required by many companies, schools, and other entities.


Monday, President Joe Biden called on companies, nonprofit groups, government agencies, and schools to "step up vaccine requirements that will reach millions of more people." Vaccinations allowed people to stop worrying about diseases such as smallpox, polio, measles, mumps, and rubella, he said, and vaccines can help do the same for COVID-19.


"It only makes sense to require a vaccine to stop the spread of COVID-19," Biden said at a midday news conference. "With today's FDA full approval, there's another good reason to get vaccinated."

The FDA decision clears the way for the companies to market their vaccine, which is not permitted without full licensure. In addition, 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. The review of the 340,000-page license application was completed in just 97 days by FDA staff working "night and day," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, which approves vaccines.

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