FDA Grants Full Approval To Pfizer COVID-19 Vaccine

By Jason Hall

August 23, 2021

Corona pandemic worldwide.Pfizer/BioNTech vaccination vial.
Photo: Getty Images

Pfizer-BioNTech's two-dose COVID-19 vaccine was granted full approval by the Food and Drug Administration for all individuals age 16 and older on Monday (August 23), CNN reports.

On Friday (August 20), sources with knowledge of the plan told the New York Times that the target date for approval was Monday, though paperwork and negotiations with the FDA and Pfizer-BioNTech were ongoing and could've delayed the process.

Pfizer-BioNTech is now the first and only coronavirus vaccine to get full FDA approval, as it -- along with the Moderna and Johnson & Johnson's vaccines -- has already been approved for emergency use authorization.

The decision is expected to lead the FDA to open the door for more vaccine mandates, CNN reports.

On August 8, White House chief medical advisor Dr. Anthony Fauci told the Associated Press that he hoped vaccines would receive full approval "within the next few weeks," adding that he hoped it would be "within the month of August" and that full approval would lead more companies and schools to mandate vaccines.

U.S. companies have tightened vaccine rules for employees amid another spike in COVID-19 cases nationwide during recent weeks.

The rise in cases and full approval from the FDA could help persuade individuals who are hesitant to get the vaccine.

More than 203 million doses of the Pfizer-BioNTech vaccine have already been administered nationwide and more than 91 million people have received two doses, according to data released by the Centers for Disease Control and Prevention on Friday (August 20) via CNBC.

Pfizer and BionNTech initially began the process of applying for their biologics license for their vaccine in May after being granted emergency use authorization from the FDA in December.

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