FDA Fully Approves Pfizer’s COVID Vaccine

by Casey Harper


The U.S. Food and Drug Administration gave full approval Monday to the Pfizer COVID-19 vaccine, a major step that will likely have significant implications for vaccination mandates nationwide. The Moderna and Johnson & Johnson vaccines have not yet received full FDA authorization.

The Pfizer vaccine previously received FDA authorization, which allowed its emergency use but did not give the full approval. Pfizer is the first company to receive full approval in the U.S.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” Acting FDA Commissioner Janet Woodcock said. “While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product.”

Many Americans have held off receiving a COVID-19 vaccine, arguing the FDA had not yet given full approval. Several companies and institutions had also held back implementing vaccine mandates, citing the same concern.


Now that the Pfizer vaccine has full FDA approval, many companies will likely put in place those mandates, though it’s unclear how they would manage any mandates with Pfizer and Johnson & Johnson vaccines not full approved.

“This is a crucial milestone that will empower many more employers to mandate vaccination,” Leana Wen, a medical doctor and visiting professor at George Washington University, wrote on Twitter. “It will help people understand this vaccine as they do all others: safe, effective & life-saving.”

Woodcock said the full FDA approval should increase vaccination rates in the U.S.

“While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated,” she added. “Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.”

Moderna and Johnson & Johnson are still waiting for the FDA seal of approval.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research. “We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness, and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities. We have not lost sight that the COVID-19 public health crisis continues in the U.S. and that the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

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Casey Harper is a Senior Reporter for the Washington, D.C. Bureau.
Photo “Philippines: COVID-19 Vaccine” by Asian Development Bank. CC BY-NC-ND 2.0.






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