Pfizer-BioNTech’s Comirnaty Becomes First COVID-19 Vaccine to Receive Full US FDA Approval

The US Food and Drug Administration has approved the Biologics License Application (BLA) for COMIRNATY (COVID-19 Vaccine, mRNA) developed jointly by Pfizer Inc. (New York, NY, USA) and Biopharmaceutical New Technologies (BioNTech Mainz, Germany) to prevent COVID-19 in individuals 16 years of age and older, making it the first COVID-19 vaccine to receive FDA approval.

COMIRNATY, which is based on BioNTech’s proprietary mRNA technology, contains messenger RNA (mRNA), a kind of genetic material. The mRNA is used by the body to make a mimic of one of the proteins in the virus that causes COVID-19. The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the virus that causes COVID-19. The mRNA in Comirnaty is only present in the body for a short time and is not incorporated into - nor does it alter - an individual’s genetic material.

The vaccine has been available in the US under Emergency Use Authorization (EUA) since December 11, 2020 (as the Pfizer-BioNTech COVID-19 Vaccine). The EUA permitted essential rollout of vaccine doses across the US to help provide protection during the COVID-19 public health emergency, based on initial data from the pivotal Phase 3 clinical trial. For FDA approval, Pfizer and BioNTech submitted a comprehensive data package that included longer-term follow-up data from the Phase 3 trial, where the vaccine’s high efficacy and favorable safety profile were observed up to six months after the second dose. The BLA submission package also included the manufacturing and facilities data required for licensure. Pfizer and BioNTech completed submission of the BLA in May 2021, and the BLA was granted Priority Review in July 2021.

“Based on the longer-term follow-up data that we submitted, today’s decision by the FDA affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed. About 60% of eligible Americans are fully vaccinated, and infection, hospitalization and death rates continue to rise rapidly among unvaccinated populations across the country,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “I am hopeful this approval will help increase confidence in our vaccine, as vaccination remains the best tool we have to help protect lives and achieve herd immunity. Hundreds of millions of doses of our vaccine already have been administered in the US since December 2020, and we look forward to continuing to work with the US government to reach more Americans now that we have FDA approval.”

“Today's full approval by the FDA underlines the vaccine's high efficacy and favorable safety profile,” said Ugur Sahin, M.D., CEO and Co-founder of BioNTech. “Our companies have shipped more than one billion doses worldwide, and we will continue to work tirelessly to broaden the access to our vaccine and to be prepared for potential emerging escape variants.”

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine. 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,” said Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research. “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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