Pfizer/BioNTech’s COVID-19 Vaccine Notches Full Approval from USFDA

August 23rd, 2021 – In yet another milestone in the battle against the coronavirus, the USFDA has granted full approval to Pfizer/BioNTech’s vaccine to prevent COVID-19 disease in individuals 16 years of age and older. The mRNA vaccine BNT162b2, which encodes an optimized SARS-CoV-2 full-length spike glycoprotein, will be marketed under the brand name ‘Comirnaty’.

“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 percent 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 CEO of 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 U.S. since December 2020, and we look forward to continuing to work with the U.S. government to reach more Americans now that we have FDA approval.”

First FDA-Approved COVID-19 Vaccine

Comirnaty’s approval marks many historic firsts, the most remarkable being it’s the first COVID-19 vaccine to bag the FDA’s full approval. It is also the first FDA-approved mRNA-based vaccine for any indication.

Earlier the vaccine had obtained a historic emergency use approval (EUA) from the agency on December 11th, 2020. However, emergency authorization isn’t the same as a full approval. With this landmark decision, several organizations, including universities and the military, can now mandate COVID-19 vaccinations for their workers.

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic. 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,” said Acting FDA Commissioner Janet Woodcock, M.D.

Although more than 200 million doses of the vaccine have been administered since the EUA last December, the full approval would build confidence in unvaccinated individuals. According to a survey conducted by the Kaiser Family Foundation in June, three in ten unvaccinated adults said they would be more likely to get vaccinated if one of the vaccines received full approval.

“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. Today’s milestone puts us one step closer to altering the course of this pandemic in the US,” Woodcock added.

A Timely Approval

As per statistics released by the CDC, around 73% of the population over 18 have received at least one vaccine dose. However, the emergence of the highly contagious Delta variant has necessitated full vaccination among the population at a faster rate. In light of this development, the Biden administration recently proposed that most Americans get a booster shot eight months after their second dose.

In June, White House Chief Medical Advisor Dr. Anthony Fauci had advocated for more Americans to get vaccinated before the delta variant predominated new cases in the US. He also emphasized getting both doses of the vaccine. “Particularly if you had that first dose, make sure you get that second dose. If not, please get vaccinated,” he had warned.

Considering the rise in the number of COVID-19 cases caused by the Delta variant, several experts welcomed the full approval.

“Full approval could not come at a more important time, as the highly contagious delta variant continues to drive up caseloads and deaths across the US,” said Dr. Richard Besser, President, and CEO of the Robert Wood Johnson Foundation and former acting director of the CDC. “I am hopeful that full approval will address any remaining concerns and will move many people to a ‘yes’ on vaccination.”

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Author

Rajaneesh K. Gopinath