FDA Issues Full Approval for Pfizer, BioNTech Vaccine

Vaccine Product Approval Process by Food and drug administration (FDA) or center of disease control (CDC) | FDA Issues Full Approval for Pfizer, BioNTech Vaccine | featured

The US Food and Drug Administration (FDA) issued its full approval to the COVID-19 vaccine developed by Pfizer and BioNTech. Their vaccine became the first coronavirus to earn the coveted status.

This also means that government agencies, businesses, and institutions can be more confident in continuing their planned vaccine mandates.

RELATED: Booster Shot Open to Americans With Moderna, Pfizer Vaccines

First COVID-19 Vaccine With Full Approval

With full approval, Pfizer and BioNTech can now market their vaccine in the United States. The companies designated the name Comirnaty for the vaccine. Reportedly, the choice of brand name is a play in the words community, mRNA, and immunity. 

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Previously, all COVID-19 vaccines available right now are under the FDA’s Emergency Use Authorization. The approval, issued last December, temporarily allows government agencies to give Americans vaccine shots in light of the pandemic’s urgency.

At this point, Pfizer and BioNTech already administered more than 204 million doses. This is according to data compiled by the Centers for Disease Control and Prevention.

FDA Under Pressure to Issue Full Approval for Vaccine

With the pandemic continuing to surge, federal health officials were under pressure to issue full approval for any of the COVID-19 vaccines operating under a EUA.

As early as May, Pfizer and BioNTech submitted their application for a Biologics license, which covers the use of their vaccine for patients 16 years old and up.  

However, FDA experts need to go through a trove of data before they can confidently issue an approval. This includes reading through and evaluating hundreds of thousands of pages of vaccine data from 40,000 trial participants.

During their evaluation, the FDA discovered that the vaccine’s 91% effectiveness rate is lower than its earlier claimed rate of 95%.

Despite the lower effectiveness rate, Acting FDA Commissioner Janet Woodcock said in a statement that companies met the agency’s standards for “high standards for safety, effectiveness, and manufacturing quality” even during its EUA stage.

“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,” the FDA statement said. The FDA organized a media briefing last Monday to discuss the full approval. 


Many Americans Still Hesitant

Even with the coronavirus still resurgent in the US after a year, many Americans remain hesitant about getting a vaccine. Currently, only about 60% of the total US population has at least one dose of any COVID-19 vaccine.

The rest are either adamant about not getting the vaccine or will wait for further developments before deciding.

However, a full approval status may help convince hesitant Americans of the vaccine’s safety and effectiveness. In particular, a Kaiser Family Foundation survey said that 30% of unvaccinated American adults said they would likely get a vaccine if they have the FDA’s full approval.

Full Approval Applies to 16 Years and Older Only

Despite the full approval status, the Pfizer-BioNTech vaccine only applies to Americans 16 years and older. Application of the vaccine to children between 12 to 15 years of age remains under Emergency Use Authorization.

In fact, Dr. Peter Marks, the FDA’s top vaccine regulator, said that the FDA continues to work for full approval for the age bracket once it completes the needed data.

“Currently, there are still trials ongoing and so the agency has to wait for the company to submit the data for those trials. We certainly want to make sure that we get it right,” he said.

Watch the ABC News video reporting that the FDA grants full approval to Pfizer COVID-19 vaccine:

Will the FDA’s full approval convince you to take the COVID vaccine or make you recommend it to family and friends?

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