FDA grants full approval to Covid-19 vaccine developed by Pfizer, BioNTech

On Monday, the Food and Drug Administration, FDA approves the Covid-19 vaccine developed by Pfizer and its partner BioNTech.

This is the long-awaited development that public health officials hope will persuade some people who remain hesitant about the vaccine to get the shot.

The Pfizer vaccine is the first of the pandemic vaccines used in the United States to transition from emergency use status to full licensure. 

FDA says the vaccine was now approved for use in people ages 16 and up, the only group for which Pfizer now has the required six months of follow-up safety data. 

Study of the vaccine in 12- to 15-year-olds began later, and the six-month follow-up is still underway.

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Until it can be submitted to the FDA and an extension of the license can be issued, the vaccine will continue to be used in 12- to 15-year-olds under the emergency use authorisation.

Pfizer and BioNTech are still conducting a clinical trial to support the vaccine’s use in children of 11 years and younger. The vaccine was first put into emergency use in the United Kingdom last December. However, it has been given to hundreds of millions of people around the world.

Several countries have already granted the vaccine a license, and roughly 70 others have given it emergency use status. According to STAT News, Pfizer and BioNTech have made 1.2 billion doses of the vaccine to date. 

That figure is expected to rise to 3 billion doses; in 2022, the companies project they will produce 4 billion doses. 

The U.S. government has purchased 1 billion doses of the vaccine. Half for use in this country and half to donate to low-income countries.

“[Monday’s approval] affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Pfizer CEO Albert Bourla said in a statement. 

“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,” Bourla added.

The FDA has been under intense pressure to fast-track full approval of the vaccine, given that some people who remain unvaccinated have cited the emergency use authorisation as the reason for their reluctance to get the jab. 

Approval was also expected to make it easier for some public and private organisations and require vaccination. By law, the FDA had to rule on the application no later than eight months from when the final documents were submitted — May 21. 

But in the face of the political pressure to process the application well before the Jan. 21, 2022, deadline, the agency committed publicly to pull out all the stops to get the job done.

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