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FDA grants first COVID-19 vaccine full approval

Newsman The Food and Drug Administration on Monday granted full approval of the Pfizer COVID-19 vaccine, becoming the first covid-19 vaccine to transition from an emergency authorization status to full FDA approval. Eight months after first authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the United States, the Food and Drug Administration has issued its full stamp of approval.

U.S. Surgeon General Dr. Vivek Murthy, predicting on ABC’s “This Week” Sunday that full approval may “tip” some fence-sitters towards taking the shot, and prompt more workplaces and schools to move forward on requirements.

“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 said upon Pfizer’s approval.

Full licensure also means Pfizer-BioNTechwill be allowed to advertise their vaccine.

Moderna has already begun the process of applying for a full license and Johnson & Johnson – which makes the other COVID-19 vaccine authorized for emergency use in the U.S. – plans to apply later this year.

“Based on the longer-term follow-up data that we submitted, today’s approval for those aged 16 and over affirms the efficacy and safety profile of our vaccine at a time when it is urgently needed,” Albert Bourla, Pfizer CEO said in a statement to ABC. “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.”

The prioritized review entailed government scientists pouring over hundreds of thousands of pages of safety and efficacy data at a rapid-fire pace, conducting meticulous inspections of Pfizer’s manufacturing process.

The full approval indicates that Pfizer has shown enough effectiveness and safety data to meet the stringent Biologics License Application (BLA) requirements, which includes at least six months of safety data from a majority of the volunteers in a large, final stage clinical trial.

Pfizer’s full and formal approval will now pave the way for further vaccine mandates in both the public and private sector, akin to existing vaccine mandates for other FDA-approved vaccines.

Federal, state and local health officials have  expressed optimism that full approval will help dissolve some of the lingering hesitancy around taking a shot that until now has been only authorized for emergency use — a forecast recent polling has also reflected.

Pfizer was the first to request full approval in the U.S.; other Covid vaccine makers are likely to follow suit. All three authorized vaccines were granted emergency authorization based on massive clinical trials involving tens of thousands of volunteers.

Federal health officials have come under immense political pressure from all sides to get the approval done as soon as possible — as much of the country faces yet another surge, and the Delta variant threatens hard-fought wins in the fight against the virus.

The FDA had made clear getting Pfizer’s vaccine to the approval finish line is a top priority, with an “all hands on deck approach” and “moving forward as rapidly as possible.”

“We recognize that for some, the FDA approval of COVID-19 vaccines may bring additional confidence and encourage them to get vaccinated,” an agency spokesperson told ABC in late July, promising any approved vaccine would meet “rigorous standards for safety, effectiveness, and quality.”

The FDA confirmed late last year through a more streamlined evaluation process that the vaccine, from pharmaceutical giant Pfizer and its partner German startup BioNTech, was safe, effective and could be reliably produced.

The license application included more than 340,000 pages of material, three times the earlier emergency use authorization submission, which weighed in at 110,000 pages.

The companies have manufactured more than 2 billion doses, with over 200 million administered in the U.S., the most of any of the three vaccines currently allowed for use in the country. 

The full license includes four more months of efficacy and safety data, confirming earlier trial results and detailing manufacturing processes. 

The Pfizer-BioNTech emergency use authorization was based on clinical trials involving about 37,000 people. The full approval was based on study results involving more than 44,000 people followed for six months.

The license only applies to those 16 and over, but the vaccine will continue to be allowed for those 12 to 15 under the previous authorization. 

Acting FDA Commissioner Dr. Janet Woodcock said she hoped the approval would help alter the course of the pandemic in the United States.

“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,” Woodcock said in a statement. “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.” 

Some people reluctant to take a vaccine authorized for emergency use may be willing to get a vaccine that has full approval, Dr. Anthony Fauci told USA TODAY’s editorial board earlier this month. 

“When the FDA, God bless them, finally go from an EUA to a BLA, I believe that a certain number of people will spontaneously make the decision that, ‘OK, now I’m convinced. I’m going to get vaccinated,'” he said.

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