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.
Now that the companies’ detailed, so-called biologics license application has been granted, it’s expected vaccination will be required by many companies, schools and other entities.
The FDA decision also clears the way for the companies to market their vaccine, which is not permitted without full licensure. And it may launch a race for booster shots, allowing doctors to prescribe extra Pfizer-BioNTech shots “off label” to anyone they think should get one.
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.
“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,”
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.
“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,” Pfizer chairman and 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.”
The full authorization process involves more data and more time in part because once a drug or vaccine is authorized by FDA, doctors are able to prescribe it “according to the practice of medicine,” also known as off-label.
“Not that we’re recommending off-label uses, but there is a broader potential use of that product,” said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research at FDA, which approves vaccines.
“When we give a biologics license, we are really saying that we have a lot of confidence in that product, in the safety, efficacy, manufacturing information, not just when it’s used exactly according to how it’s labeled, but potentially if it were used somewhat differently by physicians,” he said.
This ability to prescribe off-label also means doctors can authorize people to get an extra Pfizer-BioNTech shot, even before booster shots are made available to the general public likely to begin the week of Sept. 20.
“It might discourage people from waiting eight months” to get a booster shot, as the administration recommends, said Dr. Jesse Goodman, an infectious disease specialist at the Georgetown University School of Medicine.
And it might make it harder for people who are immunocompromised, who are allowed to get boosters now, to access shots, said Norman Baylor, president and CEO of Biologics Consulting. “It could create a competition for the immunocompromised,” he said in a call last week with reporters.
But otherwise, the change will be mostly psychological, he said in an interview.
“Really, there are not major differences,” said Baylor, who spent 20 years with the FDA, including running its Office of Vaccines Research and Review.
The legal backing of full approval means more businesses and schools will start requiring the COVID-19 vaccine, said Dorit Rubinstein Reiss, a law professor at the University of California, Hastings College of the Law, and an expert on vaccine requirements
“Most places which are nervous about the EUA will likely move immediately as soon as there’s a BLA,” she said.
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.
In one recent poll, 72% parents of children ages 12 to 17 said full approval would make them more confident in the safety of the vaccines.
Full licensure also means Pfizer-BioNTech will be allowed to advertise their vaccine.
Moderna and Johnson & Johnson, which make the other two authorized vaccines, are further behind in the licensure process, but are expected to go through the same steps in the coming months.
Are You Vaccinated or Plan on Getting Vaccinated?
