Pfizer-BioNTech vaccine 1st to win FDA full approval
Eight months after authorizing the Pfizer-BioNTech COVID-19 vaccine for emergency use in the USA, the Food and Drug Administration issued its full stamp of approval.
Now that the companies’ detailed, so-called biologics license application has been granted, it’s likely that vaccination will be required by many companies, schools and other entities.
On Monday, President Joe Biden called on companies, non-profit groups, government agencies and schools to “step up vaccine requirements that will reach millions more people.”
Vaccinations allowed people in this country to stop worrying about diseases such as smallpox, polio, measles, mumps and rubella, he said, and vaccines can help do the same for COVID-19.
“It only makes sense to require a vaccine to stop the spread of COVID-19,” Biden said at a news conference. “With today’s FDA full approval, there’s another good reason to get vaccinated.”
The FDA decision clears the way for the companies to market their vaccine, which is not permitted without full licensure. 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 review of the 340,000-page license application was completed in just 97 days by FDA staff working “night and day,” said Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, which approves vaccines.
“We completed this in about 40% of the normal clock time for a submission of this magnitude,” he said.
The license application was three times the size of the emergency use authorization submission, which weighed in at 110,000 pages.
The companies have manufactured more than 2 billion doses, more than 200 million of which were administered in the USA, the most of any of the three vaccines allowed for use in the country. The full license includes four more months of efficacy and safety data, confirming 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 applies only to those 16 and over, but the vaccine is 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.”
Acting FDA Commissioner Janet Woodcock said she hoped the approval would help alter the course of the pandemic in the USA.
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