A photo taken on January 15, 2021, shows a pharmacist holding with gloved hands a vial of the undiluted Pfizer-BioNTech vaccine for Covid-19, stored at -70° in a super freezer of the hospital of Le Mans, northwestern France as the country is conducting a vaccination campaign to prevent the spread of the new coronavirus.
Jean-François Monier | AFP | Getty Images
The Food and Drug Administration has granted Pfizer and BioNTech full US approval for their Covid-19 vaccine – becoming the first in the US to win the coveted title and give even more companies, schools and universities more confidence to adopt vaccine mandates .
Until now, the mRNA vaccine was on the US market under an Emergency Use Authorization, which was granted by the FDA in December. Since then, more than 204 million of the Pfizer injections have been administered, according to data collected by the Centers for Disease Control and Prevention.
Federal health officials have been under increasing pressure from the scientific community and advocacy groups to fully approve the vaccine from Pfizer and BioNTech since the drug manufacturers submitted their application to the agency in early May. The companies filed an application for biologics with the FDA on May 7 for patients 16 and older.
While more than 60% of the total US population has had at least one dose of a Covid vaccine, many Americans say they are still hesitant to get vaccinated even as the highly contagious delta strain spreads. Full approval may convince some Americans the shots are safe, doctors and epidemiologists say. In fact, a study by the Kaiser Family Foundation found that 3 in 10 unvaccinated adults said they would be more likely to be vaccinated if one of the vaccines received full approval.
Full approval is “more psychological than anything,” said Dr. Paul Offit, a voting member of the agency’s advisory committee on vaccines and related biologics. “I mean, you’ve already delivered over 320 million doses out there. The vaccines already have a huge safety and efficacy profile.”
The US approval is also likely to spark a new wave of vaccine mandates from corporate America. Major companies — from Walt Disney to Walmart — have already told some or all of their employees to fully vaccinate against Covid this fall. Still, some private companies may be hesitant to demand the shots before getting full approval, even if they had the legal authority to do so, said Dorit Reiss, a law professor at UC Hastings College of the Law.
The Pentagon said it would mandate vaccinations for service workers “no later” than mid-September, or sooner if the FDA grants full approval sooner.
“You’ll see the empowerment of local businesses, giving mandates that can be colleges, universities, business parks, a whole host of them and I wholeheartedly support that,” said Dr. Anthony Fauci, White House Chief Medical Officer on Aug. 8, when asked about full approval of the vaccines. “The time has come. … We need to go the extra mile to get people vaccinated.”
Pfizer’s injection is the first Covid vaccine to gain full regulatory approval in the US. Federal regulators had previously said they would work as soon as possible to release Pfizer’s vaccines.
Standard vaccine reviews generally take several months to a year or more to determine if they are safe and effective for use in the general public. But because of the pandemic, which has killed more than 628,000 Americans, the FDA allowed the use of the shots under an EUA.
In a public health emergency, vaccine production and approval can be streamlined through emergency licensing. Former Health Minister Alex Azar declared a public health emergency on January 31, 2020. The health emergency has been extended several times, most recently in late July. The FDA allowed the use of the shots with only two months of safety data under an EUA. It is not the same as an application for a biological license, or a request for full approval, which requires at least six months of data.
Before granting full approval, FDA scientists should carefully review the companies’ clinical trial data, including for any discrepancies or safety concerns, said Offit, who is also director of the Vaccine Education Center at Children’s Hospital in Philadelphia.
It’s a lot of data, Offit said. He previously said that when Merck submitted his data from his study of the rotavirus vaccine for 70,000 individuals, the pages generated could have exceeded the height of the Sears Tower — a 1,450-foot skyscraper in Chicago now known as Willis Tower.
“The FDA will do what it thinks it needs to do to make sure the American public is safe,” he said.
Full approval is also very beneficial for companies applying, said former FDA Commissioner Dr. Robert Califf in a telephone interview in May.
This will allow Pfizer and BioNTech to sell the shots directly to US consumers. Companies cannot promote their products under an EUA, he said. It also ensures that the shot remains in the market once the pandemic is over and the US is no longer considered an “emergency”.
“The vaccines still need to be administered under the supervision of a professional who is qualified,” Califf said. “It’s not like they can send the vaccines to people’s homes, but they can advertise on TV and promote their products under the watchful eye of the FDA.”
Pfizer and BioNTech have said they expect to generate billions from the vaccine. With full approval, the companies could also decide to charge more for the vaccines, health experts say.
The companies have already increased the price of their vaccine in the European Union, according to the The Washington City Times. They now charge $23 per dose, up from their previous price of $18.40, according to the report.
Pfizer and BioNTech also plan to ask the FDA to approve a third dose as a booster injection after full approval. Last week, the Biden administration said it was preparing to offer booster shots to all eligible Americans beginning the week of September 20.
This is a story in development. Come back for updates.