The Food and Drug Administration on Monday granted the Covid-19 vaccine from Pfizer and BioNTech full approval – as the first in the US to receive the coveted award and even more companies, schools and universities have more confidence in accepting vaccine mandates gives.
To date, the mRNA vaccine, marketed as Comirnaty, has been available on the US market under an Emergency Use Authorization issued by the FDA in December. Since then, more than 204 million Pfizer shots have been administered, according to the Centers for Disease Control and Prevention.
Federal health officials have been under increasing pressure from the scientific community and stakeholders to fully approve Pfizer and BioNTech’s vaccine since drug makers filed their applications with the agency in early May. The companies filed for approval with the FDA for biologics for patients 16 years and older on May 7, ensuring full approval.
According to the US authorities, FDA scientists evaluated “hundreds of thousands of pages” of vaccine data from 40,000 study participants. The vaccine was found to be 91% effective in preventing Covid – slightly lower than the 95% efficacy rate study data shown when the vaccine was approved late last year and before the Delta variant turned in prevailed in the USA
Pfizer’s vaccine met “the agency’s high standards of safety, efficacy and manufacturing quality,” said Acting FDA Commissioner Janet Woodcock in a statement. “While millions of people have already safely received COVID-19 vaccines, we recognize that FDA approval of a vaccine may now create additional confidence for some to be vaccinated.”
The FDA held a media briefing at 11 a.m. on Monday to discuss approval.
Although more than 60% of the entire US population has received at least one dose of a Covid vaccine, many Americans say they are still reluctant to get vaccinated even if the highly contagious Delta variant spreads. Full approval could convince some Americans the shots are safe, doctors and epidemiologists say. In fact, a survey 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 got full approval.
Full approval was “more psychological than anything,” said Dr. Paul Offit, a voting member of the Agency’s Vaccines and Related Biological Products Advisory Committee. “I mean, you’ve already given more than 320 million doses out there. The vaccines already have tremendous safety and efficacy profiles.”
US approval is also likely to kick off a new wave of US vaccine mandates. Big companies – from Walt Disney to Walmart – have already told some or all of their employees that they need to get a full Covid vaccination this fall. Still, despite having legal authority to do so, some private companies may be reluctant to request the shots before full approval, said Dorit Reiss, a law professor at UC Hastings College of the Law.
The Pentagon said it will make vaccinations mandatory for service members “no later than” by mid-September, or sooner if the FDA grants full approval earlier.
“You will see the strengthening of local businesses that are mandating what could be colleges, universities, offices, etc., and I strongly support that,” said Dr. Anthony Fauci, Chief Medical Officer of the White House, on Aug. 8, when asked about full approval of the vaccines. “The time has come … we have to take the extra step to get people vaccinated.”
Pfizer’s shot is the first Covid vaccine to receive full regulatory approval in the U.S. Federal regulators had previously announced that they would work as soon as possible to clear Pfizer’s vaccines.
The vaccine is still subject to an emergency approval for children aged 12-15 as the company continues to collect data. Dr. Peter Marks, the FDA’s chief vaccine agency, said Monday the agency would approve vaccination for children under the age of 12 as “soon” as possible once the company submits the data.
“Studies are currently ongoing and the agency will have to wait for the company to submit the data for these studies,” he said during a briefing. “We definitely want to make sure we’re getting it right.”
Marks also addressed misinformation about the syringe, including the fact that it contains microchips and causes infertility.
“We have heard false claims that the Covid-19 vaccine causes infertility, contains microchips, and causes Covid-19. And worse, we’ve heard false claims that thousands of people died from the vaccine, ”he said. “Let me be clear: these claims are simply not true.”
Standard vaccination tests generally take several months to a year or more to determine if they are safe and effective for the general public. But due to the pandemic that killed more than 628,000 Americans, the FDA has approved the use of the shots under an EUA.
In the event of a public health emergency, the manufacture and approval of vaccines can be streamlined through emergency authorizations. Former Health Minister Alex Azar declared a health emergency on January 31, 2020. The health emergency was renewed several times, most recently at the end of July. The FDA allowed the shots to be used under an EUA with just two months of safety data. It’s not the same as a biologics license application or a full approval application that requires at least six months of data.
Before granting full approval, FDA scientists must carefully review the companies’ clinical trial data, including for inconsistencies or safety concerns, said Offit, who is also director of the Vaccine Education Center at Children’s Hospital of Philadelphia.
It’s a lot of data, Offit said. He previously said when Merck presented its data from its 70,000-person rotavirus vaccine study, the pages generated may have exceeded the height of the Sears Tower – a 1,450-foot tall skyscraper in Chicago now known as the Willis Tower.
“The FDA will do what it thinks it must do to make sure the American public is safe,” he said.
Full approval is also very beneficial for filing companies, said former FDA commissioner Dr. Robert Califf in a phone interview in May.
Pfizer and BioNTech can now market the shots directly to US consumers. Companies cannot advertise their products under an EEA, he said. It also allows the shot to stay in the market once the pandemic is over and the US is no longer viewed as an “emergency”.
“The vaccines must continue to be given under the supervision of a qualified professional,” said Califf. “It’s not that they can send the vaccines home. They can, however, advertise on television and promote their products under the watchful eye of the FDA.”
Pfizer and BioNTech have announced they will generate billions from the vaccine. If fully approved, companies could also decide to charge more for the vaccines, health experts say.
According to the Financial Times, companies have already raised the price of their vaccine in the European Union. They are now charging $ 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 after full approval. Last week the Biden administration said it was preparing to offer booster shots to all eligible Americans from the week of September 20th.
– CNBC’s Rich Mendez contributed to this report.