The FDA grants full approval to Pfizer-BioNTech’s Covid vaccine

The Food and Drug Administration on Monday agreed to full approval of the Pfizer and BioNTech Covid-19 vaccine – becoming the first in the United States to win the coveted designation and giving even more companies, schools and universities a more great confidence to adopt vaccination mandates.

Until now, the mRNA vaccine, which will be marketed as Comirnaty, was on the U.S. market under an Emergency Use Authorization that was granted by the FDA in December. Since then, more than 204 million Pfizer shots have been administered, according to data compiled 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 Pfizer and BioNTech vaccine since the drugs submitted their candidacy to the agency in early May. Companies have submitted a Biological License Application, which ensures full approval, to the FDA on May 7 for patients 16 years of age or older.

FDA scientists have evaluated “hundreds of thousands of pages” of vaccine data, according to the U.S. agency.

The Pfizer vaccine met the agency’s “high standards for safety, efficacy and manufacturing quality,” Janet Woodcock, acting FDA commissioner, said in a statement. “While millions of people have already received COVID-19 vaccines safely, we recognize that for some, FDA approval of a vaccine may now instill additional confidence to be vaccinated.”

The FDA will hold a media briefing at 11 a.m. Monday to discuss approval.

Although more than 60% of the total U.S. population has had at least one dose of a Covid vaccine, many Americans say they are still reluctant to be vaccinated, even when the highly contagious delta variant spreads. Full approval may convince some Americans that the blows are safe, say doctors and epidemiologists. In fact, a survey from at the Kaiser Family Foundation found 3 in 10 unvaccinated adults who would be more likely to be vaccinated if one of the vaccines received full approval.

Complete approval is “more psychological than anything else,” said Dr. Paul Offit, a voting member of the Advisory Committee on Vaccines and Related Organic Products. “I mean you already have over 320 million doses administered that are out. Vaccines already have a huge profile of safety and effectiveness.”

U.S. approval is also likely to spur a new wave of vaccine orders from corporate America. Major companies – from Walt Disney to Walmart – have already told some or all of their employees that they must be completely vaccinated against Covid this fall. However, some private companies may have hesitated to apply for the blows before full approval, even if they had the legal authority to do so, said Dorit Reiss, a law professor at UC Hastings College of Law.

The Pentagon has said it will make vaccinations mandatory for service members “no later” than mid-September, or sooner if the FDA grants full approval sooner.

“You’re going to see the empowerment of local businesses, giving mandates that could be universities, colleges, businesses, a healthy variety and support it firmly,” said Dr. Anthony Fauci, the White House medical director. , on August 8, when he asked about the full approval of the vaccines. “The time has come … … we need to go one step further to vaccinate people.”

Pfizer’s coup is the first Covid vaccine to receive full regulatory approval as U.S. federal regulators had already said they would work as soon as possible to remove Pfizer vaccines.

And standard vaccine magazines they usually 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 has allowed the use of the blows under a U.S. flag.

In a public health emergency, the manufacture and approval of vaccines can be simplified by means of emergency permits. Former Health Secretary Alex Azar declared a public health emergency on January 31, 2020. The health emergency has been renewed several times, more recently at the end of July. The FDA allowed the use of the blows with just two months of safety data in a USA. It is not the same as a Biological License Application, or a full approval application, which requires at least six months of data.

Before granting full approval, FDA scientists must carefully look at the companies ’clinical trial data, even for any discrepancies or safety concerns, said Offit, who is also director of the Vaccine Education Center at the Philadelphia Children’s Hospital.

That’s a lot of data, Offit said. He said earlier when Merck presented its data from the 70,000-person rotavirus vaccination process, the pages that were generated could exceed the height of the Sears Tower – a 1,450-foot skyscraper in Chicago that is now known as and Willis Tower.

“The FDA will do what it thinks it needs to do to ensure that the American public is safe,” he said.

Full approval is also very beneficial for companies filing an application, the former FDA commissioner, Dr. Robert Califf, said in a telephone interview in May.

With it, Pfizer and BioNTech are now able to market the hits directly to American consumers. Companies cannot promote their products under one USA, he said. It also allows the coup to stay on the market once the pandemic is over and that the United States is no longer considered in an “emergency”.

“Vaccines should be administered under the supervision of a qualified professional,” Califf said. “It’s not like they can send vaccines to people’s homes. However, 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. Under full consent, companies may also decide to charge more for vaccines, health experts say.

Companies have already increased the price of their vaccine in the European Union, according to the Financial Times. They now pay $ 23 per dose, in addition to 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 boost after complete approval. Last week, the Biden administration said it was preparing to offer reinforcements to all eligible Americans starting the week of September 20th.

This is a developing story. Please check back for updates.

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