One of the COVID-19 vaccines received full approval in the USA: how it differs from the emergency one that other drugs have

Administration for Sanitary Supervision of Food Quality and The U.S. Drug Administration (FDA) has given full approval for the Pfizer / BioNTech COVID-19 vaccine, becoming the first in the U.S. to receive the coveted title, and has given more businesses, schools and universities greater confidence in meeting vaccine requirements. Writes about it CNBC.

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So far, the mRNA vaccine that will be marketed as Comirnaty has been on the US market under an emergency use authorization issued by the FDA in December 2020. Since then, more than 204 million Pfizer vaccinations have been given, according to data compiled by the Centers for Disease Control and Prevention (CDC).

Federal health officials have been under growing pressure from the scientific community and advocacy groups to fully approve the Pfizer / BioNTech vaccine since drug manufacturers filed an application with the agency in early May. On May 7, the companies filed with the FDA for a license for biologics that receive full approval for patients aged 16 and over.

FDA scientists assessed "hundreds of thousands of pages" of vaccine data from 40 trial participants. The vaccine was 000% effective in preventing COVID-19 — slightly lower than the 91% efficacy trial data that showed when the shot was authorized late last year and before the delta variant spread in the United States.

“The Pfizer vaccine meets high standards of safety, effectiveness and manufacturing excellence,” said Acting FDA Commissioner Janet Woodcock. “While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA's vaccine approval may now provide additional confidence to get vaccinated.”

Although more than 60% of the entire US population has received at least one dose of COVID-19 vaccine, many Americans say they are still hesitant to get vaccinated, even as the highly contagious delta variant has spread. Full approval may convince some Americans that vaccinations are safe. In fact, a survey by the Kaiser Family Foundation found that 3 out of 10 unvaccinated adults said they were more likely to get vaccinated if one of the vaccines gets full approval.

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Full approval is "more psychological than anything else," said Dr. Paul Offit, a member of the agency's Vaccine Advisory Committee. “I mean, over 320 million doses have already been administered. The vaccines already have a tremendous safety and effectiveness profile.”

The U.S. approval could also trigger a new wave of demands for vaccines. Major companies from Walt Disney to Walmart have already told some or all of their employees that they should be fully vaccinated against COVID-19 this fall. Still, some private companies have been hesitant to require vaccines before full approval, even though they have the legal authority to do so, said Dorit Reiss, a law professor at the University of California Hastings College of Law.

The Pentagon said it will make vaccinations mandatory for military personnel "no later than" mid-September, or sooner if the FDA grants full approval sooner.

The Pfizer shot is the first COVID-19 vaccine to receive full approval from U.S. regulators. Federal regulators previously said they would work as quickly as possible to approve the vaccines.

The vaccine is still pending emergency approval for children 12 to 15 years old as the company continues to collect data. Dr. Peter Marks, the FDA's chief immunization regulator, said the agency will act as quickly as possible to approve vaccinations for children under 12 as soon as the company provides data.

“Currently, testing is still ongoing, so the agency has to wait for the company to submit data from these tests,” he said. “We certainly want to make sure we do everything right.”

Marx also drew attention to misinformation about the vaccine, including that it contains microchips and causes infertility.

“We have heard false claims that the COVID-19 vaccine causes infertility and contains microchips. And to make matters worse, we have heard false claims that thousands of people have died from the vaccine,” he said. “Let me be clear: these allegations are simply not true.”

Routine vaccine reviews usually take months to a year or more to determine if they are safe and effective for use in the general population. But due to a pandemic that killed more than 628 Americans, the FDA has approved emergency use.

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In the event of a public health emergency, vaccine production and approval can be facilitated by issuing emergency approvals. Former head of the Department of Health, Alex Azar, declared a public health emergency on January 31, 2020. The health emergency has resumed several times, most recently at the end of July. The FDA has approved vaccines with safety data sheets in just two months in accordance with the EUA. This is not the same as a biological license application or full approval request that requires at least six months of data.

Before giving full approval, FDA scientists must 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 of Philadelphia.

“That’s a lot of data,” Offit said. He previously said that when Merck presented its data from a 70-person rotavirus vaccine trial, the pages generated could exceed the height of the Sears Tower, a 000-foot (1450 m) skyscraper in Chicago, Illinois, now known as Willis. Tower.

“The FDA will do what it believes it needs to do to make sure the American public is safe,” he said.

Full approval is also very helpful for companies that are applying, said former FDA Commissioner Dr. Robert Kaliff.

It also allows the vaccine to remain on the market after the pandemic is over and the US is no longer considered an "emergency."

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“The vaccines will still have to be administered under the supervision of a qualified professional,” Califf said. “They can't send vaccines to people's homes. However, they can advertise on television and promote their products under the scrutiny of the FDA.”

Pfizer / BioNTech said they expect billions from the vaccine. With full approval, companies could decide to raise vaccine fees, health experts said.

Companies have already raised vaccine prices in the European Union, according to the Financial Times. They now charge $ 23 per dose, up from the previous price of $ 18,40, according to the report.

Pfizer and BioNTech also plan to ask the FDA to approve the third dose as a booster dose after full approval. Last week, the administration of US President Joe Biden said it prepares to offer additional shots to all eligible Americans starting September 20.

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