Covid vaccine gains full approval, paving the way for duty

Photo taken on January 15, 2021 is a gloved hand with a vial of undiluted Pfizer-BioNTech vaccine for Covid-19 stored at -70 ° in a superfreezer at Le Mans Hospital in northwestern France. Shows the pharmacist who has in. The country is continuing its vaccination campaign to combat the spread of the new coronavirus.

Jean-Francois Monnier | AFP | Getty Images

The Food and Drug Administration has granted Pfizer and BioNTech full US approval for the Covid-19 vaccine. This was the first time in the United States to win the coveted designation and give more businesses, schools and universities the confidence to adopt vaccine obligations.

So far, mRNA vaccines have been on the US market under the Emergency Use Authorization granted by the FDA in December. Since then, more than 204 million Pfizer shots have been administered, according to data compiled by the US Centers for Disease Control and Prevention.

Federal health officials have been under pressure from the scientific community and advocacy groups to fully approve Pfizer and BioNTech vaccines since the drug company submitted its application to the authorities in early May. On May 7, the two companies submitted a biopharmacy approval application to the FDA to ensure full approval for patients 16 years and older.

More than 60% of the total population of the United States has been vaccinated with the Covid vaccine at least once, but many Americans hesitate to vaccinate despite the prevalence of highly contagious delta variants. It states that it is. Full approval may convince some Americans that the shot is safe, doctors and epidemiologists say. In fact, according to a Kaiser Family Foundation study, 3 in 10 unvaccinated adults are more likely to be vaccinated if one of the vaccines is fully approved.

Full approval is “more psychological than anything else,” said Dr. Paul Offit, a voting member of the authorities’ Vaccine and Related Biopharmaceutical Advisory Board. “I mean you are already taking over 320 million doses that are there. The vaccine already has a huge safety and efficacy profile.”

US approval could also spur a new wave of vaccine obligations from the US for businesses. Leading companies from Walt Disney to Wal-Mart have already stated that some or all of their employees will need to be fully vaccinated against Covid this fall. Still, some private companies may be hesitant to request a shot, even if they have the legal authority to do so before full approval, said Dritt of the Faculty of Law at UC Hastings College. Professor Rice said.

The Pentagon said it would require service members to be vaccinated by mid-September, or earlier if the FDA gave full approval early.

Dr. Anthony Fauci, Chief of Staff of the White House, said on August 8th, “We can see the empowerment of local businesses and empower them to be universities, universities, offices, and more. I strongly support. ” Asked about full approval of the vaccine. “The time has come …. We have to take additional steps to vaccinate people.”

Pfizer Shot is the first Covid vaccine in the United States to be fully regulatory approved. Federal regulators have previously stated that they will work as quickly as possible to clear Pfizer’s vaccine.

Standard vaccine reviews usually take months to a year or more to determine if they can be used safely and effectively by the general public. However, due to a pandemic that killed more than 628,000 Americans, the FDA allowed the use of shots under the EUA.

In public health emergencies, vaccine production and approval can be streamlined through emergency approval. Former Secretary of Health and Welfare Alex Azar declared a public health emergency on January 31, 2020. Health emergencies have been updated several times, most recently in late July. The FDA has allowed the use of shots under the EUA with only two months of safety data. This is not the same as a biopharmacy approval application or a full approval request. This requires at least 6 months of data.

Ofit, who is also the director of the Vaccine Education Center at Philadelphia Children’s Hospital, says FDA scientists need to carefully examine corporate clinical trial data, including inconsistencies and safety concerns, before giving full approval. Said.

According to Ofit, this is a lot of data. When Merck submitted data for 70,000 rotavirus vaccine trials, the pages generated could have exceeded the height of Chicago’s 1,450-foot skyscraper, Sears Tower, now known as Willis Tower. He said earlier that he has sex.

“The FDA will do what it considers necessary to ensure the security of the American people,” he said.

Full approval is also very beneficial to companies submitting applications, former FDA Commissioner Dr. Robert Califf said in a telephone interview in May.

This allows Pfizer and BioNTech to sell shots directly to US consumers. He said companies cannot promote their products under the EUA. You can also leave shots on the market after the pandemic is over and the United States is no longer considered an “emergency”.

“The vaccine must be given under the supervision of a qualified professional,” says Caliph. “They can’t send vaccines to people’s homes, but they can advertise on television and promote their products under FDA supervision.”

Pfizer and BioNTech say they expect to generate billions of dollars from vaccines. With full approval, companies can also decide to charge more for the vaccine, health experts say.

According to the Financial Times, the two companies are already raising vaccine prices in the European Union. According to the report, they are currently charging $ 23 per dose, up from the previous $ 18.40.

Pfizer and BioNTech will also ask the FDA to approve a third dose as a booster shot following 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.

This is a developing story. Check for updates.

Covid vaccine gains full approval, paving the way for duty

Source link Covid vaccine gains full approval, paving the way for duty

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