Pfizer’s COVID-19 Vaccine Receives Full FDA Approval (UPDATE)

Sources say the Food and Drug Administration's approval could come as soon as Monday, as the nation experiences a surge in the Delta variant cases.


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UPDATED 8/23, 9:51 a.m. ET: The Pfizer-BioNTech COVID-19 vaccine received full approval from the Food and Drug Administration on Monday, the New York Times reports.

See original story below.

The Pfizer-BioNTech COVID vaccine is expected to receive full regulatory approval as soon as next week.

According to the New York Times, the U.S. Food and Drug Administration was looking to complete the authorization process by the end of this week. However, sources close to the agency said regulators were continuing paperwork and negotiations with the company as late as Friday. The FDA reportedly seeks to fully approve the vaccine as early as Monday, weeks ahead of the unofficial Labor Day deadline.

The move would make the Pfizer vaccine the first to be fully licensed by the federal government. The two-dose shot was the first to receive emergency use authorization by the FDA, followed by the Moderna and Johnson & Johnson vaccines. It is being distributed across the U.S. and is available for those 12 and older. More than 200 million doses of the vaccine have been administered in the country.

NYT states that a spokesperson for the FDA declined to comment.

News of the “imminent” approval comes as the nation experiences a surge in Delta variant cases. As pointed out by the Times, a full authorization may increase inoculations among the vaccine-hesitant and could result in additional vaccine mandates at the workplace.

Dr. Anthony Fauci, the director of the National Institute of Allergy and Infectious Diseases, previously expressed optimism that one of the vaccines would receive FDA approval before September.

“I hope — I don’t predict — I hope that it will be within the next few weeks. I hope it’s within the month of August,” he said several weeks ago. “If that’s the case, you’re going to see the empowerment of local enterprises, giving mandates that could be colleges, universities, places of business, a whole variety and I strongly support that. The time has come. … We’ve got to go the extra step to get people vaccinated.”

Earlier this week, President Joe Biden implemented vaccine requirements for federal employees. Those who refuse to receive a shot could face disciplinary actions and restrictions, including mandatory testing, masking, and social distancing practices.

“Right now, too many people are dying or watching someone they love die and say, ‘If I’d just got the vaccine,’” Biden said from the White House earlier this week. “This is an American tragedy. People are dying who don’t have to die … I know this is hard to hear. I know it’s frustrating. I know it’s exhausting to think we’re still in this fight. I know we hoped this would be a simple straightforward line, without problems or new challenges. But that isn’t real life.”

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