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Full approval for Pfizer Covid vaccine could come from FDA Monday, report says

Empty vials of the Pfizer COVID-19 vaccine are seen at a first come first serve drive-thru vaccination site operated by the Lake County Health Department on January 28, 2021 in Groveland, Florida.

Paul Hennessy | NurPhoto | Getty Images

The Food and Drug Administration is working to approve the Pfizer and BioNTech Covid-19 vaccine on Monday, The New York Times reported, citing sources.

The review process could move past that date, The Times said, as paperwork and negotiations with the company continue.

The move would make it the first vaccine to go from emergency use authorization to full FDA approval.

The FDA declined to comment on the Times report to CNBC.

U.S. companies have tightened vaccine rules for employees as Covid cases spiked across the country in recent months, and some cited full approval from the FDA as part of the decision-making process.

Full approval from the FDA could also help convince individuals hesitant about getting vaccinated until the shot was fully signed off on.

Pfizer and BioNTech initially began the process of applying for their biologics license for the two-dose vaccine in May after receiving emergency use authorization from the FDA last December. The FDA sets a six-month target for approving high-priority drugs.

The companies announced Monday that they began the approval process for their third booster dose after submitting clinical trial data to the FDA.

If formally authorized, Pfizer and BioNTech’s vaccine would remain available on the market after the pandemic ends, and the companies would also be able to advertise the vaccine direct-to-consumer. Pharmaceutical manufacturers with an EUA are prohibited from promoting their vaccines, CNBC previously reported.

Top health officials from agencies including the Centers for Disease Control and Prevention, White House and FDA said in a statement Wednesday that the effectiveness of mRNA vaccines declines over time, especially for those with compromised immune systems or for anyone inoculated early in the vaccine rollout.

More than 203 million doses of Pfizer and BioNTech’s vaccine have been administered nationwide, fully immunizing over 91 million people in the U.S., according to the CDC.

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