Empty vials of the Pfizer COVID-19 vaccine are seen at a first-entry vaccination site served operated by the Lake County Department of Health 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 exceed that date, The Times said, as proceedings 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 vaccination standards for employees as Covid cases have increased nationwide in recent months, and some cited full FDA approval as part of the making process. of decisions.
Full FDA approval could also help convince people who doubt the vaccine until the session is fully started.
Pfizer and BioNTech initially began the process of applying for a biological product license for the two-dose vaccine in May after receiving FDA emergency use authorization last December. The FDA sets a six-month goal for high-priority drug approval.
The companies announced Monday that they have begun the process of approving their third dose of booster after submitting clinical trial data to the FDA.
If formally authorized, the Pfizer and BioNTech vaccine would remain available on the market after the pandemic ended, and companies could also advertise the vaccine directly to the consumer. Pharmaceutical manufacturers with the U.S. are banned from promoting their vaccines, CNBC previously reported.
Senior health officials from agencies, including the Centers for Disease Control and Prevention, the White House and the FDA, said in a statement on Wednesday that the effectiveness of mRNA vaccines is declining over time, especially for to those with compromised immune systems or to anyone inoculated at the beginning of vaccine development.
According to the CDC, more than 203 million doses of Pfizer and BioNTech vaccine have been administered nationwide, completely immunizing more than 91 million people in the United States.