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–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 Covid vaccine to go from emergency use authorization to full FDA approval.
The FDA declined to comment on the Times report to CNBC.
White House chief medical advisor Dr. Anthony Fauci told the Associated Press on Aug. 8 that he hoped vaccines would start receiving full approval “within the month of August,” adding that full approval would lead more companies and schools to mandate vaccines.
U.S. companies have tightened vaccine rules for employees as Covid cases have spiked across the country in recent weeks, and some cited full approval from the FDA as part of the decision-making process.
Full approval could also help persuade people who are hesitant about getting vaccinated until the FDA fully signs off on the shot.
More than 203 million doses of the Pfizer-BioNTech vaccine have been administered nationwide, fully immunizing more than 91 million people in the U.S., according to CDC data as of Friday.
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 in December. The FDA sets a six-month target for approving high-priority drugs.
If formally authorized, Pfizer and BioNTech’s vaccine would remain available on the market after the pandemic ends, and the companies would be able to advertise the vaccine directly to consumers. Pharmaceutical manufacturers with an EUA are prohibited from promoting their vaccines, CNBC previously reported.
The companies announced on Aug. 16 that they began the approval process for a booster dose for fully vaccinated people after submitting clinical trial data to the FDA.
Top health officials from agencies including the Centers for Disease Control and Prevention, the White House and the FDA said in a statement Wednesday that the effectiveness of mRNA vaccines declines over time, especially for those with compromised immune systems. They said the U.S. will begin widely distributing booster shots to the public in September.
