Empty Pfizer COVID-19 vaccine vials will be delivered on Jan.
Paul Hennessy | NurPhoto | Getty Images
The Food and Drug Administration is working on the approval of the Pfizer-BioNTech Covid-19 vaccine on Monday, the New York Times reported, citing sources.
The review process could go beyond that date, the Times said, as paperwork and negotiations with the company continue.
The move would make it the first Covid vaccine to move from emergency approval to full FDA approval.
The FDA declined to comment on the Times report to CNBC.
The Senior Medical Advisor to the White House, Dr. Anthony Fauci, told the Associated Press on Aug. 8 that he hoped vaccines would get full approval “within the month of August,” adding that full approval would lead to more companies and schools requiring vaccines.
US companies have tightened vaccination regulations for employees as Covid cases have increased across the country in recent weeks, and some cited full FDA approval as part of the decision-making process.
Full approval could also help convince people who are reluctant to get vaccinated until the FDA has fully approved the vaccination.
According to CDC data on Friday, more than 203 million doses of the Pfizer BioNTech vaccine have been administered nationwide, fully vaccinating more than 91 million people in the United States.
Pfizer and BioNTech began applying for their biologics license for the two-dose vaccine in May after receiving emergency clearance from the FDA in December. The FDA sets a six month target for approval of high priority drugs.
If formally approved, Pfizer and BioNTech’s vaccine would remain available in the market after the pandemic ended and the companies could promote the vaccine directly to consumers. Pharmaceutical manufacturers with an EUA are banned from promoting their vaccines, CNBC previously reported.
The companies announced on Aug. 16 that they had initiated the approval process for a booster dose for fully vaccinated individuals after submitting clinical trial data to the FDA.
Top health officials from agencies like 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 in those with compromised immune systems. They said the US would start distributing booster shots to the public in September.
Read the full New York Times report here.