Empty vials of Pfizer’s COVID-19 vaccine are seen on Jan. 28, 2021 in Groveland, Florida, at a first-come, first-served drive-thru vaccination site operated by the Lake County Health Department.
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 go beyond that date, the Times said, as paperwork and negotiations continue with the company.
The move would make it the first Covid vaccine to move from emergency use authorization to full FDA approval.
The FDA declined to comment on the Times report to The Washington City Times.
White House medical adviser Dr. Anthony Fauci, told the Associated Press on Aug. 8 that he hoped vaccines would gain full approval “within the month of August,” adding that full approval would lead to more companies and schools mandating vaccines.
US companies have tightened vaccine rules for workers as Covid cases have increased across the country in recent weeks, with some citing full FDA approval as part of the decision-making process.
Full approval may also help convince people who are hesitant to get vaccinated until the FDA fully approves the inclusion.
More than 203 million doses of the Pfizer-BioNTech vaccine have been administered nationwide, completely immunizing more than 91 million people in the US, according to CDC data as of Friday.
Pfizer and BioNTech initially began applying for their biological license for the two-dose vaccine in May, after receiving emergency use approval from the FDA in December. The FDA sets a six-month target for high-priority drug approval.
If formally approved, the vaccine from Pfizer and BioNTech would remain available on the market after the pandemic is over, and the companies could advertise the vaccine directly to consumers. Pharmaceutical manufacturers with an EUA are not allowed to promote their vaccines, The Washington City Times previously reported.
The companies announced on Aug. 16 that they were entering 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 people with compromised immune systems. They said the US will start widely distributing booster shots to the public in September.
Read the full New York Times report here.