August 24, 2021: -On Monday, the Food and Drug Administration is working to approve the Pfizer-BioNTech Covid-19 vaccine, The New York Times reported, citing sources.
The review process could move over the date, the Times said, as paperwork and negotiations with the company continue.
The move will make it the first Covid vaccine from emergency use authorization to full FDA approval.
White House chief medical advisor Dr. Anthony Fauci told the Associated Press on August 8 that he hoped vaccines would begin to be fully approval “within August,” adding that full acceptance would lead more companies and schools to mandate vaccines.
U.S. companies have tightened vaccine rules for employees as Covid cases have surged all over the country in the past weeks, and some cited full approval from the FDA as part of the decision-making process.
Full approval could also help persuade people hesitant about getting vaccinated until the FDA fully signs off on the shot.
According to CDC data, as of Friday, over 203 million doses of the Pfizer-BioNTech vaccine have been administered nationwide, fully immunizing above 91 million people in the U.S.
In May, Pfizer and BioNTech initially started applying for their biologics license for the two-dose vaccine after taking the emergency use authorization from the FDA in December. The FDA sets a six-month target for approving high-priority drugs.
If authorized formally, Pfizer and BioNTech’s vaccine would remain available on the market after the pandemic comes to an end, and the companies would be able to advertise the vaccine directly to consumers. Pharmaceutical manufacturers with a EUA are prohibited from promoting their vaccines, CNBC previously reported.
The companies announced on August 16 that they began the approval process for a booster dose for fully vaccinated people after submitting clinical trial data to the FDA.
On Wednesday, top health officials from agencies, including the Centers for Disease Control and Prevention, the White House, and the FDA, said in a statement that the effectiveness of mRNA vaccines decreases over time, especially for the ones with compromised immune systems. They said the U.S. would begin widely distributing booster shots to the public in September.