U.S Food and Drug Administration is aiming to give full approval to Pfizer-BioNTechs’s two-dose coronavirus vaccine Monday, according to reports citing multiple sources. When this happens, the Pfizer vaccine would become be the first to receive full approval from the U.S. government.
Both the two-dose Pfizer and Moderna vaccines, and Johnson and Johnson’s one-dose vaccines are all currently authorized for emergency use by the FDA. These vaccines are allowed for use when there are no approved nor available alternatives for medical products.
According to a report from Politico, the approval would affect 16 and older. Once approved, Federal and state health officials are expecting that this will make a way for hesitant Americans to finally take the vaccine. Recent polls showed that some Americans don’t want to take a vaccine that was only authorized for emergency use.
The New York Times also reported that FDA was hoping to push for the approval Friday but there were still paper works and negotiations taking place. Originally, the agency had recently set an internal goal to approve the Pfizer BioNTech vaccine around Labor Day, early September.
Earlier this week, cities like New York and New Orleans already mandated vaccines for indoor activities like restaurant dining and gym visitations. Other cities are expected to follow once the Pfizer vaccine is fully approved. Universities and hospitals are also likely to mandate the vaccination to the 1.3 million active-duty groups within the middle of September, according to the Pentagon earlier this month.
There are more than 203 million doses of the Pfizer-BioNTech vaccine that has been administered nationwide. More than 91 million people in the U.S. are already fully immunized according to CDC data Friday, CNBC reported.
The FDA also approved last week the third dose for both Pfizer BioNTech and Moderna vaccines for the severely immunocompromised. President Biden said Wednesday that fully vaccinated adults must get booster shots eight months after receiving their second doses starting September 20.
On the other hand, Moderna’s application for full approval for its coronavirus vaccine is still being reviewed and a decision could be several weeks from now.