Pfizer-BioNTech’s COVID vaccine is expected to receive full approval from the Food and Drug Administration as soon as Monday. Should it occur, it would be the first COVID-19 vaccine to be fully approved and authorized for emergency use by the FDA.
Many experts say that many businesses and schools are likely to mandate vaccines if the approval goes through, and more people are likely to get vaccinated.
Negotiations are ongoing with Pfizer-BioNTech, and it’s possible the review process could be extended past Monday.
Dr. Anthony Fauci had previously said that he expected full approval for some vaccines “within the month of August.”
In the meantime, many businesses in the U.S. have become stricter with their vaccine requirements for employees, likely due to sharp increases in Covid cases across the country. Many of those companies have said that once the FDA granted their full approval, they would have no qualms in mandating vaccines for their workers.
Many people in the U.S. have also stated that their hesitancy with getting the vaccine was due to the FDA not having given full approval of the vaccine. Now that it looks likely, many are expected to move forward to get the shot.
Thus far in the U.S., Pfizer-BioNTech’s vaccine has fully immunized 91-plus million people as of Friday. In all, more than 203 million doses of the vaccine have been administered.
Pfizer-BioNTech started the application process with the FDA for their two-dose vaccine in May. The company had previously received authorization for emergency use authorization in December. The Food and Drug Administration seeks to approve high-priority pharmaceuticals within six months.
Once fully authorized by the FDA, the vaccine would be available to consumers even after the pandemic ends. Pfizer/BionNTech would also be able to target and advertise the vaccine to consumers directly. Pharmaceutical companies who only have emergency use authorization are prohibited from advertising and promoting their vaccines.
On August 16, Pfizer/BioNTech said they began an approval process for fully vaccinated people to receive a booster dose. The company said that its clinical trial showed efficacy was waning in people who received the first two shots and that a booster was necessary to restore maximum protection.
The FDA, Centers for Disease Control, and the White House have now all stated that the efficacy of mRNA vaccines dwindle over time. People with compromised immune systems are at a higher risk and needed a booster to restore enhanced effectiveness of the vaccine.
In September, the U.S. will start offering booster shots to anyone who qualifies.