Health and Human Services Secretary Alex Azar announced Friday morning that the Food and Drug Administration will grant Pfizer and its German partner, BioNTech, emergency use authorization for their COVID-19 vaccination.
Azar broke the news during an interview with “Good Morning America.”
“I’ve got some good news for you here on ‘Good Morning America’ that just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine,” Azar said.
Azar said the approval is expected in the “next couple of days” and that the first vaccinations in the U.S. could be administered Monday or Tuesday.
He said the FDA is working with Pfizer to negotiate the information doctors need to prescribe it appropriately.
An independent panel of advisers voted Thursday to recommend that the FDA authorize Pfizer and BioNTech’s vaccine.
Ahead of the meeting, the FDA released its initial review of Pfizer’s data, which confirmed it is 95% effective and safe for most adults.
The FDA released a statement Friday morning saying it has informed Pfizer "that it will rapidly work toward finalization and issuance of an emergency use authorization. The agency has also notified the U.S. Centers for Disease Control and Prevention and Operation Warp Speed, so they can execute their plans for timely vaccine distribution."
Pfizer and BioNTech applied for emergency use authorization on Nov. 20, and the vaccine has already been authorized for emergency use in the United Kingdom and Canada, with the U.K. administering its first shots earlier this week.
Just as Azar was making his announcement, President Donald Trump was voice on Twitter his frustrating about what he views as a slow approval process.
"[I]t is still a big, old, slow turtle," Trump said of the FDA. "Get the dam vaccines out NOW, [FDA Commissioner] Dr. [Stephen] Hahn. ... Stop playing games and start saving lives!!!"
As of Friday morning, 15.6 million Americans have been infected with the coronavirus and more than 292,000 have died.
On Dec. 17, the same FDA panel that met Thursday will convene again to review Moderna’s vaccine candidate, which early data showed was 94.5% effective.