Alex Azar Says Pfizer Vaccine Will Be Given to Americans in 'Next Couple of Days'
The Food and Drug Administration (FDA) plans to issue an emergency use authorization for the COVID-19 vaccine developed by American pharmaceutical giant and their German partners BioNTech, Health and Human Services Secretary Alex Azar said on Friday.
Azar told Good Morning America that the vaccinations could begin as soon as Monday or Tuesday of next week.
"Well I've got some good news for you 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.
"In the next couple of days probably as we work to negotiate the information doctors need to prescribe it appropriately, we should be seeing the authorization of this first vaccine. We will work with Pfizer to get that shipped out. So we could be seeing people getting vaccinated Monday, Tuesday of next week."
On Thursday, the FDA's Vaccines and Related Biological Products Advisory Committee (VRBPAC)—made up of independent scientific and public health experts from around the country—met to discuss the first submission to the agency for a COVID-19 vaccine emergency use authorization (EUA) regarding the Pfizer/BioNTech candidate.
In a statement published on Friday, FDA commissioner Stephen Hahn said: "Following yesterday's positive advisory committee meeting outcome regarding the Pfizer-BioNTech COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization."
The VRBPAC voted 17 to four in favor of issuing the EUA, with one member abstaining—approving the vaccine for use in people 16 years of age and older.
"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," Hahn said.
An FDA analysis of the vaccine published earlier this week confirmed the manufacturer's data that the vaccine was 95 percent effective after two doses, while also finding "no specific safety concerns identified that would preclude issuance of an EUA."
<script async src="https://platform.twitter.com/widgets.js" charset="utf-8">NEW: HHS Azar says FDA will proceed with emergency use authorization for Pfizer-BioNTech COVID-19 coronavirus vaccine and vaccinations could come as soon as Monday or Tuesday of next week. https://t.co/v1dsjMAvCK pic.twitter.com/48CGRJRTVs
— Good Morning America (@GMA) December 11, 2020
President Donald Trump has piled pressure on the FDA for months to approve the vaccine, often accusing the agency of moving too slowly.
On Friday, President Trump tweeted: "Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!"
Pfizer submitted its request for an EUA on November 20, and since then, FDA employees had been working "around the clock" to evaluate the necessary information "in a comprehensive and science-based manner," Hahn said in a statement published on Thursday.
"I can assure you that no vaccine will be authorized for use in the United States until FDA career officials feel confident in allowing their own families to receive it," he said.
This is breaking story was updated with additional information.
