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The Food and Drug Administration is “very close” to granting emergency use authorization for a coronavirus vaccine developed by Pfizer in partnership with the German firm BioNTech, said Alex Azar Friday.
The vaccination of the first Americans outside clinical trials could begin on Monday, the health secretary said.
“I’ve got some good news for you here,” Azar told ABC’s Good Morning America on Friday. “Just a little bit ago the FDA informed Pfizer that they do intend to proceed towards an authorization for their vaccine.
“We will work with Pfizer and get that shipped out so we could be seeing people getting vaccinated Monday, Tuesday of next week.”
The step followed a vote on Thursday by an outside panel of experts convened by the FDA to recommend authorization of the vaccine. The recommendation signaled that the first approval of a Covid-19 vaccine for use in the US was imminent.
That would mark a major milestone in a pandemic that has killed more than 285,000 Americans and 1.5 million people globally. The US would become the third country in the world to have authorized the use of the Pfizer/BioNTech vaccine in the broader public behind the UK and Canada, and it will be the most populous country to do so.
A similar advisory panel will review a second vaccine, developed by Moderna with the National Institute of Allergy and Infectious Diseases, on 17 December.
The United Kingdom began administering the Pfizer/BioNTech vaccine earlier this week. Azar said that the FDA had reviewed a recommendation by UK health officials that people with a medical history of serious allergic reactions should avoid the vaccine, after two healthcare workers who suffer from severe allergies and carry epipens had allergic reactions to the vaccine, and had to be treated. They have since recovered.
“There was really good discussion at the advisory committee yesterday, especially around these issues of the allergic reactions that we saw in the United Kingdom,” Azar said.
As a last step before issuing the authorization, the regulator needs to finalize guidance for doctors about prescribing the vaccine and advising patients.
“It’s very close, it’s really just the last dotting of i’s and crossing of t’s,” Azar said.
Azar said earlier this week that he had been in contact with members of the Joe Biden transition team to ensure a smooth rollout of the vaccines. Both the Pfizer and Moderna vaccines require two does for maximum efficacy. Hundreds of millions of Americans could be vaccinated over the next year.
Jessica Glenza contributed to this report.
Source: The Guardian
Keyword: FDA ‘very close’ to granting emergency use authorization of Pfizer Covid vaccine | Coronavirus