The White House chief of staff, Mark Meadows, has reportedly told the head of the US Food and Drug Administration to authorize Pfizer’s coronavirus vaccine on Friday or prepare to resign.
Meadows leaned on Hahn during a phone conversation on Friday, according to the Washington Post. It came after Donald Trump tweeted that the FDA was “a big, old, slow turtle”, and told FDA commissioner Stephen Hahn to “get the dam vaccines out NOW”.
The warning from Meadows led the FDA to speed up its timetable for potential emergency approval of the Pfizer/BioNTech vaccine from Saturday morning to later on Friday, according to the Post. The vaccine would be the first to roll out across the US, after also being approved in the UK and Canada.
An unnamed official told Reuters that Meadows’ comment about resigning “wasn’t a red line” but was more of a quip with the intention of urging “the FDA to act quickly and get the job done and stop the delays”.
The White House declined to comment, although an administration official said Meadows does request regular updates on the progress toward a vaccine.
“This is an untrue representation of the phone call with the chief of staff,” Hahn said in a statement. “The FDA was encouraged to continue working expeditiously on Pfizer-BioNTech’s EUA request. FDA is committed to issuing this authorization quickly, as we noted in our statement this morning.”
Earlier in the day, the health secretary, Alex Azar, said the FDA was “very close” to granting emergency use authorization for the vaccine and that vaccination of the first Americans outside clinical trials could begin on Monday.
“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 States recorded more than 224,000 confirmed cases on Thursday and 2,768 deaths, slightly down from a record high 3,124 deaths a day earlier, according to the coronavirus resource center at Johns Hopkins University.
“If we have a smooth vaccination program where everybody steps to the plate quickly, we could get back to some form of normality, reasonably quickly,” Dr Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told CNN. “Into the summer, and certainly into the fall.”
But that was a distant promise for many communities with overtaxed healthcare systems struggling to handle the surge of patients. At least 200 US hospitals were at full capacity last week and in one-third of all hospitals, more than 90% of all ICU beds were occupied, according to a CNN review of weekly data released by the health department.
A top coronavirus adviser to President-elect Joe Biden warned that Americans should plan “no Christmas parties”, with weeks of continued pressure on healthcare systems anticipated ahead.
“The next three to six weeks at minimum … are our Covid weeks,” Dr Michael Osterholm, the director of the center for infectious disease research and policy in Minnesota and a member of Biden’s coronavirus advisory board, told CNN. “It won’t end after that, but that is the period right now where we could have a surge upon a surge upon a surge.”
The US Congress failed again on Thursday to strike a deal on a new package for coronavirus relief, after the Senate majority leader, Mitch McConnell, torpedoed $160bn in state and local funds from what had been an emerging $900bn deal.
The Senate adjourned until next week when legislators were expected to resume their efforts.
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 Is and crossing of Ts,” 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: US Politics - theguardian.com
