- The Washington Times - Friday, December 11, 2020

The Food and Drug Administration is racing to grant emergency approval to Pfizer’s coronavirus vaccine by late Friday amid pressure from the White House, even telling President Trump’s “Operation Warp Speed” to get ready while it finishes its work.

FDA Commissioner Stephen Hahn signaled that regulators have made up their minds but are finalizing the wording of its emergency use authorization for doctors.

But Mr. Trump lashed out at Dr. Hahn on Twitter, saying he wanted immediate action amid signs the agency planned to act Saturday morning.

White House Chief of Staff Mark Meadows told the agency to get it done faster, according to reports in The New York Times and The Washington Post.

The Post reported that Mr. Meadows told Dr. Hahn to submit his resignation if he doesn’t get it done late Friday, though Dr. Hahn disputed that characterization of the conversation in a statement to various outlets.



An FDA advisory panel late Thursday said the vaccine merited the “EUA” that would clear the way for the first U.S. inoculations outside of trials.

“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 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,” Dr. Hahn said Friday.

Speaking to ABC, Health Secretary Alex Azar said the authorization should come in the “next couple of days” as they finalize prescribing information, though White House pressure appeared to move up the deadline.

It’s unclear if approving the shots late Friday instead of Saturday would get the shots into arms any faster.

“We could be seeing people getting vaccinated Monday, Tuesday of next week,” Mr. Azar told “Good Morning America.” “It’s really close, it’s just the last dotting of Is and crossing of Ts.”

On Twitter, Mr. Trump said the FDA has plenty of money but it bogged down by bureaucracy. He said the agency is a “big, old, slow turtle.”

“Get the dam [sic] vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!” he wrote.

Operation Warp Speed is expected to load nearly 3 million vials onto FedEx and UPS planes within 24 hours of the FDA’s approval. States told the federal government where the shipments should go.

The federal operation will hold back nearly 3 million additional doses, so the first recipients can be assured their booster shot 21 days later. It is also reserving 500,000 doses in case of early mishaps.

States are expected to begin inoculating health workers and residents of long-term care facilities within a day of receiving their share of doses, though governors will have the final say over who’s first in line.

Immunizing every American who wants the vaccine will take months, stretching into late spring or early summer, as the country enters a daunting period.

The coronavirus killed roughly 3,000 Americans on successive days, and doctors and nurses are worn down by the flood of patients. More than 107,000 patients are hospitalized for COVID-19 across the country.

New York Gov. Andrew Cuomo, a Democrat, said indoor dining in New York City will shut down again on Monday as he tries to stave off another wave of the virus and stabilize hospitalization rates. Eateries are likely to cry foul, saying they’re on the brink of collapse and 70% of New York cases have been traced to household gatherings anyway.

Pfizer, which developed the messenger-RNA shots with German company BioNTech, requested emergency approval on Nov. 20 after data showed its vaccine was 95% effective against COVID-19. It beat several other drugmakers to the punch, though Moderna is right behind it with shots that also use mRNA to teach the body how to fend off the virus.

Johnson & Johnson is developing a promising single-dose shot and could be approved during the first two months of 2021.

Among other drugmakers, Sanofi-GlaxoSmithKline said the launch of its vaccine likely wouldn’t occur until late 2021 after clinical trials showed an inadequate response in older people.

AstraZeneca, meanwhile, said it will work with Russian scientists to see if its vaccine can be combined with Moscow’s Sputnik V vaccine to increase efficacy.

Canada recently approved the Pfizer vaccine and the U.K. started injecting it into people this week, heaping pressure on U.S. regulators.

Mr. Trump has emphasized the speedy development of vaccines and therapeutics over mitigation measures like mask-wearing and avoiding crowds.
He tied recent progress on the effort to his complaints about election results that show he lost to Democratic rival Joseph R. Biden.

“The Swine Flu (H1N1), and the attempt for a vaccine by the Obama Administration, with Joe Biden in charge, was a complete and total disaster. Now they want to come in and take over one of the ‘greatest and fastest medical miracles in modern-day history.’ I don’t think so!” he tweeted.

“I just want to stop the world from killing itself!” he said.

 

 

 

 

The Food and Drug Administration said Friday it is nearing emergency approval of Pfizer’s coronavirus vaccine and even told President Trump’s “Operation Warp Speed” to get ready to launch.

The statement from FDA Commissioner Stephen Hahn suggests regulators have made up their minds but are finalizing the wording, after an advisory panel late Thursday said the vaccine deserved emergency use authorization.

“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 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,” Dr. Hahn said.

Mr. Trump fumed on Twitter early Friday, saying it’s time to hit the big red button.

“While my pushing the money drenched but heavily bureaucratic [FDA] saved five years in the approval of NUMEROUS great new vaccines, it is still a big, old, slow turtle. Get the dam vaccines out NOW, Dr. Hahn @SteveFDA. Stop playing games and start saving lives!!!” he wrote.

Mr. Trump also tied the efforts to complaints about election results that show he lost to Democratic rival Joseph R. Biden.

“The Swine Flu (H1N1), and the attempt for a vaccine by the Obama Administration, with Joe Biden in charge, was a complete and total disaster. Now they want to come in and take over one of the ‘greatest and fastest medical miracles in modern-day history.’ I don’t think so!” he tweeted.

“I just want to stop the world from killing itself!” the president said.

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