As Vaccines Move, Warp Speed Leader Rues Political Pressure
FDA’s emergency use authorization for the Pfizer Inc.-BioNTech SE vaccine followed hours later.
(Bloomberg) -- With the first coronavirus vaccine on the move in the U.S. and a second close behind, the head of the initiative created to speed the process rued political pressure on the approval process.
Moncef Slaoui of Operation Warp Speed was asked on “Fox News Sunday” about reports the U.S. Food and Drug Administration chief was told Friday his job was in jeopardy if the agency didn’t approve the first Covid vaccine by day’s end.
If a phone call along those lines between Mark Meadows, the White House chief of staff, and FDA Administrator Stephen Hahn happened as reported, “I think it was useless and unfortunate, and so are some of the tweets,” he said.
President Donald Trump tweeted directly to Hahn’s account on Friday, saying “Get the dam (sic) vaccines out NOW” and “Stop playing games.”
FDA’s emergency use authorization for the Pfizer Inc.-BioNTech SE vaccine followed hours later, and a day after a panel of independent experts convened by the FDA voted 17 to 4 that the benefits of the vaccine outweighed the risks.
Public pressure “did never translate into any kind of interference of any sort” on Operation Warp Speed, said Slaoui, who spent 30 years in vaccine research at the pharmaceutical company GlaxoSmithKline PLC. He said he “would expect the FDA would have worked the same way.”
The FDA’s decision on Friday set in motion a complicated immunization drive that will launch across the country in coming days.
The first doses of the vaccine will be delivered on Monday, and the initial delivery is expected to be completed in all 50 states by Wednesday, according to Gustave Perna, the army general who serves as chief operating officer for Operation Warp Speed.
Many states, including New Jersey, will start injecting health-care workers and nursing home residents on Tuesday.
The FDA will consider a second vaccine candidate, from Moderna Inc., at an advisory committee meeting on Dec. 17, and approval could come soon after. More vaccines are expected to be brought to market next year, expanding the arsenal doctors will have to rein in a virus that has killed almost 300,000 Americans.
Hahn said the distrust many people have expressed in the government approval process was a “significant problem” but that one that could be overcome with a commitment to transparency.
Collins Urges ‘Reset’
“The way we get through this is to achieve herd immunity,” Hahn said Sunday on ABC’s “This Week” of combating Covid-19. “And that means we need to vaccinate a significant number of people in this country, including those who are hesitant.”
Francis Collins, director of the National Institutes of Health, said some skepticism about the vaccines is “borne of potential interference from some source or another” that he said “did not determine the outcome.”
“I would like to plead to people who are listening to this, this morning, to really hit the reset button on whatever they think they knew about this vaccine that might cause them to be so skeptical,” Collins said on NBC’s “Meet the Press.”
“Few if any vaccines that have ever been subjected to this level of scrutiny,” Collins said. He added that experts would say 70% to 80% of Americans need to be immune to the virus before it will be gone.
“We think we can get there by June or so for almost all of the 330 million Americans who are interested in getting this vaccine, but if only half of them do so, this could go on and on and on,” Collins said.
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