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Tuesday, September 29, 2020

Trump rebuts doctors, says vaccine to be given widely in October

The administration’s goal is to have 100 million vaccine doses available by Dec. 31, Vice President Mike Pence said in an interview on Fox News late Wednesday.

By: Bloomberg | September 17, 2020 8:48:39 am
As Democrats balk, Trump to make high court pick by SaturdayTrump has questioned the legitimacy of voting by mail-in ballot in the past, claimed that it is susceptible to massive fraud. (File)

A coronavirus vaccine could be distributed widely to the public as early as October, President Donald Trump said on Wednesday, contradicting statements by some of his top health officials that ranged from the end of March to the end of 2021. “What we’ve done with the streamlining” has “been incredible,” Trump said during a news conference.

The administration’s goal is to have 100 million vaccine doses available by Dec. 31, Vice President Mike Pence said in an interview on Fox News late Wednesday.

The president said earlier comments by Robert Redfield, the director of the U.S. Centers for Disease Control and Prevention, that disbursement of the vaccine would come some time in late spring or summer of next year were “a mistake.” Trump said he called Redfield after his testimony Wednesday before a Senate Appropriations subcommittee hearing to tell him that his comments weren’t correct.

“I think he misunderstood the questions,” Trump said of Redfield.

In a tweet after Trump’s news conference concluded, Redfield said, “I 100% believe in the importance of vaccines and the importance in particular of a #COVID19 vaccine. A COVID-19 vaccine is the thing that will get Americans back to normal everyday life.”

Redfield wasn’t the only top U.S. health official offering a less ambitious forecast for getting a Covid-19 vaccine out to the public. Paul Mango, deputy chief of staff for policy at the Department of Health and Human Services, said it would probably be widely available by the end of March. And Anthony Fauci, the head of the National Institute for Allergy and Infectious Diseases, forecast a timeline similar to Redfield’s.

Fauci called Mango’s first-quarter timeline for full vaccine use “aspirational” in an interview Wednesday. It’s more likely, Fauci said, that it happens toward the middle to the end of 2021. “It depends on what the vaccine is,” he said.

Trump’s timeline depends on a great many assumptions, including that the first vaccine approved for emergency use works at a high level, that there are no major safety issues or delays within the first groups that receive it, and that the manufacturing and disbursement of the vaccine goes off without a hitch.

In an interview for the Bloomberg Equality Summit to take place on Sept. 23, Fauci said he’s “reasonably confident” that at least one vaccine will be available by November or December. Wide-scale adoption of a vaccine, along with continuing — though less intense — reliance on social distancing and mask-wearing will allow a return to near-normal by the end of 2021, he said.

FILE – In this July 27, 2020, file photo, a nurse prepares a shot as a study of a possible COVID-19 vaccine, developed by the National Institutes of Health and Moderna Inc., gets underway in Binghamton, N.Y. (AP Photo/Hans Pennink, File)

By then, Fauci said, “I believe we can approach and perhaps reach a degree of normality that closely resembles what we had before this particular outbreak occurred.”

“If you’re asking me when is it going to be available to the American public,” Redfield said to a Senate Appropriations subcommittee hearing, “I think we’re probably looking at late second quarter, third quarter 2021,” which would suggest some time in late spring or summer of next year.

Public-health experts and drugmakers have expressed alarm that the White House is placing extraordinary pressure on the U.S. Food and Drug Administration to clear a vaccine before Trump stands for re-election on Nov. 3.

Former FDA Commissioner Scott Gottlieb, who served under the Trump administration, said on CBS’s “Face the Nation” that it’s “atypical” that the approval process of any drug or vaccine would be discussed within a political context.

“I don’t think we’re going to see an authorization before the election,” said Gottlieb, who sits on Pfizer Inc.’s board of directors. He added that the American public is more likely to receive the inoculations within the first half of 2021.

Fauci, meanwhile, said he was confident existing checkpoints for approval, including an independent data and safety monitoring board, would prevent interference.

Warp Speed

Scott Atlas, an adviser to the president, said during the Trump news conference that 24 hours after a vaccine is approved on an emergency basis by the FDA, the government will start delivering the shots to the public.

The U.S., through its “Operation Warp Speed” program, has already secured supply of coronavirus vaccines furthest along in clinical trials, including those being developed by Pfizer Inc. and BioNTech SE, AstraZenca Plc in partnership with the University of Oxford, and Moderna Inc.

Operation Warp Speed was formed by the Trump administration to unite health agencies and the Department of Defense with the objective of accelerating the development and production of a coronavirus vaccine. The medicines typically require years to develop and test before they’re approved for sale.

Mango, speaking in a telephone interview, said the administration is confident it will have 100 million doses of an effective vaccine for elderly people, who are more vulnerable to the virus, available before the end of the year. He stressed that “there’s never a 100% guarantee” that timelines will be met.

If a vaccine is approved in October, only about 20 million doses will be ready for distribution and use, he said.

“Whether that happens in October, November or December is a bit out of our hands,” Mango said, referring to a vaccine approval. “I would say it’s possible, it’s certainly possible, it happens in October. It’s more likely it happens in November or December.”

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