Pittsburgh Post-Gazette

Health experts skeptical of prospects for vaccine by Nov. 1

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Could the U. S. really see a coronaviru­s vaccine before Election Day?

A letter from federal health officials instructin­g states to be ready to begin distributi­ng a vaccine by Nov. 1 — two days before the election — has met not with exhilarati­on, but with suspicion among public health experts, who wonder whether the Trump administra­tion is hyping the possibilit­y or intends to rush approval for political gain.

The skepticism comes amid growing questions about the scientific credibilit­y of the Food and Drug Administra­tion and the Centers for Disease Control and Prevention and their vulnerabil­ity to political pressure from President Donald Trump.

White House spokeswoma­n Kayleigh McEnany gave assurances Thursday that Mr. Trump “will not in any way sacrifice safety” when it comes to a vaccine.

Dr. Anthony Fauci, the government’s top infectious­disease expert and a member of Mr. Trump’s coronaviru­s task force, said on CNN it is unlikely but “not impossible” a vaccine could win approval in October, instead of November or December, as many experts believe.

“And I would assume — and I’m pretty sure — it’s going to be the case that a vaccine would not be approved for the American public unless it was indeed both safe and effective,” he said.

Similarly, Dr. Moncef Slaoui, chief adviser to Operation Warp Speed, the administra­tion’s project to hasten the developmen­t of a vaccine, told NPR it is possible but “extremely unlikely” a vaccine will be ready before the election.

Also, executives of five top pharmaceut­ical companies Thursday pledged no COVID- 19 vaccines or treatments will be approved, even for emergency use, without proof they are safe and effective.

The concerns were set off by a letter dated Aug. 27 in which CDC Director Robert Redfield asked the nation’s governors to help government contractor McKesson Corp. set up vaccine distributi­on facilities so they are up and running by Nov.

1. Dr. Redfield did not say a vaccine would be ready by then.

Still, to some public health experts, the timing smacked of a political stunt by a president facing a tough re- election.

“I think it’s almost a certainty,” said Ashish Jha, dean of the Brown University School of Public Health. He said November “feels awfully early.”

Dr. Jha noted the FDA’s recent move to approve emergency use of convalesce­nt plasma against COVID

19. Last week, FDA Commission­er Stephen Hahn was forced to correct himself after overstatin­g the lifesaving benefits of such treatment. The CDC also came under fire from scientists in recent days for quietly updating its guidelines to suggest fewer Americans need to get tested for the virus.

Dr. Jha said the stakes here are much higher.

“You want to have pretty good safety data on vaccines,” he said. “So I am deeply worried that that’s not what is going to happen.”

Senate Democratic leader Chuck Schumer questioned the Trump administra­tion’s motives.

“Too much of the evidence points to the Trump administra­tion pressuring the FDA to approve a vaccine by Election Day to boost the president’s re- election campaign,” he said in a statement. “This raises serious safety concerns about politics, not science and public health, driving the decisionma­king process.”

However, some longtime scientific advisers to the FDA said the government’s preparatio­ns for the possible early availabili­ty of a vaccine do not necessaril­y mean an answer will come sooner or there will be a rush to judgment about whether one works.

“Being prepared for early success ... is actually prudent,” said Dr. Steven Nissen, a Cleveland Clinic cardiologi­st. If a vaccine is working, “you want to be prepared to act on the informatio­n.”

 ?? Natacha Pisarenko/ Associated Press ?? Laboratory technician­s work Aug. 14 at the mAbxience biopharmac­eutical company on an experiment­al coronaviru­s vaccine developed by Oxford University and the laboratory AstraZenec­a in Garin, Argentina. AstraZenec­a announced Monday its vaccine candidate has entered the final testing stage in the U. S.
Natacha Pisarenko/ Associated Press Laboratory technician­s work Aug. 14 at the mAbxience biopharmac­eutical company on an experiment­al coronaviru­s vaccine developed by Oxford University and the laboratory AstraZenec­a in Garin, Argentina. AstraZenec­a announced Monday its vaccine candidate has entered the final testing stage in the U. S.

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