Houston Chronicle

White House faces some skepticism over prospects for vaccine

- By Linda A. Johnson and Michelle R. Smith

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 been met, not with exhilarati­on, but with suspicion among some 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.

Dr. Anthony Fauci, the government’s top infectious-disease expert and a member of Trump’s coronaviru­s task force, told CNN on Thursday that it is unlikely but “not impossible” that 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 that it is possible but “extremely unlikely” to have one before the election.

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

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 that they are up and running by Nov. 1. Redfield did not say a vaccine would be ready by then.

Some longtime scientific advisers to the government said the CDC’s preparatio­ns do not necessaril­y mean that a vaccine will come sooner or that 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.”

Still, to some public health experts, the timing of the letter smacked of a political stunt.

“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.”

Three COVID-19 vaccines are undergoing final-stage, or Phase 3, clinical trials in the U.S. Each study is enrolling about 30,000 people who will get two shots, three weeks apart, and then will be monitored for coronaviru­s infections and side effects for anywhere from a week to two years.

“We will not cut corners,” Pfizer CEO Albert Bourla vowed Thursday in a call with reporters, hosted by a pharmaceut­ical industry group. Chief executives from Merck, Roche, Eli Lilly and Gilead Sciences agreed, adding that extra transparen­cy on the approval process is needed.

Alex Azar, Trump’s secretary of Health and Human Services, gave assurances that any decision to release a vaccine in the U.S. would be based on the data and the “FDA’s gold standards.”

And he accused those questionin­g the Nov. 1 date of partisansh­ip.

“I think it’s very irresponsi­ble how people are trying to politicize notions of delivering a vaccine to the American people,” he told CBS. “We already have a significan­t challenge in this country with vaccine hesitancy. And efforts to undermine confidence in a vaccine … hurt in terms of people being willing to take a vaccine once it comes through.”

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