#Dr. Anthony Fauci says rushing a vaccine may jeopardize testing of others

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Dr. Anthony Fauci, director of the National Institute for Allergy and Infectious Disease
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Dr. Anthony Fauci warned against fast-tracking a coronavirus vaccine through an emergency use authorization before it is proven safe in large trials — saying it could have a chilling effect on testing of other inoculations, according to a report.

“The one thing that you would not want to see with a vaccine is getting an EUA (emergency use authorization) before you have a signal of efficacy,” the nation’s top infectious diseases expert told Reuters.

“One of the potential dangers if you prematurely let a vaccine out is that it would make it difficult, if not impossible, for the other vaccines to enroll people in their trial,” said Fauci, the director of the National Institute of Allergy and Infectious Diseases.

Scientists and health experts have voiced concerns that President Trump might apply pressure on the Food and Drug Administration to approve a vaccine before November to increase his chances of winning another term.

Fauci, a member of the White House coronavirus pandemic task force, declined to comment about the president.

On Sunday, Trump announced an EUA by the FDA for convalescent plasma to be used as a COVID-19 treatment.

His announcement came after the FDA last week halted an emergency approval for the approach to allow for more data to be reviewed.

This prompted Trump to accuse the agency of deliberately slow-walking coronavirus treatments and therapeutics before the election.

FDA Director Stephen Hahn said Sunday that the treatment is “safe and shows promising efficacy.”

Large-scale clinical trials of the leading vaccine candidates from Moderna, Pfizer and AstraZeneca, which aim to enroll tens of thousands of volunteers, were launched in recent weeks.

Last week, Johnson & Johnson said it hoped to include 60,000 subjects in its Phase 3 trial, according to Reuters.

Fauci said the FDA’s guidance on inoculations — both for full approval and for an EUA — explicitly requires a demonstration that they are safe and effective.

He noted that an EUA is typically used for products to “diagnose, prevent and treat serious or life-threatening diseases where the known benefits outweigh the potential risks of the product.”

An EUA might be proper when studies have shown safety and effectiveness, but before the FDA has completed its review of a company’s marketing application, he said.

“To me, it’s absolutely paramount that you definitively show that a vaccine is safe and effective, both,” the doctor told Reuters. “We would hope that nothing interferes with the full demonstration that a vaccine is safe and effective.”