Story at a glance

  • The nation's top infectious diseases expert cautioned against preemptively approving a coronavirus vaccination for distribution.
  • Several candidates are in Phase 3 clinical trials.

The top U.S. infectious diseases expert cautioned Monday that rushing out a COVID-19 vaccine under special emergency use guidelines before it has been proved safe and effective could undermine the testing of other — possibly more successful — vaccines. 

Anthony Fauci made the comments in an interview with Reuters following concerns from scientists and health experts that President Trump could apply pressure on the U.S. Food and Drug Administration (FDA) to distribute a vaccine before November’s election. 

Trump announced on Sunday the emergency use authorization for plasma from recovered COVID-19 patients to treat current patients, but its benefits have not been assessed in randomized, placebo-controlled clinical trials. 


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The former head of the FDA said Monday plasma could be beneficial, but the treatment may not be a “home run.” Meanwhile, the World Health Organization cautioned against the “low-quality” evidence of plasma’s efficacy and stated the treatment should still be an experimental therapy.  

When it comes to a vaccine, several pharmaceutical companies have entered into Phase 3 clinical trials with their vaccine candidates, including AstraZeneca and the University of Oxford, Moderna, and Pfizer. The latter two companies are each testing their product on 30,000 human subjects.

But Fauci warned that rolling out a vaccine without proper testing and approval could have a chilling effect on other trials and possibly a more effective and safe vaccine.

“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,” Fauci 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.”

Some scientists have voiced concerns about emergency use authorization provisions being used to usher out a vaccine too quickly. Fauci pointed out that the FDA’s guidance on vaccines requires a demonstration of both safety and effectiveness.

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

Concerns over the politicalization of emergency use authorizations arose after Trump ratcheted up pressure on the FDA over the weekend. He accused the “deep state” at the FDA of slowing the development of treatments and vaccines before the November election. The president also reiterated that sentiment a day later, telling reporters that he believed some health officials were impeding decisions for “political reasons.” 

In response to the speculation that the convalescent plasma approval was a result of political pressure, the head of the FDA, Stephen Hahn, refuted claims that the emergency use authorization was politically motivated.

"We at FDA do not permit politics to enter into our scientific decisions. This happens to be a political season but FDA will remain data driven. On behalf of FDA‘s 18,000 career employees,  I want to reassure the American public about this commitment," Hahn said on Twitter.


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Published on Aug 25, 2020