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The top U.S. infectious diseases expert made comments came a day after the Food and Drug Administration (FDA) granted an EUA for the use of convalescent plasma to treat COVID-19. That authorization is controversial because the data is not supported by robust clinical testing.
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, according to The Hill.
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.”
There is also growing concern that the current presidential administration will exert pressure on the FDA to approve a vaccine candidate prior to the Nov. 3 election.
Among other risks, approving a vaccine before it has been fully and properly researched could badly affect the prospects for candidates still in development. "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," Fauci was quoted by The Motley Fool as saying.
|(Photo: The Motley Fool)|
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.
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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