Some health experts are worried that politics will interfere with the creation of a safe and effective coronavirus vaccine, NPR reports.
Despite assurances from the Food and Drug Administration that their decisions are based on science and not politics, many say the Trump administration’s “Operation Warp Speed” effort to push out a vaccine as fast as possible is troubling.
The president’s initiative has a goal of pushing out initial doses of a coronavirus vaccine by January 2021. The plan cuts the typical development of a vaccine from years down to just months.
The shortened timeline has some concerned that scientific corners may be cut, NPR reports. They are also concerned that President Donald Trump will use the vaccine to boost his reelection chances if it is announced as an “October surprise.”
The FDA already stated a coronavirus vaccine will be approved under atypical guidelines. At minimum, the vaccine must be tested in thousands of people to see if there are any rare side effects and if it is effective in preventing the disease. It also noted that the vaccine only needs to be 50% sufficient, not 100%.
Experts say they are most concerned over whether the FDA will approve a vaccine under an emergency use authorization, or EUA.
"The EUA rules are loose," Paul Offit, a vaccine developer at the Children's Hospital of Philadelphia and a member of the FDA's Vaccines and Related Biological Products Advisory Committee, told NPR.
Offit said he is concerned the FDA may be pressured into approving an EUA without enough due diligence and review from independent scientists.
Leaders of the Infectious Diseases Society of America and HIV Medicine Association say they are also concerned about the FDA handing out an EUA for a vaccine candidate.
"We want to underscore that it is critical that FDA ensures sufficient safety and efficacy data are available and have been reviewed by internal as well as independent experts prior to granting an EUA," they wrote to the FDA.
FDA Commissioner Stephen Hahn penned an editorial in medical journal JAMA earlier this month in an effort to shut down concerns raised by some that politics would get in the way of science.
"The physician leadership of the U.S. Food and Drug Administration (including the authors of this Viewpoint) unequivocally state that candidate COVID-19 vaccines will be reviewed according to the established legal and regulatory standards for medical products," Hahn wrote.
"Given the widespread potential use of a COVID-19 vaccine, transparent discussion at FDA's Vaccines and Related Biological Products Advisory Committee will be needed prior to vaccine authorization or licensure to ensure clear public understanding of the evidence supporting vaccine safety and efficacy," he added.
Still, many say the Trump administration’s promise to speed up the approval process could work against finding an effective vaccine. According to NPR, the less time spent testing the vaccine could result in less known about the vaccine’s possible side effects and effectiveness.
Offit told NPR coming up with a vaccine is the “best way out” of the coronavirus.
“And to shake the American confidence further with either an unsafe or ineffective vaccine would be, I think, a disaster,” he said.
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