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Operation warp speed companies4/4/2023 “That accounts for the anger and revulsion that has been evinced toward the idea of partisan politics influencing FDA decision-making,” she adds. The Food and Drug Administration (FDA) should decide whether to approve a vaccine for public use based on the apolitical grounds of science, as it has historically, Bateman-House says. “The idea is that perhaps one of these COVID-19 vaccines in development might be prematurely released for use - via an emergency use authorization order - on political grounds,” says Alison Bateman-House, MPH, PhD, assistant professor in the division of medical ethics at NYU Grossman School of Medicine in New York City. Several national research organizations raised objections and concerns. These signified the election was possibly affecting the regulatory process and scientific research. In the first week of September, the Centers for Disease Prevention and Control (CDC) asked state governors to be ready for vaccine distribution by early November, before the general election. In early August, President Trump said he expected a coronavirus vaccine to be ready by the Nov. In May, President Trump launched Operation Warp Speed, including agreements with pharmaceutical companies and a $12 billion federal investment in six vaccine candidates with the intention of shaving years off the typical decade-plus vaccine development process. The United States is at a challenging and possibly dangerous crossroad as the desire for speedy development of a COVID-19 vaccine might be pushing political concerns ahead of safety, efficacy, and the regulatory process, bioethicists and researchers say.
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