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The White House has blocked the Food and Drug Administration (FDA) from enacting stricter federal guidelines on the emergency release of a potential coronavirus vaccine, The New York Times reported on Monday. The FDA first submitted the proposal for new guidelines in late September, but they were immediately rebuffed by President Trump and top officials who worried it would delay the release of a vaccine as Trump's "Operation Warp Speed" has sought to quickly move one through the approval process. According to the Times, the new guidance included the recommendation that volunteers in the vaccine clinical trials be followed for around two months after receiving their final dose before an official vaccine authorization is granted. The recommendation is part of an effort to make sure an approved vaccine is safe. The Times reports that specific part of the proposed guidelines was the sticking point for White House officials. The report comes as the FDA is looking to reassure the public that it is following the science and will make sure any vaccine is safe and effective before authorizing it amid fears of political pressure from Trump. Trump had signaled he may not approve the guidelines after they were proposed.
“We’re looking at that. That has to be approved by the White House. We may or may not approve it. That sounds like a political move,” Trump told reporters at a White House briefing when asked if he agreed with the FDA's plan. “Why would [companies] have to be adding great length to the process? We want to have people not get sick. The vaccine is very important,” Trump said, adding, “I think that was a political move more than anything else.” It marks another instance of Trump and the White House breaking with top health officials on public health guidelines and his assessments about the threat posed by the virus. Meanwhile, some have raised questions about the safety of a vaccine. Last month nine pharmaceutical companies signed a joint pledge not to approve any vaccine without confidence in its safety and efficacy.
