President Donald Trump is considering avoiding US regulatory standards to fast-track an experimental COVID-19 vaccine from the UK for use in America ahead of the presidential election.
The British vaccine is being developed in partnership between pharmaceutical giant AstraZeneca and Oxford University. Trump is considering pressing the U.S. Food and Drug Administration to provide an “emergency use authorization” for the British vaccine in October, the FT reported, citing unnamed sources. AstraZeneca said it hasn’t talked about such an order with the Trump administration.
Trump, his poll numbers sinking in the middle of his administration’s misusing of the COVID-19 pandemic, has been selling nonscientific treatments ahead of the election despite of the possible health risks.
On Sunday, the eve of the Republican National Convention, he reported his Food and Drug Administration had given emergency acceptance for blood plasma treatment for coronavirus patients a treatment that hasn’t been proven effective in robust clinical trials. President Donald Trump revealed the order at a news conference, calling it a “great thing.” He vowed that “you’ll be hearing” about vaccines “very soon.”
The British vaccine emerged relatively safe in a study of 1,000 patients reported in the Lancet late last month though with many side effects. But it’s still unknown if the vaccine will prevent coronavirus or decrease symptoms. It could be MANY months before that’s set on in larger Phase 3 clinical attempts with several thousand volunteers. Most experts foresee a vaccine will be ready next year.
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The FDA’s emergency blood plasma order was provided a day after President Donald Trump made the allegations against the agency in a wildly suspicious tweet of being part of a “deep state conspiracy” to intentionally wreck his reelection by not following acceptance of COVID-19 vaccines and treatments. The FDA had at first obstructed approving blood plasma as a treatment at the demand of top health officials, who said insufficient proof that it works.
White House chief of staff Mark Meadows and Treasury Secretary Steven Mnuchin told top Democrats in a July 30 meeting that Trump is considering fast-tracking the British vaccine, a source briefed on what was said told the Financial Times. House Speaker Nancy Pelosi (D-Calif.) warned at the meeting that there could be no “cutting corners” on a vaccine that risks safety, according to the source.
A spokesman for Mnuchin refused that the treasury secretary stated AstraZenaca or is aware of FDA plans concerning an experimental vaccine.
Michael Caputo, a spokesperson for Health and Human Services, which includes the FDA, told the Financial Times that it’s “absolutely false” the FDA would provide an emergency use order for a vaccine before the election. He called such theory a “lurid resistance fantasy.”
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Pushing a vaccine before it’s supported by scientists at the FDA could precipitate a major showdown in the Trump administration. FDA Commissioner Stephen Hahn guaranteed physicians in a conference call earlier this month that he won’t be affected by politics, but that “all of our decisions will continue to be based on good science.”
Peter Marks, head of the FDA’s Center for Biologics Evaluation and Research, said this month in a call with officials and pharmaceutical representatives that he would step down if the Trump administration accept a vaccine before it’s proven to be secure and effective, Reuters reported.
“You have to decide where your red line is, and that’s my red line,” Marks said. “I would feel obligated [to quit] because in doing so, I would indicate to the American public that there’s something wrong.”
