US president Donald Trump is considering bypassing standard testing procedures to push an unproven British coronavirus vaccine in the US in time for the presidential election, the Financial Times has reported.
The vaccine is being developed in partnership between pharmaceutical giant AstraZeneca and Oxford University. Trump is considering pressuring the US Food and Drug Administration to issue an “emergency use authorisation” for the British vaccine in October, the FT reported.
AstraZeneca said it hasn’t discussed such an order with the Trump administration.
Trump, his poll numbers sagging amid his administration’s mishandling of the coronavirus pandemic, has been touting unproven treatments ahead of the election regardless of the possible health risks.
On Sunday, the eve of the Republican National Convention, he announced his Food and Drug Administration (FDA) had given emergency approval for blood plasma treatment for Covid-19 patients – a treatment that hasn’t been proven effective in robust clinical trials. Trump announced the order at a news conference, calling it a “great thing”.
He promised that “you’ll be hearing” about vaccines “very soon”.
The vaccine appeared relatively safe in a study of 1,000 patients reported in the Lancet late last month – albeit with several side effects. But it’s still not known if the jab will actually prevent Covid-19 or lessen symptoms.
It could be a number of months before that’s determined in larger Phase 3 clinical trials with several thousand volunteers. Most experts predict a vaccine will be ready next year.
The FDA’s emergency blood plasma order was issued a day after Trump accused the agency in a tweet of being part of a “deep state conspiracy” to deliberately sabotage his reelection by not shortcutting approval of Covid-19 vaccines and treatments.
The FDA had initially stalled approving blood plasma as a treatment at the request of top health officials, who cited insufficient evidence 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, the FT said. House speaker Nancy Pelosi warned at the meeting that there could be no “cutting corners” on a vaccine that risks safety, according to the paper’s source.
A spokesperson for Mnuchin denied that the treasury secretary mentioned AstraZeneca, or is aware of FDA plans regarding an experimental vaccine.
Michael Caputo, a spokesperson for the US health and human services department – which includes the FDA – told the FT it was “absolutely false” the FDA would issue an emergency use order for a vaccine before the election. He called such speculation a “lurid resistance fantasy”.
Pushing a vaccine before it is supported by scientists at the FDA could trigger a major showdown in the Trump administration. FDA commissioner Stephen Hahn assured physicians in a conference call earlier this month that he won’t be influenced by politics, but that “all of our decisions will continue to be based on good science”.
Peter Marks, head of the FDA’s Centre for Biologics Evaluation and Research, said this month in a call with officials and pharmaceutical representatives that he would resign if the Trump administration approves a vaccine before it’s proven to be safe and effective.
“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.”
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