Trump administration looking to fast-track Oxford University’s potential coronavirus vaccine

There are concerns that the Oxford/AstraZeneca trial is too small for US regulators to approve

In this handout photo released by the University of Oxford samples from coronavirus vaccine trials are handled inside the Oxford Vaccine Group laboratory in Oxford, England Thursday June 25, 2020. Scientists at Oxford University say their experimental coronavirus vaccine has been shown in an early trial to prompt a protective immune response in hundreds of people who got the shot. In research published Monday July 20, 2020 in the journal Lancet, scientists said that they found their experimental COVID-19 vaccine produced a dual immune response in people aged 18 to 55. (John Cairns, University of Oxford via AP)
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The administration of US President Donald Trump is looking at fast-tracking an experimental coronavirus vaccine, despite its unproven safety, for use before the Presidential elections, the Financial Times reported.

The potential vaccine, being developed by AstraZeneca and Oxford University, is considered one of the most promising candidates out of a crowded field of competing drugs.

But the trial is too small to meet US safety and efficacy standards and its use could prompt redundancies among the US government's scientific community, the FT reported.

The plan would involve issuing an “emergency use authorisation” (EUA) in September or October, with the election on November 3.

The coronavirus outbreak is already a factor in election campaigning with Joe Biden attacking Donald Trump’s leadership during the crisis.


White House chief of staff Mark Meadows and Treasury Secretary Steven Mnuchin, have told top Democrats, including Nancy Pelosi, that the EUA could be made as early as September.

Mr Mnuchin has said the administration expected an EUA for a vaccine before full approval.

AstraZeneca said that late-stage Phase 2 and Phase 3 trials for its vaccine candidate are still ongoing in the UK and other markets globally and that it did not anticipate efficacy results until later this year.

US government scientific agencies have said a vaccine would need to be studied in at least 30,000 people to pass its safety threshold.

AstraZeneca’s study has enrolled 10,000 volunteers. It has also started a larger study with 30,000 volunteers, but the results from that will come later.

The company has denied discussing an EUA with the US government.

"AstraZeneca has not discussed emergency use authorisation with the US government and it would be premature to speculate on that possibility," a company spokeswoman told Reuters.

There are no approved vaccines for Covid-19, but AstraZeneca's shot, called AZD1222, is widely seen as one of the leading candidates, and is further along the testing trail than most others.

Peter Marks, director of the Food and Drug Administration’s Centre for Biologics Evaluation and Research – which is responsible for assessing the vaccines – told Reuters last week he would resign if a vaccine was approved before definitive data showing it to be safe and effective was available.

“I could not stand by and see something that was unsafe or ineffective that was being put through.

“You have to decide where your red line is, and that’s my red line. “I would feel obligated [to resign] because in doing so, I would indicate to the American public that there’s something wrong,” Dr Marks said.

People named in the FT report have refused to comment, including the White House and a representative for Mr Mnuchin.