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

Samples of the University of Oxford coronavirus vaccine trials are handled at a laboratory. AP

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.

• 

  The vaccine, called Sputnik V, takes its name from the Soviet-era satellite. The Russian Direct Investment Fund via Reuters

• 

  Samples of the vaccine developed by the Gamaleya Research Institute of Epidemiology and Microbiology. Reuters

• 

  The Russian vaccine is named after the Sputnik V satellite which was the first to enter orbit during the space race. Alamy

• 

  The speed with which Russia has approved has stunned observers. Bloomberg

• 

  Russian President Vladimir Putin said his daughter had already been given the vaccine. EPA / Sputnik

• 

  Industrial production of the new vaccine is due to start next month. Bloomberg

• 

  The Russian vaccine is based on the DNA of the common cold, but experts are sceptical about its effectiveness. Bloomberg