- Región:
- USA
- Categoría:
- Society
Oxford University Covid-19 vaccine firm denies Trump talks
AstraZeneca says it has not discussed ‘emergency use authorisation’ with the US
The company manufacturing the Oxford University coronavirus vaccine has denied it is in talks with the Trump administration about fast-tracking its vaccine for emergency use ahead of November’s presidential elections.
With both Russia and China pressing ahead with inoculations involving experimental vaccines yet to pass final efficacy and safety trials, the Trump administration has become increasingly frustrated with the Food and Drug Administration (FDA), which the president has tried to suggest is slowing approval of a vaccine for “political reasons”.
In a statement released following a report in the Financial Times, the pharmaceutical giant AstraZeneca insisted it had “not discussed emergency use authorisation with the US government and it would be premature to speculate on that possibility”.
It added that “late stage phase 2/3 trials for [the vaccine] are ongoing in the UK and other markets globally, and we do not anticipate efficacy results until later this year”. The team at Oxford University developing the vaccine directed queries to AstraZeneca.
The report claimed Trump officials were anxious to authorise the vaccine for use ahead of the US presidential elections in November.
According to the FT report, one option being explored by the Trump administration would involve the FDA awarding “emergency use authorisation” for the vaccine in October on the basis of the relatively small UK study.
US government licensing rules usually require studies on up to 30,000 people, three times the scale of the UK testing already under way.
According to the report, the White House chief of staff, Mark Meadows, and Steven Mnuchin, the Treasury secretary, told top Democrats that the administration was considering fast-tracking a vaccine – potentially the AstraZeneca one - according to a person briefed on a 30 July meeting the pair held with Nancy Pelosi, the Democratic speaker of the House of Representatives.
Any emergency approval, however, would face considerable hurdles, not least the already flagged up threat of resignations of FDA leaders, including Peter Marks, the director of the agency’s Center for Biologics Evaluation and Research – responsible for assessing the vaccines – who has publicly warned he would quit if pressured to approve a vaccine before testing is complete.
“I could not stand by and see something that was unsafe or ineffective that was being put through,” Marks told Reuters earlier this week.
“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.”