The Trump administration is considering bypassing normal US regulatory standards to fast-track an experimental coronavirus vaccine from the UK for use in America ahead of the presidential election, according to three people briefed on the plan.
One option being explored to speed up the availability of a vaccine would involve the US Food and Drug Administration awarding “emergency use authorisation” (EUA) in October to a vaccine being developed in a partnership between AstraZeneca and Oxford university, based on the results from a relatively small UK study if it is successful, the people said.
The AstraZeneca study has enrolled 10,000 volunteers, whereas the US government’s scientific agencies have said that a vaccine would need to be studied in 30,000 people to pass the threshold for authorisation. AstraZeneca is also conducting a larger study with 30,000 volunteers, although the results from that will come after the smaller trial.