August 23, 2020
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 authorization” (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 authorization. AstraZeneca is also conducting a larger study with 30,000 volunteers, although the results from that will come after the smaller trial.
Making a vaccine available before the election could allow US President Donald Trump to claim he has turned the tide on a virus that has killed more than 170,000 Americans following widespread criticism of his handling of the pandemic.
In his convention speech on Thursday night, Joe Biden, Mr. Trump’s Democratic opponent, said that the US response to the virus was the “worst performance of any nation”. However, if the Trump administration does rush through emergency authorization ahead of the election by skirting normal government guidelines, it could dent already shaky public confidence in the safety of vaccines ahead of one of the largest mass-immunization programs in US history.
Mark Meadows, White House chief of staff, and Steven Mnuchin, Treasury secretary, have told top Democrats that the administration was considering fast-tracking a vaccine, according to one person briefed on a July 30 meeting the pair held with Nancy Pelosi, the Democratic Speaker of the House of Representatives. Mr. Meadows said in the meeting that there could be emergency authorization, possibly for the AstraZeneca vaccine, in September. Mr. Mnuchin added that the administration expected a EUA for a vaccine before full approval, said the person, who added that Ms Pelosi warned that there should be “no cutting corners” in the vaccine approval process.