One option being considered to speed up the availability of a vaccine would involve the US Food and Drug Administration granting an “emergency use authorization” (EUA) in October to a vaccine under development as part of a partnership between AstraZeneca and the University of Oxford, based on the results of a relatively small UK study whether it is successful, the people said.
The AstraZeneca study recruited 10,000 volunteers, while US government scientific agencies said a vaccine would need to be studied in 30,000 people to pass the clearance threshold. AstraZeneca is also conducting a larger study with 30,000 volunteers, although the results follow after the smallest trial.
Making a vaccine available ahead of the election could allow US President Donald Trump to say he’s turned the tide on a virus that has killed more than 170,000 Americans amid widespread criticism of his handling of the pandemic. In his speech at the convention Thursday night, Joe Biden, Mr. Trump’s Democratic opponent, said the US response to the virus was the “worst performance of any country.”
However, if the Trump administration rushes to get emergency clearance ahead of the election by bypassing normal government guidelines, it could undermine already fragile public confidence in vaccine safety ahead of one of the world’s largest immunization programs. mass of United States history.
White House chief of staff Mark Meadows and Treasury secretary Steven Mnuchin told Main Democrats the administration was considering speeding up a vaccine rollout, a person briefed at a meeting said. July 30 that the couple held with Nancy Pelosi, the Democrat. Speaker of the House of Representatives.
Mr Meadows told the meeting that there could be an emergency clearance, possibly for the AstraZeneca vaccine, in September. Mr Mnuchin added that the administration expected an EUA for a vaccine before full approval, the person said, who added that Ms Pelosi warned that there should be “no shortcuts” in the vaccine approval process.
A spokesperson for the Treasury Secretary said: “Secretary Mnuchin has not commented on AstraZeneca, nor is he aware of the specifics of the AstraZeneca vaccine candidate. He is also not aware of any plans the FDA may have regarding emergency use clearance for any potential vaccine, beyond what he has heard publicly stated.
“The secretary believes, and has always believed, that any decision on vaccine candidates and any possible EUA rests with the FDA.”
The White House made no comment.
Separately, on Sunday, the FDA issued an “emergency use authorization” for the use of convalescent plasma for the treatment of coronavirus in hospital patients, in what the White House called a “major therapeutic breakthrough. “.
Stephen Hahn, Commissioner of the FDA, said study data has shown that “plasma from patients who have recovered from Covid-19 has the potential to help treat those who are suffering from the effects of this terrible virus” .
If the FDA grants emergency approval for the AstraZeneca vaccine based on the Oxford study, it could lead to a series of resignations from the agency.
Earlier this week, Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research – which is responsible for evaluating vaccines – told Reuters he would step down if the agency approved a jab before definitive data show that it was safe and effective.
“I couldn’t stand aside and see something dangerous or ineffective that was being put through,” Dr. Marks said. “You have to decide where your red line is, and that’s my red line. ”
He continued, “I would feel obligated [to resign] because in doing so, I would be indicating to the American public that there is something wrong.
Dr Marks declined to comment on the FT.
Michael Caputo, a spokesman for the US Department of Health and Human Services – which contains the FDA – said any claim that the administration would issue an EUA before the election was “absolutely false.”
Mr Caputo said the administration hoped a vaccine would be developed by the first quarter of 2021.
“We have always worked towards this goal. I was never told at any time that this goal had changed, ”he said. “To speak of an October surprise is a sinister resistance fantasy. Irresponsible rhetoric about a dangerous or ineffective vaccine approved for public use is designed to undermine the president’s response to the coronavirus.
On Saturday, Mr Trump slammed the FDA in a tweet that appeared to accuse the agency of slowing enrollment in coronavirus vaccine and drug trials to delay study results until after the election.
“The deep state, or whoever, at the FDA, makes it very difficult for drug companies to get people to test vaccines and therapies,” Mr. Trump wrote in a tweet that tagged Dr. Hahn. “Obviously, they hope to delay the response after November 3. Must focus on speed and save lives! ”
Ms Pelosi replied to Mr Trump at a press conference on Saturday.
She said, “The FDA has a responsibility to approve drugs, judging by their safety and effectiveness, not by a White House statement on the speed and politicization of the FDA.”
She added: “It was a very dangerous statement from the president. Even for him, it went above and beyond in terms of endangering the health and well-being of the American people.
Two of those briefed on the plans said the relatively small trial in the UK was not designed to produce enough data of the kind that would be required for emergency clearance in the US. US drugmakers Moderna and Pfizer, which are also testing vaccines, both plan to enroll 30,000 participants in phase III studies they began in July. Moderna said it will complete registration by the end of September, while Pfizer said it has already registered 11,000.
One of those briefed on the plan said: “I don’t see a way forward for [AstraZeneca]”, Based on the trial of 10,000 people. “They’re not going to get there. They will not have clinical endpoints ”
The person predicted that if Dr. Marks quit, other scientists in his FDA division would follow his lead.
A spokesperson for AstraZeneca said he had “not discussed emergency use authorization with the US government” and that it “would be premature to speculate on this possibility”.
Paul Offit, a vaccine expert at Children’s Hospital in Philadelphia, said it would be “very disappointing” for the Trump administration to prepare such a plan even before seeing the data as it risked “politicizing the science”.
He said that even if the study was successful, a trial of 10,000 people wouldn’t be large enough to rule out more rare side effects. “The job of the FDA is to protect the American public if they consider this data to be inadequate.”
Dr Hahn was criticized earlier this year after the FDA granted emergency clearance for hydroxychloroquine – an unproven drug repeatedly touted by Mr Trump – before reversing his decision when several studies showed that the drug was not an effective treatment for the coronavirus.
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Public health officials in the United States have repeatedly stressed the importance of following normal processes when approving a Covid-19 vaccine.
In June, Francis Collins, director of the National Institutes of Health, told CNN: “Each vaccine should be tested on approximately 30,000 volunteers. We don’t think we have enough analytical power to be able to document the effects of the vaccine unless you hit around that number.
Robert Redfield, head of the Centers for Disease Control and Infection, told the FT on Friday: “While we have talked about doing this at ‘warp speed’, it is not through cuts to our efforts to keep people safe. vaccines or scientific integrity.
A person working on U.S. efforts to find a vaccine said the Trump administration’s exploration of ways to bypass normal procedures sparked infighting among top scientists in the government. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, and Dr Collins stress the importance of scientific rigor as Moncef Slaoui, the White House vaccine czar, wants to move forward, has declared the person.
Additional reports Clive Cookson and Donato Mancini in London and Kiran Stacey in Washington