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US health officials downplay hopes of pre-election vaccine

Two top US public health officials have played down the chances of having a coronavirus vaccine before the election, despite President Donald Trump insisting that one would be available “within weeks”.

Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, and Stephen Hahn, Food and Drug Administration head, told Congress that drug companies still face hurdles to getting approval.

Dr Fauci told the Senate health committee he expected a vaccine to be authorised by November at the earliest. Dr Hahn told the panel the FDA would soon issue additional guidelines, which experts say will make it all but impossible to achieve authorisation any sooner.

The comments contradict assurances from Mr Trump that a vaccine is imminent, and threaten to exacerbate tensions between the president and his administration’s most senior medical officials.

Those tensions were exposed at a White House press conference later on Wednesday when Mr Trump questioned the move by his FDA chief to issue new guidelines, and said the White House would have control.

“We are looking at that. That has to be approved by the White House,” the president said. “That looks like a political move.”

In another example of discrepancies between the views expressed by top health officials and the White House, Scott Atlas, a White House adviser on coronavirus, said Robert Redfield, the director of the US Centers for Disease Control and Prevention, had provided misleading testimony at the same Senate hearing on Wednesday.

Mr Redfield, who has been previously attacked by Mr Trump, told the Senate that the CDC was conducing large-scale serology testing in the US and that preliminary results suggested that “most Americans have not been infected” and were “still vulnerable to the infection serious illness and death”.

“More than 90 per cent of the population remains susceptible,” Mr Redfield said.

Hours later at the White House briefing, Mr Atlas said Mr Redfield had “misstated something”. He said much of the CDC data was old, and that it did not include other forms of testing which showed that the proportion of Americans who were susceptible was much lower.

Pressed on who people should trust given the contradictory comments, Mr Atlas said: “You’re supposed to believe the science and I am telling you the science.”

He also denied reports that Deborah Birx, a leading member of the White House coronavirus task force, was considering leaving the group because she was frustrated that Mr Trump was listening too much to Mr Atlas who was providing him with misleading information.

At the Senate hearing, Dr Fauci said he was “cautiously optimistic that we will be able to have a safe and effective vaccine, although there is never a guarantee of that”.

He said studies so far showed that people induced a response that was comparable to, if not better than, natural infection.

“And so as these trials go on we predict that sometime by the end of this year — let’s say November or December — we will know whether or not these are safe and effective,” Dr Fauci said.

Four companies have a Covid-19 vaccine in phase 3 clinical trials that involve testing tens of thousands of people around the world.

Dr Hahn told the Financial Times last month he was willing to grant an emergency authorisation to a vaccine before the end of those trials if there was enough data to ensure the benefits outweighed the risks.

Since then, however, his agency has been working on additional guidelines for drugmakers which would make it very difficult to secure an authorisation before November.

Three people with knowledge of those guidelines told the Financial Times this week that the guidelines would include waiting until about half of trial participants had been monitored for at least two months after receiving their last injection before declaring a vaccine to be safe.

Experts say such a standard would make it highly unlikely that any company would be ready to apply for authorisation before the US presidential election on November 3.

Dr Hahn told the committee on Wednesday: “[The FDA] will work to provide additional information, so that it is clear what we expect to see should a sponsor choose to submit an emergency use application [EUA].

“FDA also expects that an EUA request would include a plan for active follow-up to monitor safety among individuals who receive the vaccine. In the end, FDA will not authorise or approve a vaccine that we would not feel comfortable giving to our families.”

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