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The chief executive of Moderna Therapeutics, one of the companies developing a coronavirus vaccine, dealt a blow to Donald Trump’s hopes of having a jab ready before the U.S. presidential election, saying his company would not be able to apply for the authorization until at least the end of November. .
Stéphane Bancel told the Financial Times on Wednesday that Moderna would not be ready to apply for emergency use authorization from the Food and Drug Administration before November 25 at the earliest.
He added that he did not expect to have full approval to distribute the drug to all sectors of the population until next spring, undermining Trump’s claim in Tuesday’s presidential debate that a jab would be available “much sooner.”
Speaking at the FT US Pharma and Biotechnology Conference, Mr. Bancel said: “November 25 is the time when we will have enough safety data to be able to include [emergency use authorisation] file that we would send to the FDA, assuming the safety data is good, that is, a vaccine is considered safe. “
The timeline for authorizing a coronavirus vaccine has become one of the most divisive issues in American politics and was the subject of a bitter exchange between Trump and his Democratic rival Joe Biden during the presidential debate Tuesday night.
Trump insisted a vaccine would be available sooner than his own scientific advisers predict, and even directly contradicted Moncef Slaoui, the head of his Vaccine Task Force at the White House, who has said he hopes a vaccine will be available. generally between April and June of next year. .
Trump said Tuesday night: “I have talked to companies and we can do it much sooner. . . I’ve talked to Pfizer, I’ve talked to all the people you have to talk to: Moderna, Johnson & Johnson and others. They can go much faster than that. “
He added: “We may have the answer before November 1.”
He also accused Biden of politicizing the vaccine development process, saying, “People like this would rather make it political than save lives.”
Bancel said Moderna wouldn’t be ready to submit an application to serve the entire population until at least the end of January, making March the earliest month it thought it could be approved. “I think a delay [first quarter], early [second quarter] approval is a reasonable time frame, based on what we know about our vaccine. “
It added that Moderna would not be able to apply for a limited emergency clearance before November 1, due to guidelines agreed to with the FDA that require at least half of the trial participants to have undergone two months of screening after their final injection. .
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Moderna injected the 15,000th participant in her 30,000-person trial last Friday, she said, making November 25 as soon as possible to complete the two-month evaluation.
The FDA’s own guidelines have been controversial, with Trump calling them “political” and threatening to overturn them. But Stephen Hahn, the FDA’s director, said at the FT conference earlier this week that his agency would back them even in the face of political pressure.
Those guidelines mean Trump’s most realistic hope for a pre-election vaccine is likely to come from Pfizer, whose CEO Albert Bourla has said he expected to have “an answer” on the vaccine from his company by the end of October.
Bancel told the FT that Pfizer was on an accelerated timeline due to a shorter period between its two takes, as well as the way the company has designed its tests.
