WASHINGTON/NEW YORK (Financial Times) -- The CEO of Moderna Therapeutics, one of the companies developing a coronavirus vaccine, dealt a blow to U.S. President Donald Trump's hopes of having a vaccine ready before the presidential election, saying his company would not be able to apply for authorization until at least late November.
Stephane Bancel told the Financial Times on Wednesday that Moderna would not be ready to seek emergency use authorization from the U.S. Food and Drug Administration before Nov. 25 at the earliest.
He added that he did not expect full approval to distribute the drug to all sections of the population until next spring, undermining Trump's claim during Tuesday's presidential debate that a vaccine would be available "a lot sooner."
Speaking at the FT's U.S. Pharma and Biotech Conference, Bancel said: "November 25 is the time we will have enough safety data to be able to put into a EUA [emergency use authorization] file that we would send to the FDA -- assuming that the safety data is good; in other words, a vaccine is deemed to be safe."
The timeline for authorizing a vaccine has become one of the most divisive issues in American politics, and was the subject of an acrimonious exchange between Trump and his Democratic rival Joe Biden during Tuesday's debate.
Trump insisted a vaccine would be available sooner than his own scientific advisers predict, and even directly contradicted Moncef Slaoui, head of the White House vaccine task force, who has said he expects a vaccine to be available between April and June next year.
The president said on Tuesday night: "I've spoken to the companies and we can have it a lot sooner ... I've spoken to Pfizer, I've spoken to all of the people that you have to speak to, Moderna, Johnson & Johnson, and others. They can go faster than that by a lot."
He added: "It's a possibility that we'll have the answer before November 1."
He also accused Biden of politicizing vaccine development, saying: "People like this would rather make it political than save lives."
Bancel said Moderna would not be ready to file an application to serve the whole population until at least late January, making March the earliest he thought it could be approved. "I think a late [first quarter], early [second quarter] approval, is a reasonable timeline, based on what we know from our vaccine."
He added it would not be possible for Moderna to file for a limited emergency authorization before Nov. 1 due to guidelines agreed with the FDA that require at least half of trial participants to have undergone two months of screening following their final injection.
Moderna injected the 15,000th participant in its 30,000-person trial last Friday, he said, making Nov. 25 the earliest it could complete the two-month screening.
FDA guidelines have themselves been contentious, with Trump calling them "political" and threatening to overrule them. But Stephen Hahn, head of the FDA, told the FT conference earlier this week that his agency would stand by them even in the face of political pressure.
Those guidelines mean that Trump's most realistic hope of a preelection vaccine is likely to come from Pfizer, whose CEO Albert Bourla has said he hoped to have "an answer" on his company's vaccine by the end of October.
Bancel told the FT that Pfizer was on an accelerated timeline because of a shorter period between its two vaccines, as well as the way the company has designed its trials.