The CEO of Moderna Therapeutics, one of the companies developing the coronavirus vaccine, has struck at Donald Trump’s hopes of a strike before the US presidential election, saying his company will not be able to apply for a permit at least until late November.
Stefan Bansel told the Financial Times on Wednesday that Moderna would not be ready to seek emergency authorization from the Food and Drug Administration before November 25th.
He added that he did not expect to receive full approval for the distribution of the drug to all segments of the population until next spring, undermining Mr Trump̵
During the US Conference on Pharmacy and Biotechnology at the FT, Mr Bansel said: “November 25 is the time when we will have enough safety data to be able to join the EUA [emergency use authorisation] file that we would send to the FDA – if we assume that the safety data is good, ie. the vaccine is considered safe. “
The timetable for allowing the coronavirus vaccine has become one of the most contentious issues in US policy and has been the subject of a heated exchange between Mr Trump and his Democratic rival, Joe Biden, during Tuesday’s presidential debate.
Mr Trump insists the vaccine will be available sooner than his own scientific advisers predict, and even directly contradicts Moncef Slavey, head of his White House vaccine working group, who said he expects the strike to be publicly available. between April and June next year.
Mr Trump said Tuesday night: “I spoke to the companies and we can do it much earlier. . . I’ve talked to Pfizer, I’ve talked to everyone you need to talk to – Moderna, Johnson & Johnson and others. They can go much faster than that. “
He added: “It is possible that we will receive the answer before November 1.”
He also accused Mr Biden of politicizing the vaccine development process, saying: “People like this prefer to do it politically rather than save lives.”
Mr Bancel said Moderna would not be ready to apply for a full-service service at least until the end of January, making March the earliest that it could be approved. “I think it’s too late [first quarter], early [second quarter] approval, is a reasonable schedule based on what we know from our vaccine. “
He added that it would not be possible for Moderna to apply for a limited emergency authorization before November 1, due to FDA-agreed guidelines that require at least half of test participants to undergo screening two months after their last injection.
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Moderna injected the 15,000th participant in its trial with 30,000 people last Friday, he said, making November 25 at the earliest so he could complete the two-month screening.
The FDA guidelines are controversial, with Mr. Trump calling them “political” and threatening to repeal them. But FDA chief Stephen Hahn told an FT conference earlier this week that his agency would stand by them even in the face of political pressure.
These guidelines mean that Mr Trump’s most realistic hope for a pre-election vaccine is likely to come from Pfizer, whose CEO Albert Burla said he hoped there would be a “response” to his company’s vaccine by the end of October.
Mr Bancel told the FT that Pfizer was on an accelerated schedule due to the shorter period between the two shots and the way the company had designed its tests.