The chief executive of Modern Therapeutics, one of the companies developing the coronovirus vaccine, slammed Donald Trump’s hopes of getting a job ready before the US presidential election, saying his company would apply to the authority by at least the end of November Will not be able to do. .
Stephen Bansell told the Financial Times on Wednesday that Modern would not be ready to seek emergency use authorization from the Food and Drug Administration before November 25 at the earliest.
He said he did not expect full approval to distribute the drug to all sections of the population until next spring, undermining Mr Trump’s claim in Tuesday’s presidential debate that a jab would be available “very soon”.
Speaking at FT’s US Pharma and Biotech Conference, Mr Banksel said: “25 November is the time when we will have enough safety data to put in the EU. [emergency use authorisation] The file we will send to the FDA – assuming the safety data is good, that is, a vaccine is considered safe. ”
The time to authorize the coronovirus vaccine has become one of the most divisive issues in American politics, and was the subject of a sharp exchange between Mr. Trump and his Democratic rival Joe Biden during Tuesday’s presidential debate.
Mr. Trump insisted that a vaccine would be available sooner than his own scientific advisors predicted, and even said directly to his White House Vaccine Task Force chief, Monsep Saloi, that he has It is expected to be generally available between April and June next year. .
Mr Trump said on Tuesday night: “I have spoken to companies and we can complete it very soon. . . I’ve talked to Pfizer, I’ve talked to all the people you have to speak to – Modern, Johnson & Johnson, and others. They can go much faster than this. ”
He said: “It is a possibility that we will reply before 1 November”
He also said that Mr. Biden accused him of politicizing the vaccine development process, saying: “Such people will make it political rather than save lives.”
Mr Bansell said that the moderns would not be ready to file an application to serve the entire population at least by the end of January, making March as soon as possible they thought it could be approved. “I think it’s late [first quarter], soon [second quarter] Approval is a reasonable timeline, based on what we know from our vaccines. ”
He said it would not be possible for the modern to file for limited emergency authorization before November 1, as at least half of the trial participants undergo two-month screenings after their last injection, according to FDA-agreed guidelines .
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Modern injected the 15,000th participant in its 30,000-person trial last Friday, saying it could complete a two-month screening on November 25 as soon as possible.
The FDA guidelines themselves have been controversial, with Mr. Trump calling them “political” and threatening to overthrow them. But FDA chief Stephen Hahn said at the FT conference earlier this week that his agency would stand by him even under political pressure.
Those guidelines mean that the most realistic expectation of Mr. Trump’s pre-election vaccine is likely to come from Pfizer, whose chief executive Albert Borla has said he expects to have a “reply” to his company’s vaccine by the end of October.
Mr. Bansell told the FT that Pfizer was on a quick timeline due to a short duration between its two shots, as well as the way the company designed its tests.