- The CEO of Moderna said Wednesday that he expects its coronavirus vaccine to be ready for use in late March or early April 2021.
- "I think a late Q1, early Q2 approval is a reasonable timeline," Stéphane Bancel told a conference hosted by the Financial Times.
- Bancel added that Moderna would be ready to submit the vaccine to the US Food and Drug Administration for "emergency use authorization" on November 25, 2020.
- He previously told Business Insider the company would most likely know in November whether its experimental coronavirus vaccine worked.
- During Tuesday's presidential debate, President Donald Trump claimed that the US was "weeks away" from getting a vaccine. Early 2021 appears to be a more realistic timeline.
- Learn more about the race for a coronavirus vaccine in our live event on October 5. Sign up here.
The CEO of Moderna, one of the leading drugmakers developing a coronavirus vaccine, said on Wednesday that he thinks his company's vaccine will be ready for use in late March or early April 2021.
"I think a late Q1, early Q2 approval is a reasonable timeline, based on what we know from our vaccine," Stéphane Bancel told the US Pharma and Biotech Conference hosted by the Financial Times.
Bancel went on to say that Moderna will not be ready to submit the vaccine to the US Food and Drug Administration (FDA) for a Biologics License Application (BLA) until at least late January 2021.
A BLA is a request for permission to fully licence a drug to the general population. Per Bancel's timeline, March would be the earliest time the drug can be approved, the FT noted.
Bancel also told the conference that Moderna would not try to get emergency use authorization (EUA) from the FDA until November 25, 2020. Those qualified for emergency use include frontline health workers.
"November 25 is the time we will have enough safety data to be able to put into an EUA file that we would send to the FDA, assuming that the safety data is good, i.e. a vaccine is deemed to be safe," he told the conference, according to the FT.
"The EUA, we think, will be an important medical tool to start addressing people at very high risk, like healthcare worker[s], like the elderly," he added, according to CNN.
Last month Bancel told Business Insider's Andrew Dunn that Moderna would most likely know in November whether its experimental coronavirus vaccine works.
Moderna initially planned to submit the vaccine for emergency approval on November 1, Bancel told CNBC in September.
At the conference, Bancel said Moderna is readying its production lines in the face of pressing demand.
"We are trying to really get ahead of the game, so that if the safety is good, efficacy is good, manufacturing will not delay the availability of a vaccine on an emergency use basis first," he said.
Drugmakers under pressure from Trump
President Donald Trump has for weeks touted the impending arrival of a coronavirus vaccine, even as drugmakers say they are not ready yet. (Trump himself tested positive for the virus on Thursday night.)
During Tuesday night's first presidential debate Trump claimed the US was only "weeks away from a vaccine."
"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 said.
But Pfizer's chief executive officer, Albert Bourla, rubbished Trump's claim in an internal note to employees on Thursday in which he said the company's vaccine process will be "moving at the speed of science," according to the Associated Press.
"The only pressure we feel — and it weighs heavy — are the billions of people, millions of businesses and hundreds of government officials that are depending on us," Bourla wrote.
Bancel, meanwhile, told the Wednesday conference Moderna had not been subject to any political pressure.
"Nobody, since we started this race against the virus in early January, from any party, from any branch of government, from any country, has asked us to go faster or to go slower," he said.
The head of the FDA, Stephen Hahn, said at the same conference that he will stand by the FDA's testing process and won't rush through a vaccine.
Moderna and Pfizer are among a handful of pharmaceutical giants who are nearing the final stages of testing their vaccines.
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