If Moderna’s coronavirus vaccine is proven safe and effective, the general population could have access to it by late March or early April next year, Moderna CEO Stéphane Bancel said on Wednesday.
“I think a late Q1, early Q2 approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said at a conference hosted by the Financial Times.
If the safety and efficacy data checks out, Bancel says he anticipates Moderna will be able to file a Biologics License Application (BLA) with the US Food and Drug Administration by late January or early February of 2021.
A BLA requests the FDA to consider fully licensing a drug, while emergency use authorization (EUA) expedites a drug or vaccine candidate for use on an emergency basis.
Bancel said Moderna could file for an EUA on November 25, at the earliest. “The EUA, we think, will be an important medical tool to start addressing people at very high risk, like health care worker, like the elderly,” he said.
Bancel said Moderna is working to ramp up manufacturing ahead of an approval of its vaccine candidate.
“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,” said Bancel.
Bancel added that he believes Moderna’s vaccine will be mainly available to high risk populations, like healthcare workers and the elderly, under emergency use authorization from the FDA.
“As for the general population, my understanding is that it will be full BLA, a typical product approval, that I think could come in late Q1, early Q2,” he said.
Many experts have expressed strong concern that the Trump administration could be putting pressure on the vaccine development process to try to get a vaccine approved before election day. President Trump has claimed that the FDA might be politically motivated to delay approval of a vaccine.
Bancel said he has received no political pressure, in either direction.
“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.
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