“I think a late first trimester, early second trimester approval is a reasonable timeframe, based on what we know about our vaccine,” Bancel said at a conference hosted by the Financial Times.
If the safety and efficacy data is verified, Bancel says it expects Moderna will be able to apply for a Biologics License (BLA) with the United States Food and Drug Administration. here late January or early February 2021.
A BLA asks the FDA to consider a full license for a drug, while Emergency Use Authorization (EUA) speeds up the use of a drug or vaccine candidate in an emergency.
Bancel said Moderna could file an EUA application by November 25 at the earliest. “We believe that the EUA will be an important medical tool to start reaching out to people at very high risk, like health workers, like the elderly,” he said.
Bancel added that he believes Moderna’s vaccine will be primarily available to high-risk populations, such as healthcare workers and the elderly, under emergency use clearance from the FDA.
“As for the general population, my understanding is that this will be a full BLA, a typical product approval, which I think could happen at the end of the first trimester, at the beginning of the second trimester.” , did he declare.
Many experts have expressed deep concern that the Trump administration could pressure the vaccine development process to try and get a vaccine approved before election day. President Trump has asserted that the FDA may be politically motivated to delay approval of a vaccine.
Bancel said he had received no political pressure, either way.
“No one, 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.