Moderna CEO Stéphane Bancel said if its Covid-19 vaccine is proven safe and effective, it could be available to the general population by late March or early April.
Moderna began its Phase 3 clinical trial for a Covid-19 vaccine in the US in July. It’s one of four companies that have begun Phase 3 Covid-19 vaccine trials in the US — the others are Johnson & Johnson, Pfizer/BioNTech and AstraZeneca.
The AstraZeneca trial was paused after an unexplained illness in a volunteer, and US health authorities are still considering crucial questions that remain around the injections of the experimental vaccine.
“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.
But there are several steps that will have to come before that.
If the safety and efficacy data checks out, Bancel says he expects Moderna will be able to file a Biologics License Application (BLA) with the US Food and Drug Administration by late January or early February. That application asks the FDA to consider fully licensing a drug, while an emergency use authorization (EUA) expedites a drug candidate for use on an emergency basis.
Moderna could file for an EUA as early as November 25 for people who are deemed high priority, including health care workers and the elderly, Bancel said at a conference hosted by the Financial Times.
Until a vaccine is available, experts have for long said the country’s most powerful tools against the pandemic are face masks and other safety measures like social distancing.
But even when a vaccine is ready, health officials like Fauci have said there will still be room for the virus to spread, as it’s unlikely the vaccine will be 100% effective or taken by 100% of the population.
“I think if we can get 75 to 80% of the population vaccinated, I think that would be a really good accomplishment,” Fauci said last week.