“I think a late [first quarter], early [second quarter] approval is a reasonable timeline, based on what we know from our vaccine,” Bancel said, according to the FT.

A spokesperson for Moderna confirmed Bancel’s comment at the conference noting that the company expects to have enough vaccine testing data to apply with the FDA for emergency use authorization by November 25.

The timeline is a setback for Moderna, which said earlier this month that it could seek emergency authorization for a vaccine as soon as November 1. It also deals a blow to claims by President Donald Trump, which he repeated on Tuesday in his debate with Joe Biden, that a vaccine could be ready in a matter of weeks, or before the November 3 presidential election.