Moderna not able to seek FDA emergency use of COVID-19 vaccine before November 25, says CEO

1 October 2020

Speaking at the Financial Times’ US Pharma and Biotech Conference yesterday, Moderna Therapeutics’ (Nasdaq: MRNA) chief executive Stéphane Bancel stated that the company will not be able to apply for emergency use authorization (EUA) in the USA for its COVID-19 vaccine candidate mRNA-1273 before November 25 at the earliest, reflecting the minimum amount of time needed to accumulate enough safety data.

This is due to guidelines agreed with the Food and Drug Administration that require at least half of trial participants to have undergone two months of screening following their final injection, he explained.

This was seen as a blow to Donald Trump’s hopes of having a jab ready before the US presidential election scheduled for November 3, the FT stated, noting that the timeline for authorizing a coronavirus vaccine has become one of the most divisive issues in US politics, and was the subject of an acrimonious exchange between Mr Trump and his Democratic rival Joe Biden during Tuesday night’s presidential debate.

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