Dealing a blow to President Trump's hope to have a vaccine before Election Day, Moderna's (NASDAQ:MRNA) CEO said the company's coronavirus vaccine won't be ready by Nov. 3.
Speaking at a Financial Times-organized biotech and pharmaceutical conference, Stephane Bancel said that "November 25 is the time we will have enough safety data to be able to put into an EUA [Emergency Use Authorization] file that we would send to the FDA — assuming that the safety data is good, i.e., a vaccine is deemed to be safe."
An Emergency Use Authorization is fast-track, limited approval the FDA grants for medications or vaccines that can treat or prevent diseases that post a significant enough threat to the population.
Moderna has leapt to prominence with its MRNA-1273, considered one of the leading coronavirus vaccine candidates, if not the overall leader. It has done extremely well in early stage testing and is currently undergoing a phase 3 clinical trial.
On the hope that it would boost his popularity in the run-up to the election, Trump has promoted the idea that a safe and effective vaccine will be on the market in the very near future. A great many public health experts and pundits say that will happen next year at the earliest, however.
While biotech and pharmaceutical companies are developing a host of vaccine candidates, none has yet finished its clinical testing, and no major regulatory authority has approved any of them.
Investors didn't react too strongly to Bancel's pronouncement, as it's likely few of them were expecting MRNA-1273 to finish testing and win approval over the next couple of weeks. The company's shares inched up on Wednesday, not quite reaching the S&P 500 Index's gain on the day.