A vaccine before the election? Doubt it, Moderna says

Sept. 30, 2020

Moderna’s CEO said this week that the company will most likely not be ready to apply for an emergency use authorization with the FDA before the Nov. 3 election.

Moderna is one of four companies with a coronavirus candidate in late-stage trials in the U.S. and is currently neck-and-neck with AstraZeneca/University of Oxford and Pfizer/BioNTech who also have vaccines currently undergoing large-scale phase 3 trials. Johnson & Johnson also started phase 3 testing in the U.S. on Sept. 23. All of the companies are testing their candidates on tens of thousands of participants. 

Moderna’s CEO told the Financial Times that the earliest it expects to file for an EUA is Nov. 25.

Earlier this week, Pfizer’s CEO indicated that the company could be ready to submit phase 3 data by late October. But dozens of researchers have urged the company to hold off until November when two full months of safety data will be available.

The news from Moderna comes as speculations swirls around whether or not the companies are facing political pressure to get a vaccine approved before the election. During the presidential debate on Tuesday, President Trump claimed that the U.S. could be “weeks away from a vaccine.”