Moderna Could Earn EUA for COVID-19 Vaccine in December, CEO Says

Moderna CEO Stéphane Bancel said that the drugmaker’s COVID-19 vaccine candidate could receive an Emergency Use Authorization (EUA) in December if all goes according to plan, with interim data expected out next month.

In an online interview, the pharma executive said the company expects to have enough interim data in the later part of November to file an EUA submission with the FDA if the data prove positive.

“I will expect the FDA to take a few weeks to review everything and to make sure everything is well, so that potentially if the data is good, to get an [EUA] sometime in December,” Bancel said.

That timeframe likely puts Moderna’s vaccine candidate, mRNA-1273, near the front in the race for emergency authorization along with Pfizer (DID, Oct. 19). Two other hopefuls, AstraZeneca and Johnson & Johnson, have paused their vaccine trials as they investigate possible safety issues.

Although the FDA has imposed stricter standards for vaccine emergency authorization, requiring companies to collect a minimum two months of safety data for half of their study participants, Bancel said the company had already fulfilled those requirements as of September.

If the company’s first interim results fail to support authorization, Bancel said it has a second interim study lined up for December that would push a possible EUA back to late January or early February.

Moderna is currently aiming to make 20 million doses of its two-dose vaccine by the end of 2021. For next year, the company expects to produce at least 500 million doses, “and we’re working to get up to [1 billion doses],” the Moderna chief said.

Bancel claimed that the combined forces of its U.S. facility and its partner Lonza’s New Hampshire plant provide enough capacity to supply the entire U.S. population with the vaccine. The government has ordered 100 million doses of mRNA-1273 under a $1.5 billion Operation Warp Speed contract that leaves the door open for 400 million more (DID, Aug. 13). — James Miessler