Moderna Says COVID-19 Vaccine Could Be Ready As Soon As December With FDA Approval

Moderna says its COVID-19 vaccine could be ready for U.S. distribution as early as December.

Speaking at a Wall Street Journal tech conference, CEO Stéphane Bancel said Moderna expects interim results from phase three clinical trials by November, a timetable that could place an emergency approval from the FDA in December.

There are still some possible wrinkles, however: Moderna needs a minimum number of their 30,000 volunteers to contract COVID-19 before it can prove those without the vaccine were more likely to do so. Low infection rates could delay results.

If the results from that first population aren’t conclusive, Moderna would need to wait for a larger number of sick volunteers before seeking FDA approval. That would likely push a vaccine timetable into early 2021.

Last week vaccine competitor Pfizer said it would be seeking FDA approval in late November, as well, which would put its distribution date in December. Two other potential vaccines from Johnson & Johnson and AstraZeneca have their trials on hold pending investigations into unexplained illnesses among volunteers.

New FDA regulations require that vaccine developers wait two months from the last dose of their drug to prove long-term safety and efficacy. President Donald Trump fought their implementation, hoping to get a vaccine out before the November presidential election.

Both Pfizer and Moderna are set to clear this bar, with Moderna’s trials starting in July. It typically takes several weeks for the FDA to arrive at a decision once the drug is submitted, although if there was ever a drug that would be given extra resources it would be these.

Bancel said that Moderna projects it can produce 20 million doses in 2020, and 500 million in 2021. Moderna and its manufacturing partner, Lonza Ltd. say they will be able to meet U.S. demand. They will also be manufacturing the drug in Switzerland to distribute internationally.

Despite their expectations, Bancel said that manufacturing vaccines is a complex process with many moving parts that need to come together simultaneously.

"Unlike sometimes when you make a recipe at home, if you miss one ingredient, you might decide to still go ahead and make your meal,” he said, “In our case we cannot do that. We need all the ingredients to be there on time to be able to make a lot of vaccine."

"If one ingredient is missing, we cannot make a vaccine."