Moderna Might Seek Government OK for Vaccine in December

Ralph Ellis

October 23, 2020

Pharmaceutical company Moderna has enrolled all 30,000 volunteers in its coronavirus vaccine clinical trial and might seek emergency use authorization for the vaccine as early as December if the trials prove it's safe.

Moderna Chief Executive Stéphane Bancel, speaking at The Wall Street Journal's annual Tech Live conference, said that timetable would not hold up if all the safety benchmarks are not met.

"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, but in our case, we cannot do that," Bancel said. "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."

In a news release issued Thursday, Massachusetts-based Moderna said it had enrolled all 30,000 volunteers and had administered the second dose of the vaccine to 26,650 of them.

The news release said the 30,000 volunteers included 7,000 people over 65 and 5,000 under 65 who have chronic diseases such as diabetes that put them at increased risk if they catch coronavirus.

The company also made efforts to include minorities in the clinical trials and signed up 11,000 people from communities of color, including 6,000 who identify as Hispanic or LatinX and more than 3,000 participants who identify as Black or African American.

Dr. Stephen Hoge, Moderna's president, said the clinical trials must hit three benchmarks before the company can apply to the FDA for emergency use authorization, CNN reported.

Of the 30,000 volunteers, 53 must become sick with coronavirus. Of those 53, at least 40 must be volunteers who received the placebo, which would show the vaccine is 75% effective. The third FDA-mandated benchmark is that at least eight weeks must pass after all volunteers receive their second shot to see if they develop side effects.

Three other companies are holding clinical trials for a coronavirus vaccine in the United States ― Pfizer, Astra-Zeneca and Johnson & Johnson. Astra-Zeneca and Johnson & Johnson have paused their trials because volunteers became sick.

Pfizer's CEO Albert Bourla said in mid-September that the company's vaccine might be ready for distribution before the end of the year.


Wall Street Journal. "Moderna CEO Expects Covid-19 Vaccine Interim Results in November."

Moderna. "Moderna Completes Enrollment of Phase 3 COVE Study of mRNA Vaccine Against COVID-19 (mRNA-1273)."

CNN. "First large-scale US Covid-19 vaccine trial reaches target enrollment of 30,000 participants."

CBS. "Full transcript of ‘Face the Nation' on September 13, 2020."