Moderna is one step closer to a COVID-19 vaccine. Racing ahead with its candidate, mRNA-1273, the biotech has now finished enrolling the 30,000 participants needed for its late-stage trial.
Testing the vaccine candidate against placebo, the trial includes thousands of people from communities of color and thousands at higher risk of severe coronavirus.
Moderna and its contract research partner PPD enrolled more than 7,000 Americans over 65, plus more than 5,000 who are under 65 but have conditions such as diabetes or severe obesity. The high-risk groups make up 42% of the trial, the company said Thursday.
Plus, after the company slowed enrollment in September to make sure minority groups were represented, investigators managed to recruit a total of 11,000 people from communities of color, or 37% of the trial population.
The company released full breakdown of enrollment in slides accompanying the announcement.
Reacting to Thursday’s news, Eric Topol, director of the Scripps Research Translational Institute, tweeted that the COVID-19 vaccine progress so far represents an “extraordinary biomedical research triumph" just seven months into the pandemic.
After Moderna and its partners received the viral sequence of the novel coronavirus early this year, they entered human testing in record time this spring. The work progressed to phase 3 in late July, and now tens of thousands of Americans from around the country are participating in the study.
The company doesn’t expect to be ready to file for an FDA emergency use authorization until late November. But this week, Operation Warp Speed head Moncef Slaoui said that COVID-19 vaccines from Moderna and Pfizer could reach all Americans by June 2021 if politics doesn’t slow uptake.
Moderna plans to present its progress at today’s FDA public hearing on COVID-19 development. The meeting runs all day and is streaming on YouTube.