Moderna Will Expand Its Vaccine Studies to Include 5 to 11-Year-Old Children
Moderna plans to expand the size of its clinical trial testing its Covid-19 vaccine in kids ages 5 to 11, the company confirmed to CNBC on Monday.
The U.S. drugmaker is expanding the trial, which began in late March, to increase the likelihood of detecting potential rare side effects, the company said, declining to say how many children it ultimately hopes to enroll. The Food and Drug Administration last month added a warning label to the Pfizer and Moderna Covid-19 vaccines to list a rare risk of heart inflammation, which was reported in young people, as a potentially rare side effect.
“It is our intent to expand the trial and we are actively discussing a proposal with the FDA,” the company told CNBC in a written statement. “At this point, we expect to have a package that supports authorization in winter 2021/early 2022, should the FDA choose to use the authorization avenue.”
