Moderna seeks to expand its pediatric clinical trial, expanding the number of kids that would participate in the clinical trial in the age range of 5 to 11, the company shared with CNBC earlier this week. Why? The purported reason is that the company wants to expand the total number of subjects for additional safety, as this boosts the chance of sensing likely rare side effects. The company declined to share how many more children in the 5 to 11 age range would be included. Importantly, the U.S. Food and Drug Administration (FDA) issued a warning label last month to both mRNA vaccine makers (Moderna and Pfizer-BioNTech) due to a condition associated with the vaccines—heart inflammation reported in young people that were vaccinated.
Comments to CNBC
CNBC reported recently, “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.”
Part of a study called KidCove (NCT04796896), the Phase 2/3 2-part, open-label, dose-escalation, a...
Note: If you need assistance with your subscription or would like to discuss a corporate subscription for more than 10 employees please contact us or use the chat (bottom right).