Moderna (NSDQ:MRNA) said two 50-μg doses of its mRNA-1273 vaccine fared well in a planned interim analysis of the Phase 2/3 KidCOVD study involving children between the ages of 6 and 11.
Last week, rival vaccine maker Pfizer (NYSE:PFE) announced that two 30-μg doses of the BNT162b2 vaccine were 90.7% against COVID-19 in a study involving children aged 5 to 11.
Moderna did not release interim efficacy numbers. Instead, it announced that two doses of its vaccine led to antibody levels 1.5 times higher in children than those it found in young adults in the Phase 3 COVID-19 study.
Moderna also reported that the shots were generally well-tolerated in the age cohort, which had 4,753 participants.
Side effects were similar to those found in adults, including fatigue, headache, fever, and injection-site pain most frequently.The company reported that the study met its primary endpoint and that it would submit the data to FDA and other regulatory agencies as well as a peer-reviewed publication.
Moderna also is testing its vaccine in younger children. The KidCOVE study includes an age group ranging from 2 to 5. It has another testing the vaccine in young children aged 6 months to under two years of age.
FDA is closely monitoring clinical trial data for signals related to myocarditis, a form of heart inflammation rarely linked to mRNA vaccines.
The agency has scheduled a VRBPAC meeting for tomorrow to discuss the prospect of extending emergency use authorization to the Pfizer-BioNTech COVID-19 vaccine fin children between 5 and 11.
Filed Under: clinical trials, Drug Discovery, Infectious Disease