Moderna’s mRNA COVID-19 vaccine Spikevax (formerly COVID-19 vaccine Moderna) was first authorized in the EU in January 2021. It is currently authorized for use in people aged 12 and older. Moderna has now applied to the European Medicines Agency (EMA) to evaluate the vaccine for children aged 6 to 11 years. This is the company’s first application for the use of their vaccine in this age group. The company plans to submit the data to other regulatory agencies around the world. The EMA’s Human Medicines Committee (CHMP) will review the vaccine data, including the results of an ongoing clinical trial. The current timeline for the evaluation is approximately two months, if everything goes well.
The KidCOVE study is a randomized, observer-blind, placebo-controlled expansion study to evaluate the safety, tolerability, reactogenicity, and efficacy of two 50 µg doses of the vaccine administered to healthy children 28 days apart. The study population is divided into three age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years). The study is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), which is part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services (HHS). The ClinicalTrials.gov identifier is NCT04796896.
- Moderna Inc., Cambridge, MS, USA
- European Medicines Agency (EMA), Amsterdam, The Netherlands
Also of Interest
- ChemistryViews Collection: SARS-CoV-2 Virus – What We Know About Vaccines and Immunity