Moderna (NSDQ: MRNA) has filed paperwork to permit the evaluation of two 50-µg doses of its Spikevax (mRNA-1273) vaccine in children ages 6-11 years in the European Union.
Moderna has filed paperwork to permit the evaluation of its Spikevax vaccine in children ages 6–11 years in the European Union.
Last week, the company announced that FDA had delayed its review of the mRNA-1273 vaccine in 12- to 17-year-olds to investigate reports of myocarditis apparently linked to the vaccine.
EU regulatory authorities have not yet authorized a COVID-19 vaccine for children younger than 12. The Austrian capital of Vienna, however, will begin vaccinating young children against the novel coronavirus on November 12.
Cambridge, Massachusetts–based Moderna has an ongoing Phase 2 trial, dubbed “KidCOVE,” investigating the use of its vaccine in children as young as 6 months of age.
The company reports that vaccine efficacy — measured as protection against symptomatic diseases — was 100% two weeks after administering a single 50-µg dose of mRNA-1273.
A single dose was 65% effective at protecting against asymptomatic infection after two weeks.
The study also found that the vaccine had a favorable reactogenicity profile at the 50-µg dose level.
Moderna is conducting the research in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
The European Medicines Agency (EMA) issued a positive opinion on the use of Spikevax in adolescents in the summer.
In late October, EMA authorized a booster of the Spikevax vaccine at least six months after completing the primary series.
Filed Under: clinical trials, Drug Discovery