Moderna Inc revealed on Monday that its coronavirus vaccine (Covid-19) elicited a “robust” neutralizing antibody response in children aged 6 to 12. In the following days, the American biotechnology company plans to submit these findings to the US Food and Drug Administration (FDA), the European Medicines Agency (EMA), and other international agencies.
Moderna has yet to acquire emergency FDA approval for administering its Covid-19 vaccination to teenagers, but in the meanwhile, it is investigating lesser dosages in youngsters. The safety, acceptability, and efficacy of two 50 g doses of the mRNA-1273 vaccine in children were evaluated in a randomized, observer-blind, and placebo-controlled research involving 4,753 children aged 6 to 12.
In a statement, Moderna CEO Stéphane Bancel said, “We are encouraged by the immunogenicity and safety profile of mRNA-1273 in children aged 6 to under 12 years and are pleased that the study met its primary immunogenicity endpoints.”
The vaccine was “generally well tolerated with a safety and tolerability profile generally consistent” with the findings of the Phase 3 trial in adolescents and adults, according to Moderna. The majority of adverse events were mild or moderate in intensity, according to the business. Fatigue, headache, fever, and injection site pain were the most common adverse effects.
The findings of the study have not been published in a peer-reviewed journal, and they are still being examined by an independent safety monitoring committee. The participants will be tracked for 12 months after their second dose in order to assess long-term protection and safety.
In the meantime, children aged 6 months to under 6 years of age are still being enrolled in the Phase 2/3 trial.