E-Paper
Moderna reports ‘robust' response of its Covid-19 vaccine in kids aged 6 to 12
Moderna is yet to receive emergency authorisation from the FDA for administering its Covid-19 vaccine in teens but has moved ahead to study lower doses in children while it waits for the nod.
Moderna Inc on Monday announced that its vaccine against coronavirus disease (Covid-19) showed 'robust' neutralizing antibody response in children aged 6 to 12 years. The American biotechnology company said it plans to submit these data to the US Food and Drug Administration (FDA), European Medicines Agency (EMA) and other global regulators in the coming days.
Moderna is yet to receive emergency authorisation from the FDA for administering its Covid-19 vaccine in teens but has moved ahead to study lower doses in children while it waits for the nod. The randomised, observer-blind, and placebo-controlled study was conducted in 4,753 participants aged 6 to 12 to evaluate the safety, tolerability, and efficacy of two 50 µg doses of the mRNA-1273 vaccine in children.
“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,” Moderna CEO Stéphane Bancel said in a statement.
According to Moderna, the vaccine was “generally well tolerated with a safety and tolerability profile generally consistent” with the results of the Phase 3 trial in adolescents and adults. The company has reported mild or moderate severity in the majority of adverse events. The most common side effects were fatigue, headache, fever, and injection site pain.
The study has not been published in a peer-reviewed publication and the findings continue to be monitored by an independent safety monitoring committee. In order to assess long-term protection and safety, the participants will be monitored for 12 months after their second dose.
Meanwhile, the enrolment for the Phase 2/3 study in children aged 6 months to under 6 years of age continues.
