Moderna has completed a second-phase study for using its Covid-19 vaccine in children aged six months to under 6 years, it noted in a press release. In coming weeks, it’s planning to apply for federal authorization from the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA).
The study noted it administered two 25 microgram doses of mRNA-1273 to children six months to under 6 years. The vaccine amount equates to 25% of the mRNA-1273 robust neutralizing antibody titers given to adults.
“Given the need for a vaccine against COVID-19 in infants and young children, we are working with the U.S. FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane Bancel said in the statement.
A study was conducted during the omicron wave, with micro doses administered 28 days apart. Nearly 11,700 pediatric participants have been enrolled in the company’s study in the U.S. and Canada for all youth up to 18. Approximately 4,200 of the participants are two to under 6 years old, and 2,500 are six months to under 2 years of age. Around 6,700 participants are six months to under 6 years old.
Only 17% of six months to under 6-year-olds reported adverse reactions such as fever; those 2 to under 6 years old reported 14.6% experienced adverse events. There were no extreme reactions — death, myocarditis, pericarditis, or multisystem inflammatory syndrome — reported in the study.
Efficacy in children six months to 2 years was 43.7%, and in children 2 to under 6 years, 37.5%. No severe Covid-19 cases were reported in either age group.
Moderna is preparing to evaluate boosters of mRNA-1273, its booster candidate mRNA-1273.214, including the omicron variant booster and mRNA-1273. The boosters are being evaluated for pediatric patients six months to under 6 years, 6 to under 12 years, and adolescents.
Study participants will be monitored for 12 months following their second dose to assess long-term safety and health status. All data will be overseen by an independent safety monitoring committee.
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