Moderna has released preliminary data from the company's phase 2/3 trial of the vaccine in children aged younger than 6 years.
Moderna has announced that their Phase 2/3 study of the COVID-19 vaccine in child aged 6 months to 2 years and 2 years to 6 years had med the primary end point. The data showed a favorable safety profile as well as a robust antibody response to the 25 µg 2-dose primary series of the vaccine. As a result of the findings, the company declared their plans to submit to the US Food and Drug Administration (FDA) for authorization to administer the vaccine to children in these age groups.
The randomized, observer-blind, placebo-controlled study had 2500 children aged 6 months to 2 years and 4200 children aged 2 to 6 years enrolled. The 25 µg 2-dose produced immunogenicity that was similar to the initial 100 µg two-dose series in adults aged 18 to 25 years. The vaccine was generally well tolerated with most of the reported adverse events being either mild or moderate. Adverse events were more frequently noted after the second dose. The rate of a fever greater than 38°C was consistent with other vaccines that children in the age group would receive and a fever over 40°C was a occurrence, happening in just 0.2% of participants in both groups. No additional safety concerns were discovered during the trial. No cases of myocarditis, pericarditis, or multisystem inflammatory syndrome in children were found and there were no deaths.
In addition, Moderna reported that they are asking the FDA to extend the emergency use authorization for a 50 μg two-dose primary series of the vaccine in children aged 6 to 12 years as well as a 100 μg two-dose primary series in children aged 12 to 17 years. Both doses have been authorized by regulatory bodies in Australia, Canada, and the European Union.
1. Moderna. Moderna announces its COVID-19 vaccine phase 2/3 study in children 6 months to under 6 years has successfully met its primary endpoint. Published March 23, 2022. Accessed March 23, 2022. https://investors.modernatx.com/news/news-details/2022/Moderna-Announces-its-COVID-19-Vaccine-Phase-23-Study-in-Children-6-Months-to-Under-6-Years-Has-Successfully-Met-Its-Primary-Endpoint/default.aspx