Moderna has applied for a change to the Conditional Marketing Authorization (CMA) to the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to evaluate a two-dose batch of Spikevax 19 µg / COVID-25 vaccine, children aged 6 months to <6 years
“We are proud to announce this report regarding the use of our COVID-19 vaccine in children from six months to <6 years of age," said Stéphane Bancel, Moderna CEO. “We believe that our vaccine will be able to safely protect little ones from SARS-CoV-2, which is important in our continued fight against COVID-19”.
Positive, interim results from the Phase II / III KidCOVE study showed a strong neutralizing antibody response in the age group 6 months to <6 years after administration of two doses of the mRNA-1273 base series and a favorable safety profile. Antibody titers in the predefined subgroups 6 to 23 months of age and 2 to <6 years of age met statistical criteria for similarity to that observed in adults in the COVE study, which served the main purpose of the study.
The results previously announced included a confirmatory preliminary efficacy analysis for cases collected primarily during the Omikron variant wave, including home COVID-19 testing. When the analysis is limited to only those confirmed by a positive RT-PCR for SARS-CoV-2 by a central laboratory, vaccine efficacy remained significant at 51%. (95 proc. CI: 21–69) in children 6 months to <2 years of age i 37% (95 proc. CI: 13–54) in children aged 2 to <6 years. These efficacy estimates are similar to the efficacy estimates for the vaccine against the Omikron variant after two doses of mRNA-1273 in adults.
In addition, the tolerance profile was generally consistent with that observed in children 6 to less than 12 years of age, adolescents 12 to 17 years of age and adults.
The KidCOVE study is an ongoing, randomized, blind, placebo-controlled extension study designed to evaluate the safety, tolerability, reactogenicity and efficacy of Spikevax administered to healthy children 28 days apart. The study population was divided into three age groups (6 to <12 years, 2 to <6 years, and 6 months to <2 years).
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The KidCOVE study is conducted in partnership with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) and the Biomedical Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the US Department of Health and Human Services (HHS). The ID in the ClinicalTrials.gov database is NCT04796896.
Moderna is currently investigating booster doses for the two oldest pediatric cohorts and is planning a study to assess the potential in children 6 months to <6 years of age. The company is evaluating booster doses of mRNA-1273 and its bivalent potential booster, mRNA-1273.214, which includes both Omikron-specific mRNA and mRNA-1273.
On February 24, 2022, the CHMP (Committee for Medicinal Products for Human Use) of the European Medicines Agency issued a positive opinion authorizing the marketing authorization of Spikevax for children aged 6 years. years and older.