Community Modern asks Food and Drug Administration the authorization to use its Covid vaccine for children under six years of age. The request came after a study showed that the vaccine probably elicits an immune response in babies. The anti-Covid link to the youngest segment of the population – from 6 months to 5 years – was long awaited. The experiments on young people and very young people had started just over a year ago. The company announced in January last year that data regarding possible Sars-Cov-2 vaccinations for children between the ages of 2-5 would be ready by spring. In February last year, howeverEma (European Medicines Agency) had recommended that the use of Modernas Spikevax Covid vaccine be extended to children between 6 and 11 years of age.
The application to the Food and Drug Administration (Fda) was submitted today and the company announces that “similar requests will also be international regulatory authorities. Stéphane BancelCEO of Moderna – it’s the vaccine mRNA-1273 will be able to safely protect these children from Sars-CoV-2“And this” will be especially appreciated by parents and health professionals. In March, Moderna reported positive preliminary results from the Phase 2/3 KidCOVE study, in which a “robust neutralizing antibody response“In the age group 6 months to less than 6 years after a two-dose primary series of mRNA-1273, along with a favorable safety profile,” reads a statement issued by the US company.
The antibody titers in the age subgroups 6 months to 23 months and 2 years to 5 have “Met the statistical criteria for equality with adults in the COVE study“, For which the primary goal was reached. The results included a preliminary efficacy analysis of cases collected mainly during the wave of the Omicron variant of Sars-CoV-2 (among these also cases detected by home testing for Covid). By limiting the analysis to laboratory-confirmed positive cases only with molecular testing, “the efficacy of the vaccine remained significant at 51% for infants under 2 years of age and at 37% from 2 to 5 years of age. These efficacy estimates are similar to the efficacy estimates for the Omicron vaccine in adults, ”emphasizes Moderna. The submission of the emergency permit application will be completed next week. Moderna is also studying booster doses for all pediatric cohorts. The KidCOVE study was conducted in collaboration with the National Institute of Allergy and Infectious Diseases (Niaid, part of the National Institutes of Health-Nih) and with the Biomedical Advanced Research and Development Authority (Barda).