After months of stops and starts, Moderna announced today it seeks emergency use authorization from the Food and Drug Administration (FDA) of a two-dose primary series of its COVID-19 vaccine for children ages 6 months to 6 years.The company said positive interim analysis of a phase 2/3 study showed a robust neutralizing antibody response and a favorable safety profile.37% to 44% protection against OmicronThe trial used two doses of the company's mRNA vaccine on children at one-fourth the dose of the adult primary vaccine series.
No deaths, myocarditis, pericarditis, or multisystem inflammatory syndrome in children (MIS-C) were reported in more than 6,000 pediatric study participants."We now have clinical data on the performance of our vaccine from infants six months of age through older adults," said Stephane Bancel, chief executive officer of Moderna, in a press release. "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."The vaccine, however, was not as successful at preventing illnesses in young children as it was in previous trials of adults and adolescents.
Conducted during the Omicron variant surge, Moderna's trial showed a 43.7% vaccine efficacy in children 6 months to 2 years and 37.5% in the 2- to 5-year age-group.Children under the age of 5 are the only group of Americans not yet eligible for COVID-19 vaccination.According to the New York Times, Pfizer and BioNTech are expected to release trial results of their vaccine in children 5 years and under next month; the pediatric vaccinations series will consist of three shots given at one-tenth the strength of the standard vaccine.BA.2 now