Moderna has requested authorization from the U.S. Food and Drug Administration (FDA) for its coronavirus vaccine for children under six years of age. “We are proud to share that we have initiated our EUA [emergency use authorization] submission for authorization for our COVID-19 vaccine for young children,” said Stephane Bancel, chief executive officer of Moderna. “We believe mRNA-1273 will be able to safely protect these children against SARS-CoV-2, which is so important in our continued fight against COVID-19 and will be especially welcomed by parents and caregivers.”
Pfizer and BioNTech recently announced that they will request permission to provide the coronavirus vaccine to infants and children from ages 0 to five.
Moderna's announcement continued by stating that the positive interim data from the KidCOVE Phase 2/3 study, which was announced on March 23, 2022, demonstrated a strong neutralizing antibody response in the six-month-to-younger-than-six-years-old group following a two-dose initial series of mRNA-1273 with a safe profile. The antibody titers of those predefined 6-months-to-23-months and 2-years-and-under-6 years-of-age sub-groups fulfilled similar statistical requirements of the adult COVE study, which was its main objective.
The previously announced results also included an initial efficacy study on the majority of cases from the Omicron wave and also the possibility of testing at home for COVID-19. If the analysis is restricted to only cases that were confirmed to be positive for SARS-CoV-2 by central lab RT-PCR, vaccine efficacy was found to be significant at 51 percent (95 percent CI: 21-69) from between six months and two years of age and 37 percent (95 percent CI 13-54) between two and six years. These estimates of efficacy are similar to the estimates of vaccine effectiveness for adults against the Omicron variant following two doses of 1273 mRNA.
The announcement stated that the EUA request for infants ranging in age from six months to six years is expected to be completed by the end of the week. “Moderna is also currently studying booster doses for all pediatric cohorts,” the company announced.
However, the majority of American children have already been infected with the coronavirus, as per research conducted by the U.S. Centers for Disease Control and Prevention (CDC). Wednesday's report “found that three-quarters of children 11 and under have already contracted the virus. The federal agency tested over 200,000 blood samples, looking to identify antibodies indicating previous infection.” Further to that, the American Academy of Pediatrics (AAP) reported that around 28.01 percent of U.S. children have had two doses of the vaccine; however, the AAP also discovered some states had reported that children had accounted for between 0.00 percent and 0.27 percent of deaths from the coronavirus.