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Moderna on Wednesday released interim results indicating that its mRNA-1273 COVID vaccine produced “robust” neutralizing antibody titers in children aged 6 months to 6 years — levels similar to those seen in adults.
Vaccine efficacy against infection was 43.7% in children aged 6 months to 2 years and 37.5% among children aged 2 years to 6 years, the new data from its phase 2/3 KidCOVE study show.
The company explains the lower efficacy numbers by noting that its study involving these younger children was conducted during the Omicron wave. The same decrease in efficacy against infection was reported in adults during the Omicron surge, they note.
A majority of COVID-19 cases were mild in the approximately 6900 children aged 6 months to 6 years in the study. No severe COVID-19 cases, hospitalizations, or deaths were reported.
The primary series of two 25-μg doses of the vaccine given 28 days apart was generally well tolerated. Most adverse events were mild to moderate. For example, temperature >38° C (>100.4° F) was reported for 17.0% of the 6-month-old to 2-year-old group and for 14.6% of the 2-year-old to 6-year-old group. A few children, 0.2% of each group, experienced a temperature >40° C (>104° F).
Moderna plans to include these response, efficacy, and safety data in an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of the vaccine in these younger children in the coming weeks.
“We now have clinical data on the performance of our vaccine on infants from 6 months age through older adults,” Moderna CEO Stephane Bancel said in a news release. He described the interim results as “good news for parents of children under 6 years of age.”
In Other News
Moderna also announced that it began the FDA EUA submission process for a 50-μg two-dose primary series for children aged 6 years to 12 years.
The company is also updating its EUA submission for a 100-μg two-dose primary series for children and adolescents aged 12 years to <18 years.
Similar to its booster research in adults, Moderna plans to evaluate the potential of a booster dose for all pediatric populations, including those aged 6 months to <6 years, 6 years to <12 years, and adolescents. The company is evaluating both a booster dose of mRNA-1273 and its bivalent booster candidate (mRNA1273.214), which includes an Omicron variant booster and mRNA-1273.