Moderna Seeks FDA COVID-19 Vaccine Authorization for Children Six Months to Six Years Old

Moderna will soon be seeking FDA Emergency Use Authorization of its COVID-19 vaccine Spikevax for children aged six months to six years old after an interim analysis of a phase 2/3 trial indicated its efficacy against serious infections.

The interim data from the 6,700-participant study showed “a robust neutralizing antibody response” and the tolerability profile was consistent with what was observed in children between six and 12 years old, the company said. The Moderna data showed the vaccine’s efficacy was 43.7 percent for children under age two and 37.5 percent effective for children under age six. There were no severe side effects reports and COVID cases in those who contracted the disease were mild.

Currently, Moderna’s vaccine is only FDA-approved for people age 18 years or older. The company has already filed for Emergency Use Authorization for the vaccine in children and adolescents under age 18 but older than six years.