Moderna is set to ask the Food and Drug Administration on Thursday to approve its COVID-19 vaccine for kids under 6 years old, a new report said.
The drugmaker will make its formal request after a clinical trial showed its vaccine worked effectively in babies, toddlers and preschoolers, Politico reported, citing three sources with knowledge.
Moderna still needs to file final datasets to the FDA that won’t be ready until May 4 for a completed application, Politico added.
So far only the Pfizer-BioNTech vaccine is authorized for use in children younger than 12 years old. Children under 5 remain the only segment of the US population that isn’t eligible for one of the COVID vaccines.
Moderna announced in March that it planned to ask regulators to greenlight two small-dose shots for young children with the hopes of getting approval by summer.
“Given the need for a vaccine against COVID-19 in infants and young children we are working with the US FDA and regulators globally to submit these data as soon as possible,” Moderna CEO Stéphane Bancel said at the time.
The clinical trial showed that quarter-dose-sized shots were as effective for kids under 6 as regular-sized shots were for adults.
Moderna is also expected to ask for approval for children ages 6 to 11, Politico said.
Representatives of the FDA and Moderna both declined comment to the news site on Wednesday.
With reporting by Emily Crane