Moderna said Monday that its vaccine is safe for children ages 6-11 years old and promotes a “robust” immune response after two smaller doses, according to interim data from a study that comes just ahead of an FDA meeting to consider the shots for children. A study of more than 4,500 kids was conducted.
The company says it plans to submit the data to the U.S. FDA “in the near term.” The random, placebo-controlled expansion study involved a two-dose vaccine. The dosage is half that of the adult vaccine. The majority of side effects were mild or moderate in severity, similar to those in adults, the company said. The most common solicited adverse events were fatigue, headache, fever and injection site pain.
“We are encouraged by the immunogenicity and safety profile,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We look forward to filing with regulators globally and remain committed to doing our part to help end the COVID-19 pandemic with a vaccine for adults and children of all ages.”
The FDA has not announced a decision on Moderna’s vaccine for kids ages 12 through 17. According to an article, Moderna submitted results from that study in June. A panel of FDA advisers will vote this week on whether to authorize Pfizer and BioNTech’s COVID-19 vaccine for use in children 5 to 11.