Moderna on Thursday (April 28) officially asked the FDA to authorize its “up to 44% effective” COVID-19 vaccine for “emergency use” in children as young as 6 months old.
Moderna still needs to complete its emergency use authorization filing by sending final datasets to the agency, which the company said will not happen until next week. The FDA has also committed to holding a meeting of its outside advisory committee before authorizing any vaccines for young children.
“We recognize parents are anxious to have their young children vaccinated against COVID-19,” an agency spokesperson said. “While the FDA cannot predict how long its evaluation of the data and information will take, we will review any EUA request it receives as quickly as possible using a science-based approach.”