All those parents of young children who have felt left behind as every other age category has been approved for vaccines and boosters might finally have a solution soon. Moderna officially requested authorization from the FDA on Thursday for a two-dose regimen for kids 5 and younger.
“There is an important unmet medical need here with these youngest kids,” Dr. Paul Burton, Moderna’s chief medical officer, told The Associated Press. Two kid-size shots “will safely protect them. I think it is likely that over time they will need additional doses. But we’re working on that.”
Approval could make 18 million children across the U.S. newly eligible to receive a vaccine. Pfizer is set to seek approval in the coming weeks for a three-dose vaccine schedule for kids younger than 5 after its two-dose regimen proved inadequate.
Peter Marks, head of the FDA’s vaccine program, said the FDA will “move quickly without sacrificing our standards” and told a Senate committee that, “It’s critically important that we have the proper evaluation so that parents will have trust in any vaccines that we authorize.”
In clinical trials for kids 5 and younger, including babies as young as 6 months, Moderna’s two-dose schedule prompted immune systems to produce high levels of COVID antibodies. The shots are one quarter the size of adult doses. While Pfizer’s vaccine is approved for kids as young as 5, Moderna’s is currently approved only for adults in the U.S., though in other countries it is administered to children ages 6 and up.
As with adult vaccines, the omicron variant — still the dominant strain — has proven more elusive than previous variants, preventing symptomatic infection 40 to 50% of the time in Moderna’s trial. The vaccine has been highly effective, however, at preventing severe illness and death. According to CDC figures, nearly 500 kids younger than 5 have died from COVID in the U.S.