And why is it taking so long?
are still recruiting participants for at least some of their study sites, but reaching that higher enrollment cap shouldn’t be a problem, Towner says. Kaiser Southern California is one of the sites across the country testing Moderna’s vaccine in kids younger than 12—and for each trial spot that opens up, Towner says he receives at least 10 applications from eager parents. “There’s definitely a strong interest in this clinical trial,” Towner says.
Before granting emergency-use authorizations for adult and teen vaccines, the FDA reviewed two months of follow-up safety data from trial participants. It’s likely to want at least that much data from pediatric trials, and perhaps more. An FDA spokesperson referred TIME to agencyand officials’ previous comments suggesting it will review at least two months of data for kids.
Dr. Kari Simonsen, who is leading Omaha Children’s Hospital and Medical Center’s pediatric trial of the Pfizer-BioNTech vaccine, says she feels two months of follow-up is enough.