The FDA attempted to shed light on the rigorous review process behind yet-to-be authorized COVID-19 vaccines among kids under 12 on Friday as young children remain ineligible for vaccines amid the start of school, stoking concerns and frustration among parents, teachers and pediatricians.
“The FDA is working around the clock to support the process for making COVID-19 vaccines available for children,” the agency wrote in a statement, adding in part, “this process is complex and relies on robust manufacturer trials and data.”
The FDA noted that children might need different doses or strength formulations than older populations, which adds on work to manufacturers’ clinical trials.
Pfizer and Moderna’s pediatric clinical trials are ongoing and, when those trial data become available, it could pave the way for the companies to request emergency approval for the vaccines in kids under 12. Dr. Scott Gottlieb, former FDA commissioner and Pfizer board member, told CNBC that Pfizer will likely request emergency approval for use of its vaccine among kids aged 5 to 11 in October, with potential authorization by late fall or early winter. Meanwhile, Moderna’s trial data for kids ages 5-11 could come by late fall or early winter, Insider reported.
The trials include at least two months of follow-up for safety monitoring, after which companies will analyze trial data to determine safety and efficacy, the FDA noted on Friday, adding it would work with manufacturers to make sure the analysis is “robust” and up to the agency’s standards.
The FDA will then “carefully, thoroughly and independently examine the data to evaluate benefits and risks and be prepared to complete its review as quickly as possible, likely in a matter of weeks rather than months,” the FDA wrote, noting that the pace of the review process depends on timing and quality of companies’ submitted data.
“…We very much hope to have pediatric COVID-19 vaccines available in the coming months,” the FDA added in part. In the interim, the FDA urged all those eligible for vaccination to do so to offer protection to younger children, and adhere to preventive steps like wearing a mask.