FDA ADVISERS RECOMMENDING MODERNA SHOTS FOR AGES 6-17
Age group has had access to Pfizer’s vaccine since 2021
An expert committee advising the Food and Drug Administration on Tuesday unanimously recommended Moderna’s coronavirus vaccine for use in children and adolescents ages 6 to 17, an important step before emergency authorization.
The FDA will likely follow the panel’s advice in the coming days, as it has done consistently during the pandemic, and grant authorization. But doing so may have little immediate effect, since the age group has had access to Pfizer-BioNTech shots since last year. To date, Moderna’s shots have been authorized only for adults.
Today, the committee is scheduled to vote on a more pressing question: whether to recommend emergency authorization of both the Moderna and Pfizer vaccines for the nation’s youngest children, who are still not eligible for any coronavirus shots. Both the FDA and the Centers for Disease Control and Prevention will prioritize decisions on that matter over Moderna shots for older children and teens because of the unmet need, officials familiar with the planning said.
The votes on the Moderna vaccine came at the end of a daylong meeting that focused in part on the medical and social consequences of COVID-19 for about 50 million children and teens.
Moderna first applied to cover 12- through 17-year-olds a year ago, with two doses at the same level as adults. But federal health officials, concerned about possible links between the Moderna vaccine and a rare heart condition, myocarditis, delayed a decision. Moderna then held off on an application to cover 6- to 11-year-olds, who would receive two doses at half the strength of adult levels.
The company now says concerns about myocarditis have subsided after further research and real-world evidence. Federal health officials repeatedly addressed the risks of that side effect in the panel’s sessions.
To evaluate how the vaccine works, Moderna studied immune responses generated in children 6 to 17 and compared them with the level of neutralizing antibodies in people ages 18 to 25 after vaccination. Because of the small number of virus cases among trial participants, Moderna’s efficacy data fell far short of the data collected for adults.
Experts warned against comparing Moderna’s vaccine with Pfizer’s for elementary, middle and high schoolers, even though the vaccines have largely followed parallel tracks. Among other differences, data was collected during different periods, with different dosages.
While the FDA found that Moderna’s vaccine met the criteria for success with the antibodies it induced, regulators cautioned that a third dose would likely be necessary for children and teens, just as it has been for adults.