U.S. FDA staff says Moderna COVID vaccine effective and safe for children -Breaking
(Reuters) – U.S. Food and Drug Administration staff reviewed Friday’s statements Moderna (NASDAQ:) Inc’s COVID-19 vaccine seems safe and effective to be used by people between 6 and 17 years of age. Next week, a scientific committee will vote whether the regulator should authorize the vaccine for children.
In briefing documents, FDA reviewers stated that vaccines had elicited a similar immune response among children as in adult trials.
FDA staff reported that there was evidence to support the efficacy of Moderna COVID-19 Vaccine for preventing symptomatic COVID-19, in children aged between 6 and 17 years.
FDA staff stated, however that vaccines generally have the same side effects in children than in adults. Children younger than 5 years old had more fevers.
After studies that showed it to be linked with a greater risk of myocarditis, a form of inflammation of the heart and blood vessels, some European countries have restricted Moderna’s shot use for those younger than 25.
FDA confirmed that myocarditis was a potential risk of vaccine. But, pediatric studies by the drugmaker were too small to measure the incidence of this rare type in young children.