WASHINGTON, United States — A panel of US medical experts on Tuesday recommended the Moderna Covid vaccine for use in children aged six through 17.
Formal authorization should soon follow, at which point families will have a second option against the coronavirus, as Pfizer's vaccine was given the greenlight for teens and younger children last year.
After weighing available data, 22 experts convened by the US Food and Drug Administration unanimously agreed that the known benefits outweighed the known risks when Moderna's vaccine was administered as two shots at the adult dose of 100 micrograms to those aged 12-17, and half of that for children 6-11.
"This can be a valuable tool and having this available to families, particularly in areas where there's rising viral spread, and particularly (for) parents of children who may have comorbidities," said Ofer Levy, an infectious disease physician at Boston Children's Hospital.
Safety was demonstrated in clinical trials involving several thousand participants.
Several thousand participants took part in the clinical trials, which showed the vaccines were safe and triggered a similar level of antibodies in younger age groups as it did in young adults.
The panel said a second authorized vaccine for the pediatric population would also help mitigate against production and inventory shortages if there was only one provider.
The delay in authorizing Moderna for American children was a result of FDA concern that it caused rare cases of myocarditis, or heart inflammation, at a higher rate than Pfizer.
The FDA position has since changed. According to a slide shown at the meeting, "Some evidence suggests that myocarditis and pericarditis risk may be higher after Moderna than after Pfizer-BioNTech; however, findings are not consistent in all U.S. monitoring systems" and neither the frequency nor severity preclude authorization.
Moderna also argued its vaccine had already been given to more than 6.7 million teens and 300,000 children in countries outside the United States -- though it was also paused by several European countries for younger males, the most at-risk group for vaccine-caused myocarditis.