A panel of experts from the US Food and Drug Administration yesterday recommended Moderna’s CoV vaccine for use in children ages six to 17. The vaccine’s safety has been proven in clinical trials involving several thousand participants. Approval usually follows the expert’s recommendation shortly.
This would allow two vaccines for children in the US; the Biontech and Pfizer vaccine had already been approved last year. Moderna’s delay stemmed from FDA concerns that the vaccine causes rare cases of heart muscle inflammation (myocarditis) at a higher rate than Biontech and Pfizer.
The FDA’s stance has since changed: neither the frequency nor severity of the rare side effect would preclude approval, he said at the meeting. Experts also emphasized that a second vaccine would increase the overall security of supply.
Experts recommend the adult dose of 100 micrograms in two syringes for 12 to 17 year olds. For the youngest, it should be half. Infectious disease specialist Ofer Levy said vaccination makes sense “especially for parents of children with concomitant illnesses.”