A health ministry panel on Monday backed Moderna Inc.’s COVID-19 vaccine for emergency use in around 4 million children age 12 to 17, paving the way for final approval by the ministry in the coming days.
The panel recommended lowering the current age restriction of 18 and older without conducting an additional clinical trial in the country. Pfizer Inc.’s vaccine has already been authorized for emergency use in children 12 and older since June 1.
Moderna last month asked regulators in Japan, the U.S. and other nations to lower the minimum age for the vaccine from 18 to 12 after Moderna’s late stage clinical trial involving 3,732 adolescents showed in May that the jab was 100% effective starting 14 days after the second dose and “well tolerated” with no significant safety concerns identified.