Novavax Inc said Tuesday that its COVID-19 vaccine has received emergency use approval from the Drugs Controller General of India for children ages 12 to 17.
The approval is a worldwide first for the age group for the vaccine, which is manufactured and marketed in India by the Serum Institute of India under the brand name Covovax.
Novavax said last month its vaccine was 80% effective against COVID-19 in a late-stage trial that tested the injection on 2,247 teens ages 12 to 17.
The company said Tuesday that the vaccine elicited an immune response in the same age group in a mid- to late-stage study of 460 Indian adolescents.
Covovax is the fourth COVID-19 vaccine approved for adolescents 12 years and older in India, following Biological E’s Corbevax, Zydus Cadila’s ZyCoV-D and Bharat Biotech’s Covaxin.
India, which has so far vaccinated children aged 15 and older, started giving doses of Organic E’s Corbevax to children aged 12 to 14 years last week.
The country’s drug regulator approved Novavax’s COVID-19 vaccine in December for people 18 and older.
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