Novavax Inc said on Tuesday its Covid-19 vaccine has got emergency-use authorisation from the Drugs Controller General of India (DCGI) for children aged 12 to 17 years.
The authorisation is a global first for the age group for the vaccine, which is manufactured and marketed in the country by the Serum Institute of India under the brand name Covovax.
Novavax last month said its vaccine was 80 per cent effective against Covid-19 in a late-stage trial testing the shot in 2,247 teens aged 12 to 17 years.
The company said on Tuesday its vaccine produced an immune response in the same age group in a mid- to late-stage study involving 460 Indian adolescents.
Covovax is the fourth Covid-19 vaccine to be authorised for adolescents aged 12 years and older in the country after Biological E's Corbevax, Zydus Cadila's ZyCoV-D and Bharat Biotech's Covaxin.
India, which had so far been vaccinating children aged 15 and above, started administering doses of Biological E's Corbevax last week to children aged 12 to 14.
Last December, DCGI authorised Novavax's Covid-19 vaccine for people aged 18 years and above.