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India’s drug regulator on Tuesday cleared vaccine maker Serum Institute to enroll children ages 7 to 11 for its trial of U.S. drug maker Novavax’s COVID-19 vaccine, as the country prepares to protect children from the new coronavirus.

The South Asian nation has already administered more than 870 million doses to adults among its population of nearly 1.4 billion.

“After detailed deliberations, the committee recommended allowing enrollment of subjects aged 7 to 11 according to protocol,” said a group of subject matter experts from the Central Drugs Standard Control Organization.

The Serum Institute is already conducting a trial of its COVID-19 vaccine Covovax, a country-produced version of Novavax’s vaccine, in the 12-17 age group and has presented safety data for the first 100 participants.
The Novavax vaccine has not yet been approved by Indian health authorities. Earlier this month, Serum Institute chief Adar Poonawalla said he expects Covovax to be approved for under-18s in January or February next year.

First publication: STI

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