India Allows Serum Institute to Enrol 7-11 Year Olds in Novavax COVID-19 Vaccine Trial

By Reuters Staff

September 29, 2021

BENGALURU (Reuters) - India's drug regulator on Tuesday allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of U.S. drugmaker Novavax's COVID-19 vaccine, as the country prepares to protect children from the novel 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 deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol," a subject expert panel of the Central Drugs Standard Control Organization said.

Serum Institute is already conducting a trial of its COVID-19 vaccine Covovax, a domestically produced version of Novavax's shot, in the 12-17 age group and has presented safety data for an initial 100 participants.

The Novavax vaccine, which is based on a coronavirus protein subunit with a proprietary saponin adjuvant, is yet to be granted approval by Indian health authorities. Earlier this month, Serum Institute chief Adar Poonawalla said he expects Covovax to be approved for those below 18 years in January or February next year.

So far, only drugmaker Zydus Cadila's DNA COVID-19 vaccine has received emergency use approval in India to be used in adults and children aged 12 years and above.

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