Serum Institute Gets Nod to Enrol 7-11 Year Olds in Novavax COVID-19 Vaccine Trial
Reuters
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Bengaluru: On Tuesday, the Drugs Controller General of India (DCGI) allowed Serum Institute of India (SII) to enrol kids aged 7-11 years for trial of US drugmaker Novavax's COVID-19 vaccine, as the country prepares to protect children from the novel coronavirus.
India 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 7-11 years of age group as per the protocol," a subject expert panel of the Central Drugs Standard Control Organisation said.
Also Read: DCGI Expert Panel Recommends Against SII’s Proposal for Covovax Trial on Children
SII 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. Safety data for an initial 100 participants has already been presented.
The Novavax vaccine is yet to be granted approval by the health authorities. Earlier this month, SII 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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