India allows Serum Institute to enrol 7-11 year olds in Novavax Covid vaccine trial
Serum Institute is already conducting a trial of its COVID-19 vaccine Covovax
Bengaluru: The country's drug regulator today allowed vaccine maker Serum Institute to enrol kids aged 7-11 years for its trial of US drugmaker Novavax's COVID-19 vaccine.
"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 Organisation 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 is yet to be granted approval by the 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 the country to be used in adults and children aged 12 years and above.