Novavax trials in the 7-11 age group cleared
VACCINE MAKER SERUM INSTITUTE CAN ENROL YOUNGER TEST SUBJECTS
The national drug regulator yesterday allowed vaccine maker Serum Institute to enrol children aged 7-11 years for its 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 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 is yet to be granted approval by Indian health authorities. 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.