Serum Institute of India, which has been producing the Covisheild vaccine, has been approved by the Government of India on Tuesday, September 28 to enrol children between the ages of 7 and 11 years for its COVID-19 vaccine trial.
“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 (CDSCO), the National Regulatory Authority of India, said.
The Serum Institue of India has already conducted the first trials on select participants in the 12 to 17 years age group for its COVID-19 vaccine Covovax, which is a domestic variant of US-based Novavax’s NVAX.O vaccine shot, and reported safety data for an initial 100 participants.
This move by the Central Drugs Standard Control Organisation is made in light of the looming threat of a yet-to-hit third wave, despite the country’s accelerated pace in administering vaccine doses to its adult population over the last few months.
Over 870 million doses have been administered to citizens over the age of 18, out of which over 631 million are first doses and the rest being second doses, it brings the total percentage of the population to receive at least one dose of vaccine to 46.2%. Now, as schools and colleges reopen, the government has turned its focus on immunising children below the age of 18 against COVID-19.
Serum Institute of India is not the first vaccine maker to receive a green light to conduct vaccine trials among children in India. Bharat Biotech had previously been granted permission to conduct trials for its Covaxin for use in the age group of 2 to 18 years. Currently, only Zydus Cadila’s ZyCov-D vaccine has received emergency use approval in India to be used in children aged 12 years and above.