India's national drug regulatory body, the Central Drugs Standard Control Organisation (CDSCO), has allowed vaccine maker Serum Institute of India (SII) to conduct trials for Novovaxin COVID-19 vaccine Novavax on children aged 7-11 years, Reuters reported.
"After detailed deliberation, the committee recommended for allowing enrolment of subjects of 7 to 11 years of age group as per the protocol," a CDSCO subject expert panel stated.
The SII is already holding trials for Covovax – the Indian version of the Novavax, currently being developed and manufactured by the SII – in children aged 12-17 years, and has presented safety data for an initial 100 participants, Reuters reported.
On 16 June, Novovaxin announced that its vaccine had turned out to be more than 90 percent effective in clinical trials conducted in the United States (US), however the vaccine has not been granted Drugs Controller General of India (DCGI) approval yet.
Chief Executive Officer of the SII, Adar Poonawalla, had met Home Minister Amit Shah in August and said that he was hopeful that Covovax would be launched in October.
He had also added that the vaccine for children is likely to be available in the first quarter of 2022, contingent upon the approvals from the DCGI.
(With inputs from Reuters.)
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