New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has said that booster doses cannot be recommended without clinical trials of coronavirus. The committee was reviewing the application filed by the Serum Institute of India for booster dose at a meeting held on Friday. The panel has sought additional data from the SII, after which it will hold another meeting.
Amid the advent of the new variant of coronavirus, Omicron, the Pune-based Serum Institute had on December 1 requested the Drugs Controller General of India (DCGI) to authorize covicheras as a booster dose. SII had sought permission to administer the booster dose of its covishield vaccine based on the adequate stock of doses and increasing demand for booster shots.
The Serum Institute in its appeal had cited adequate stock of corona vaccine to deal with the emergence of new corona variant Omicron in the country and its growing concern. In SII, Government and Regulatory Affairs Director Prakash Kumar Singh also cited the United Kingdom's (UK) regulatory agency for drugs and health products, saying UK's Medicines and Healthcare Products Regulatory Agency has already given the green signal to the booster dose of the AstraZeneca ChAdOx1 nCoV-19 vaccine.
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