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Serum Institute′s application for Covishield booster dose rejected

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eMediNexus    12 December 2021

The Subject Expert Committee (SEC) on COVID-19 has rejected the application submitted by the Serum Institute of India (SII) for Covishield booster dose.

The SEC has asked the company to submit more data to justify the need to administer a third dose of the vaccine. The committee met on December 10 to review the applications from both Serum Institute of India, the maker of Covishield, and Biological E, which manufactures Corbevax vaccine.

Meanwhile, Minister of State for Health, Bharati Pravin Pawar, informed the Parliament that the Central Drugs Standard Control Organisation has permitted two companies to conduct clinical trials for the administration of vaccine booster doses. Bharat Biotech has been allowed administration of booster doses in phase II of an ongoing phase I/II clinical trial of the inactivated COVID-19 vaccine. Biological E has been permitted to carry out phase II/III clinical trial of its COVID-19 vaccine, which also includes a study of booster doses… (Money Control, December 10, 2021)

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