New Delhi, 18th January 2023: The Serum Institute of India (SII) has written to the Union Health Ministry, seeking the inclusion of its Covid vaccine Covovax as a heterologous booster dose for adults in the Cowin portal. The letter was written by Prakash Kumar Singh, director of government and regulatory affairs at the Serum Institute of India (SII).
A meeting of the National Technical Advisory Group on Immunization (NTAGI) is likely to be held soon to decide on the matter. The Drug Controller General of India (DCGI) approved the market authorization for Covovax on 16th January as a heterologous booster dose for adults. Its approval was based on the recommendations of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation.
DCGI approved Covovax for restricted use in emergencies in adults on 28th December 2021, in the 12-17 age group on 9th March 2022, and in children aged seven to 11 years on 28th June last year, subject to certain conditions.
Covovax is manufactured through technology transfer from Novavax. It has been approved for conditional marketing authorization by the European Medicines Agency and was granted an emergency-use list by the World Health Organization (WHO) on 17th December 2021. In August 2020, US-based vaccine manufacturer Novavax Inc announced a license agreement with SII for the development and commercialization of NVX-CoV2373.