Serum Institute seeks drug regulator’s approval for market authorisation of its COVID vaccine as booster dose

The Serum Institute of India (SII) has sought the drug regulator’s approval for market authorisation of its COVID-19 vaccine Covovax as a booster dose. The vaccine will be administered to those aged 18 years and above, and those who have been administered two doses of Covishield or Covaxin, official sources said yesterday.

Prakash Kumar Singh, Director, Government and Regulatory Affairs, SII, submitted a market authorisation application for the heterologous booster dose of Covovax to the drugs controller general of India (DCGI) on 17th October. It has been learnt that the DCGI’s office had raised a few queries, after which Singh submitted a reply, mentioning about the current emerging situation caused by a new corona virus variant.

Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years in June. The DCGI had approved Covovax for a restricted use in emergency situations in adults on 28th December, 2021 and for those in the 12-17-year age group, subject to certain conditions, on 9th March.

Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency (EMA) for conditional marketing authorisation. It was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) in December 2020. In August 2020, the US-based vaccine maker Novavax had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate, in India and Low- and Middle-Income Countries (LMICs).

Edits by EP News Bureau