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 for those aged 18 years and above who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.
Prakash Kumar Singh, director, of 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 October 17.
It has been learnt that the DCGI's office had raised a few queries, after which Singh submitted a reply, mentioning the current emerging situation caused by a new coronavirus variant.
Covovax was approved by the DCGI for restricted emergency use in children aged seven to 11 years in June.
The DCGI approved Covovax for restricted use in emergency situations in adults on December 28, 2021, and for those in the 12-17 age group, subject to certain conditions, on March 9.
Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation.
It was granted an emergency-use listing by the World Health Organisation (WHO) on December 2017, 2020. In August 2020, US-based vaccine maker Novavax Inc. 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.