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The Serum Institute of India (SII) has sought for approval for market authorisation for its COVID-19 vaccine Covovax to be administered as booster dose for those who for those aged 18 years and above and have been administered two doses of Covishield or Covaxin.
The market authorisation application for the heterologous booster dose of Covovax has been submitted to the drugs controller general of India (DCGI) on October 17, Prakash Kumar Singh, director, government and regulatory affairs, SII, said.
Following this, the DCGI’s office raised a few queries, and Singh submitted a reply noting the current emerging situation caused by a new coronavirus 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 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 emergency-use listing by the World Health Organization (WHO) on December 2017, 2020. In August 2020, US-based vaccine maker Novavax Inc. 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.
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