The central drug regulatory authority Drugs Controller General of India (DCGI) has recommended market authorisation for Serum Institute of India's Covid vaccine Covovax as a heterologous booster dose for those who have already taken two doses of Covishield or Covaxin
SII's director Prakash Kumar Singh recently wrote to DCGI for approval of Covovax as the heterologous booster dose for those aged 18 years and above owing to the rise in the number of COVID cases globally, a source close to the development cited.
"The subject expert committee (SEC) of the CDSCO on Wednesday deliberated on the issue and recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin," an official source said.
Covovax has already been approved for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022 and also in children aged 7-11 years on June 28, 2022 subject to certain conditions.
Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorization. It was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc. had announced a licence agreement with SII for development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.
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