By PTI
NEW DELHI: An expert panel of the central drug regulatory authority has recommended market authorisation for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.
Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India (SII) had recently written a letter to Drugs Controller General of India (DCGI) for approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating covid-19 pandemic situation in some countries, the sources said.
“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.
The DCGI had approved Covovax 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 ocvid-19 vaccine candidate in India and low-and-middle-income countries.
NEW DELHI: An expert panel of the central drug regulatory authority has recommended market authorisation for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.
Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India (SII) had recently written a letter to Drugs Controller General of India (DCGI) for approval of Covovax heterologous booster dose for those aged 18 years and above in view of escalating covid-19 pandemic situation in some countries, the sources said.
“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.
The DCGI had approved Covovax 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 ocvid-19 vaccine candidate in India and low-and-middle-income countries.
