DCGI approves market authorisation for SII’s Covid vaccine Covovax as heterologous booster dose
3 min read
By PTI
NEW DELHI: The Drug Controller General of India (DCGI) has accepted market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who’ve been administered two doses of Covishield or Covaxin, official sources stated on Monday.
The DCGI’s approval got here following suggestion by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
Prakash Kumar Singh, Director of Government and Regulatory Affairs on the Serum Institute of India (SII), had not too long ago written to the DCGI for the approval of Covovax heterologous booster dose for these aged 18 years and above in view of the escalating COVID-19 pandemic scenario in some nations, an official supply had stated.
“The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had 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 supply stated.
The DCGI had accepted Covovax for restricted use in emergency conditions in adults on December 28, 2021, within the 12-17 age group on March 9, 2022, and in youngsters aged 7-11 years on June 28 final 12 months topic to sure circumstances.
Covovax is manufactured by know-how switch from Novavax. It has been accepted by the European Medicines Agency for conditional advertising and marketing authorisation.
It was granted emergency-use itemizing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc.had introduced a licence settlement with the SII for the event and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income nations.
NEW DELHI: The Drug Controller General of India (DCGI) has accepted market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who’ve been administered two doses of Covishield or Covaxin, official sources stated on Monday.
The DCGI’s approval got here following suggestion by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
Prakash Kumar Singh, Director of Government and Regulatory Affairs on the Serum Institute of India (SII), had not too long ago written to the DCGI for the approval of Covovax heterologous booster dose for these aged 18 years and above in view of the escalating COVID-19 pandemic scenario in some nations, an official supply had stated.
“The Subject Expert Committee of the CDSCO on Wednesday deliberated on the issue and had 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 supply stated.
The DCGI had accepted Covovax for restricted use in emergency conditions in adults on December 28, 2021, within the 12-17 age group on March 9, 2022, and in youngsters aged 7-11 years on June 28 final 12 months topic to sure circumstances.
Covovax is manufactured by know-how switch from Novavax. It has been accepted by the European Medicines Agency for conditional advertising and marketing authorisation.
It was granted emergency-use itemizing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc.had introduced a licence settlement with the SII for the event and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income nations.
