Govt panel recommends market authorisation for Covovax jab as heterologous booster dose
By PTI
NEW DELHI: An skilled panel of the central drug regulatory authority has advisable market authorisation for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who’ve been administered two doses of Covishield or Covaxin, official sources mentioned on Thursday.
Prakash Kumar Singh, director (authorities and regulatory affairs) at Serum Institute of India (SII) had lately written a letter to Drugs Controller General of India (DCGI) for approval of Covovax heterologous booster dose for these aged 18 years and above in view of escalating covid-19 pandemic scenario in some international locations, the sources mentioned.
“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 supply mentioned.
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 addition in youngsters aged 7-11 years on June 28, 2022 topic to sure situations.
Covovax is manufactured via expertise switch from Novavax. It has been accepted by the European Medicines Agency for conditional advertising authorization.
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 SII for growth and commercialization of NVX-CoV2373, its ocvid-19 vaccine candidate in India and low-and-middle-income international locations.
NEW DELHI: An skilled panel of the central drug regulatory authority has advisable market authorisation for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who’ve been administered two doses of Covishield or Covaxin, official sources mentioned on Thursday.
Prakash Kumar Singh, director (authorities and regulatory affairs) at Serum Institute of India (SII) had lately written a letter to Drugs Controller General of India (DCGI) for approval of Covovax heterologous booster dose for these aged 18 years and above in view of escalating covid-19 pandemic scenario in some international locations, the sources mentioned.
“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 supply mentioned.
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 addition in youngsters aged 7-11 years on June 28, 2022 topic to sure situations.
Covovax is manufactured via expertise switch from Novavax. It has been accepted by the European Medicines Agency for conditional advertising authorization.
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 SII for growth and commercialization of NVX-CoV2373, its ocvid-19 vaccine candidate in India and low-and-middle-income international locations.
