By Express News Service
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.
According to officials, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), which met on Wednesday, deliberated on the issue. They recommended for market authorisation of Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources added.
Official sources said Prakash Kumar Singh, director (government and regulatory affairs) at the Pune-based SII had recently written 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 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 has also been granted emergency-use listing by the WHO on December 17, 2021.
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.
According to officials, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO), which met on Wednesday, deliberated on the issue. They recommended for market authorisation of Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources added.
Official sources said Prakash Kumar Singh, director (government and regulatory affairs) at the Pune-based SII had recently written 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 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 has also been granted emergency-use listing by the WHO on December 17, 2021.
