Panel clears Serum Institute’s Covovax for booster dose
NEW DELHI: An expert panel of the central drug regulatory authority has recommended market authorisation for Serum Institute of India’s COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin.
Prakash Kumar Singh, director (government and regulatory affairs) at the SII, had recently written a letter to the Drugs Controller General of India (DCGI) for approval of the Covovax heterologous booster dose for those aged 18 years and above in view of the escalating COVID-19 situation in some countries.
“The subject expert committee (SEC) of the CDSCO (Central Drugs Standard Control Organisation) on Wednesday deliberated on the issue and recommended market authorisation of COVID-19 jab Covovax as a heterologous booster dose,” a source said.
The DCGI had approved Covovax for restricted use in emergency situations for adults on December 28, 2021, for the 12-17 age group on March 9, 2022, and for children aged 7-11 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 authorisation and was granted emergency-use listing by the World Health Organisation (WHO) on December 17, 2021.
In August 2020, the US-based vaccine maker Novavax Inc. had announced a licence agreement with the SII for development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.