NEW DELHI, 12 Jan: An expert panel of the central drug regulatory authority has recommended market authorisation for Serum Institute of India’s (SII) 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.
SII Director (Government & Regulatory Affairs) Prakash Kumar Singh had recently written a letter to the Drugs Controller General of India 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 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 28 December, 2021, in the 12-17 age group on 9 March, 2022, and also in children aged 7-11 years on 28 June, 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. It was granted emergency-use listing by the World Health Organisation on 17 December, 2021.
In August 2020, 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. (PTI)