The Drug Controller General of India (DCGI) has approved the marketing of the COVID-19 vaccine Covovax as a heterologous booster dose for adults who have received two doses of Covishield or Covaxin, official sources said Monday.
The DCGI’s approval followed the recommendation of the Subject Expert Committee of the Central Drugs Standards Control Organization (CDSCO).
Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), had recently written to the DCGI for the approval of the heterologous booster dose of Covovax for persons aged 18 and above in view of the escalating COVID -19 pandemic situation in some countries, an official source had said.
“The CDSCO Subject Expert Committee deliberated on the matter on Wednesday and recommended marketing authorization of Covid jab Covovax as a heterologous booster dose for adults who have received two doses of Covishield or Covaxin,” said an official source.
The DCGI had approved Covovax under certain conditions for limited emergency use in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and in children 7-11 years old on June 28 last year.
Covovax is manufactured by technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorization. It was listed for emergency use by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc. announced a licensing agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low- and middle-income countries.
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