The DCGI's approval came following recommendations by the Subject Expert Committee of the Central Drugs Standard Control Organisation.
The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021. (Supplied)
The Drug Controller General of India (DCGI) has approved market authorisation for the Covid-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Monday.
The DCGI’s approval came following recommendations by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
Serum Institute of India (SII) Director of Government and Regulatory Affairs Prakash Kumar Singh, had recently written to the DCGI for the approval of Covovax heterologous booster dose for those aged 18 years and above in view of the escalating Covid-19 pandemic situation in some countries, an official source said.
“The Subject Expert Committee of the CDSCO on Wednesday (11 January) deliberated on the issue and had 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 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 in children aged 7-11 years on 28 June last year 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 an emergency-use listing by the World Health Organization (WHO) on 17 December, 2021.
In August 2020, US-based vaccine maker Novavax Inc announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate in India and low-and-middle-income countries.
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