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DCGI approves market authorisation for SII’s COVID vaccine Covovax as heterologous booster dose

The DCGI's approval came following recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO)

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The Drug Controller General of India (DCGI) has approved market authorisation to COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said yesterday.

The DCGI’s approval came following recommendation by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).

Prakash Kumar Singh, Director, Government and Regulatory Affairs, Serum Institute of India (SII), 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 had said.

The SEC of the CDSCO recently 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, according to an official source.

The DCGI had approved Covovax for restricted use in emergency situations in adults on 28th December, 2021, in the 12-17 years age group on 9th March, 2022, and in children aged 7-11 years on 28th June last year subject to certain conditions.

Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency (EMA) for conditional marketing authorisation. It was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) on 17th December, 2021. In August 2020, the United States (US)-based vaccine maker Novavax had announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate in India and in Low-and-Middle-Income Countries (LMICs).

Edits by EP News Bureau

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