DGCI approves market authorisation for Covovax as heterologous booster dose

The Drug Controller General of India (DCGI) has approved market authorisation to Serum Institute of India’s Covid-19 vaccine Covovax as a heterologous booster dose for adults, official sources told PTI on Monday.

Covovax can be used as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, they said.

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

It also comes at the time when a total of 26 cases of COVID’s XBB.1.5 has been found in India so far INSACOG data showed on Monday. The variant has been in 11 states and Union territories till now, including Delhi, Maharashtra and West Bengal. The XBB.1.5 is behind the massive surge in COVID cases in the United States. The XBB.1.5 strain is a relative of the Omicron XBB variant, which is a recombinant of the Omicron BA.2.10.1 and BA.2.75 subvariants. Combined, XBB and XBB.1.5 make up 44 per cent of cases in the US. The World Health Organisation (WHO) said 38 countries have reported XBB.1.5 cases, of which 82% have been reported in the US, 8% in Britain and 2% in Denmark.

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Speaking on the market authorization of Covovax, 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 Covovax heterologous booster dose for those aged 18 years and above in view of escalating COVID-19 pandemic situation in some countries, an official source had said.

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

Covovax is a recombinant spike protein nanoparticle vaccine that was approved for restricted use on adults and children last year. It is manufactured through technology transfer from American biotechnology company Novavax and has been approved by the European Medicines Agency for conditional marketing authorisation.

 It was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021.

In August 2020, US-based vaccine maker Novavax Inc. had announced a licence 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.

(With inputs from PTI)

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