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  • COVID vaccine: DCGI...

COVID vaccine: DCGI approves market authorisation for Serum Institute Covovax as heterologous booster dose

Ruchika SharmaWritten by Ruchika Sharma Published On 2023-01-17T11:14:43+05:30  |  Updated On 14 Feb 2024 1:52 AM IST
COVID vaccine: DCGI approves market authorisation for Serum Institute Covovax as heterologous booster dose
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Covovax is manufactured through technology transfer from Novavax.

New Delhi: The Drug Controller General of India (DCGI) has approved market authorisation for 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 recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (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 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 Subject Expert Committee 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.
Read also: CDSCO panel recommends market authorization for Covovax jab as heterologous booster dose
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 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 Organization (WHO) on December 17, 2021.
Read also: Novavax COVID jab shows high levels of protection against infection in two large phase-3 trials
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.

Read also: SII CEO Adar Poonawalla says Covovax to get approval as booster in next 10-15 days

Drug Controller General of IndiaDCGICOVID 19coronaviruscoronavirus vaccineCovovaxcovishieldcovaxinCDSCONovavax
Source : PTI
Ruchika Sharma
Ruchika Sharma

    Ruchika Sharma joined Medical Dialogue as an Correspondent for the Business Section in 2019. She covers all the updates in the Pharmaceutical field, Policy, Insurance, Business Healthcare, Medical News, Health News, Pharma News, Healthcare and Investment. She has completed her B.Com from Delhi University and then pursued postgraduation in M.Com. She can be contacted at editorial@medicaldialogues.in Contact no. 011-43720751

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