The DCGI earlier approved Covovax for restricted use in emergency situations in India, subject to certain conditions.
The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021. (Supplied)
An expert panel of the central drug regulatory authority has recommended market authorisation for the Covid-19 vaccine Covovax of the Serum Institute of India (SII) as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said on Thursday, 12 January.
“The subject expert committee (SEC) of the CDSCO on Wednesday deliberated on the issue and recommended for market authorisation of Covid-19 jab Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin,” an official source said.
SII Director (Government and Regulatory Affairs) Prakash Kumar Singh recently wrote a letter to the Drugs Controller General of India (DCGI) for approval of the Covovax heterologous booster dose for those aged 18 years and above in view of the escalating Covid-19 pandemic situation in some countries.
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 also in children aged 7-11 years on 28 June, 2022 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 Organisation (WHO) on 17 December, 2021.
In August 2020, US-based vaccine maker Novavax Inc announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its Covid-19 vaccine candidate in India and low-and-middle-income countries.
Last month, the Union Health Ministry approved Bharat Biotech’s intranasal Covid-19 vaccine as a booster dose for those above 18 years of age.
The nasal vaccine — iNCOVACC (BBV154) — received approval from the DCGI in November for restricted use in an emergency situation for those above 18 years as a heterologous booster dose.
The approval for the vaccine comes amid a spurt in Covid-19 cases in China and some other countries — and concern that there may be a spike in India as well, though experts have said it is unlikely.
(With PTI inputs)
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