Covid-19: As the threat of coronavirus is far from over, the Serum Institute of India (SII) has sought the drug regulator's approval for market authorisation of its COVID-19 vaccine Covovax as a booster dose. According to official sources, it has sought approval for those aged 18 years and above who have been administered two doses of Covishield or Covaxin.
Earlier on October 17, Prakash Kumar Singh, director of government and regulatory affairs at SII, submitted a market authorization application to the Drug Controller General of India (DCGI) for the heterologous booster dose of Covovax.
DCGI approved Covovax for limited emergency usage
According to reports, the DCGI's office had a few concerns, following which Singh submitted a reply by outlining the current situation that was developing due to a new coronavirus variant. This year in June, the DCGI approved Covovax for limited emergency usage in children between the ages of seven and eleven.
The DCGI had approved Covovax for restricted use in emergency situations in adults on December 28, 2021, and for those in the 12-17 age group, subject to certain conditions, on March 9.
EMA approved conditional marketing authorisation of Covovax
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 an emergency-use listing by the World Health Organization (WHO) on December 2017, 2020. In August 2020, US-based vaccine maker Novavax Inc.
had 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.
It should be noted here that India has been witnessing a steady decline in cases with the average daily cases falling to 158 in the week ending December 19.
(With PTI inputs)
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