Serum Institute seeks Centre's approval for Covid-19 vaccine Covovax as booster shot for Adults

New Delhi, Dec 22: 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 for those aged 18 years and above who have been administered two doses of Covishield or Covaxin, official sources said on Thursday.

Prakash Kumar Singh, director, government and regulatory affairs, SII, submitted a market authorisation application for the heterologous booster dose of Covovax to the drugs controller general of India (DCGI) on October 17. It has been learnt that the DCGI's office had raised a few queries, after which Singh submitted a reply, mentioning about the current emerging situation caused by a new coronavirus variant, as reported by PTI.

Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years in June.

The DCGI had approved Covovax for a 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. It may be noted that Covovax is the indigenous version of a Covid-19 vaccine developed by Novovax Inc and manufactured under a licence of the Serum Institute of India. In terms of formulation, it is a recombinant protein vaccine that uses spike proteins to familiarise the human body with how to develop immunity against SARS-CoV-2.

Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation.

In December 2021, Covovax was granted the World Health Organisation's (WHO) approval to be used as a booster shot to counter the scare posed by variants of coronavirus. The WHO stated in a press release, "The vaccine, named Covovax, is produced by the Serum Institute of India (SII) under licence from Novavax and is part of the COVAX facility portfolio, giving a much-needed boost to ongoing efforts to vaccinate more people in lower-income countries."

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.