<p>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.</p>.<p>Prakash Kumar Singh, director, of 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.</p>.<p><strong>Also Read | <a href="https://www.deccanherald.com/state/top-karnataka-stories/covid-19-karnataka-makes-masks-mandatory-in-closed-spaces-1174115.html">Covid-19: Karnataka makes masks mandatory in closed spaces</a></strong></p>.<p>It has been learnt that the DCGI's office had raised a few queries, after which Singh submitted a reply, mentioning the current emerging situation caused by a new coronavirus variant.</p>.<p>Covovax was approved by the DCGI for restricted emergency use in children aged seven to 11 years in June.</p>.<p>The DCGI 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.</p>.<p>Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation.</p>.<p>It was granted an emergency-use listing by the World Health Organisation (WHO) on December 2017, 2020. In August 2020, US-based vaccine maker Novavax Inc. 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.</p>
<p>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.</p>.<p>Prakash Kumar Singh, director, of 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.</p>.<p><strong>Also Read | <a href="https://www.deccanherald.com/state/top-karnataka-stories/covid-19-karnataka-makes-masks-mandatory-in-closed-spaces-1174115.html">Covid-19: Karnataka makes masks mandatory in closed spaces</a></strong></p>.<p>It has been learnt that the DCGI's office had raised a few queries, after which Singh submitted a reply, mentioning the current emerging situation caused by a new coronavirus variant.</p>.<p>Covovax was approved by the DCGI for restricted emergency use in children aged seven to 11 years in June.</p>.<p>The DCGI 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.</p>.<p>Covovax is manufactured through technology transfer from Novavax. It has been approved by the European Medicines Agency for conditional marketing authorisation.</p>.<p>It was granted an emergency-use listing by the World Health Organisation (WHO) on December 2017, 2020. In August 2020, US-based vaccine maker Novavax Inc. 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.</p>