Covovax vaccine manufacturer SII seeks drug regulator's nod for market authorisation as Covid-19 booster dose
Covovax was approved by the DCGI for a restricted emergency use in children aged seven to 11 years in June.
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.
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.
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 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.
Get Latest Business News, Stock Market Updates and Videos; Check your tax outgo through Income Tax Calculator and save money through our Personal Finance coverage. Check Business Breaking News Live on Zee Business Twitter and Facebook. Subscribe on YouTube.
RECOMMENDED STORIES
SBI Senior Citizen FD Rates: What Rs 1 lakh, Rs 3 lakh, and 5 lakh investments will give you in 1-, 3- and 5-year FDs
Top 7 SIP Mutual Funds in 1 Year: What Rs 10,000, Rs 15,000, and Rs 20,000 SIPs have given in each fund
IPL 2024 Eliminator Ticket Booking: Where and how to buy IPL Playoffs Eliminator match tickets online - Check ticket price, other details
Dividend, bonus, stock split stocks next week: SBI, Trent, Colgate Palmolive, Bharat Dynamics, Tata Consumer Products, other stocks to trade ex-date
Top Large-cap vs flexi-cap vs ELSS mutual fund: Which fund has given maximum returns in SIP and lump sum in 3 years
04:26 PM IST