COVID vaccine: SII seeks DCGI nod for market authorisation of Covovax as booster dose

Published On 2022-12-23 09:00 GMT   |   Update On 2024-02-13 21:12 GMT
Advertisement

New Delhi: 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. 
Advertisement
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.

Read also: SII Cervical cancer vaccine CERVAVAC likely to be launched in April next year

Serum Institute of India is an Indian biotechnology and biopharmaceuticals company headquartered in Pune, India. The company was founded by Dr. Cyrus Poonawalla in 1966.

Tags:    
Article Source : with inputs

Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.

NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.

Our comments section is governed by our Comments Policy . By posting comments at Medical Dialogues you automatically agree with our Comments Policy , Terms And Conditions and Privacy Policy .

Similar News