The Serum Institute of India (SII) has written to the union health ministry seeking the inclusion of its COVID vaccine Covovax in the CoWIN portal as a heterologous booster dose for adults, official sources said yesterday.
The letter was written by Prakash Kumar Singh, Director, Government and Regulatory Affairs, SII, they said.
The National Technical Advisery Group on Immunisation (NTAGI) is likely to hold a meeting soon to decide on the matter.
The Drugs Controller General of India (DCGI) on 16th January approved market authorisation for Covovax as a heterologous booster dose for adults who have been administered two doses of either Covishield or Covaxin.
Its approval was based on recommendations by the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO).
The DCGI approved Covovax for restricted use in emergency situations in adults on 28th December, 2021, in the 12-17 year age group on 9th March, 2022, and also in children aged seven to 11 years on 28th June last year subject to certain conditions.
Covovax is manufactured through technology transfer from Novavax.
It has been approved by the European Medicines Agency (EMA) for conditional marketing authorisation, and was granted Emergency Use Listing (EUL) by the World Health Organization (WHO) on 17th December, 2021.
In August 2020, Novavax had earlier announced a licence agreement with SII for the development and commercialisation of NVX-CoV2373, its COVID-19 vaccine candidate in India and Low-and-Middle-Income Countries (LMICs).
Edits by EP News Bureau