Serum Institute of India 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 on Wednesday.
The letter was written by Prakash Kumar Singh, Director, Government and Regulatory Affairs at Serum Institute of India (SII), they said.
The Drug Controller General of India (DCGI) on January 16 approved market authorisation for Covovax as a heterologous booster dose for adults who have been administered two doses of either Covishield or Covaxin.
The DCGI’s approval was based on recommendations by the subject expert committee (SEC) of the Central Drugs Standard Control Organisation.
The DCGI approved Covovax for restricted use in emergency situations in adults on December 28, 2021, in the 12-17 age group on March 9, 2022, and also in children aged seven to 11 years on June 28 last year subject to certain conditions.
Covovax is manufactured through technology transfer from Novavax.
It has been approved by the European Medicines Agency for conditional marketing authorization and was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, US-based vaccine maker Novavax Inc. had earlier announced a licence agreement with the SII for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.