DCGI granted market authorisation for SII's Covid vaccine Covovax as heterologous booster dose

The Drug Controller General of India (DCGI) has approved the COVID-19 vaccine Covovax for marketing as a heterologous booster dose for adults who have received two doses of Covishield or Covaxin, according to official sources. The DCGI approved the recommendation of the Central Drugs Standard Control Organization's Subject Expert Committee (CDSCO). According to an official source, Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), recently wrote to the DCGI requesting approval of a Covovax heterologous booster dose for those aged 18 and above in light of the escalating COVID-19 pandemic situation in some countries.

"The CDSCO's Subject Expert Committee deliberated on the issue on Wednesday and recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have received two doses of Covishield or Covaxin," an official source said. Covovax was approved by the DCGI for limited use in emergency situations in adults on December 28, 2021, in children aged 7 to 11 years on March 9, 2022, and in children aged 7 to 11 years on June 28, last year, subject to certain conditions. Covovax is made possible by a technology transfer from Novavax.

The European Medicines Agency has granted it conditional marketing authorization. On December 17, 2021, the World Health Organization (WHO) granted it emergency-use status. Novavax Inc., based in the United States, announced a licence agreement with the SII in August 2020 for the development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate, in India and low-and-middle-income countries.