Finance
An expert panel of the central drug regulatory authority has recommended market authorization for Serum Institute of India’s Covid vaccine Covovax as a heterologous booster dose for adults who have received two doses of Covishield or Covaxin, as per reports of Press Trust of India.
According to official sources, Prakash Kumar Singh, director (government and regulatory affairs) at Serum Institute of India (SII), recently wrote a letter to the Drugs Controller General of India (DCGI) requesting approval of Covovax heterologous booster dose for those aged 18 years and above in light of the escalating COVID-19 pandemic situation in some countries.
“The subject expert committee (SEC) of the CDSCO deliberated on the issue and recommended for market authorisation of Covid jab Covovax as a heterologous booster dose for adults who have been administered 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, children aged 7-11 years on March 9, 2022, and children aged 7-11 years on June 28, 2022, subject to certain conditions.
Covovax is manufactured 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 an emergency-use listing.
Novavax Inc., based in the United States, announced a license agreement with 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.
