Green signal for Covovax booster dose

An expert panel of the central drug regulatory authority has recommended market authorization for Serum Institute of India’s COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin. Prakash Kumar Singh, director (government and regulatory affairs) at the SII, had recently written a letter to the Drugs Controller General of India (DCGI) for approval of the Covovax heterologous booster dose for those aged 18 years and above in view of the escalating COVID-19 situation in some countries. The DCGI had approved Covovax for restricted use in emergency situations for adults on December 28, 2021, for the 12-17 age group on March 9, 2022, and for children aged 7-11 on June 28, 2022, 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, the US-based vaccine maker Novavax Inc. had announced a license agreement with the SII for development and commercialization of NVX-CoV2373, its COVID-19 vaccine candidate in India and low-and-middle-income countries.

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