New Delhi: An expert panel of the central drugs regulatory authority is likely to take a decision on Wednesday on granting market authorisation to SII's COVID-19 vaccine Covovax as a heterologous booster dose for adults who have been administered two doses of Covishield or Covaxin, official sources said.
The Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO) is scheduled to meet on January 11.
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Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), had written a letter to the the Drugs Controller General of India (DCGI) recently for the approval to Covovax as a heterologous booster dose for adults in view of the escalating pandemic situation in some countries, an official source told.
The DCGI had approved Covovax for restricted use in emergency situations for adults on December 28, 2021, for those in the 12-17 age group on March 9, 2022, and also in children aged 7- 11 years on June 28, 2022, subject to certain conditions.
Covovax is manufactured by the SII through technology transfer from Novavax.
It has been approved by the European Medicines Agency for conditional marketing authorisation.
It was granted emergency-use listing by the World Health Organization (WHO) on December 17, 2021.
In August 2020, U.S.-based vaccine maker Novavax Inc. had 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.
Also Read:COVID vaccine: SII seeks DCGI nod for market authorisation of Covovax as booster dose