The Drug Controller General of India (DCGI) has approved the use of Serum Institute of India’s (SII) Covovax as a heterologous booster dose for those who have previously taken two doses of Covaxin or Covishield, official sources said. A heterologous booster is when the third dose is different from the earlier doses.
The DCGI's approval came following the recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
Prakash Kumar Singh, director of Government and Regulatory Affairs at the Serum Institute of India (SII), recently wrote to the DCGI for the approval of Covovax heterologous booster dose, for those aged 18 years and above, in view of the escalating COVID-19 pandemic situation in some countries, an official source said.
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 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 June 2022, Hyderabad-based Biological E. Limited (BE)’s COVID-19 vaccine Corbevax had been approved by DCGI as a heterologous COVID-19 booster dose to individuals aged 18 years and above after 6 months of administration of primary vaccination (two doses) of Covaxin or Covishield vaccines for restricted use in emergency situations.
(With inputs from PTI)