The Drug Controller General of India (DCGI) has granted market authorization to the COVID-19 vaccine Covovax as a heterologous booster dose for adults who have previously received two doses of either Covishield or Covaxin, according to official sources. This approval from the DCGI follows a recommendation by the Subject Expert Committee of the Central Drugs Standard Control Organisation (CDSCO).
Push for Approval
Prakash Kumar Singh, Director of Government and Regulatory Affairs at the Serum Institute of India (SII), recently petitioned the DCGI for the authorization of Covovax as a heterologous booster dose for individuals aged 18 years and above. This request was made in light of the escalating COVID-19 pandemic situation in various countries, as per an official source familiar with the matter.
Committee Deliberations
The Subject Expert Committee of the CDSCO convened to discuss the matter and subsequently recommended the market authorization of Covovax as a heterologous booster dose for adults who have received two doses of Covishield or Covaxin, stated an official source.
Regulatory Timeline
The DCGI had initially granted approval for Covovax’s restricted emergency use in adults on December 28, 2021, followed by approval for the 12-17 age group on March 9, 2022, and for children aged 7-11 years on June 28 of the same year, subject to specific conditions.
Manufacturing and Global Approval
Covovax is manufactured through technology transfer from Novavax and has received conditional marketing authorization from the European Medicines Agency. Additionally, it obtained emergency-use listing from the World Health Organization (WHO) on December 17, 2021.
Partnership and Development
In August 2020, Novavax Inc., a US-based vaccine manufacturer, entered into a license 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.
Hiroto Suzuki
