The country’s top drug regulator, Drugs Controller General of India (DCGI), has granted permission for conducting the phase-3 clinical trial of Covid-19 vaccine Covovax as a booster dose in adults, according to official sources in the Union Health Ministry.
The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) had, on March 5, recommended permission for conducting the phase-3 clinical trial for Covovax as a booster dose in adults who have been fully vaccinated with either Covaxin or Covishield at least three months ago.
The DCGI approved Covovax for restricted use in emergency situations in adults on December 28 last year and for inoculating the beneficiaries in the 12-17 years age group, subject to certain conditions, on March 9.
The vaccine has not been included in the country's inoculation programme against Covid-19. Director, Government and Regulatory Affairs at the Serum Institute of India (SII), Prakash Kumar Singh, submitted an application to the DCGI in February, seeking permission to conduct a phase-3, observer-blind, randomised, controlled study to evaluate the safety and immunogenicity of Covovax for booster doses in adults who had received primary vaccination either with Covishield or Covaxin at least three months ago, according to the official sources.