India`s drugs regulator gives nod to phase-3 clinical trial of Covovax as Covid-19 booster dose

New Delhi: The Drugs Controller General of India (DCGI) granted permission on Wednesday (March 23) for conducting the phase-3 clinical trial of Covid-19 vaccine Covovax as a booster dose in adults, official sources said. 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, an official source had said.

Singh had stated that many countries were administering booster doses to their citizens, considering the uncertainties of the pandemic.
"We are sure that your approval for conducting this clinical trial will ensure early availability of Covovax for booster-dose use for the people of our country as well as the world at large, in line with our prime minister's vision of 'Making in India for the World'. "Our firm is committed to providing world-class life-saving vaccines at an affordable price under the visionary leadership of our CEO, Dr Adar C Poonawalla. We request you to kindly grant us permission to conduct a phase-3 clinical trial for booster dose of Covovax in Indian adults," he had stated in the application.

Covovax is manufactured by technology transfer from Novavax and is approved by the European Medicines Agency for conditional marketing authorisation. It was granted emergency-use listing by the World Health Organization (WHO) in December 2020. In August 2020, US-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 low-and-middle-income countries and in India.