Indias drugs regulator gives nod to phase-3 clinical trial of Covid vaccine Covovax
New Delhi Mar 23 PTI The Drugs Controller General of India DCGI granted permission on Wednesday for conducting the phase-3 clinical trial of COVID-19 vaccine Covovax as a booster dose in adults official sources saidThe 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 agoThe 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 9The vaccine has not been included in the countrys inoculation programme against COVID-19Director 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 saidSingh had stated that many countries were administering booster doses to their citizens considering the uncertainties of the pandemicWe are sure that your approval for conducting this clinical trial will ensure an 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 ministers vision of Making in India for the WorldOur 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 Covovaxin Indian adults he had stated in the applicationCovovax 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 2020In August 2020 US-based vaccine-maker Novavax Inc had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373 its COVID-19 vaccine candidate in low-and-middle-income countries and in India PTI PLB RC
New Delhi Mar 23 PTI The Drugs Controller General of India DCGI granted permission on Wednesday for conducting the phase-3 clinical trial of COVID-19 vaccine Covovax as a booster dose in adults official sources saidThe 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 agoThe 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 9The vaccine has not been included in the countrys inoculation programme against COVID-19Director 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 saidSingh had stated that many countries were administering booster doses to their citizens considering the uncertainties of the pandemicWe are sure that your approval for conducting this clinical trial will ensure an 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 ministers vision of Making in India for the WorldOur 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 Covovaxin Indian adults he had stated in the applicationCovovax 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 2020In August 2020 US-based vaccine-maker Novavax Inc had announced a licence agreement with the SII for the development and commercialisation of NVX-CoV2373 its COVID-19 vaccine candidate in low-and-middle-income countries and in India PTI PLB RC
