Registration for human trials of Indian vaccine for COVID-19 begins from July 7
The two Indian vaccine candidates, namely COVAXIN and ZyCov-D will now be tested on 1,125 healthy volunteers in the two phases of the trials.
In response to the directions by ICMR, the maximum number of the institutes have started the subject enrolment process for the first phase of the human trial for the COVID-19 vaccine from July 7, 2020.
Indian Council of Medical Research (ICMR) had earlier written to 12 medical institutes in the country to start the first phase of human clinical trials by registering volunteers. The authority has been speeding up the process as Indian vaccines are in the global race to end the pandemic.
In the recent development, DGCI had given its approval for the human trail to both COVAXIN which has been developed in the collaboration of ICMR and Bharat Biotech and ZyCov-D Vaccine, developed by Zydus Cadila.
India starts its human trial on two Indian vaccine candidates:
As the enrolment of volunteers starts today, the two Indian vaccine candidates, namely COVAXIN and ZyCov-D will now be tested on 1,125 healthy volunteers in the two phases of the trials.
The evaluation of the vaccines will be on the basis of its safety, tolerability, reactogenicity, and immunogenicity. The proposed age group of the volunteers for the trails is 18-55 years for Phase 1 and 12-65 years for Phase 2.
To win over the ongoing COVID-19 pandemic, more than 140 candidate vaccines across the world are under various stages of development. Similarly, Indian institutions have also engaged in Research and Development to successfully develop the COVID vaccine in India.
Director of Centre for Cellular and Molecular Biology, Hyderabad, Dr. Rakesh Mishra stated that people must not lower their guards amid the scientific progress on vaccine development. He also appreciated the timely approach of the government which provided the required push for the scientific development in the country.
ICMR had earlier announced that it has been planning to launch COVAXIN by August 15, 2020, in collaboration with Bharat Biotech. Both ICMR and Bharat Biotech have been jointly working for the preclinical as well as the clinical development of COVAXIN.
Earlier DGCI had given its approval to Bharat Biotech to initiate phase 1 and phase 2 human clinical trials of COVAXIN. The approval was given after the vaccine maker submitted results from preclinical studies which demonstrated safety and immune response.
Bharat Biotech Chairman had also informed that the National Institute of Virology (NIV) and ICMR were instrumental in the development of India’s first indigenous vaccine candidate COVAXIN.
Indigenously developed COVID-19 vaccine ZyCov-D which is developed by Hyderabad based Zydus Cadila Healthcare Ltd. also received DGCI approval to start human clinical trials. The approval was given after the company submitted successful data of the clinical trials on animals.
The approval process of the ZyCov-D vaccine was fast-tracked on the recommendation of the subject committee on COVID-19 who highlighted the ongoing unmet medical need and health emergency amid the pandemic.