The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's facility located in Genome Valley in Hyderabad and human clinical trials are scheduled to start across India in July, the company said.
Giving details of the trial, he said, "The randomised, double-blind, placebo-controlled Phase 1/2a study will evaluate the safety, reactogenicity (adverse response to vaccination), and immunogenicity (beneficial immune response) of our investigational SARS-CoV-2 vaccine candidate". Therefore, we can rely on them until we get an effective vaccine after the human trials. "We're now ready to move forward into clinical development through human trials", Krishna Ella, Bharat's chairman and managing director, said. The proactive support and guidance from the CDSCO has enabled approvals to this project.
This is the first India-made vaccine and developed from a strain of the virus that was isolated locally and weakened under laboratory conditions.
An illustration of COVAXIN, the vaccine candidate for COVID-19 developed by Bharat Biotech. "Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies", he added.Ella said inactivated viruses have proven safety records and Bharat Biotech has expertise in vero cell culture vaccine manufacturing platform as it has already manufactured rabies, polio, Japanese Encephalitis and Rotavirus vaccines.
Pune-based Serum Institute and Delhi-based Panacea Biotec, too, are leading candidates from India to develop a Covid-19 vaccine.
China's military has approved a coronavirus vaccine for use within its ranks. The vaccine candidate was developed jointly by CanSino and a research institute at the Academy of Military Science (AMS).
There are now 224 candidate vaccines in development globally, according to the data collected by the Coalition for Epidemic Preparedness Innovations (CEPI). While 129 are in the pre-clinical evaluation phase.
As of Monday, the country had tallied 1.35 million cases of COVID-19 and almost 58,000 deaths, according to case tracker Worldometers.
Chinese military have been cleared to receive a Covid-19 vaccine.