ICMR DG Balram Bhargava has written a letter to Bharat Biotech and principal investigators of medical colleges to complete the trial procedure of indigenous COVID-19 vaccine in a fast track method, so that results of a clinical trial can be launched by August 15.
R. Vasudev of KGH, who is tipped to part of the team along with Dr. Arjuna to conduct the human clinical trials, said that the trials will be made on fully fit and healthy volunteers who are free from any strains of virus and infections, including COVID-19.
This is the second Indian vaccine to get DCGI nod for human trials. "ICMR and BBIL are jointly working for the preclinical as well as clinical development of this vaccine", he wrote.
Bharat Biotech developed the inactivated vaccine at at its high-containment facility located in Genome Valley.
Dr Krishna Ella, Chairman and Managing Director of the company, has collaborated with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) for developing the vaccine. Besides, it was also reportedly the first firm in the world to find a Zika virus vaccine.
The human trials began in Wuzhi County, central China's Henan Province on April 12. "This is going at a speed no other vaccine has ever gone".
Few, however, have been able to start their large-scale Phase 3 trials.
The U.S. government announced this week it reached an agreement with Gilead Sciences to have most of the biopharmaceutical company's production of remdesivir, the only drug licensed so far to treat the coronavirus, available to the U.S. for the next three months.
There were no safety concerns for the vaccine candidate in repeat dose toxicology studies, Zydus said. Zydus Cadila had submitted it successful animal trial data with the regulatory body, where the animal subjects - mice, rabbits, guinea pigs, rats - developed antibodies against the deadly virus.