By M Somasekhar
Hyderabad: India has joined the ‘hot race’ to develop a potential COVID-19 vaccine with a significant announcement that a consortia has got regulatory approval to carry out human trials for COVAXIN, starting in July.
Bharat Biotech, the Hyderabad-based vaccine maker is leading the consortia consisting of the Indian Council of Medical Research (ICMR) and the Pune-based, National Institute of Virology (NIV).
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.
In a statement, the consortia said, the Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare has granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
The crucial human trials are scheduled to start across India in July 2020.
The Chairman and Managing Director of the Bharat Biotech, Dr Krishna Ella said with strong support from the consortia partners and Government, the entire development process was accelerated through national regulatory protocols.
The company deployed its full strengths in R&D, manufacturing and completed the comprehensive pre-clinical studies. The results are promising, show exhaustive safety and effective immune responses in laboratory studies, he added.
Interestingly, Bharat Biotech is in collaboration with a University of Wisconsin in the development of another Vaccine too. It has extensive manufacturing facilities and is geared to produce millions of doses.
The company also came up with a vaccine for H1N1 or Swine Flu epidemic several years ago. It has also established one of the few BSL-3 containment facilities, which is a pre-requisite for the manufacture and testing of advanced vaccines.
In the bouquet of 16 Vaccines it has developed and markets, with necessary global regulatory approvals and WHO-pre-qualifications are the Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.
There are more than a dozen Indian initiatives with Corporates and Research Institutes and at various stages of development.