Bharat Biotech has started human trials for much talked about COVAXIN, India’s first vaccine candidate for COVID-19. The vaccine is being developed by the Hyderabad-based biotech company in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The Drug Controller General of India (DCGI) had recently granted permission to initiate Phase I & II human clinical trials for COVAXIN. The company has already stated that it will initially develop 200 million vials of the vaccine.
Earlier, the vaccine was in the news after the ICMR set the August 15 deadline for its launch. After being warned by doctors, the ICMR defended its moves saying the process was exactly in accordance with globally accepted norms.
The premier medical research body said the letter by its Director General Dr. Balram Bhargava to principal investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.
“Trials will be done following the best practices and rigour,” the Indian Council for Medical Research(ICMR) said in a statement, seeking to address concerns voiced by several experts who said the timeline set by the research body may not be realistic.
“ICMR’s process is exactly in accordance with the globally accepted norms to fast-track the vaccine development for diseases of pandemic potential wherein human and animal trials can continue in parallel.”
The statement further said that in the larger public health interest, it is important for the ICMR to expedite the clinical trials with a promising indigenous vaccine, adding it is committed to treat the safety and interest of people of India as a topmost priority.
“While issues raised in public domain from time-to-time by commentators are welcome, as they form an important part of feedback loop, the best of India’s medical professionals and research scientists should not be second guessed for their professionalism or adherence to the highest scientific rigour.”