Harish Gupta ( National Editor, Lokmat Group)
New Delhi, July 4
The cat is out of the bag as to why the Indian Council of Medical Research (ICMR) set August 15 date for developing and launch a coronavirus vaccine.
It transpires that the developer of the most-sought vaccine in the world, Bharat Biotech company of Hyderabad, may be allowed to launch the vaccine immediately after the successful Phase-I and Phase-II trials without waiting for four phases of trials which takes minimum six months to one year. But in the instant case, the government and ICMR, may short-circuit the process.
A clue was given by none other but the Chairman and managing director of the Bharat Biotech company, Dr Krishna Ella himself.
That is a decision for the government to take. If phase I & II data is good, it is up to the government and regulators. Our job is to execute the project and show the results.”
It is clear that the vaccine can be launched after the phase-I and Phase-II trials if the regulators and government so permits.
Interestingly, the regulator (ICMR) itself is a partner in the Covaxin with Bharat Biotech and Institute of Virology in Pune is also a partner which is owned by the government itself.
The ICMR which was playing coy since yesterday on the issue. Asserted today“the letter by DG-ICMR (Dr Balram Bhargava) to investigators of the clinical trial sites was meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants."
“The process of Vaccine development “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."
Dr Bhargava had sent out letters to 12 top clinical research agency "envisaged" launching a novel coronavirus vaccine by Independence Day. The Union Health Ministry refused to comment and no government authority was willing to join the issue as it created a furore among experts and political class.