By Sunil Garodia
First publised on 2020-07-06 18:09:56
Vaccines are used to prevent infections. Hence, their effectiveness has to be scientifically proven as per admissible norms before they are launched in the market for the use of the general public. However strong and urgent be the health scare for which the vaccine is being developed, the due process cannot be bypassed to launch a product that has not been stringently tested and approved for its efficacy in preventing the infection.
Hence, the ICMR directive to Bharat Biotech to "speed-up" clinical trials of the vaccine, that they are jointly developing as a "top priority project", so that it can be launched within August 15 must be condemned. Clinical trials cannot be sped up. There are thousands of things involved and continuous feedbacks and monitoring of patients administered with the vaccine during such trials take time. In any case, no vaccine or drug can be safely launched before successful clinical trials on a given set of individuals (a small number in Phase 1 and then a much larger number in Phase 2) over a given period of time. The results, such as the development of antibodies in the recipients, are closely monitored by scientists. It is not a process that submits itself to pre-set deadlines. Even the identification, selection and getting volunteers are time consuming processes.
The bureaucracy in India must not try to undermine scientific norms just to please their political masters. In fact, since they are supposed to be subject-experts (as Dr. Balram Bhargava, director-general of ICMR is), they must make the political leadership aware of the pitfalls involved in rushing things. There is no doubt that a vaccine, when developed, would be a huge relief to the entire humanity. But if due process is not followed and a dud vaccine is launched, India will become the laughing stock of the world. Hence, instead of setting deadlines, ICMR should insist on getting things done in the most scientific way following all global norms. Shortcuts will be self-defeating.