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A Risky Venture

India should not be in a hurry to develop a COVID-19 vaccine

THE Indian Council of Medical Research (ICMR) recently directed a company called Bharat Biotech to fast track the development of Covaxin, an indigenous vaccine to fight the coronavirus. The bewildering part of the ICMR plan was to launch the vaccine by August 15, which had obvious political connotations. Launching the use of the vaccine within such a short time was well-nigh impossible. After a flood of criticism, the ICMR stepped backwards and said it only wanted the trials of the vaccine completed by August 15 and not to start its public use on that day. The ICMR further said in its defence that it was supporting the clinical development of the Bharat Biotech vaccine as the “vaccine candidate” being developed by the company appeared to be “promising”. The ICMR has selected 12 medical centres including one in Goa for clinical trials of the vaccine, saying that the Drugs Controller General of India has accorded permission to conduct phase 1 and 2 clinical trials. Though ICMR pleaded that globally accepted norms of fast-tracking were being followed in the development of Covaxin and that the safety and the interests of people of India were its topmost priority, experts feel that it was humanly impossible to develop a vaccine in such a short time unless the safety was compromised.

The development of a vaccine usually takes a long time and is the outcome of an expensive and uncertain process. The average time for a vaccine to hit the market has been 10.7 years and only 6 percent of those in the making stand a chance of entering the market. The fastest vaccine that got approval of the world health authorities was the one developed for mumps, which was accorded approval after four years of trials that began in 1963. Though a vaccine for treatment of HIV has been in the making for over three decades, it is still under clinical trials. Experts believe that though the protocols may be changed in cases of pandemics it cannot be done in such a hurry. They are sceptical about the ICMR’s plan to compress three phases of clinical trials into five weeks to develop the vaccine.  Some of them have gone to the extent of saying that any conclusions drawn from trials done in such a short period would be highly suspect.

It hardly convinced anyone when ICMR director general Balaram Bhargava pleaded that expediting the process was “meant to cut unnecessary red tape, without bypassing any necessary process, and speed up recruitment of participants.” While it is known that red tape exists in government processes it has not been found prevalent in development of medical cure for any disease. Is the fast tracking of the vaccine really meant for a larger human cause or is it to fit some announcement plan of the political masters? Experts say that the process for developing the right dose of vaccine to be given to people could take at least a couple of months and that clinical trials could take anything between one and half years and three years and in some cases even decades. Any attempt to subvert the process and expedite development of vaccines without following the protocol could prove dangerous for human safety for whose cause the vaccine is being developed. Failure of the vaccine at a later stage could also cause a huge embarrassment to the Indian authorities.

Though the process for development of COVID-19 vaccine has been shortened worldwide, none of the researchers have sought to curtail the vital clinical trials. The Oxford Vaccine Group researchers, who began phase I trials of Astra Zeneca’s vaccine in April, have recently entered phase III. The vaccine is scheduled to go into production on completion of phase III of clinical trials and is expected to hit the markets by September. It is true that rapid spread of virus is a cause of concern for the authorities and experts believe that spread would continue till a vaccine is found. While finding a COVID-19 vaccine is necessary, any overambitious venture just to claim to be the first among the nations to have developed it could on the contrary hurt the image of a country which is known for scientific achievements.

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