- Ever since the novel coronavirus global pandemic infected the universe, there is any number of countries – including the most advanced, the developed and the developing – are in the race to invent an effective vaccine to get rid of the virus. Such as been the damage wrought by the virulent virus that the countries are leaving no stone unturned in investing every available resource to ensure the vaccine sees the day of light sooner.
- No sooner the enormity of the challenges confronting humanity started emerging in the face of the exceedingly contagious virus, concerted efforts were afoot amongst the scientific community across many countries. Ramping up respective Research & Development wings to set about inventing effective vaccine ensued. Racing against time, there were associations formed, joint ventures signed, alliances forged to march ahead took precedence over everything else.
- Conservative estimate and past experiences suggest that inventing vaccines might take a considerable time for the processes involved in developing the same is not only exhaustive but has to cater to laid down scientific parameters that cannot be compromised. Though concerned governments wish to fast track time tested development cycle of vaccine, researchers involved should not accede to such requests by stringently sticking to the protocol.
PC: the conversation
- For the uninitiated, the general stages of the development of a vaccine involve six stages i.e. exploratory stage, preclinical stage, clinical development, regulatory review and approval, manufacturing, and quality control. Most importantly, clinical development has three exhaustive phases where thousands of people are tested for efficacy and safety before initiating mass vaccination processes.
- Though fully aware of the above procedures, it is baffling to note that the Director-General of ICMR (Indian Council for Medical Research) letter setting a deadline of August 15 to launch the COVID-19 vaccine in the country. What prompted such inexplicable pronouncement needs thorough deliberations for sure. Political compulsions or bureaucratic obedience? Whatever might be the reason(s), surely defies scientific logic and data available at hand!
- Further, the ICMR letter also exhorted the hospitals selected by advising to fast track all approvals for initiation of clinical trials mentioning that the government is monitoring the same at the topmost level. The letter ended with not so veiled warning that non-compliance will be viewed strictly. After the letter evoked dismay and outrage, subsequent clarification issued stated the letter aimed to cut unnecessary red tape without compromising on safety, best practices, and rigour. How convenient!
- Understandably, red-tape reigns supreme in our country but that does not allow forsaking due processes by acquiescing to the unreasonable demands of the authorities concerned whatever might be the compulsions. The ICMR has a huge responsibility to safeguard and uphold ethical parameters zealously before announcing to the world about vaccine invention. We wait for the vaccine with bated breath but without shortcuts please!