Covid-19 vaccine 'nationalism' puts human lives at risk

The urgent need to find a quick solution to the raging Covid-19 pandemic has given rise to a global tendency to take risks and short-cuts. China’s biotechnology firm CanSino has pressed into service the People’s Liberation Army (PLA) epidemiologist, Major General Chen Wei, to oversee its vaccine hunt. Chen Wei herself took one of the first shots of the experimental vaccine to display national fervour.

One hopes the same fervour has not overwhelmed the Indian Council of Medical Research (ICMR) which, along with National Institute of Virology (NIV), has thrown its weight behind a Covid-19 vaccine being developed by Bharat Biotech International Ltd (BBIL). In a letter on July 2, the DG ICMR instructed 12 institutes and hospitals to fast track clinical trials for the indigenous vaccine. Although the timeline submitted by the BBIL in its application to Clinical Trial Registry of India (CTRI) gives the date of the first enrolment of trial participants as July 13 and the entire duration of the trial to be 15 months, the DG ICMR dictated a different deadline, August 15 or Independence Day, for launching the vaccine for public use. Bhargava’s letter sets a precise deadline for “public use” of the vaccine within six weeks of the commencement of clinical trials. Although the ICMR later clarified that no international or ethical protocol would be violated and that it was only cutting “red tape” and expediting early testing phases (Phase 1 and 2) so that “population-based trials for efficacy could be initiated without delay”, a severe blow has already been inflicted on the autonomy of the country’s premier research institution and its processes. As it turns out, the Ethics Committee in at least the AIIMS, one of the 12 sites selected for the trials, has reportedly not yet approved the protocol submitted for clinical trials. The AIIMS Director has, in fact, said that the deadline is unrealistic. The initial two phases of the clinical trials determine the doses, their safety and efficacy of a vaccine in humans. All the facilities conducting the trials have to be prepared for vaccine-associated enhanced respiratory disorders. There is no denying the urgency in the pandemic to fast track a vaccine, but clearly, not at the cost of safety and ethical standards.

Globally, there are over 150 candidate vaccines, of which about 18 are at various stages of clinical trials. Apart from Bharat Biotech, there are others in the country — a vaccine candidate developed by Serum Institute of India, Pune, in collaboration with the Oxford University and the DNA vaccine being developed by Zydus Cadila Healthcare Ltd — which have been cleared by the regulator for clinical trials. But it will only be by the end of next year that a vaccine may be ready for public use. Hastening the process is hardly a substitute for established protocols to ensure that patients’ lives are not put to risk.

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