IRRATIONAL TARGET
Search for vaccine must not compromise on trials
There is no question that the pandemic has put a severe strain on economies, companies, and individuals. Worse, it is becoming clear as various countries and regions go in and out of lockdowns that there is no real possibility of returning to a pre-pandemic “normal” until there is a vaccine that is universally available, safe, and effective. Thus, there is, of course, an understandable and even justifiable sense of urgency when it comes to the search for a vaccine. Yet those qualifiers — available, safe, and effective — are no less important when it comes to dealing with a global pandemic. It is in this context that the Indian Council of Medical Research’s (ICMR’S) widely publicised letter to 12 principal investigators at major medical centres has caused great concern. The letter, signed by the director general of the ICMR, Balram Bhargava, in a somewhat peremptory tone instructed those investigators to “fast-track” the approval process for clinical trials for a vaccine being developed by Hyderabad-based firm Bharat Biotech in collaboration at certain stages with the ICMR itself. Most worryingly, the letter set a date, August 15, for the rollout of the vaccine — barely six weeks away.
By any standard, a six-week deadline for a vaccine that has not even gone into proper clinical trials is indefensible. Even at the most compressed timelines being considered elsewhere in the world, a 12- to 18-month development period is being discussed. This could be reduced somewhat by bringing exceptional resources to bear and by cutting some red tape. But the basic requirements for any trial and testing stage remain the same. Vaccines have to prove that they are harmless to various specific sub-groups of the population — the elderly, those with specific diseases, children, and so on. Then they have to be delivered to a large group of people, alongside a control set that do not receive it, in order to demonstrate efficacy. This last stage is proving particularly hard to speed up, as some argue that it essentially requires the groups to be subject to the normal exposure to the spread of the virus in the population. When it comes to a vaccine that is meant to be universally available, there is even greater need to ensure that it meets standards. What is being discussed here is global scale: The costs of an error are cataclysmic. There is thus no way in which the ICMR’S originally stated release date can be justified.
The body has now clarified that it meant merely to cut through various red tape concerns. This is a laudable aim. But if that was all that was intended, it does not square with the August 15 deadline. It is fair to ask, given the significance of that date, whether political considerations are playing a part in what should be a purely scientific endeavour. Nor is it clear what the ICMR’S locus standi is to issue such a letter, as it is not the appropriate regulator. In any case, a regulator joining hands with a private player to produce a vaccine makes it an active player. In that case, the question is: Who will regulate the regulator? The Indian Academy of Sciences has condemned the letter, saying that the timeline is “unreasonable and without precedent”. This is putting it mildly. The search for a vaccine is too important to be left to such amateurish and political bungling. It is vital that the rush for a vaccine shouldn’t end up exacerbating the problem.