A couple of days back, there appeared a news item talking about India having its own indigenous vaccine Covaxin for COVID-19 by August 15. There appeared to be a letter from Indian Council of Medical Research (ICMR) to leading hospitals and their principal investigators granting fast track license to Phase I and Phase II trials for the vaccine. The vaccine produced by Bharat Biotech, a Hyderabad based pharmaceutical firm in collaboration with ICMR and National Institute of Virology Pune seems to have shown promising results in the pre-clinical trials. Given the announcement it seemed that India was on the cusp of launching the COVID vaccine by August 15 setting a virtual cat among the pigeons in varying ways. ICMR has clarified that if successful, Phase III trials would start by August 15.
In the normal course, the trials are very long. While Phase I trials might be short, the Phase II and Phase III trials often last for years before they are approved for market use. This often has been viewed as a hindrance in the development of the drugs and thus escalation of costs. This invariably results in the high prices, longer monopoly period to accommodate for the longer pay back period, and perhaps less utility. The post “Permissionless Innovation and the Wuhan Pandemic” discussed at length the prospective deterrence in finding an early cure for the disease. The current round of the Wuhan pandemic and the accompanying economic disruption is making the world move on a fast track for the vaccine though it is believed that vaccine is unlikely to be available before the second half of 2021. In this context, Indian moves made one wonder over its logic and had many others perplexed. Of course there was a welcome and perhaps a feeling of an early relief from the virus. The hype might be premature but nevertheless would be interesting to decode the possible Indian logic in fast tracking a vaccine at a speed not seen in the last half a century or so.
Viruses compete in a Darwinian world and thus to borrow from Adam Smith function in their self-interest. An interesting proposition towards the same is put forth by Sharon Moalem in his book Survival of the Sickest . His propositions are worth being reminded of. To any microbe, as it is to any living being, the primary objective would be to ensure the survival of the species into the succeeding generations. Therefore, the symptoms manifested during an illness are in essence tools for the microbes to spread their habitat. It would not be wrong, to paraphrase from Moalem’s words that humans during an illness are under a spell of ‘microbial hynoptism’. The hypnotic spell makes one sneeze during cold so that the rhino virus causing the cold gets expelled from the system and move on into another system. Therefore, cold does not create immobility because the only way the virus can apparently spread is through human contact. In case of malaria however, the microbe has a third party vector, the female Anopheles mosquito which ensures the disease spreads from person to person. The person thus is immobilized for vector spread. In case of coronavirus, the spread is primarly through human contact and thus in large set of population, to validate from Moalem’s hypothesis must not cause strong reactions that result in prolonged immobility or death. This would be contrary to the self-interest of the Chinese virus in perpetuating the species.
Secondly, as the vector spreads, the one most likely to do so would be the weaker strains. The stronger and more virulent of the strains will incapacitate people causing mortality thus ending the line of species there itself. The ones relatively weaker will pass from person to person thus becoming the dominant strain over a period of time. The natural mutations will also make the virus become weaker. The Spanish flu of 1918-1921 was eradicated primarily through this fashion. Reports from Italy for instance are suggesting lower viral loads in the cases being reported of late and lesser impact as relative to the ones reported in March-April at the peak of the epidemic. In India too, large percentage of cases are asymptomatic or with very mild symptoms losing their infectiousness in about ten days. This is an important reason as to why ICMR must publish CT values and the reproduction ratio and their inter-linkages.
Coming back to the vaccine, it is on the same alignment of the propositions elucidated by Maolem. In fact, almost every major vaccine that has emerged has borrowed from the same principles perhaps subconsciously but nevertheless effective. It was the Jennerian model that is at work and perhaps could save the world from the effects of the Wuhan originated virus. At heart, is the attenuated virus that hardly has the potential to create any damage to the human body. Yet the presence of the virus creates antibodies that protect the body for a reasonable time in the future. The RNA vaccines have never been tested before and therefore in all probability will take quite a bit of time before they can be commercialised on large scale. The best chance still lies in the attenuated virus being used as vaccine.
The game plan of ICMR seems to be predicated on a simple strategy. Phase III trials often involve in excess of ten thousand people. The vaccine must prove itself in the natural environment rather than the controlled clinical environment to be validated for efficacy. What ICMR might do is to scale up the phase III trials to more than a lakh or two of population residing primarily in the hotspots like Mumbai and Delhi. There would be twinfold achievement. Containing the viral spread as also validating the vaccine in a natural environment that gives India a major edge in the global battle for vaccine. The precautionary principle is sought to be traded off for some degree of permissionless innovation given the circumstances that exist today. There would also be a lead time for building up the vaccine manufacturing facilities to enable the mass vaccination across the country and perhaps across the world. In case, the attenuated virus does demonstrate contagiousness, the ones spread will be the weaker versions hardly causing any visible impact or at least hopeful of the same. Further this spread will be more an induced mutation than a natural one catalysing the demise of the Chinese virus.
As one seeks to decode the message aside of the signals it sends to the rest of the world, the idea is perhaps to create short term immunity and keeping the virus at bay till a longer and more effective version emerges. The idea that vaccine might be effective in India will send the other pharmaceutical companies into fast tracking their own versions. It is a winner take all approach in the global market and no firm would likely to be left behind. The regulatory decisions are often political and firms are good at lobbying politically to gain foothold in various markets. Each country would like to liberalize its tracking process to circumvent any possible edge to an Indian vaccine firm. It cannot be ruled out the message being sent is not just a domestic morale booster but an implicit message to the rest of the world to pull their socks and bring their offers into the market in a quicker time. Either way, notwithstanding the hype and (hopefully not) perhaps disappointment, it might be a win-win for Indian policy and pharmaceutical firms.
Thoughts on Theory and Practice 