The first task at hand, and already underway, is identifying the vaccine most appropriate, available and affordable for India.
Not unexpectedly, after months of bitter struggle, the world is witnessing a euphoria, bordering on exultation, around the emergence of a handful of Covid-19 vaccines. India is no exception. Perhaps on the back of this optimism, it is experiencing faster than anticipated economic recovery, the stock market is booming, and more significantly, there is a palpable uplift in the general mood and confidence. Many now believe that the success of the three of four vaccines currently either undergoing late stage human trials, or awaiting full regulatory approvals, means that the end is in sight of the widespread derailment and devastation caused by the insidious coronavirus.
Fairly soon, much like the richer nations, India (with about ten million people already infected by Covid-19) should have access to vaccines against the dreaded pathogen. However, before we get our jabs, we need to deal with a number of wide-ranging issues with alacrity and dispassion. These include assessing the relative efficacy of the developed antidotes, making calls on rolling them out, broadly knowing they will not be 100% effective, and evolving the elaborate delivery logistics required, including the appropriate cold chain. Understandably, time would be taken to finalise the procurement of adequate quantities of the short-listed vaccines and landing on its pricing, combined with the thorny issue of figuring out an equitable order to distribute them. Finally, the identifying and skilling an army of vaccinators with the appropriate wherewithal to administer the vaccine would need to be undertaken in a time bound manner.
The more important element in this plan will centre on issues of scale and speed with which this herculean exercise has to be undertaken. In Phase 1, between January and August 2021, the plan is to inoculate 300 mn people as per the government appointed National Expert Group on Vaccine Administration (NEGVAC). This includes 10 mn healthcare workers, 20 mn “front line warriors” (largely public personnel performing Covid related mitigation roles) and 270 mn above the age of 50 and others with co-morbidities. While identifying such sections is warranted, we have yet to address the prioritisation post the first phase, as well as whether the vaccines will be available in the open market to purchase. To put the numbers in context, to attain even so called “herd immunity”, about 60% of the population (close to 800 mn) will need to be vaccinated—which, keep in mind, would need two doses each.
With the virus’ known contagious nature, the primary, if not entire responsibility of a successful roll-out and execution, is likely to fall on the country’s fragile and inadequately funded public health system and infrastructure, rather than upon private health care players. Even in terms of financial and physical resources, the Centre and State governments will need to tap into their own pools and monetary reserves. Unfortunately, meaningful large-scale philanthropy and community endeavours have yet to fully embed themselves in the grain of Indian private enterprise (interestingly, it is the Central public sector and publicly funded institutions, and not the country’s growing number of wealthy people that have hitherto majorly contributed to the PM Cares Fund set up to attract donations for coping with Covid-19).
The first task at hand, and already underway, is identifying the vaccine most appropriate, available and affordable for India. None of the hurriedly developed contenders have yet undergone the entire gamut of prescribed human trials to be permitted for wider use and sale in the open market. With most of them using the novel mRNA messenger platform that makes the immune system produce antibodies, as of 15 December, emergency use authorisation (EAU) has been granted to only two vaccines in limited geographies viz. US, Canada, Mexico, UK, Singapore, Israel, Saudi Arabia, UAE and Bahrain.
The arguably front-runner, jointly developed by the American company Pfizer and the German BioNtech, which claims success in 95% of clinical trials conducted on 44,000 people, has been cleared for emergency use in the UK, US, Canada, Mexico, Singapore, Israel, UAE and Bahrain. The Moderna (US) vaccine, developed using same technology and with similar efficacy , may get limited approval from the US’ Food & Drug Administration shortly. Neither, even in their limited trials has been tested on all sections of people, particularly of South Asian origin. Both, more so the Pfizer-BioNtech vaccine, are not thermostable and require ultracold temperatures from manufacturing through the entire supply chain till finally administered. Another potential indicator of their unsuitability for the developing world is the prohibitive pricing of US $35-40 per dose.
The vaccine developed by the Anglo-Swedish Astra-Zenca and Oxford University is based on an older platform used for producing the antidotes against diseases such as polio, small pox, typhoid etc. It uses inactivated or weakened chimpanzee cold viruses on a single strand of mRNA (which carries genetic information for protein synthesis to trigger an immune response in the patient’s body) and is expected to have 90% efficacy (earlier trials had shown it 60%). Its advantage in India over the Pfizer and Moderna vaccines would come from the higher temperatures required to conserve and carry it, something that may be more feasible in warmer tropical nations. At under $5 a dose its affordability is better. In anticipation of the approvals, it is being contract-manufactured by the Serum Institute of India, Pune. Now that UK has granted it EAU, similar permission should be forthcoming from the Indian regulators who have requested UK immunogenicity data.
Two other pharma players—American companies Johnson & Johnson and Novavax—are developing their inoculations on a platform similar to AstraZenca. They remain in late stage trials and EAUs may be authorised in the next few months. Both are also exploring ramping up their production in India, which, decidedly, has low cost advantages in its favour (70% of the world’s vaccines and 65% of global exports are from India, with Hyderabad’s Genome Valley a favoured vaccine-making location).
In addition, there are four indigenously developed vaccines that are demonstrating promise, though they remain at early stages of trials. The most advanced in the process of securing approvals is Covaxin of Bharat Biotech (Hyderabad), developed in collaboration with the Indian Council of Medical Research and National Institute of Virology. Zydus Cadilla (Ahmedabad) is next in queue, followed by Biological E Ltd (Hyderabad) undertaking stage 2 trials for a recombinant protein Covid-19 candidate, developed along with Baylor College of Medicine, Houston. The final Indian contender is by Gennova Biopharma (Pune) deploying the new mRNA technology but is in earlier stages.
Finally, the two other notable players in the global arena are RDIF/Gamaleya Research Institut, Russia with their Sputnik V (90% claimed efficacy) and China’s Sinopharma’s Sinovac (86% claimed efficacy). Both are under use in their home countries, and last week UAE approved the Chinese product. Reportedly, both vaccines have been offered to India and Dr Reddy’s Laboratory, Hyderabad and AstraZenaca have been approached by the designer of Sputnik V to collaborate in manufacturing and conduct of “mix and match” trials, respectively. For both vaccines, however, their technology-base and clinical trial-results are not yet in the public domain.
Across all these vaccines, there are several commonalities. On the positive side, none of them is based on live microbes, the use of which could interfere with patients with serious ailments like cancer, coronary malfunctioning and respiratory difficulties. They all seem to start providing immunity fairly soon (within a week or two of administering the second dose), and their known side effects are relatively mild, with headaches, body pains or fevers usually lasting no more than two days.
On the flip side, the issues of concern are that all have been developed in an unprecedented short time of 6-11 months. Hurried clinical trials have determined only their short-term safety and efficacy, and there is no clarity on their long-term effect. No extensive clinical trials have been conducted on pregnant women and minor children, and the EAUs in most places have been granted without dedicated country specific trials. Furthermore, none on the table has proved healing effects beyond 6 months or at most a year, and they will probably have to be periodically repeated. This is complicated further with the fact that the efficacy of stored vaccines rapidly diminishes after a rather short useful life (varying between a fortnight for Pfizer-BioNtech and 6 months for AstraZenca).
At the global level, it is imperative that relentless R&D efforts continue to enhance the reliability, durability and affordability of solutions to curb the onslaught of the dreaded coronavirus. Apart from the preventive vaccines, there should not be letting up on the evolving of effective therapeutic treatments, curative as well as preventive. Such efforts should not get overshadowed by the hunt for a vaccine.
For a country as populous and financially stretched as India, now is not the time for sitting back. No single vaccine will provide a silver bullet. We will have to watch roll-outs in developed countries, move fast in selecting vaccines (we may inevitably need them from multiple sources), and then set off on the arduous path of vaccinating a billion people.
Part 2 of this article, which focuses on the procurement, logistics, pricing and implementation of the vaccination process in India, will appear next week.
Dr Ajay Dua, a public policy specialist and a developmental economist by training, is a former DG ESIC and Union Secretary.