A syringe with a vaccine is seen ahead of trials by volunteers testing for COVID-19 at a research centre in Johannesburg, August 2020. Photo: Reuters/Siphiwe Sibeko.
As India’s COVID-19 case load tops 50 lakh, and death toll due to the diseases cross 82,000, many believe that this is just the beginning of the more unprecedented part of the ongoing pandemic. The Indian Council of Medical Research (ICMR) recently had the results of its first national seroprevalence survey published. They indicate that India had more than 64 lakh COVID-19 infections (among adults) in early May 2020. The ‘infection to case ratio’ (ICR) was 81.6, which means for every confirmed case of COVID-19 in India, around 81 individuals were infected with the virus (during the survey period at least).
In early May this year, India was testing less than one lakh samples per day, but this has now increased to more than 10 lakh a day. As the testing capacity has been scaled up significantly since May, the ICR should have gone down since. Nonetheless, a large fraction of the Indian population remains vulnerable to COVID-19, and can be protected with a safe and effective vaccine as and when it becomes available.
However, this is easier said than done. The first issue obviously is the approval of a safe and effective vaccine, and then its availability – in a phased manner – and accessibility to all Indians, which can take several months after approval. Right now, there are several vaccine candidates around the world at different stages of clinical trials, and new vaccine candidates are joining this race.
History tells us that only a handful of these candidates will eventually be approved for use. Specifically, candidates at the preclinical trial stage have a roughly 7% chance of succeeding, while those that make it to clinical trials have a 20% or so chance. But even with accelerated trial protocols, it is unlikely that we will have a vaccine by the end of this year (excluding those that receive emergency use authorisation).
In this scenario, it is imperative for India to critically examine the global COVID-19 vaccine development scenario and ramp up its own efforts to secure an effective and safe vaccine for its population in time.
While the vaccine race is on, governments around the world are currently competing to ensure their respective populations have access to a sufficient number of doses. As part of Operation Warp Speed, the US government has signed deals worth billions of dollars with vaccine makers, to provide vaccines to its population by January 2021. A coalition of four European nations – France, Germany, Italy and the Netherlands – has set up the Inclusive Vaccines Alliance to have early vaccine access for their people as well as to have vaccines manufactured in Europe. The UK has signed deals with AstraZeneca, Pfizer/BioNTech and Valneva for 190 million doses all together. China is hoping to use its battery of vaccine candidates (four of them in phase 3 trials) to secure a geopolitical advantage.
However, WHO director-general Dr Tedros Adhanom Ghebreyesus recently expressed concerns over vaccine nationalism. He warned that such an approach wouldn’t end the crisis as much as extend it, since the competition could lead to unnecessary price hikes, and encourage parties to hoard vaccines, precipitating a life-threatening shortage for those who need it elsewhere.
In April this year, the WHO and several other organisations had launched a global collaboration named ‘Access to COVID-19 Tools’ to accelerate the development, production and equitable access to COVID-19 diagnostics, therapeutics and vaccines. As part of this accelerator, WHO, the Coalition for Epidemic Preparedness Innovations and Gavi – a ‘vaccine alliance’ – have launched COVAX, an initiative to ensure COVID-19 vaccines are available around the world, including in low- and middle-income countries.
Members of COVAX are currently in talks with vaccine manufactures as well as representatives of 172 countries, including India. Some 80 countries have already joined the coalition, including Japan, Israel, the UK, Brazil, Canada, Norway and Switzerland.
Right now, COVAX has nine vaccine candidates in its portfolio. Of these, two – the Oxford vaccine and Moderna’s vaccine – are in phase 3 clinical trials. Additionally, nine more candidates are currently being evaluated for inclusion. All COVAX participating countries will have equal access to these vaccines once the latter are ready. In the first phase of distribution, all countries will receive doses equal to 20% of their population. The initiative aims to have two billion doses available by the end of 2021.
In the hyper-connected world we live in today, no one is safe until everyone is safe. From this point of view, COVAX is a major step forward to ensure global health security, particularly by making sure low-income countries are not left behind in the competition to secure enough doses.
India has the second-largest population in the world, with a sizeable number of elderly people and people with comorbidities. At the same time, it is one of the major vaccine-producing countries, and will certainly play a key role in the production of several approved vaccines. Serum Institute of India, Pune, has already signed a deal to manufacture the Oxford vaccine. Dr Reddy’s has tied up with the Russian Direct Investment Fund to distribute 100 million doses of the Sputnik V vaccine.
While India’s two homegrown vaccine candidates, Bharat Biotech’s Covaxin (with ICMR) and Zydus Cadila’s ZyCoV-D, have shown promise thus far, although the results of the phase 2 clinical trials they’re both in are yet to be seen. Against this background, let’s consider the fact that India is yet to enter into any formal deals to secure vaccine supplies.
The question facing India is this: should it wait to approve its homegrown vaccine candidates or should it sign a deal with the companies or governments behind candidates currently in phase 3 trials – either through COVAX or on its own?
It is understandable that in addition to science, various geopolitical factors will play a role in this decision. However, waiting might not be the best option for a country of more than a billion people, and India should proactively explore all options right now to ensure vaccines are available at the earliest, once approved.
And the time to act is now. When the candidates currently in phase 3 clinical trials receive their respective approvals, manufacturers will be contractually obligated to fulfil advance orders first before availing the doses to others. By that time, even granting homegrown candidates an ’emergency use authorisation’ wouldn’t be a viable option, since people would prefer the approved vaccines.
Now, while entering into agreements for individual vaccine candidates is an option, COVAX provides access to a portfolio of vaccines. There are of course pros and cons to joining COVAX. For example, by joining this coalition, India will not be required to negotiate individually with multiple manufacturers, or put all its apples in one or even a few baskets. COVAX has access to several vaccine candidates, so joining this group would provide a sort of insurance against the risk of securing early availability of vaccines for up to 20% of the country’s population (in phase one).
Moreover, it’s likely that India and the world will be responding to the novel coronavirus and its effects on society even after 2021, so securing sustained – instead of patchy – supply of vaccines will become crucial in the long-run.
If India decides to join COVAX – the deadline is September 18 – it will certainly be a boost to COVAX and a major blow to ‘vaccine nationalism’.
As such, India can bargain for a few things in exchange for its participation: (i) inclusion of at least two vaccine candidates from India in the portfolio, provided the candidates fulfil COVAX’s requirements; (ii) at least 20% of all vaccine manufacturing for COVAX should be done in India; and (iii) India should have a seat at the tables of all major decision making bodies.
This said, the huge upfront cost commitment to join COVAX is a major consideration. COVAX is currently also drawing flak for its population-based distribution policy, and lack of transparency. All countries may not be equally affected by COVID-19. However, population-based distribution doesn’t account for factors like the number of senior citizens and the number of people with comorbidities in a country. And yes, COVAX needs to be more transparent with regards to identifying vaccine candidates and placing advance orders.
COVID-19 is certainly not Earth’s last pandemic. In fact, the planet is likely to periodically face large-scale epidemics and pandemics involving new microorganisms. As such, the current pandemic is an opportunity for the world to come together and develop a joint framework of collaboration and commitment on issues on the use of critical health resources, like vaccines, to ensure global health security.
Mahesh Devnani is an associate professor of hospital administration and joint medical superintendent at PGIMER, Chandigarh. The views expressed here are the author’s own.