COVID-19 Update

COVID vaccination poses both a challenge and an opportunity

Print edition : January 15, 2021

Celebrations in the Christmas week in Kolkata. As people get back to normal lives and social interactions increase, a second wave of the infection is a possibility that cannot be wished away. Photo: Swapan Mahapatra/PTI

A volunteer undergoing Covaxin clinical trial at Civil Hospital, Sola, one of the hospitals selected for vaccine trials, in Ahmedabad on November 27. Photo: VIJAY SONEJI

It would be premature to believe that the epidemic has burnt out and unpardonable to leave the population unguarded against a possible catastrophe. That is why the vaccine is so welcome, but there are many challenges in its administration.

As the year comes to a close, there is finally some good news on the COVID-19 front. The number of new cases has gone down quite dramatically, and a vaccine has become available. Both are highly awaited developments. But it is not yet time to celebrate.

At its peak, around September 11, 2020, India was recording over 97,000 new cases and 1,250 deaths a day. As of December 15, the figures dropped to 26,401 cases and 380 deaths a day. What could be the reason for this decline? Could it be effective public health control, or just poor measurement, or has herd immunity crossed the threshold levels? Or is this just the lull before the storm—a deferred epidemic, the worst of which is yet to come?

Poor measurement is no doubt a problem. One has to account for the fact that the five or six top performing States in terms of traditional health indicators like maternal and child survival, and whose social determinants of health are clearly better, have the highest number of reported cases per million or of deaths. The degree of under-reporting was estimated in one study as about 90 missed infections for every detected case. While the two States, Delhi and Kerala, with the highest rates per million of the population missed about 25 infections for every detected case, the proportion of missed cases in States with weaker public health systems such as Uttar Pradesh and Bihar could be 300:1. Thus Kerala reports 19,034 cases per million and Uttar Pradesh reports only 2,436 cases, while the all-India average is 7,355 cases per million. On the other hand, the trend in the number of cases reported is likely to be more reliable than the absolute numbers. And there can be little doubt about a declining trend in the past two months.

Better care and ability to handle the spread may have improved the ability to flatten the curve. Access to testing has also increased, and further after the peak crisis months of July to October, beds for hospitalisation also became easier to access. It is likely that isolation of sick cases, whether in COVID-19 hospitals, or in care centres or at home, is now more robust than in the first few months of the pandemic. High levels of stigma could also paradoxically contribute to more sick people and contacts staying at home.

Another contributory factor for the decline in COVID cases is that in select population clusters the proportion of those who have been infected (otherwise known as herd immunity) has reached a level where epidemic spread no longer occurs. Spread at a lower rate does, however, continue. We still do not know the exact threshold level of herd immunity required for preventing epidemic spread. The most frequently cited figure is 60 per cent, but that assumes a level of infectivity which may change with changes in behaviours as well as the spread of mutant strains.

However, as is typical of all diseases with epidemic potential, there would be many clusters where the proportion of non-immune population is high, and outbreaks in such clusters would continue to occur. It is in such circumstances that most nations in the West are experiencing a huge second wave. In this second wave, the regions that did well in the first round are likely to do worse simply because the proportion of unimmunised persons is higher. We can see that to some extent in Kerala, which did very well in controlling the disease in the first few months but slipped into high levels of case incidence in later months.

The second wave is not inevitable, and a robust disease surveillance system backed with active testing, contact-tracing, and isolation or quarantine, can prevent this—as many nations in the Asia-Pacific region have shown. But premature celebration, and the resulting complacence that the epidemic is behind us, could leave us vulnerable to an intense second wave. And second waves, as we know from the 1918 flu pandemic, could be worse than the first.

Also read: Safety concerns delay vaccine approval in India

This is the big reason why the coming of the vaccine is so welcome. It would be premature to believe that the epidemic has burnt out and unpardonable to leave the population unguarded against a possible catastrophe. While the proportion of those with severe or fatal forms of the disease may be low, the absolute numbers are high enough to make this disease one of the leading causes of adult mortality in India. There has been one crore cases and 1.5 lakh deaths owing to this disease in 2020. Though it is possible that sub-clinical infections, undetected by the usual antibody tests, have provided herd immunity or that virulence of the virus has decreased, it is also possible that we would face a second wave with increased virulence. And even if herd immunity thresholds are adequate to break an epidemic spread, disease incidence and mortality may be high enough to cause serious public health concern. Good public health planning cannot rest merely on wishful thinking and a hope that the epidemic will slow down by itself. It is not only the mortality rates that are a cause of concern. The lockdowns in the wake of the epidemic spread have severely affected economic activities across the world, and the introduction of vaccination would go a long way in reviving the economy. Even in the industrialised world, which has fairly robust, universalised social security networks and universal health care, vaccines are urgently required to open up economies. Just as an RT-PCR test has become mandatory for most international travel, a proof of vaccination is certainly going to become a mandatory requirement for travel soon in all developed nations.

In countries like India, as normal economic life resumes, the degree of social mixing will sharply go up and may result in new outbreaks and cycles of lockdowns and unemployment. This would affect large sections of the working population with no social security and the absence of a return to normalcy may itself curb demand in a major way.

It is, therefore, not surprising that almost every single political party in India has promised free and universal vaccination against COVID-19 as soon as vaccines are available. These promises are loudest just before elections. But in official pronouncements, there is much backtracking from earlier commitments to free and universal access to this vaccine. Clearly, there are many challenges that any programme of vaccine delivery would have to address. Important among these are determining the effectiveness and safety of the vaccine, organising procurement and delivery, building capacity for storage and distribution, and determining priorities for immediate distribution, while planning for ensuring access for all.

Introduction of new vaccines

The first challenge is the ability to innovate an effective vaccine that would be appropriate to the Indian context. Any vaccine that is introduced has to undergo clinical trials that demonstrate that it at least provides effective protection against severe disease and reduces mortality along with a high level of safety, since normal persons are being given the injection. The big change in December 2020 is that there are now five vaccines that are on the market or close to being so, and according to information circulated, the mid-term third phase of clinical trials have found these to be effective. These are the Pfizer vaccine, the Moderna vaccine, the Oxford-Astrazeneca, the Russian Gamaleya of Sputnik V, and the Chinese vaccine CoronaVac. Of these, only the Oxford vaccine’s clinical trial data are published in a peer-reviewed journal.

Also read: Oxford vaccine enjoys advantages in race to beat COVID-19

The data of the others have been made available to national regulatory bodies, and different nations have provided “Emergency Use Authorisation” (EUA) for one of more of these. EUA is more of an early and temporary licensing method and only implies that the vaccine is likely to qualify for full approval once all the data are in. The World Health Organisation (WHO) itself has not certified any.

One concern regarding the clinical trials is that the end point used for measuring effectiveness is the reduction in symptomatic cases among those vaccinated as compared with the control population. While this is likely to be associated with reduced mortality, sample sizes are not as yet adequate to establish that. Post-introduction follow-up studies are needed to know for sure that it would be equally effective in the elderly and in persons with co-morbidities who are more vulnerable to fatality. The current sample sizes are too small even to establish safety adequately, and extensive post-introduction surveillance will be required.

Further, we do not know the duration of immunity these vaccines will provide, and though it could be life-long, it could also be as short as one year. We also do not know for certain that it will reduce asymptomatic infections and whether such individuals could continue to spread disease. Also, the vaccines till date need two doses spaced about a month apart to be effective.

All of this means that mass vaccination will need to be accompanied by extensive monitoring and surveillance. Thus, vaccination is not a one-off effort but has to be built into the structure of a comprehensive health systems approach with adequate outreach and surveillance. While digitisation of vaccination data could help to an extent, projection of such digitisation as a stand-alone or main solution and its use as a short cut to systems strengthening is insufficient and misleading.

Vaccine Logistics

The next major challenge is addressing the requirements of vaccine logistics, and this includes procurement, storage, distribution and vaccine delivery.

In procurement, both costs and the ability to ramp up domestic production are important considerations. The Pfizer and Moderna vaccines are costlier at approximately $20 and $33 per dose and are not under production in India. Gamaleya is $10 and there is only one company licensed to manufacture this. Oxford-AstraZeenca is relatively affordable at $ 4, but this would still be costlier than any vaccine we currently use. There is an Indian version of this vaccine, called Covishield, which is ready for manufacture in India by the Serum Institute of India (SII) under voluntary licensing with Astrazeneca, and potentially its production can be scaled up. But, there are no binding agreements as yet with the Indian government, though the SII has agreements for advance purchases with many industrialised countries and the international COVAX Facility. Nor has the government announced any budget on what it is willing to spend for such vaccination or even a White Paper outlining its proposed strategy.

When it comes to storage and distribution, the Pfizer vaccine, which requires minus 70 degree Celsius storage facilities, becomes an unviable option in Indian circumstances. Moderna’s requirements are less (minus 15 to minus 25 degrees C), but still far in excess of Indian cold storage capacity. The Oxford-AZ vaccine and the Russian and Chinese vaccines, however, need only +2 to +8 degrees C temperature for storage. But, given the volumes, even this would be a challenge. Existing vaccine supply chain requirements largely cater to children below one year of age, and to expand from that to vaccinating the entire population is a huge leap. Uninterrupted, safe and reliable supplies at tens of thousands of delivery sites also require well-functioning logistics management systems, and except in three or four States, these too are under-developed.

Additional capacity vs re-purposing

Increasing capacities to vaccinate a major part of India’s population requires a substantial increase in storage infrastructure, equipment, vaccine transport vehicles, and, not least, a tremendous investment in human resources. This requires financial resources but it also needs the time to build the physical and organisational structures required.

Instead of investing in increasing infrastructure and human resources, the government would be tempted to simply re-purpose existing primary health-care capacity to take on this load. Such re-purposing displaces essential health services and can cause untold and unmeasured harm to people’s health. In an earlier phase, the government created bed capacity for managing severe cases of COVID 19 by converting busy public hospitals providing a wide range of tertiary health care into dedicated COVID hospitals. This in effect was a cessation of essential public hospitals services, and the displaced patients were pushed into the high-cost private sector (often not even that, for the private sector was itself shut down).

Also read: Will antibodies be able to protect us from COVID-19?

There is a similar danger in initiating COVID-19 vaccinations through the existing public sector, without the necessary increase of infrastructure and human resources. If even a part of existing staff and infrastructure are simply re-purposed, other chronic diseases like tuberculosis and HIV (human immunodeficiency virus) infections are likely to see a huge rise, and hard-won achievements in maternal and child survival may face a setback. And other epidemic-prone diseases can flare up.

For a second generation of vaccines

In the coming year a number of new vaccines are likely to enter the market. Across the world, over a hundred vaccines are being developed and many of these could have advantages over currently available vaccines. India itself has an indigenously developed vaccine, Covaxin of Biotech, which has entered the third phase of trials. Fortunately, political pressures to prematurely certify this product have been checked, giving the researchers time to develop more evidence and credibility for the vaccine. Advantages that future vaccines could provide include a single dose requirement as compared with two doses currently; a longer duration of immunity; ability to store at room temperature; or easier ways to administer, such as drops. And the next generation of vaccines need to be even more affordable and be part of domestic manufacture, so that supplies are reliable and there is no drain on national revenue. The possibilities are immense.

All of this will require research institutions in India and all over the world to press ahead with their research. But current global innovation regimes can be an impediment to the discovery of new and more appropriate drugs and vaccines. They have so far failed to deliver on any curative medicine for COVID-19 and failed to share information on or transfer technology for better vaccine development. Vaccine developers are working in silos in competition with each other, when the need is for shared information and collaborative work. To address this bottleneck, in one of the most significant developments in global trade policy since the Doha declaration, India and South Africa have sponsored a joint resolution calling for the suspension of a wide variety of intellectual property rights to enable research, innovation and transfer of technology for new COVID-19 products and for scaling up manufacture of existing products. This resolution has found support from most developing nations, but predictably been opposed by the same few developed nations who support and profit from big pharma. But this is an opportunity for developing nations to push ahead with or without the waiver, to develop more relevant approaches to innovation and manufacture of essential medical products.

Prioritisation

Even in the best-case scenario, it is difficult to imagine going to scale with extensive vaccination programmes in India before the middle of 2021 and reaching a substantial proportion of those in need before the end of 2022. Therefore, the question of who will get priority access to free vaccines becomes all-important. WHO has already released two (read here and here) guidance documents to define the principles and goals that national and global policies should prioritise.

In India a committee has been constituted (National Expert Group on Vaccine Administration for COVID-19, or NEGVAC) and plans have been drawn up, though such plans are far from transparent or participatory. What we do know is that the plans prioritise all health workers who are estimated at about one crore, then all front-line workers defined as including the police, armed forces and civil defence, and municipal workers estimated at about two crores. After this, it is the elderly and those with co-morbidities, estimated at 27 crores, who would be the priority.

There are other important categories that are not mentioned. Two of the five principles that WHO spells out are equity, which is understood as reaching out to those more vulnerable for socio-economic reasons, and reciprocity, which is defined as “those who bear significant additional risk and burden of COVID-19 response for the benefit of society”. By these criteria migrant workers who would be travelling across States and face high exposure owing to their working conditions, and who lack access to health care and social security should also be on the priority list. While those on international travel will be certain to access the vaccine as an entitlement, it remains to be seen whether working people and all sections that cannot practise social distancing will have an entitlement to get free vaccines. Only a commitment to universal access to free vaccination would ensure this.

Also read: COVID-19 patients are being treated with drugs such as itolizumab despite insufficient evidence on their efficacy

Faced with financial, logistic and managerial constraints, it would be tempting for the government to adopt a policy where vaccination of a small part of the population is paid for and the rest is left to the private sector. It would be relatively easy for the government to get away with such a minimal intervention policy. Without a major health communication effort there is likely to be a lack of expressed demand for the vaccine in large segments of the population characterised by low health awareness. Stigma is already one of the big barriers for access to care in most under-developed regions. In such communities, herd immunity would soon decrease the rate of spread of the disease, and excess mortality could go unnoticed. Government inaction on the vaccine front could also get re-enforced by more modern forms of vaccine hesitancy in sections of civil society.

Finally, while vaccines may become available, recognition has to dawn that vaccines are public goods only if vaccination is a public good. Further, that universal vaccination will be feasible and justifiable only if it goes along with the strengthening of health systems in a manner that recognises the entire public health system as a public good.

Universal vaccination is not only the act of giving two doses of vaccine to all eligible individuals. It includes building up extensive disease surveillance systems which in turn requires extensive outreach services as well as testing capacity, and the ability to identify, manage and compensate those who develop complications, and continue with both public health measures and hospital care for some time to come.

The rising tide of people’s movements should find in this crisis an opportunity to push the government to honour its political commitment to provide universal vaccination as part of ensuring the people’s right to health and health care.

Dr T. Sundararaman is Global Coordinator, People's Health Movement, and former Executive Director, National Health Systems Resource Centre, New Delhi.

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