Context: Three vaccine developers have now made applications to the Central Drug Standard Control Organisation (CDSCO), India’s drug regulator, seeking emergency use approval for their candidate COVID-19 vaccines which are still under trial. With this, the question of equitable distribution of a vaccine has come into the picture. It is as much a global concern as it is local.
Mains: GS IV- (Vaccination and ethical issues) Public/Civil service values and Ethics in Public administration: Status and problems; ethical concerns and dilemmas in government and private institutions; laws, rules, regulations and conscience as sources of ethical guidance; accountability and ethical governance; strengthening of ethical and moral values in governance; ethical issues in international relations and funding; corporate governance.
- For more than 200 years, vaccines have reduced rates of sickness and death, improved well-being, and enhanced human flourishing.
- A vaccine provides a dual benefit: a direct benefit to the person receiving it, and an indirect benefit to other members of the community through the creation of herd immunity.
- Thus, there are both self-interested and altruistic reasons for being vaccinated.
- Vaccines are responsible for many global public health successes, such as the eradication of smallpox and significant reductions in other serious infections like polio and measles.
- Even so, vaccinations have also long been the subject of various ethical controversies. However, many ethical issues surround the development and use of vaccines.
- These issues include:
- Personal choice vs. the greater public good
- Development and testing of vaccines;
- Informed consent about the benefits and risks of vaccination; and
- Equitable distribution of vaccines.
India's Vaccination policy
- It may be assumed that the knowledge and wherewithal to run a full-scale vaccination programme rests with the health administration- both at the central and the State level.
- India has a fairly reliable vaccine delivery system for children, as part of the universal immunisation programme.
- However, in terms of scope, this is far wider; in fact, a mammoth task. All people in the country must have access to the vaccine, and, if necessary, periodic doses of it.
- Indeed, the mobilisation for this task in India should be nothing short of heroic, as and when the vaccine is available here.
- Meanwhile, the government must get its act together on developing a policy specific to the COVID-19 vaccine; from preparing resources- both material and human- for the manufacture, storage, distribution and delivery.
- This includes taking sensitive, but firm, decisions guided by evidence, on who will receive the vaccine, how, when and where. Putting down a standard operating protocol for every stage of the vaccine will serve the government well when the baton is finally passed on to it.
|Ethical Concerns in COVID-19 Vaccination|
- Personal choice vs the greater public good:
- Ethical debates and objections to vaccination and other mandates arise because some individuals and communities disagree with the mandates, and/or have religious or philosophical beliefs that conflict with vaccination.
- For example, in an effort to protect the greatest number of people, public health vaccine regulations may infringe upon individual autonomy and liberty.
- Tension results when individuals want to exercise their right to protect themselves and/or their children by refusing vaccination, if they do not accept existing medical or safety evidence, or if their ideological beliefs do not support vaccination.
- Ultimately, as with Hardin’s Tragedy of the Commons, as more individuals behave in a manner that fails to consider the common good, there is a detrimental effect on the overall well-being of the group and, therefore, on the well-being of each individual, including those individuals who chose to forgo vaccination.
- “Optimism bias,” with respect to COVID-19, as a lot of people tend to think that their personal risk is low, makes vaccination seem unnecessary to them. However, this behaviour can prove fatal in battling a pandemic like COVID-19 pandemic.
- Development and testing of vaccines:
- Ethical discussions also surround the research and testing of vaccines, including discussions about vaccine development, and study design, population, and trial location.
- To be licensed, vaccines go through many years of research and must pass rigorous safety and efficacy standards.
- The vaccine development and research process include diverse experts many scientific and social disciplines, including public health, epidemiology, immunology, and statistics, and from pharmaceutical companies.
- These stakeholders may have conflicting priorities and motives, which contributes to various ethical discussions.
- Sometimes researchers disagree about whom to include in vaccine trials.
- To properly test a vaccine’s effectiveness, a clinical trial including a control group that does not get the test vaccine is usually necessary.
- This involves careful assessment of accelerated clinical trials, involving long term safety of volunteers.
- Additionally, it is important to understand a vaccine’s safety and efficacy in various populations, but testing a vaccine in vulnerable populations, such as children, also raises ethical concerns.
- The boundaries of pharmaceutical companies are being stretched to approve COVID-19 vaccine in record time raises concerns about efficacy.
- Informed consent about the benefits and risks of vaccination:
- Ethical debates also surround vaccine implementation and delivery, such as those concerning informed consent.
- For example, Ethical discussions are a key component of HIV vaccine research and development because HIV vaccines pose numerous unique ethical challenges.
- AIDS stigma may put vaccine trial participants at psychological risk if they encounter discrimination.
- In addition, researchers have to figure out how to provide appropriate and adequate medical care and protection from stigma for participants who screen HIV positive.
- And, researchers have to consider that if participants misunderstand the trial, they may think that they are protected from the virus and put themselves at risk.
- The complexity of these issues places ethics analyses at the forefront of HIV vaccine research.
- Requiring specific consent is ethical and appropriate, so that patients are better informed about vaccines, and have adequate time to ask questions if needed.
- Public trust in the efficacy and safety of the vaccine is crucial whenever a new vaccine is launched.
- Equitable distribution of vaccines:
- A recent Lancet study pointed out, some wealthy nations have secured more than 2 billion doses of potential future COVID-19 vaccines using advance purchase agreements. This would certainly create a scarcity for developing countries like India.
- Several vaccine shortages have made headlines over the last 10 years.
- Shortages result from too few vaccine producers and suppliers.
- From an ethical perspective, increasing the number of vaccine producers would greatly influence health positively.
- When vaccines are in short supply, medical providers must make decisions about who should be protected, and who must be left vulnerable to disease.
- It may be argued that healthcare workers fighting the pandemic at the forefront are most vulnerable to contracting the disease and hence they need to get it first. Or, the elderly with comorbidities need to be vaccinated first.
- To further complicate matters, the places with poor infrastructure to support wide-scale vaccination may face many competing health and social priorities.
- Public health and medical officials must make difficult decisions about which health needs to address, and how to incorporate vaccination into often-scarce services.
|COVID-19: Vaccine Distribution Ethics|
- As COVID-19 continues to take the world by storm, and vaccine developers race toward safe and effective candidates to stem the tide of the pandemic, health officials and policymakers are grappling with a significant philosophical and ethical challenge: how to best allocate limited vaccines doses to the world’s population.
- Below is an overview of some of the ethical dilemmas:
- Number of life saved
- The risk to die from COVID-19 especially increases over 85, which accounts for about 45% of the mortality.
- The risk is higher among the elderly who reside in care homes, where the risk of infection is higher than in the case of elderly living in isolation or with few contacts.
- Other risk groups include being the recipient of an organ transplant, haematological cancers, certain neurological conditions, chronic kidney disease, immunosuppression, dementia, stroke, diabetes, chronic pulmonary disease, obesity, malignancy, liver disease etc.
- Implicit in the idea of prioritising care home residents and workers, as well as healthcare workers is that this will significantly reduce infections among those at the highest risk.
- This principle could be extended to anyone who has contact with vulnerable people, such as carers.
- If we prioritize this criterion, then we are likely to maximize the number of lives saved.
- However, there are plausibly other values, apart from saving lives, which should be included or at least considered.
- Years of Life Saved
- In a related but different way, those who have most life years to gain are usually those who have so far lived the least. Thus, age itself may be an independent value on the grounds that young deserve to have their life saved because they have had less life.
- It is plausible that what matters is not only whether a person’s life is saved, but how long it is saved for.
- It is morally different to save a person for 50 years than it is to save them for one year.
- These values (probability of survival and length of survival) can be combined into the notion of “expected life years gain”.
- Expected life years gain is calculated by multiplying the probability of survival x duration of survival.
- Here is an example of a quick calculation of how this might work.
- The mortality rate from COVID-19 for 60-64-year-olds has been estimated (in absence of other risk factors) as somewhere between 1% and 3.6%.
- Assuming 100% vaccine efficacy, and given an average life expectancy for a 62-year-old male of 85, a vaccine would give this person an extra 23 years.
- The expected utility, where utility is defined in terms of life-years gain, is 0.69 per case of COVID-19 avoided.
- On the basis of the same calculation, the expected utility for people aged 80-84 years old (age-specific mortality rate around 15% according to the most pessimist estimates) is 1.2. For 40-49 years old, it would be 0.156.
- This simple calculation suggests that the greatest benefit might be achieved by targeting the vaccine to the elderly
- This is essential in a situation of limited availability of resources.
- Current estimates suggest that vaccination is most cost-effective in terms of quality-adjusted life-year(QALY) gained if targeted at groups with a higher risk of hospitalization and death.
- Indeed, vaccinating patients at the highest risk from COVID-19 would potentially save more money than it cost. The model suggests that the vaccine would still be cost-effective if targeted at adults aged 50-64, although each QALY would, in that case, be more costly – which in conditions of limited resources means that fewer QALYs can be gained, other things being equal.
- However, other factors need to be considered.
- Vaccine Effectiveness
- A vaccine may have different levels of effectiveness in different groups.
- Flu vaccination, for instance, is much less effective in the elderly as their immune systems fail because of immunosenescence.
- Targeting the young might better protect the vulnerable via indirect protection.
- For example, if the vaccine were only 50% effective in over 80-year-olds, it could make sense to prioritise the 60-year-olds if the vaccine is fully effective in them.
- In this case, vulnerability is not the only or even the primary criterion for prioritization in access to the vaccine.
- High-Risk group
- Those whose role is more important during pandemic might permissibly be given higher priority if their getting sick would translate into significant societal harm.
- Although the idea might appear controversial, the public does give moral weight to “social worth”
- Adopting this criterion, we might, for instance, give priority to “key workers” (e.g. those working in hospitals, police, garbage collectors, those in delivery services, etc) who must go to work to keep the economy functioning and expose themselves to greater risks.
- Affordibility & Accesibility
- Ensuring affordability implies that ability to pay, or a person’s health paying capacity, could determine who gets access to a vaccine and who doesn’t.
- For example, the rich can afford to early vaccine access with perquisites, as private plane rides out of town, calls with world-leading experts and access to luxurious medical care.
- The government can put price controls regulations that would cap or set prices—provide an effective approach to vaccine affordability and thus accessibility.
- However, if impose price controls, vaccine manufacturers might opt to not sell or supply adequate quantities, prioritising high-profit markets instead.
- Number of life saved
- Private entities such as pharmacists and testing labs could be enrolled as authorised agents of the state government to deliver vaccinations.
- They could administer the vaccine to eligible persons, identified by Aadhaar as being part of the priority list, and charge a small fee for administering the vaccine.
- Those preferring to go to government dispensaries could still get a vaccination entirely free.
- Decentralised delivery will help to avoid crowding in public sector dispensaries which can easily turn into super-spreader events.
- It is essential to ensure that the distribution of limited vaccine supplies across states is done on a transparent basis.
- It could be the proportion of the total population; the proportion of new covid cases; or covid deaths which indicate the intensity of the infection or the age composition of the population.
- Each of these three criteria would give different results. All can be used by giving them weights.
- This calls for high levels of transparency on the criteria going into drug approvals and also on the results from the early vaccinations.
- Effective Communication
- Since the vaccine cannot be mandatory and has to rely on voluntary uptake, we need an effective communication strategy to counter fears.
- It would help to launch a campaign with prominent people being vaccinated publicly on TV to increase public confidence.
How Vaccines get approval in India?