Ethical Dilemmas and Challenges involved in Covid-19 Vaccine Delivery

Please Share with maximum friends to support the Initiative.

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.

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:
    1. Personal choice vs. the greater public good
    2. Development and testing of vaccines;
    3. Informed consent about the benefits and risks of vaccination; and
    4. Equitable distribution of vaccines.

Case Study

  • Sometimes vaccine mandate controversies include multiple and interrelated ethical dilemmas.
  • This is the case for the vaccine for the human papillomavirus (HPV), a sexually transmitted disease (STD).
  • The US FDA approved the first HPV vaccine in 2006.
  • After the ACIP recommended three doses of the vaccine for girls aged 11-12, various state legislatures attempted to mandate vaccination.
  • Ethical objections to this mandate have ranged to include religious concerns that a vaccine to protect against an STD contradicts abstinence-based messages; fears that the vaccine could potentially force a child to undergo an intervention misaligned with her family’s beliefs; and
  • Human rights questions about the fairness of providing a vaccine to one sex only (though now in the United States the vaccine is recommended for all adolescents).


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


  1. 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.
  2. 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.

  3. 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.
  4. 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 
      • Cost-effectiveness
        • 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.
Way Ahead
  • Decentralization
    • 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.
  • Transparency
    • 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. 

Additional Information

How Vaccines get approval in India?

  • What are these vaccine candidates?
    • COVISHIELD: Pune-based Serum Institute of India has sought approval for its version of the vaccine developed by Oxford University and AstraZeneca, which it has been testing in India for the last few months. The candidate is currently in phase-III trials in India. In its application, Serum has submitted the safety data from a phase I and phase II trials, while the effectiveness data has been sourced from phase-III trials of the same vaccine in the UK and Brazil.
    • COVAXIN: Bharat Biotech, a Hyderabad-based company that is developing a vaccine, Covaxin, in collaboration with the National Institute of Virology, an ICMR institute in Pune, has started phase-III trials only recently and is yet to enrol all the participants as per its design. Its application is based mainly on the safety data from phase-I and phase-II trials.
    • BNT162b2: the US pharmaceutical major Pfizer hasn’t carried out clinical trials in India of its vaccine, developed in collaboration with BioNTech, but has still sought approval to use it here based on the results of the trials conducted in the US. The Pfizer-BioNTech vaccine is the first one to receive the regulator’s approval anywhere in the world, having been granted emergency use authorization in the UK last week.
  • What are the regulatory provisions for the approval of vaccines in India?
    • Clinical trials of new drugs and vaccines, and their approvals, are governed by the New Drugs and Clinical Trials Rules, 2019. 
    • The 2019 rules provide for an “accelerated approval process” in several situations that would include one like the current pandemic.
    • In such situations, there is a provision for granting approval to a drug that is still in clinical trials, “provided there is a prima facie case of the product being of meaningful therapeutic benefit”.
    • “Accelerated approval may also be granted to a new drug if it is intended for the treatment of a serious, or life-threatening condition, or disease of special relevance to the country, and addresses unmet medical needs,” one of the relevant provisions of the Rules says. The definition of a new drug in the 2019 Rules includes a vaccine.
    • Further, it makes it clear that a new drug, or a vaccine, can be considered for approval if “remarkable” effectiveness is reported even from phase-II trials.
    • “If the remarkable efficacy is observed with a defined dose in the phase-II clinical trials of the investigational new drug for the unmet medical needs of serious and life-threatening disease in the country, it may be considered for grant of marketing approval by the central licensing authority based on phase-II clinical trial data.
    • In such cases, additional post-licensure studies may be required to be conducted after approval to generate the data on a larger population.
    • Accordingly, the approval granted to drugs or vaccines that are still in clinical trials is temporary and valid only for one year. 
  • How different are Indian regulations from those elsewhere?
    • Some provisions in the 2019 Rules, like those mentioned above, are different compared to what has been prescribed by the US Food and Drugs Administration (FDA), which had issued very specific guidelines for approval of vaccines for Covid-19.
    • The FDA has made it clear that an emergency use authorization can be considered only after sufficient data from phase-3 trials are generated, and an application cannot be made on the basis of data only from phase-1 or phase-2 trials. 
  • What about vaccines that have done well in trials outside the country?
    • The 2019 Rules do not say anything specific about whether data from a trial conducted in another country can be considered while assessing an application for accelerated approval to a drug or vaccine to be used in India.
    • But the Indian health authorities have said they were keeping an open mind, and it would all depend on what scientists and experts make of the data that are presented to them.
    • In making this assessment, the expert committee in India would be willing to look at data generated during trials conducted in other countries as well, as is the case with the applications made by Serum Institute and Pfizer.

Please Share with maximum friends to support the Initiative.

Enquire now

Give us a call or fill in the form below and we will contact you. We endeavor to answer all inquiries within 24 hours on business days.