A vial of the Moderna COVID-19 vaccine Photo: CNS/Eduardo Munoz If significant numbers of people chose not to be vaccinated, the result could be significant loss of life and serious illness in the community and especially among those who are most vulnerable, writes Bishop Kevin Doran
Early in December 2020, the Irish Catholic Bishops issued a statement welcoming the progress that has been made in developing a vaccine for Covid-19. The statement encourages a generous response to the forthcoming vaccination programme on the part of Catholics and offers relevant ethical guidance. In this longer article, I hope to fill in some of the detail which could not have been included in a short statement. My intention is to present the teaching of the Church, against the background of what we know about vaccines in general and the Covid-19 vaccines in particular, and taking into account the reality of the Covid-19 pandemic. I hope this may be of help to people in making an informed judgement.
The prevention of illness and disease is an integral part of healthcare. Vaccination, as an aspect of preventive medicine, is recognised and encouraged by the Catholic Church as an essential element of the mission of healthcare professionals. Both the development of vaccines and the immunisation of whole populations are regarded as being “undoubtedly a positive step” when it comes to the prevention of infectious diseases. Thanks to large scale childhood vaccination programmes in the 1960s many diseases like TB, German measles (rubella) and polio have almost completely disappeared in Ireland.
As with any aspect of healthcare, it is important that vaccination programmes are developed and carried out in a way which serves the common good. Our moral responsibilities can be considered under three particular headings:
- The development and production of a vaccine;
- The manner in which the vaccine is tested;
- The fair and equitable distribution of the vaccine.
The Development of Vaccines using Attenuated Viruses
While the idea of vaccination has been explored for many centuries, it was only in the late eighteenth century that scientists began to develop vaccines using animals. This practice was refined during the nineteenth and twentieth centuries, as researchers explored how vaccines could be produced using the live virus itself. The virus is ‘attenuated’ (or weakened) by being grown over a number of cycles in conditions which cause it to lose its capacity for causing serious illness, while remaining strong enough to produce an immune reaction. This process requires a living biological ‘host’ in which the virus is grown. Over the years researchers have worked with cells taken from chicken or duck embryos, from rabbits, hamsters and monkeys.
Vaccination, as an aspect of preventive medicine, is recognised and encouraged by the Catholic Church”
Since the middle of the twentieth century, many vaccines, including some of those most commonly used to prevent childhood diseases were developed and produced using human foetal cell-lines as the ‘host’. These cell-lines were developed using biological tissue taken from specific identifiable foetuses aborted in the 1960’s. This has, understandably, raised serious moral concerns and conscientious objections.
Developing Covid-19 Vaccines
The rapid global spread of the Covid-19 virus has given rise to a great number of research projects aimed at producing a vaccine. The development of a vaccine which is safe, effective, and widely available represents the best chance of a return to normal living, for all of us, but especially for older people and those with serious underlying conditions. Alongside the technical and scientific questions, which tend to dominate, the concern has once again been raised that some of the Covid-19 vaccines make use of human foetal cell-lines.
Advances in science have given rise to significant variations in immunology, so that many vaccines today use cell-lines developed either from ethically sourced human cells (such as umbilical cord blood) or from animal cells (such as Vero monkey cells). The majority of the candidate vaccines for Covid-19 do not depend for their design, development or production on the use of human foetal cell-lines.
For many years, scientists have been exploring an approach to the production of vaccines using messenger RNA (or mRNA). The Pfizer BioNTech vaccine and the Moderna vaccine, which are among the first Covid-19 vaccines to be approved, use this new cutting-edge technology. Instead of weakened strains of the virus itself, they use chemically produced mRNA which mimics the action of the virus and trains the immune system to respond. Neither of these vaccines involves the use of human foetal cell-lines or indeed animal cells of any kind in its design, development or production, though it is acknowledged that they made use of a foetal cell-line for one of the confirmatory lab tests. State-of-the-art immunology is becoming distanced from association with abortion. The new mRNA vaccines may be the first in a whole new generation of vaccines.
A Note on the Morality of Using some Covid-19 Vaccines
What can we say about vaccines which do depend on the use of human foetal cell-lines? Does our use of the vaccines constitute some kind of immoral involvement with the original abortion, even if it took place many years ago? Does it suggest, even unintentionally, some acceptance of abortion or destructive research on human embryos as long as it is for a ‘good’ purpose?
What can we say about vaccines which do depend on the use of human foetal cell-lines?”
In December 2020, the Congregation for the Doctrine of the Faith (CDF), building on previous Church teaching, published a doctrinal Note, supporting the principle and practice of vaccination and providing moral guidance on the development, use and distribution of vaccines. This clarification, authorised by Pope Francis, confirms the guidance given by the Irish bishops as well as other episcopal conferences earlier in December. The CDF Note deals specifically with the question of whether it is morally acceptable to use vaccines which have been developed using existing human foetal cell-lines derived from abortions performed in the past. It does not set out to address the question of whether vaccines are safe or effective. This is an important question in its own right, which is primarily the responsibility of the scientific community and the health authorities of different countries.
Abortion itself is fundamentally immoral because it involves the taking of innocent human life. That remains true, even if the harvesting of foetal cells serves the purpose of medical research. But the question is not as simple as that. The Church has always made a distinction between formal (deliberate) involvement in an immoral act and material involvement, which may often be incidental and remote. Significantly, a remote material involvement, does not share in the immoral intention of the original sinful act. The recent CDF Note confirms previous teaching that, for those who are involved in biomedical research using foetal cell-lines, “there exist differing degrees of responsibility”, depending on the extent to which they have a voice in the decision.
In the context of a global pandemic, it is important to consider that vaccination is not simply a private matter”
In so far as there is a moral concern now, it does not relate primarily to abortions which took place in the past. The principal question at issue now is how our present choices might contribute to shaping biomedical research and development in the future. Catholics should, where possible, choose vaccines which do not depend on the use of foetal cell-lines. By expressing a clear, principled preference for “ethically irreproachable” vaccines, we make it clear that we do not want biomedical research in the future to depend on abortion or destructive research on human embryos. The Church encourages producers of vaccines and health authorities, even those which continue to use human foetal cell-lines, to make it clear that they reject the act of abortion and “to produce, approve, distribute and offer ethically acceptable vaccines that do not create problems of conscience for either health care providers or the people to be vaccinated”. The Pontifical Academy for Life states clearly, however, that “the burden of this important battle cannot and must not fall on innocent children and on the health situation of the population”.
The CDF Note recognises that various factors may make it impossible for doctors and their patients to actually choose a vaccine that is “ethically irreproachable”. The successful development of a safe and effective vaccine is just the first step. Other factors which may affect availability include transportation, storage, distribution and cost. Ultimately it depends on the decisions of individual governments to license and purchase such vaccines. In this way, it can be seen that moral decisions always have to do with what is practically possible. Nobody is morally required to do the impossible.
Before a vaccine is authorised for use in the general population, a series of trials takes place including, as a final stage, the testing of the vaccine on large numbers of people”
For all of these reasons, and taking into account the grave danger posed by the Covid-19 pandemic, the CDF Note states: “It must therefore be considered that, in such a case, all vaccinations recognised as clinically safe and effective can be used in good conscience with the certain knowledge that the use of such vaccines does not constitute formal cooperation with the abortion from which the cells used in production of the vaccines derive.” Catholics are free, therefore, to use any Covid-19 vaccine that is approved for clinical use, on the understanding that they themselves do not approve of or consent to abortion for the purposes of biomedical research.
A Question of Conscience:
Everyone is obliged to follow his or her well-informed conscience. In the context of a global pandemic, it is important to consider that vaccination is not simply a private matter. The CDF Note stops short of describing vaccination as a moral obligation. It does say, however, that “the morality of vaccination depends not only on the duty to protect one’s own health, but also on the duty to pursue the common good”. If significant numbers of people chose not to be vaccinated, for whatever reason, it would prove very difficult to achieve the required levels of immunity in the population. The result could be significant loss of life and serious illness in the community and especially among those who are most vulnerable, as well as long-term damage to social and economic life, which would impact on the population as a whole. This reality must inform any judgement of conscience. The only alternative to vaccination is to restrict one’s contacts until the crisis has passed. Any person who wishes to signal his or her rejection of the use of foetal cell-lines should consider whether there are other ways of doing so, than by refusing to avail of the vaccine.
Vaccine trials
Before a vaccine is authorised for use in the general population, a series of trials takes place including, as a final stage, the testing of the vaccine on large numbers of people. The pharmaceutical trial must establish whether the vaccine is effective and also whether it is safe. Such trials are not without their risks. Because there is risk involved, the testing of a vaccine on a human subject presupposes that the person concerned is fully informed, competent to make a decision and consents freely.
It is unethical to carry out biomedical research involving people who are not competent to give informed consent (for example, children or non-competent adults), unless there is a strong likelihood of personal therapeutic benefit which is proportionate to the health risk to the person in question. Similarly it would be unethical to use coercion to test a vaccine on people whose freedom to refuse is limited, like prisoners. The fact that the vaccine is for the common good would not justify violating the human rights of the individual human subject.
Pharmaceutical companies must be held accountable for ensuring that there are no short-cuts in the testing process which would expose end-users to disproportionate risks”
For reasons of public health and the protection of the global economy, there has been an understandable urgency attached to the development of an effective vaccine for Covid-19. Pharmaceutical companies must be held accountable for ensuring that there are no short-cuts in the testing process which would expose end-users to disproportionate risks. That is the role of the various regulatory authorities. Meanwhile, it is important for all of us to do our best to discern very carefully the reliability of any information that we find on social media, where opinion is so frequently presented as fact.
The distribution of vaccines
The costs of developing a vaccine are significant but the potential rewards are even greater. It is reasonable that pharmaceutical companies would wish to protect their ‘intellectual property’ investment. Commercial logic would suggest that, in the first instance, vaccines would only be made available when an individual or a nation can pay for them. In that scenario, consideration would only be given to the production of a ‘generic’ drug that is more readily accessible, after the pharmaceutical companies have covered their costs and begun to make a profit. At the time of writing, it is being reported that the vaccine developed by Astra-Zeneca and Oxford University is to be made available on a not-for-profit basis, which is highly commendable from an ethical point of view.
As we have seen, in the management of the pandemic over recent months, the balancing of public health considerations with commercial logic can be difficult and controversial. Pope Francis recently wrote: “The fragility of world systems in the face of the pandemic has demonstrated that not everything can be resolved by market freedom. It has also shown that, in addition to recovering a sound political life that is not subject to the dictates of finance, we must put human dignity back at the centre and on that pillar build the alternative social structures we need.”
In a major public health emergency, it is the poor who are most likely to suffer. HIV first appeared in humans in 1920, but it only gained attention when it appeared in the US in the 1980s. It took 20 more years, before antiretroviral therapy began to be available to the poor in developing countries.
In a major public health emergency, it is the poor who are most likely to suffer”
Speaking with particular reference to “natural disasters, epidemica, catastrophes, upheavals and various social scourges”, Pope John Paul II suggests that the world of suffering “which exists ‘in dispersion’…contains within itself a singular challenge to communion and solidarity”. In other words “we are all in this together” and our interdependence carries with it a moral responsibility.
Catholic Social Teaching, while in no way denying the importance of the free market for the common good, requires that essential medical treatment should be made available on the basis of need, not on the basis of the capacity to pay. Addressing this question, Pope Francis says: “The preferential option for the poor, this ethical-social need that comes from God’s love, inspires us to conceive of and design an economy where people, and especially the poorest, are at the centre. And it also encourages us to plan the treatment of viruses by prioritising those who are most in need. It would be sad if, for the vaccine for Covid-19, priority were to be given to the richest! It would be sad if this vaccine were to become the property of this nation or another, rather than universal and for all.”
The ownership of private property carries with it “a social mortgage”. The desire for excessive profit contributes to the development of ‘structures of sin’. This is the term coined by Pope John Paul II to describe social structures which are rooted in sinful personal attitudes, such as the thirst for power and the desire for excessive profit. There is, therefore, an ethical responsibility on pharmaceutical companies, whose income is derived from the need of those who are sick or at risk, to moderate their desire for profit. Likewise, there is an ethical responsibility on governments, under the principle of distributive justice, to ensure that, both in their own societies and in the wider world, those who are most at risk are the first to receive the vaccine, whenever a safe and effective vaccine becomes available. Even if the moral imperative of justice did not lead them to do this, common sense would suggest that they do it out of a desire for self-preservation. Just as the poverty of the third world impacts global trade, so the spread of disease in the third world will ultimately impact global health.
Many people may be unaware of the existence of an international trade agreement knows as the TRIPS (Trade-related Aspects of Intellectual Property Rights) agreement. It is an annexe to the agreement which established the World Trade Organisation (WTO) and deals with many aspects of the protection of intellectual property rights. A 2001 Ministerial Declaration on the TRIPS agreement states: “the agreement can and should be interpreted and implemented in a manner supportive of WTO Members’ right to protect public health and, in particular, to promote access to medicines for all”. Governments were, thus, free to provide for the production of generic versions of essential medicines for the domestic market under ‘compulsory license’ and without the permission of the patent holder.
In an intervention regarding the TRIPS agreement, which he made to the World Trade Organisation on behalf of the Holy See in 2002, Archbishop Diarmuid Martin applied the principle of the Universal Destination of Goods, which is central to the social teaching of the Church. He argued that there was a need to “reconcile two important values for our world community:
- Permitting governments to respond rapidly to urgent public health needs of their people, though assuring access to essential medicines at affordable prices;
- Respecting the creativity and innovative possibilities offered by a rules-based international system for the protection of intellectual property.”
He expressed a particular concern of his delegation that it had not been possible to arrive at a consensus application of the Declaration for those countries that do not have the domestic capacity to produce their own medicines.
The following year, the member states of the WTO decided on a provisional basis that countries facing public health problems and lacking the capacity to produce generic drugs could seek such medicines from third country producers under ‘compulsory licensing’ arrangements. This decision became permanent in 2017 and has the potential, if implemented in good faith, to make a significant difference when it comes to the equitable distribution of any of the vaccines developed for Covid-19.
Kevin Doran is Bishop of Elphin and Chairman of the Council for Life of the Irish bishops’ conference.
End notes
Irish Catholic Bishops Conference. “Welcoming Vaccines for the Common Good”, 10th Dec. 2020
Pontifical Council for Pastoral Assistance to Healthcare Workers. New Charter for healthcare Workers. Philadelphia, NCBC, 2017, #69
Cf. Olshansky, and Hayflick. “The Role of the WI-38 Cell Strain in Saving Lives and Reducing Morbidity” AIMS Public Health 2017 Vol 4 127-38; cf. also College of Physicians of Philadelphia: “Human Cell Strains in Vaccine Development”, 2018 from here. Sourced on 3rd Dec 2020
Cf. J.L Sherley and D. Prentice. “An Ethics Assessment of COVID-19 Vaccine Programs”, from here. Sourced on 19th Nov. 2020
Cf. CDF Note on the morality of using some anti-Covid-19 vaccines, 21st Dec. 2020. Also Pontifical Academy for Life. “Moral Reflections On Vaccines Prepared From Cells Derived From Aborted Human Foetuses”. Rome, 2005; CDF. Dignitas Personae, Rome 2008, #34-35.
These include the Bishops’ Conferences of England & Wales, Scotland and the Unites States. See also: National Catholic Bioethics Centre, Points to Consider on the Use of COVID-19 Vaccines.
CDF Note, 2020, #1
Cf. Pontifical Academy for Life (2005). See also: Consultative Group on Bioethics / Council for Healthcare. “Code of Ethical Standards for Healthcare”, Dublin: Veritas 2017, #8.11 – 8.17
Cf. CDF Note, 2020, #4
Pontifical Academy for Life, 2005. The Pontifical Academy comments in a footnote (15) that those who inappropriately refuse vaccines may find themselves responsible for the negative consequences that arise in the community from the transmission of a virus.
CDF Note, 2020, #2
CDF Note, 2020, #3
CDF Note, 2020, #5
Consultative Group on Bioethics, ibid, Part II #6.5
WMA. Declaration of Helsinki, 1964 (Revised 2013) # 28
Consultative Group on Bioethics, Ibid. Part II, #6.6
Pope Francis. Fratelli Tutti. Rome: Libreria Editrice Vaticana. 2020 #168
Pope John Paul II. Salvifici Doloris. Rome: Libreria Editrice Vaticana. 1984, #8
Pope Francis. Address at General Audience, 20th August 2020
Pope John Paul II, Solicitudo Rei Socialis, Rome: Libreria Editrice Vaticana. 1987, #42
Ibid #39.
World Trade Organisation. “Declaration On The Trips Agreement And Public Health”. Ministerial Conference Fourth Session, Doha, 9 – 14 November 2001
Archbishop Diarmuid Martin. Address at World Trade Organisation, 20th December 2002
World Trade Organisation. TRIPS Factsheet. Accessed on 3rd Sept 2020