Pontifical Academia Pro Vita
The issue under consideration concerns the lawfulness of the production, dissemination and use of some vaccines whose production is in connection with acts of procured abortion. These are live virus vaccines that have been prepared from human cell lines of fetal origin, using aborted human fetal tissues as a source of such cells. The best known and most important of these, due to its widespread use and almost universal use, is the rubella (rubella) vaccine.
Rubella (rubella) and its vaccine
Rubella (Rubeola or "German measles") 1 is a viral disease caused by a Togavirus of the genus Rubivirus and is characterized by a maculo-papular rash. It is a common childhood infection with no clinical expression in one out of two cases, self-limited and usually benign. However, the rubella virus is one of the most pathogenic infectious agents for the embryo and fetus. When the infection is acquired in pregnancy, especially in the first trimester, the risk of fetal infection is very high (about 95%). The virus replicates in the placenta and infects the fetus, causing the constellation of anomalies known as Congenital Rubella Syndrome. For example, the severe rubella epidemic that affected a large part of the United States in 1964 resulted in 20.000 cases of congenital roseola2 resulting in 11.250 miscarriages (spontaneous or surgical), 2100 newborn deaths, 11.600 cases of deafness, 3.580 cases of blindness , 1.800 cases of mental retardation. It is this epidemic that has prompted the development and commercialization of an effective vaccine against rubella, allowing effective prophylaxis of this infection.
The severity of congenital rubella and the handicaps it generates justify generalized vaccination against this disease. It is very difficult, perhaps even impossible, to avoid contamination of a pregnant woman, even if the disease of an infected person is diagnosed from the first day of the rash. An attempt is therefore made to interrupt the transmission by suppressing the nest of infection of the virus offered by unvaccinated children, thanks to the early immunization of all children (universal vaccination). This universal vaccination has resulted in a sharp decrease in the incidence of congenital rubella, with a general incidence reduced to less than 5 cases per 100.0000 live births. However, this progress remains fragile. In the United States, for example, after a spectacular decrease in the incidence of congenital rubella to a few annual cases, i.e. less than 0.1 per 100.000 live births, a new epidemic wave appeared in 1991, with an incidence rising to 0,8. 100.0000 / 1997. Such waves of resurgence of rubella were also seen in 2000 and XNUMX. These periodic episodes of resurgence testify to the persistent circulation of the virus in young adults, a consequence of insufficient vaccination coverage. This leaves a non-negligible proportion of susceptible subjects persisting, a source of periodic epidemics that put women of childbearing age at risk and who are not immunized. The reduction to elimination of congenital rubella is therefore considered a public health priority.
Vaccines currently produced using human cell strains from aborted fetuses
To date there are two human diploid cell lines, originally set up (1964 and 1970) from aborted fetal tissues, which are used for the preparation of live attenuated virus vaccines: the first line is WI-38 (Winstar Institute 38) , with diploid fibroblasts of human lung, derived from a female fetus aborted because the family believed they already had too many children (G.Sven et al., 1969), prepared and developed by Leonard Hayflick in 1964 (L.Hayflick, 1965; G .Sven et al., 1969)1, ATCC number CCL-75. WI-38 was used for the preparation of the historic RA 27/3 rubella vaccine (SAPlotkin et al., 1965)2. The second human cell line is MRC-5 (Medical Research Council 5) (human lung, embryonic) (ATCC number CCL-171), with human lung fibroblasts from a 14-week-old male fetus aborted for "psychiatric reasons" by a 5 year old woman in the UK. The MRC-1966 was prepared and developed by JPJacobs in 1970 (JPJacobs et al., XNUMX)3. Other human cell lines have been developed for pharmaceutical needs, but are not involved in currently available vaccines.4
Today the vaccines that are indicted for using human cell lines, WI-38 and MRC-5, obtained from aborted fetuses are the following:5
A) Vaccines active against rubella6:
- the monovalent rubella vaccines Meruvax® II (Merck) (USA), Rudivax® (Sanofi Pasteur, Fr.), and Ervevax® (RA 27/3) (GlaxoSmithKline, Belgium);
- the combined MR vaccines against rubella and measles, marketed under the names of MR-VAX®II (Merck, USA) and Rudi-Rouvax® (AVP, France),
- the combined vaccine against rubella and mumps marketed under the name of Biavax®II (Merck, USA),
- the combined MMR vaccine (measles, mumps, rubella) against measles, mumps and rubella, marketed under the name of MMR® II (Merck, USA), ROR®, Trimovax® (Sanofi Pasteur, Fr.), and Priorix® (GlaxoSmithkline , UK).
B) Other vaccines, also prepared using human cell lines from aborted fetuses:
- two hepatitis A vaccines, one manufactured by Merck (VAQTA), the other by Glaxo SmithKline (HAVRIX), both prepared using MRC-5;
- a varicella vaccine, Varivax®, manufactured by Merck using WI-38 and MRC-5.
- a polio vaccine, the Poliovax® (Aventis-Pasteur, Fr.) inactivated polio virus vaccine using MRC-5.
- a vaccine against rabies, Imovax®, from Aventis-Pasteur, taken from infected human diploid cells, the MRC-5 strain;
- a smallpox vaccine, ACAM 1000, prepared by Acambis using MRC-5, still under investigation.
Position of the ethical problem connected with these vaccines
From the point of view of the prevention of viral diseases such as rubella, mumps, measles, chicken pox, hepatitis A, it is clear that the development of effective vaccines against these diseases, and their use in the fight against these infections up to their eradication, through mandatory immunization of all the populations concerned, it undoubtedly represents a "milestone" in man's age-old struggle against infectious and contagious diseases.
However, these same vaccines, since they are prepared starting from viruses collected in the tissues of infected and voluntarily aborted fetuses, and subsequently attenuated and cultured using human cell strains similarly from voluntary abortions, do not fail to pose important ethical problems. The need to articulate a moral reflection on the question under consideration arises mainly from the connection existing between the preparation of the aforementioned vaccines and the procured abortions from which the biological materials necessary for such preparation were obtained.
If a person rejects any form of voluntary abortion of human fetuses, would that person not contradict themselves by admitting the use of these live attenuated virus vaccines on the person of their children? Wouldn't it be a question of true (and illicit) cooperation with evil, even if this evil took place forty years ago?
Before considering the specific case, it is necessary to briefly recall the main assumptions of the classical moral doctrine regarding the problem of cooperation in evil7, a problem that arises whenever a moral agent perceives the existence of a link between his own acts and a bad act performed. from others.
The principle of lawful cooperation in evil
The first fundamental distinction is that between formal and material cooperation. A c is configured. formal when the moral agent cooperates with the immoral action of another, sharing its evil intention. On the other hand, when the moral agent cooperates with the immoral action of another, without sharing its evil intention, a c is configured. material.
The c. material is further divided into immediate (direct) and mediated (indirect), depending on whether it is to cooperate with the execution of the bad act as such, or whether it is acting by realizing the conditions - or providing tools or products - that make possible the carrying out of the bad act. In relation, then, to the "distance" (both temporal and in terms of material connection) between the act of cooperation and the evil act by others, a c. next and a c. remote. The c. immediate material is always proximate, while c. mediated material can be proximate or remote.
The c. formal is always morally illicit since it is a form of direct and intentional participation in the evil action of the other8.. The c. material can sometimes be lawful (based on the conditions of the "double effect" or "indirect voluntary"), but when it is configured as a c. immediate material to serious attacks against human life, it is always to be considered illicit, given the preciousness of the value at stake9.
A further distinction of classical morality is that between active (or positive) cooperation with evil and passive (or negative) cooperation with evil, the former referring to the performance of an act of cooperation with an evil action performed by another, while the second to the omission of an act of denunciation or impediment of an evil action carried out by another, to the extent that there was a moral duty to do what was omitted10.. Also the c. passive can be formal or material, immediate or mediated, proximate or remote. Obviously, any c. formal passive, but also c. material passive generally should be avoided, even if it is admitted (by many authors) that there is no strict obligation to avoid it when there is a serious inconvenience.
Application to the use of vaccines prepared with cells from voluntarily aborted embryos or fetuses
In the specific case in question, three categories of people are involved in cooperation in evil, which obviously is represented by the act of voluntary abortion carried out by others: a) those who prepare vaccines using human cell strains from voluntary abortions; b) who participates in the marketing of these vaccines; c) those who need to use them for health reasons.
First of all, every form of c must be considered morally illicit. formal (sharing of the bad intention) to the act of those who performed the voluntary abortion which allowed the retrieval of fetal tissues, necessary for the preparation of vaccines. Therefore, anyone - regardless of the category they belong to - cooperating in some way, sharing their intention, in carrying out a voluntary abortion, aimed at the production of the vaccines in question, would in fact participate in the same moral malice as those who carried out this abortion. Such participation would also take place if, always sharing the abortive intention, one limited oneself not to denounce or oppose, having the moral duty to do so, such illicit action (passive formal cooperation).
If this formal sharing of the bad intention of the abortioner does not exist, any cooperation would be material, with the following specifications.
As for the preparation, distribution and marketing of vaccines made thanks to the use of biological material whose origin is linked to cells from voluntarily aborted fetuses, in principle it must be said that this process is morally illicit, since it could contribute in fact, to encourage the carrying out of other voluntary abortions, aimed at the production of such vaccines. However, it must be recognized that within the production-distribution-marketing chain, the various cooperating agents may have different moral responsibilities.
But there is another aspect to consider and it is that of the passive material cooperation that would be achieved by the producers of these vaccines, if they did not denounce and publicly reject the bad act of origin (voluntary abortion), and together they did not undertake to research and promote alternative forms, free of moral malice, for the production of the same vaccines. Such passive material cooperation, should it occur, is equally illicit.
As regards those who need to use these vaccines for health reasons, it should be noted that, excluding any c. formal, generally doctors or parents for their children who resort to the use of such vaccines, even knowing the origin (voluntary abortion), carry out a form of mediated material cooperation that is very remote, and therefore very weak, compared to the production of 'abortion, and mediated material cooperation, with respect to the commercialization of cells derived from abortions, and immediate, with respect to the commercialization of vaccines produced with these cells. Cooperation is stronger from national health authorities and systems that accept the use of vaccines.
But in this situation, the aspect of c. passive. It is up to the faithful and citizens of good conscience (family fathers, doctors, etc.) to oppose, even with conscientious objection, the increasingly widespread attacks against life and the "culture of death" that sustain them. And from this point of view, the use of vaccines whose production is linked to induced abortion constitutes at least a remote mediated passive material cooperation in abortion, and an immediate passive material cooperation in their commercialization. Furthermore, on a cultural level, the use of such vaccines contributes to creating a generalized social consensus on the work of the pharmaceutical industries that produce them in an immoral way.
Therefore, doctors and fathers have a duty to resort to alternative vaccines 11(if any), putting all pressure on political authorities and health systems to ensure that other vaccines without moral problems are available. They should invoke conscientious objection if necessary12 compared to the use of vaccines produced by cellular strains of human abortive fetal origin. Equally they should oppose by all means (in writing, through the various associations, the mass media, etc.) to vaccines that do not yet have alternatives without moral problems, by pressing for alternative vaccines not connected to a human fetus abortion to be prepared and asking a strict legal control of the pharmaceutical manufacturing industries.
As for diseases against which there are still no alternative, available, ethically acceptable vaccines, it is right to refrain from using these vaccines only if this can be done without causing significant health risks to children and, indirectly, to the population. in general. But if these are exposed to significant health hazards, even vaccines with moral problems can be used provisionally. The moral reason is that the duty to avoid passive material cooperation does not oblige if there is serious inconvenience. In addition, we find, in this case, a proportionate reason for accepting the use of these vaccines in the presence of the danger of favoring the spread of the pathological agent, due to the absence of vaccination of children. This is especially true in the case of rubella vaccination13.
In any case, there remains the moral duty to continue to fight and to use every lawful means to make life difficult for pharmaceutical companies that act without ethical scruples. But the weight of this important battle certainly cannot and must not fall on innocent children and on the health situation of the population - especially as regards pregnant women.
In summary, it must be reaffirmed that:
- there is a grave duty to use alternative vaccines and to invoke conscientious objection regarding those with moral problems;
- with regard to vaccines without alternatives, it is necessary to reiterate both the duty to fight for others to be prepared, and the lawfulness of using the first ones in the meantime to the extent that this is necessary to avoid a serious danger not only for one's own children but also and, perhaps, above all for the health conditions of the general population - especially pregnant women;
- the lawfulness of the use of these vaccines should not be interpreted as a declaration of the lawfulness of their production, marketing and use, but as a passive material cooperation and, in a weaker and more remote sense, also active, morally justified as a last resort by reason of duty to provide for the welfare of their children and of people who come into contact with their children (pregnant women);
- this cooperation takes place in a context of moral constriction of the conscience of the parents, who are subjected to the alternative of acting against their conscience or endangering the health of their children and the population in general. This is an unjust alternative that must be eliminated as soon as possible.
- JE Banatvala, DWGBrown, Rubella, The Lancet, 3 April 2004, vol. 363, n ° 9415, pp. 1127-1137.
- Rubella, Morbidity and Mortality Weekly Report, 1964, vol. 13,
p.93. SAPlotkin, Virologic Assistance in the Management of German Measles in Pregnancy, JAMA, 26 October 1964, vol. 190, pp. 265-268.
- L. Hayflick, The Limited In Vitro Lifetime of Human Diploid Cell Strains, Experimental Cell Research 1965, 37 (3): 614-636. G.Sven, S. Plotkin, K. McCarthy, Gamma Globulin Prophylaxis; Inactivated Rubella Virus; Production and Biological Control of Live Attenuated Rubella Virus Vaccines, American Journal of Diseases of Children 1969, 118 (2): 372-381.
- SAPlotkin, D. Cornfeld, Th. H. Ingalls, Studies of Immunization With Living Rubella Virus, Trials in Children With a Strain Cultured From an Aborted Fetus, American Journal of Diseases in Children 1965, 110 (4): 381-389.
- JPJacobs, CMJones, JPBaille, Characteristics of a Human Diploid Cell Designated MRC-5, Nature 1970, 277: 168-170.
- Two other cell lines, which are permanent, the aborted fetus HEK 293 cell line, obtained from severed adenovirus type 5 transformed primary human embryonic kidney cells (fetal kidney material was obtained from an aborted fetus, probably in 1972), and PER.C6, a fetal cell line created using retinal tissue from an aborted baby of 18 weeks of gestational age, were developed for the pharmaceutical production of adenovirus vectors (for gene therapy). They have not been involved in the production of any of the live attenuated virus vaccines currently in use due to their ability to develop tumor cells in the recipient. However, some vaccines, still at the development stage, against the Ebola virus (Crucell, NV and the Vaccine Research Center of the National Institutes of Health's Allergy and Infectious Diseases, NIAID), HIV (Merck), influenza (MedImmune, Sanofi pasteur), encephalitis Japanese (Crucell NV and Rhein Biotech NV) are prepared using the PER.C6® cell line (Crucell NV, Leiden, The Netherlands.
- Against these different infectious diseases, there are some alternative vaccines, which are prepared using animal cells or tissues, and therefore ethically acceptable. Their availability depends on the country concerned. Regarding the particular case of the United States, there are currently no other options in this country for vaccination against rubella, chickenpox and hepatitis A other than the vaccines proposed by Merck, prepared using the human cell lines WI- 38 and MRC-5. There is a vaccine against smallpox prepared with the Vero cell line (from the kidney of an African green monkey), ACAM2000 (Acambis-Baxter) (second generation vaccine against smallpox, preserved, not approved in the USA), which therefore offers a alternative to Acambis 1000. There are alternative vaccines against mumps (Mumpsvax, Merck), measles (Attenuvax, Merck), rabies (RabAvert, Chiron therapeutics), prepared from chicken embryos (however severe allergies have occurred with the use of these vaccines), poliomyelitis (IPOL, Aventis-Pasteur, prepared with monkey kidney cells) and smallpox (third generation vaccine against smallpox MVA, Modified Vaccinia Ankara, Acambis-Baxter)
In Europe and Japan, there are other vaccines available against rubella and hepatitis A, produced using non-human cell lines. The Kitasato Institute produces four rubella vaccines, called Takahashi, TO-336 and Matuba, prepared with cells from rabbit kidneys and one (Matuura) prepared with cells from quail embryos. The Chemo-sero-therapeutic research institute Kaketsuken produces another hepatitis A vaccine, called Aimmugen, made from monkey kidney cells. The only remaining problem is with the Varivax® varicella vaccine, for which there is no alternative.
- The rubella vaccine using the Wistar RA27 / 3 strain of live attenuated rubella virus, adapted and spread in human diploid fibroblasts WI-38 is at the center of current controversies around the morality of using vaccines prepared with the help of human cells from aborted fetuses.
- DM Prümmer O.Pr., De cooperatione ad malum, in Manual Theologiae Moralis secundum Principia S. Thomae Aquinatis, Tomus I, Friburgi Brisgoviae, Herder & Co., 1923, Pars I, Trat.IX, Caput III, n.2, pp. 429-234. .KHPeschke, Cooperation in the sins of others, in Christian Ethics. Moral Theology in the Light of Vatican II, vol.I, General Moral Theology, C. Goodliffe Neale Ltd., Arden Forest Indusatrial Estate, Alcester, Warwickshire, B49 6Er, revised edition, 1986, pp. 320-324. A. Fisher, Cooperation in Evil, Catholic Medical Quarterly, 1994, pp. 15-22. D. Tettamanzi, Cooperation, in Dictionary of Bioethics, S.Leone, S.Privitera ed., Sicilian Institute of Bioethics, EDB-ISB, 1994, pp.194-198. .L. Melina, Cooperation with morally evil actions against human life, in Interdisciplinary Commentary on the "Evangelium Vitae", E.Sgreccia, Ramòn Luca Lucas ed., Libreria Editrice Vaticana, 1997, pp. 467-490. , Manual of Bioethics, vol.I, Reprint of the third edition, Vita e Pensiero, Milan, 1999, pp. 362-363.
- Cf John Paul II, Encyclical Evangelium Vitae, 74.
- Catechism of the Catholic Church 1868.
- Such alternative vaccines are vaccines prepared from non-human cell strains, such as the Vero cell line (from monkeys) (D. Vinnedge), rabbit or monkey kidney cells, or chicken embryo cells. However, it should be noted that severe allergies have occurred with some of the vaccines thus prepared. The use of recombinant ADN technology could lead in the near future to the development of new vaccines that no longer require the use of human diploid cell cultures for virus attenuation and cultivation, because such vaccines will not be prepared. starting from the attenuated virus, but starting from the genome of the virus and the antigens thus developed (G.CWoodrow, WMMcDonnell and FKAskari). Some experimental studies have already been conducted using ADN vaccines developed from the rubella virus genome. In addition, Asian researchers are trying to use the chickenpox virus as a vector for inserting genes encoding rubella viral antigens. These studies are still preliminary and the development of vaccine preparations usable in clinical practice requires a long time and high costs. .D.Vinnedge, The Smallpox Vaccine, The National Catholic Bioethics Quarterly, Spring 2000, vol. 2, n ° 1, p.12..GCWoodrow, An Overview of Biotechnology As Applied to Vaccine Development, in "New Generation Vaccines", GCWoorow, MMLevine eds., Marcel Dekker Inc., New York and Basel, 1990, see pp. 32-37. WMMcDonnell, FkAskari, Immunization, JAMA, 10 December 1997, vol. 278, n ° 22, pp. 2000-2007, see pp. 2005-2006.
- Consequently, such a duty can lead to "conscientious objection" when the act recognized as illicit is an act permitted or even encouraged by the laws of the country and harmful to human life. The Encyclical Evangelium Vitae underlined this "obligation to oppose" the law which permits abortion or euthanasia "by conscientious objection" (n.73).
- This is especially true in the case of rubella vaccination, due to the danger of congenital rubella. Such a condition, causing severe congenital malformations in the fetus, could happen when a pregnant woman comes into contact, even for a short time, with non-immunized children and carriers of the virus. In this case the parents who have not accepted the vaccination of their children are responsible for the malformations in question and for the subsequent abortion of the fetuses, when discovered malformed.