Moral Reflections on Vaccines Prepared from Cells Derived from Aborted
Human Foetuses
Pontifical Academy for Life; Congregation for the Doctrine
of the Faith
PONTIFICIA ACADEMIA PRO VITA
Il Presidente
Prot.n.P/3431
Vatican City,
June 9 2005
Mrs Debra L.Vinnedge
Executive Director, Children of God for Life
943 Deville Drive East
Largo, Florida
33771
Stati Uniti
Dear Mrs Debra L.Vinnedge,
On June 4, 2003, you wrote to His
Eminence Cardinal Joseph Ratzinger, with a copy of this letter forwarded to
me, asking to the Sacred Congregation of the Doctrine of Faith a
clarification about the liceity of vaccinating children with vaccines
prepared using cell lines derived from aborted human fetuses. Your question
regarded in particular the right of the parents of these children to oppose
such a vaccination when made at school, mandated by law. As there were no
formal guidelines by the magisterium concerning that topic, you said that
catholic parents were often challenged by State Courts, Health Officials and
School Administrators when they filled religious exemptions for their
children to this type of vaccination
This Pontifical Academy for Life, carrying out
the commission entrusted to us by the Congregation for the Doctrine of
Faith, in answer to your request, has proceeded to a careful examination of
the question of these "tainted" vaccines, and has produced as a result a
study (in Italian) that has been realized with the help of a group of
experts. This study has been approved as such by the Congregation and we
send you, there enclosed, an English translation of a synthesis of this
study. This synthesis can be brought to the knowledge of the interested
officials and organisms.
A documented paper on the topic will be published
in the journal "Medicina e Morale", edited by the Centra di
Bioetica della Universita Cattolica in Rome.
The study, its synthesis, and the translation of
this material took some time. We apologize for the delay.
With my best regards,
Sincerely yours,
+E.Sgreccia
00193 Roma - Via della Conciliazione, 1 - Tel. 06
698.82423 - 06 698.81693 - Fax 06 698.82014
CONTENTS
A) Live vaccines
against rubella
B) Other
vaccines, also prepared using human cell
lines from aborted foetuses
Formal and material
cooperation
Immediate and
mediate material cooperation
Proximate and
remote material cooperation
Liceity of formal
and material cooperation
Active and passive cooperation
Moral Reflections on Vaccines Prepared from Cells Derived
from Aborted Human Foetuses
The matter in question regards the lawfulness of
production, distribution and use of certain vaccines whose production is
connected with acts of procured abortion. It concerns vaccines containing live
viruses which have been prepared from human cell lines of foetal origin, using
tissues from aborted human foetuses as a source of such cells. The best
known, and perhaps the most important due to its vast distribution and its use
on an almost universal level, is the vaccine against Rubella (German measles).
Rubella (German measles)
1
is a viral illness caused by a Togavirus of the genus
Rubivirus and is
characterized by a maculopapular rash. It consists of an infection which is
common in infancy and has no clinical manifestations in one case out of two, is
self-limiting and usually benign. Nonetheless, the German measles virus is one
of the most pathological infective agents for the embryo and foetus. When a
woman catches the infection during pregnancy, especially during the first
trimester, the risk of foetal infection is very high (approximately
95%).
The virus replicates itself in the placenta and infects the foetus, causing the
constellation of abnormalities denoted by the name of
Congenital Rubella
Syndrome. For example, the severe epidemic of German measles which affected
a huge part of the United States in 1964 thus caused 20,000 cases of congenital
rubella
2, resulting in 11,250 abortions (spontaneous or surgical),
2,100 neonatal deaths, 11,600 cases of deafness, 3,580 cases of blindness, 1,800
cases of mental retardation. It was this epidemic that pushed for the
development and introduction on the market of an effective vaccine against
rubella, thus permitting an effective prophylaxis against this infection.The severity of congenital rubella and the
handicaps which it causes justify systematic vaccination against such a
sickness. It is very difficult, perhaps even impossible, to avoid the
infection of a pregnant woman, even if the rubella infection of a person in
contact with this woman is diagnosed from the first day of the eruption of the
rash. Therefore, one tries to prevent transmission by suppressing the
reservoir of infection among children who have not been vaccinated, by means of
early immunization of all children (universal vaccination). Universal
vaccination has resulted in a considerable fall in the incidence of congenital
rubella, with a general incidence reduced to less than 5 cases per 100,000
livebirths. Nevertheless, this progress remains fragile. In the United States,
for example, after an overwhelming reduction in the number of cases of
congenital rubella to only a few cases annually, i.e. less than 0.1 per 100,000
live births, a new epidemic wave came on in 1991, with an incidence that rose to
0.8/100,000. Such waves of resurgence of German measles were also seen in 1997
and in the year 2000. These periodic episodes of resurgence make it evident that
there is a persistent circulation of the virus among young adults, which is the
consequence of insufficient vaccination coverage. The latter situation allows a
significant proportion of vulnerable subjects to persist, who are a source of
periodic epidemics which put women in the fertile age group who have not been
immunized at risk. Therefore, the reduction to the point of eliminating
congenital rubella is considered a priority in public health care.
Vaccines currently produced
using human cell lines that come from aborted foetuses
To date, there are two human diploid cell
lines which were originally prepared from tissues of aborted foetuses ( in 1964
and 1970) and are used for the preparation of vaccines based on live attenuated
virus: the first one is the WI-38 line (Winstar Institute 38), with human
diploid lung fibroblasts, coming from a female foetus that was aborted because
the family felt they had too many children (G. Sven
et al., 1969). It was
prepared and developed by Leonard Hayflick in 1964 (L. Hayflick, 1965; G. Sven
et al., 1969)
3 and bears the ATCC number CCL-75. WI-38 has
been used for the preparation of the historical vaccine RA 27/3 against rubella
(S.A. Plotkin
et al, 1965)
4. The second human cell line is
MRC-5 (Medical Research Council 5) (human, lung, embryonic) (ATCC number
CCL-171), with human lung fibroblasts coming from a 14 week male foetus aborted
for "psychiatric reasons" from a 27 year old woman in the UK. MRC-5 was prepared
and developed by J.P. Jacobs in 1966 (J.P. Jacobs
et al, 1970)
5.
Other human cell lines have been developed for pharmaceutical needs, but are not
involved in the vaccines actually available
6.
The vaccines that are
incriminated today as using human cell lines from aborted foetuses, WI-38 and
MRC-5, are the following:
7
- the monovalent vaccines against rubella Meruvax®!! (Merck)
(U.S.), Rudivax® (Sanofi Pasteur, Fr.), and Ervevax® (RA 27/3)
(GlaxoSmithKline, Belgium);
- the combined vaccine MR against rubella
and measles, commercialized with the name of M-R-VAX® (Merck, US)
and Rudi-Rouvax® (AVP, France);
- the combined vaccine
against rubella and mumps marketed under the name of Biavax®!! (Merck, U.S.),
- the combined
vaccine MMR (measles, mumps, rubella) against rubella, mumps and
measles, marketed under the name of M-M-R® II (Merck, US), R.O.R.®,
Trimovax® (Sanofi Pasteur, Fr.), and Priorix® (GlaxoSmithKline UK).
- two vaccines
against hepatitis A, one produced by Merck (VAQTA), the other one produced
by GlaxoSmithKline (HAVRIX), both of them being prepared using MRC-5;
- one vaccine
against chicken pox, Varivax®, produced by Merck using WI-38 and MRC-5;
- one vaccine
against poliomyelitis, the inactivated polio virus vaccine Poliovax® (Aventis-Pasteur,
Fr.) using MRC-5;
- one vaccine
against rabies, Imovax®, produced by Aventis Pasteur, harvested from
infected human diploid cells, MRC-5 strain;- one vaccine
against smallpox, AC AM 1000, prepared by Acambis using MRC-5, still on
trial.
The position of
the ethical problem related to these vaccines
From the point of
view of prevention of viral diseases such as German measles, mumps,
measles, chicken pox and hepatitis A, it is clear that the making of
effective vaccines against diseases such as these, as well as
their use in the fight against these infections, up to the point of
eradication, by means of an obligatory vaccination of all the population at
risk, undoubtedly represents a "milestone" in the secular fight of man
against infective and contagious diseases.
However, as the
same vaccines are prepared from viruses taken from the tissues of foetuses
that had been infected and voluntarily aborted, and the viruses were
subsequently attenuated and cultivated from human cell lines which come
likewise from procured abortions, they do not cease to pose ethical
problems. The need to articulate a moral reflection on the matter in
question arises mainly from the connection which exists between the vaccines
mentioned above and the procured abortions from which biological material
necessary for their preparation was obtained.
If someone rejects
every form of voluntary abortion of human foetuses, would such a person not
contradict himself/herself by allowing the use of these vaccines of live
attenuated viruses on their children? Would it not be a matter of true (and
illicit) cooperation in evil, even though this evil was carried out forty
years ago?
Before proceeding to
consider this specific case, we need to recall briefly the principles
assumed in classical moral doctrine with regard to the problem of
cooperation in evil 9, a problem which arises every time
that a moral agent perceives the existence of a link between his own acts
and a morally evil action carried out by others.
The principle
of licit cooperation in evil
The first
fundamental distinction to be made is that between formal and
material cooperation. Formal cooperation is carried out when the moral
agent cooperates with the immoral action of another person, sharing in the
latter's evil intention. On the other hand, when a moral agent cooperates
with the immoral action of another person, without sharing his/her evil
intention, it is a case of material cooperation.
Material cooperation
can be further divided into categories of immediate (direct) and
mediate (indirect), depending on whether the cooperation is in the
execution of the sinful action per se, or whether the agent acts by
fulfilling the conditions - either by providing instruments or products -
which make it possible to commit the immoral act. Furthermore, forms of
proximate cooperation
and remote cooperation can be
distinguished, in relation to the "distance" (be it in terms of temporal
space or material connection) between the act of cooperation and
the sinful act committed by someone else. Immediate material cooperation
is always proximate, while mediate material cooperation
can be either proximate or remote.
Formal
cooperation is always morally illicit
because it represents a form of direct and intentional participation in
the sinful action of another person.
10 Material cooperation
can sometimes be illicit (depending on
the conditions of the "double effect" or "indirect voluntary" action), but
when
immediate material cooperation concerns grave attacks on human
life, it is always to be considered illicit, given the precious nature of
the value in question
11.
A further
distinction made in classical morality is that between
active (or
positive) cooperation in evil and
passive (or negative) cooperation
in evil, the former referring to the performance of an act of cooperation in
a sinful action that is carried out by another person, while the latter
refers to the omission of an act of denunciation or impediment of a sinful
action carried out by another person, insomuch as there was a moral duty to
do that which was omitted
12. Passive cooperation can also be
formal or material, immediate or mediate, proximate or remote. Obviously,
every type of formal passive cooperation is to be considered illicit, but
even passive material cooperation should generally be avoided, although it
is admitted (by many authors) that there is not a rigorous obligation to
avoid it in a case in which it would be greatly difficult to do so.
Application to
the use of vaccines prepared from cells coming from embryos or foetuses
aborted voluntarily
In the specific case
under examination, there are three categories of people who are involved
in the cooperation in evil, evil which is obviously represented by the
action of a voluntary abortion performed by others:
a) those who prepare the
vaccines using human cell lines coming from voluntary abortions;
b) those
who participate in the mass marketing of such vaccines;
c) those who need
to use them for health reasons.
Firstly, one must
consider morally illicit every form of formal cooperation (sharing
the evil intention) in the action of those who have performed a voluntary
abortion, which in turn has allowed the retrieval of foetal tissues,
required for the preparation of vaccines. Therefore, whoever - regardless of
the category to which he belongs — cooperates in some way, sharing its
intention, to the performance of a voluntary abortion with the aim of
producing the above-mentioned vaccines, participates, in actuality, in the
same moral evil as the person who has performed that abortion. Such
participation would also take place in the case where someone, sharing the
intention of the abortion, refrains from denouncing or criticizing this
illicit action, although having the moral duty to do so (passive formal
cooperation).
In a case where
there is no such formal sharing of the immoral intention of the person who
has performed the abortion, any form of cooperation would be material,
with the following specifications.
As regards the preparation, distribution and
marketing of vaccines produced as a result of the use of biological material
whose origin is connected with cells coming from foetuses voluntarily
aborted, such a process is stated, as a matter of principle, morally
illicit, because it could contribute in encouraging the performance of other
voluntary abortions, with the purpose of the production of such vaccines.
Nevertheless, it should be recognized that, within the chain of
production-distribution-marketing, the various cooperating agents can have
different moral responsibilities.
However, there is
another aspect to be considered, and that is the form of passive material
cooperation which would be carried out by the producers of these
vaccines, if they do not denounce and reject publicly the original immoral
act (the voluntary abortion), and if they do not dedicate themselves
together to research and promote alternative ways, exempt from moral evil,
for the production of vaccines for the same infections. Such passive
material cooperation, if it should occur, is equally illicit.
As regards those who
need to use such vaccines for reasons of health, it must be emphasized
that, apart from every form of formal cooperation, in general,
doctors or parents who resort to the use of these vaccines for their
children, in spite of knowing their origin (voluntary abortion), carry out
a form of very remote mediate material cooperation, and thus very
mild, in the performance of the original act of abortion, and a mediate
material cooperation, with regard to the marketing of cells coming from
abortions, and immediate, with regard to the marketing of vaccines
produced with such cells. The cooperation is therefore more intense on the
part of the authorities and national health systems that accept the use of
the vaccines.
However, in this
situation, the aspect of passive cooperation is that which stands out
most. It is up to the faithful and citizens of upright conscience (fathers
of families, doctors, etc.) to oppose, even by making an
objection of
conscience, the ever more widespread attacks against life and the "culture
of death" which underlies them. From this point of view, the use of vaccines
whose production is connected with procured abortion constitutes at least a
mediate remote passive material cooperation to the abortion, and an
immediate passive material cooperation with regard to their marketing.
Furthermore, on a cultural level, the use of such vaccines contributes in
the creation of a generalized social consensus to the operation of the
pharmaceutical industries which produce them in an immoral way.
Therefore, doctors
and fathers of families have a duty to take recourse to alternative vaccines13
(if they exist), putting pressure on the political authorities and health
systems so that other vaccines without moral problems become available. They
should take recourse, if necessary, to the use of
conscientious objection
14 with regard to the use of vaccines produced by means of cell
lines of aborted human foetal origin. Equally, they should oppose by all
means (in writing, through the various associations, mass media, etc.) the
vaccines which do not yet have morally acceptable alternatives, creating
pressure so that alternative vaccines are prepared, which are not connected
with the abortion of a human foetus, and requesting rigorous legal control
of the pharmaceutical industry producers.
As regards the
diseases against which there are no alternative vaccines which are available
and ethically acceptable, it is right to abstain from using these
vaccines if it can be done without causing children, and indirectly the
population as a whole, to undergo significant risks to their health.
However, if the latter are exposed to considerable dangers to their health,
vaccines with moral problems pertaining to them may also be used on a
temporary basis. The moral reason is that the duty to avoid passive
material cooperation is not obligatory if there is grave inconvenience.
Moreover, we find, in such a case, a. proportional reason, in order
to accept the use of these vaccines in the presence of the danger of
favouring the spread of the pathological agent, due to the lack of
vaccination of children. This is particularly true in the case of
vaccination against German measles15.
In any case, there
remains a moral duty to continue to fight and to employ every lawful means
in order to make life difficult for the pharmaceutical industries which act
unscrupulously and unethically. However, the burden of this important
battle cannot and must not fall on innocent children and on the health
situation of the population - especially with regard to pregnant women.
To summarize, it
must be confirmed that:
-there is a grave
responsibility to use alternative vaccines and to make a conscientious
objection with regard to those which have moral problems;
- as regards the
vaccines without an alternative, the need to contest so that others may be
prepared must be reaffirmed, as should be the lawfulness of using the former
in the meantime insomuch as is necessary in order to avoid a serious
risk not only for one's own children but
also, and perhaps more specifically, for the health conditions of the
population as a whole - especially for pregnant women;
- the lawfulness of
the use of these vaccines should not be misinterpreted as a declaration of
the lawfulness of their production, marketing and use, but is to be
understood as being a passive material cooperation and, in its mildest and
remotest sense, also active, morally justified as an extrema ratio due to the necessity to provide for the good of one's children and of the
people who come in contact with the children (pregnant women);
- such cooperation occurs in a context of moral
coercion of the conscience of parents, who are forced to choose to act
against their conscience or otherwise, to put the health of their children
and of the population as a whole at risk. This is an unjust alternative
choice, which must be eliminated as soon as possible.
1. J. E. Banatvala, D.W.G. Brown, Rubella, The
Lancet, 3rd April 2004, vol. 363, No. 9415, pp.1127-1137
2.
Rubella , Morbidity and Mortality Weekly Report, 1964, vol. 13, p.93.
S.A. Plotkin, Virologic
Assistance in the Management of German Measles in Pregnancy, JAMA, 26th October 1964, vol.190,
pp.265-268
3.
L. Hayflick,
The Limited In Vitro
Lifetime of Human Diploid Cell
Strains, Experimental Cell Research, March 1965, vol.37, no. 3, pp.
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, August 1969, vol.
118, no. 2, pp.372-381.
4. S.
A. Plotkin, D. Cornfeld, Th.H. Ingalls, Studies of Immunization With
Living Rubella Virus, Trials in Children With a Strain coming from an
Aborted Fetus, American Journal of Diseases in children, October 1965,
vol. 110, no. 4, pp.381-389.
5. J.P. Jacobs, C.M. Jones, J.P. Bailie,
Characteristics of a Human Diploid Cell Designated MRC-5, Nature, 11
th
July 1970, vol.277, pp.168-170.
6. Two other human cell lines, that are
permanent, HEK 293 aborted fetal cell line, from primary human embryonic
kidney cells transformed by sheared adenovirus type 5 (the fetal kidney
material was obtained from an aborted fetus, in 1972 probably), and PER.C6,
a fetal cell line created using retinal tissue from an 18 week gestation
aborted baby, have been developed for the pharmaceutical manufacturing of
adenovirus vectors (for gene therapy). They have not been involved in the
making of any of the attenuated live viruses vaccines presently in use
because of their capacity to develop tumorigenic cells in the recipient.
However some vaccines, still at the developmental stage, against Ebola virus
(Crucell,NV and the Vaccine Research Center of the National Institutes of
Health's Allergy and Infectious Diseases, NIAID), HIV (Merck), influenza
(Medlmmune, Sanofi pasteur), Japanese encephalitis (Crucell N.V. and Rhein
Biotech N.V.) are prepared using PER.C6® cell line (Crucell N.V., Leiden,
The Netherlands).
7.
Against these various infectious diseases, there are some alternative
vaccines that are prepared using animals' cells or tissues, and are
therefore ethically acceptable. Their availability depends on the country in
question. Concerning the particular case of the United States, there are no
options for the time being in that country for the 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 (derived from the
kidney of an African green monkey), ACAM2000 (Acambis-Baxter) ( a
second-generation smallpox vaccine, stockpiled, not approved in the US),
which offers, therefore, an alternative to the Acambis 1000. There are
alternative vaccines against mumps (Mumpsvax, Merck, measles (Attenuvax,
Merck), rabies (RabAvert, Chiron therapeutics), prepared from chicken
embryos. (However serious allergies have occurred with such vaccines),
poliomyelitis (IPOL, Aventis-Pasteur, prepared with monkey kidney cells) and
smallpox (a third-generation smallpox vaccine MVA, Modified Vaccinia Ankara,
Acambis-Baxter). In Europe and in Japan, there are other vaccines available
against rubella and hepatitis A, produced using non-human cell lines. The
Kitasato Institute produce four vaccines against rubella, called Takahashi,
TO-336 and Matuba, prepared with cells from rabbit kidney, and one (Matuura)
prepared with cells from a quail embryo. The Chemo-sero-therapeutic Research
Institute Kaketsuken produce one another vaccine against hepatitis A, called
Ainmugen, prepared with cells from monkey kidney. The only remaining problem
is with the vaccine Varivax® against chicken pox, for which there is no
alternative.
8.
The vaccine against rubella using the strain Wistar RA27/3 of live
attenuated rubella virus, adapted and propagated in WI-38 human diploid lung
fibroblasts is at the centre of present controversy regarding the morality
of the use of vaccines prepared with the help of human cell lines coming
from aborted foetuses.
9.
D.M. Prummer O. Pr.,
De
cooperatione ad malum, in
Manuale Theologiae Moralis secundum Principia S. Thomae Aquinatis,
Tomus I, Friburgi Brisgoviae, Herder & Co.,
1923, Pars I, Trat. IX, Caput III, no. 2, pp. 429-434.
.K.H.
Peschke,
Cooperation in the sins of others, in Christian Ethics.
Moral Theology in the Light of
Vatican II, vol.1, General Moral
Theology, C. Goodliffe Neale Ltd., Arden Forest Industrial Estate, Alcester,
Warwickshire, B49 6Er, revised edition, 1986, pp. 320-324.
10. A.
Fisher,
Cooperation in Evil, Catholic Medical Quarterly, 1994, pp.
15-22.
.D.
Tettamanzi,
Cooperazione, in
Dizionario di Bioetica, S. Leone,
S. Privitera ed., Istituto Siciliano di Bioetica, EDB-ISB, 1994, pp.194-198.
.L. Melina,
La cooperazione con azioni moralmente cattive contra la vita umana,
in Commentario Interdisciplinare alia "Evangelium Vitae", E.
Sgreccia, Ramon Luca Lucas ed., Libreria Editrice Vaticana, 1997,
pp.467-490.
.E.
Sgreccia, Manuale di Bioetica, vol. I, Reprint of the third edition,
Vita e Pensiero, Milan, 1999, pp.362-363.
11.
Cf. John Paul II, Enc.
Evangelium Vitae, no. 74.
12.
No. 1868 of the Catechism of the Catholic Church.
l3. The
alternative vaccines in question are those that are prepared by means of
cell lines which are not of human origin, for example, the Vero cell line
(from monkeys) (D. Vinnedge), the kidney cells of rabbits or monkeys, or
the cells of chicken embryos. However, it should be noted that grave
forms of allergy have occurred with some of the vaccines prepared in this
way. The use of recombinant DNA technology could lead to the development
of new vaccines in the near future which will no longer require the use
of cultures of human diploid cells for the attenuation of the virus and
its growth, for such vaccines will not be prepared from a basis of
attenuated virus, but from the genome of the virus and from the antigens
thus developed (G. C. Woodrow, W.M. McDonnell and F.K. Askari). Some
experimental studies have already been done using vaccines developed
from DNA that has been derived from the genome of the German measles
virus. Moreover, some Asiatic researchers are trying to use the Varicella
virus as a vector for the insertion of genes which codify the viral antigens
of Rubella. These studies are still at a preliminary phase and the
refinement of vaccine preparations which can be used in clinical practice
will require a lengthy period of time and will be at high costs. .D.
Vinnedge,
The Smallpox Vaccine, The National Catholic Bioethics
Quarterly, Spring 2000, vol.2, no. 1, p. 12. .G.C. Woodrow,
An Overview
of Biotechnology As Applied to Vaccine Development, in
«New
Generation Vaccines)), G.C. Woodrow, M.M. Levine eds., Marcel Dekker
Inc., New York and Basel, 1990, see pp.32-37. W.M. McDonnell, F.K. Askari,
Immunization, JAMA, 10
th December 1997, vol.278, no.22,
pp.2000-2007, see pp. 2005-2006.
14.
Such a duty may lead, as a consequence, to taking recourse to "objection of
conscience" when the action recognized as illicit is an act permitted or
even encouraged by the laws of the country and poses a threat to human life.
The Encyclical Letter Evangelium Vitae underlined this "obligation to
oppose" the laws which permit abortion or euthanasia "by conscientious
objection" (no.73)
15. This is particularly
true in the case of vaccination against German measles, because of the
danger of Congenital Rubella Syndrome. This could occur, causing grave
congenital malformations in the foetus, when a pregnant woman enters into
contact, even if it is brief, with children who have not been immunized and
are carriers of the virus. In this case, the parents who did not accept the
vaccination of their own children become responsible for the malformations
in question, and for the subsequent abortion of foetuses, when they have
been discovered to be malformed.