Index
Rubella and its vaccine
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 fetus.
When a woman
catches the infection during pregnancy, especially during the first
trimester, the risk of fetal infection is very high -- approximately
95%. The virus replicates itself in the placenta and infects the
fetus, 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 live births. 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 cell aborted fetuses
To date,
there are two human diploid cell lines which were originally
prepared from tissues of aborted fetuses -- 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 fetus that was aborted
because the family felt they had too many children. It was prepared
and developed by Leonard Hayflick in 1964 [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 [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 fetus 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 [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
fetuses, WI-38 and MRC-5, are the following: [7]
A) Live
vaccines against rubella [8]
-
Monovalent vaccines against rubella Meruvax® (Merck, United States),
Rudivax® (Sanofi Pasteur, France), and Ervevax® (RA 27/3)
(GlaxoSmithKline, Belgium)
-
Combined
vaccine MR against rubella and measles, commercialized with the name
of M-R-VAX® (Merck, United States) and Rudi-Rouvax® (AVP, France)
-
Combined
vaccine against rubella and mumps marketed under the name of Biavax®
(Merck, United States)
-
Combined
vaccine MMR -- measles, mumps, rubella -- marketed under the name of
M-M-R® II (Merck, United States), R.O.R.®, Trimovax® (Sanofi
Pasteur, France), and Priorix® (GlaxoSmithKline, Belgium)
B) Other
vaccines, also prepared using human cell lines from aborted fetuses
-
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, France) 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 fetuses 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 fetuses, would
such a person not contradict himself 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 in the 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 vaccines
prepared from cells of aborted fetuses
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 fetal 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 fetuses 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 -- parents, 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 parents have a duty to take recourse to alternative
vaccines [13] -- 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 fetal
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 fetus, 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 favoring 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 measles [15].
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.
Summary
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.
------------------
References
1]
J. E. Banatvala, D.W.G. Brown. "Rubella," The Lancet, April 3, 2004,
vol. 363, No. 9415, pp. 1127-1137.
[2] S.A. Plotkin. "Virologic Assistance in the Management of German
Measles in Pregnancy," JAMA, Oct. 26, 1964, vol.190, pp. 265-268.
"Rubella , Morbidity and Mortality," Weekly Report, 1964, vol. 13,
p. 93.
[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, 11th 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 virus 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 N.V.
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 center of the present controversy
regarding the morality of the use of vaccines prepared with the help
of human cell lines coming from aborted fetuses.
[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," 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] Pope John Paul II, "Evangelium Vitae," no. 74.
[12] Catechism of the Catholic Church, no.1868.
[13] 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 -- 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.
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, Dec. 10, 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 "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 fetus, 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
fetuses, when they have been discovered to be malformed.
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