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
and its vaccine
Rubella (German
measles)
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,
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)
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).
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).
Other human cell lines have been developed for pharmaceutical needs,
but are not involved in the vaccines actually available.
The vaccines that are incriminated
today as using human cell lines from aborted foetuses, WI-38 and
MRC-5, are the following:
A)Live vaccines against rubella:
-the monovalent vaccines against
rubella Meruvax®II (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®II (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).
B) Other vaccines,
also prepared using human cell lines from aborted foetuses:
- 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, ACAM 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,
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.
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.
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.
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
vaccines
(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
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 measles.
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.
J.
E. Banatvala, D.W.G. Brown, Rubella, The Lancet, 3rd April
2004, vol. 363, No. 9415, pp.1127-1137
