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M.A. Balinska / Journal of Clinical Virology 46 (2009) 202–205 203
against HBV. Worries were also fuelled by the presence of thimerso-
ral and aluminium hydroxides used as adjuvants in the vaccine.
The four-year vaccination campaign had had very mixed results.
To begin with, the primary target was only partially reached since
less than 30% of infants were immunized. School vaccination on
the other hand was largely successful, but since it was short lived,
by 2002 fewer than 50% of all children and adolescents in France
had received complete immunization (i.e. tree injections). But per-
haps most noteworthy was the popular enthusiasm induced by
the campaign leading to vast numbers of adults epidemiologically
speaking not at risk (i.e. not belonging to the “risk” groups) being
vaccinated. All in all approximately one third of the French popula-
tion was vaccinated against HBV. The purpose of this article is not to
analyse once more the many ups and downs of the introduction of
HBV vaccination in France, which has been done elsewhere. How-
ever, a brief reminder of the consequences of this campaign and
its aftermath appears appropriate for the understanding of what
follows.1–3
First, it seems likely that relatively few infants were vaccinated
simply because they were not seen as being at risk of infection by
HBV. Second, the suspension – but as time has shown, the inter-
ruption – of the school-based vaccination campaign brought about
significant loss of confidence in the vaccine on the part both of par-
ents and health care practitioners. Finally, the fact that so many
(primarily young and female)1 adults were vaccinated made it
impossible, at the statistical level, to rule out conclusively an associ-
ation other than temporal between HBV vaccination and MS, even if
none of the early epidemiological investigations confirmed a causal
link. Since that time, to my knowledge no epidemiological study has
found strong evidence suggesting an association between HBV vac-
cination and subsequent development of demyelinating conditions,
with the noteworthy exception of Hernan’s nested case–control
study, published in 2004; others subsequently expressed hypothe-
ses in favour of HBV vaccination triggering autoimmune responses
and advocated the “precaution principle”, i.e. not vaccinating.4,5
Overall faith in the health authorities has in any case suffered sev-
eral setbacks over the last decades (for example, the Chernobyl
incident2 or the HIV contaminated blood scandal) and despite the
fact that most studies have found no link between HBV vaccina-
tion and the onset of MS, uncertainty over the safety of this vaccine
has done nothing to boost public confidence. Finally, French judges
began compensating HBV vaccinated individuals suffering from MS
at the end of the 1990s and this continues to this day.6 Although
the sales of HBV vaccine have been stable for several years and the
1994–1998 campaign appears to have had an impact by decreasing
the number of acute cases of the disease, the present vaccination
coverage rates are not high enough to interrupt transmission of the
virus.2
The question today is whether the largely negative attitude
towards HBV vaccination is amendable to change.
2. The latest available data on immunization status and
attitudes towards the HBV vaccine (2008)
2.1. Immunization status
Ten years on (2008), it is believed that still less than a third of
French infants are immunized against HBV.3 Since the interrup-
tion of the school-based campaign, pre-adolescents are no longer
1
It is known that primarily young women are affected by multiple sclerosis.
2
When the nuclear cloud caused by the Chernobyl accident passed over France,
the population was not informed or warned to stay indoors, despite knowledge on
the part of public officials.
systematically vaccinated. How many high risk individuals3 (other
than health care professionals who undergo obligatory vaccination)
are being reached by vaccination efforts and, once reached, accept
to be vaccinated is not precisely documented. However, the vaccine
to which both physicians (general practitioners and paediatricians)
and the general public are the most strongly opposed is the HBV
vaccine.7,8 Recent evidence has likewise revealed that between
2000 and 2005, public opinion towards the vaccine worsened.9
2.2. Attitudes towards the vaccine
2.2.1. General practitioners and paediatricians
Whereas in 2003 general practitioners declared themselves to
be more favourable to vaccinating infants against HBV than in
1998 (right after the suspension of the school-based campaign),
those opposing such vaccination was still close to 40% (having
decreased from 45.4% to 38.4% from 1998 to 2003).10 Later in the
year, a consensus conference supported the promotion of childhood
immunization.11 This does not seem to have greatly influenced
health care practitioners, since some months later both general-
ists and paediatricians remained highly dubious regarding both the
usefulness and the safety of vaccinating small children: nearly 88%
were unsure as to the safety of the vaccine, and over 60% doubted
its usefulness. In fact, of all vaccines included in the 2004 French
childhood immunization schedule, the HBV vaccine received the
worst score. Nearly 30% of general practitioners and paediatricians
did not follow the official recommendation of immunizing infants.
The main reasons cited for so doing were
• “Adverse events can occur later in life”.
• “The pharmaceutical industry falsifies the data”.
• “I lack confidence in the health authorities”.
Among the remaining 70 or so percent of practitioners who did
follow the official recommendation, 95% stated that parents were
“reticent”, leaving open the question as to how many children were
vaccinated even by those practitioners who advocated immuniza-
tion against HBV. Curiously, and generally speaking, both general
practitioners and paediatricians felt more comfortable about vac-
cinating all age groups other than infants, despite the fact that
notifications of severe adverse events subsequent to HBV vacci-
nation had only concerned adults and (to a much lesser extent)
adolescents.8
2.2.2. The general public
The general public’s attitudes are clearly influenced by their
family practitioners as well as by the large media coverage peri-
odically given to the subject. Thus, in 2004, 55% of the French
population would not have chosen to vaccinate their infant child,
and would have preferred vaccinating an adolescent or an adult.
Interestingly, women were more opposed to the vaccine than men
(whereas in general they are more favourable to vaccination as
such),8 an observation corroborated by a more recent study.9 But
it should be noted that in a context of great wariness towards a
vaccine such as HBV, 92% of the French population felt in 2004 that
the government “should invest more money in developing vaccines
against hepatitis C, AIDS, and cancer.”8
3
Men who have sex with men, haemodialysis patients or patients receiving blood
products, close family members of individuals with chronic HBV infection, travellers
to areas of high endemicity.
4. Author's personal copy
204 M.A. Balinska / Journal of Clinical Virology 46 (2009) 202–205
3. What conclusions are to be drawn from this data?
There is little reason to think that the situation has changed
substantially over the past three to four years. It is clear from the
surveys conducted in 2003–2005 that the perception of the use-
fulness of a vaccine is paramount; both physicians and the general
public are readier to waive possible concerns over safety if they feel
a vaccine is truly useful. In the case of HBV vaccine, it can be sur-
mised that the majority of the French population does not consider
it a useful vaccine, in particular for infants. Although safety issues
have been raised over vaccinating adolescents and adults, people
see the vaccine as more useful for these age groups and are there-
fore more willing to accept the (non-proven) risk of possible side
effects.
Beyond the issue of usefulness (which could be said to apply
to most public health interventions), the general public and physi-
cians are perhaps more aware than they were several decades ago
of the limits of scientific knowledge. To begin with, biology – and
therefore medicine – is in constant evolution. Second, we all know
that epidemiology is an imperfect science, and yet it remains the
only available tool for trying to ascertain a possible association
between HBV vaccination and the onset of MS given the unknown
aetiology of the latter disease. Furthermore, the fact that public
trust in health authorities has dwindled, as already mentioned, goes
hand in hand with a growing awareness of the political and financial
interests involved in medicine and health. The marketing of health
“products” of all sorts (from pharmaceutical drugs to vitamins and
all the way to “natural” medicines) is a reality, just as is the use
of health issues to political ends. This being said, most people are
probably not aware of the stringent regulations applied to vaccines
prior to their market availability (particularly as these are products
meant for healthy subjects), the process of pharmacovigilance for
vaccines as well as the challenges and delicate balance required in
order to attain or preserve “herd immunity”. The media for their
part pay a great amount of attention to health issues and can have
an enormous impact on public opinion. Their influence regarding
the “HBV affair” in France is certainly far from being negligible.
4. Discussion
The question is to what kind of public health do we aspire in
our Western, post-modern societies? It would appear that people
especially and rightly demand equitable access to care as well as to
those prevention measures they feel the state has the obligation to
provide (e.g. protection against pandemic influenza, or “safe” food).
The state for its part increasingly encourages the individual to look
after his/her own health (to an extent that can sometimes seem
over demanding). What position should we thus take with regard
to an immunization regarded as somewhat to very risky, which
stands less to benefit the individual than society at large? When
parents must decide whether or not to vaccinate their child against
HBV, they intuitively if not practically realize that there exists a
“gap between statistical knowledge and individual prediction”,12
furthermore, the philosophy of universal HBV vaccination is more
an act of social solidarity than of individual protection, especially
since it is difficult for parents to imagine their child as a possible
risk-taking adolescent or young adult. Consequently, the thought
of exposing a newborn to a risk, however minute or uncertain, is
distressing. One must also account for the “omission bias”, meaning
that many people will feel less guilty if they have not intervened and
a problem occurs (in this case, they do not vaccinate, but the child
subsequently develops hepatitis B), than if they do intervene and
a problem occurs (in this case, they vaccinate, and the child sub-
sequently develops multiple sclerosis). In the United Kingdom, for
example, anticipated regret from damage occurring subsequent to
vaccination against Measles–Mumps–Rubella (MMR) was found to
be the strongest predicting factor in the decision or not to vaccinate
one’s child.13
There is a tendency today to consider such issues from an ethi-
cal perspective and vaccination inherently raises ethical dilemmas.
In an ideal “ethical” world, each person should take precautions
to protect himself as well as others against infection, but this is
of course impracticable.14 There is no dearth of bioethical theo-
ries, leading to what some authors have called a “philosophical
supermarket”.15 Numerous articles have considered the ethics of
vaccination14–16—to name but a few, perhaps more relevant to
the present discussion. In all cases, one must answer a substan-
tial question: what is the best thing to do for a society made up of
individuals?–as well as a procedural question: how do we go about
doing so? Different ethical theories necessarily lead to different
answers or “solutions”. The main target of HBV vaccination being
infants (with a view to virus and thus disease elimination), several
points must be taken into account from a purely ethical point of
view:
• Immunization programmes must be evaluated not only on the
basis of their short-term but also on their long term effects.
• Freedom of choice of the individual.
• Collective responsibility for public health.
• Those who refuse vaccination for themselves but profit from oth-
ers being vaccinated.
• The specificities/medical conditions of an individual (for exam-
ple, the child of a parent with MS or a patient having suffered
demyelinating events).
Some14 have suggested that the “golden rule” in terms of ethics
is to put oneself in the place of the person most concerned by the
intervention, in this case the infant. If so, we must ask ourselves
the following question: what do we know of the risks for a child
to be vaccinated against HBV as versus not to be vaccinated? This
question can be answered only on the basis of the best available
data. We know that
• The chronic carriage of HBV in France is estimated at 0.68 but
may even be as high as 1%.4
• The percentage of carriers is higher in vulnerable populations.
• Vaccination of infants has not been associated with severe
adverse events (absence of notification of serious neurological
sequelae).
• Even if one accepts a theoretical, non-proven risk, epidemiolog-
ical modelling has shown that by vaccinating 800 000 children
aged 10–12 years, 1.1 extra demyelinating event would occur
compared to the avoidance of 21 cases of fulminating hepatitis
and 49 cases of cirrhosis.17
• Two recent studies have concluded that there exists no important
risk for children of either a first or second demyelinating event
subsequent to HBV vaccination.
Again, it must be stressed that posing the question from an eth-
ical point of view produces no “perfect” answer. However, to do
nothing is also an intervention of sorts. In face of the inevitable
uncertainties inherent to science and the human condition, in order
to advance towards a solution, one must develop a principle upon
which to build the ensuing action. In the light of what we know,
this principle might well be:
4
Given the estimates of the Institut de veille sanitaire, the chronic carriage of HBV
in the French population is somewhere around 0.68% (95% CI, 0.44–1.05), which is
higher than previously estimated percentages.
5. Author's personal copy
M.A. Balinska / Journal of Clinical Virology 46 (2009) 202–205 205
If one considers that it is in the interest of the French population
to eliminate HBV in the medium and long term, then one must
support the “universal” vaccination of infants.5
5. Conclusions: possible “solutions” in view of the
formulated principle
In terms of public health, one should seek to achieve sufficient
HBV vaccination coverage of each new cohort of infants; in terms
of individual protection, high risk groups must continue to be tar-
geted (especially as their risks of HBV infection far outweigh the
hypothesized risk of MS).
Numerous obstacles arise when wishing to follow this principle,
not the least being that our society holds dear individual freedom.
As such, vaccination cannot be imposed (as attempts to enforce
even partial obligation have recently shown),18 and is increasingly
considered as a personal choice, more as a right than a duty. Fur-
thermore, one should avoid being over confident: biomedicine is
in constant evolution and one can never be sure what new discov-
ery may come to light. The only path to follow is existing evidence
(or evidence-based medicine), but precaution must be exercised
in individual cases, even if this is only out of respect for a person
expressing fears (e.g. adverse reactions to previous vaccinations
. . .).
Beyond these difficulties, the main challenge today is how to
raise the percentage of immunised infants. Ways must be found
to improve the “image” of the HBV vaccine, stressing above all its
usefulness, since surveys suggest that this is what people perceive
as being the most important. We need perhaps better to explain to
parents the purpose of protecting their infant against what seems
to be a remote risk. In order to support further the recommen-
dation, it might be pointed out to parents that existing vaccines
are not systematically incorporated into the French childhood vac-
cination schedule (such as varicella vaccine); likewise BCG is no
longer obligatory in France as of July 2007.19 We need also to
validate vaccination as an act of solidarity among citizens of the
same community. The concept of infection has grown somewhat
hazy in countries having undergone the “epidemiological transi-
tion” and in France – at least – it is far from being understood
even with regard to such frequent affectations as the common
cold or “flu-like” syndromes.8 In order to illustrate the stakes of
infection control, it might be useful to cite current examples with
which people can identify (such as nosocomial infections or pan-
demic influenza). Health care practitioners need to have easy access
to validated, peer-reviewed data.20 The media could also play an
important role not just by reporting sensational events, such as
liability cases involving HBV vaccination,21 but also by assisting
scientists and public health authorities to translate complex sci-
ence into understandable language. Finally, as afore mentioned and
other surveys22 have shown, people hope that new vaccines will
be developed against cancer, allergies, AIDS, and so on. This pro-
vides an opportunity for enhancing the image of vaccination not
only as a past intervention that has saved millions of lives, but also
as a present and future tool of immense potential for improving
public health, by reducing the number of premature deaths, seque-
lae of infectious diseases or screening interventions, and general
illness.23
5
Oppositions to this principle could be made, such as France is a country of rel-
atively low endemicity or that the “precaution principle” must be followed in all
cases.
As concerns France, there are at least two reasons to be opti-
mistic: on the 17th of March 2008, it was officially decided that the
hexavalent vaccine (diphtheria, tetanus, acellular pertussis, HBV,
polio, and Hib) would be reimbursed within the public social secu-
rity system. This may well encourage parents to have their child
vaccinated against HBV along with the other vaccines in one fell
swoop, so to speak. Furthermore, younger generations appear to
be more favourable than their elders to vaccination as such,8 which
may well open new windows of opportunity.
Acknowledgements
My thanks go to Pierre Arwidson and Daniel Lévy-Bruhl for shar-
ing recent information.
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