Vaccination: 20 objections & 20 responses

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The ECDC (European Centre for Disease Prevention and Control) translated a document that contains a list of objections frequently raised by people opposed to vaccination and responses from immunisation specialists. This document was originally prepared by the Robert Koch-Institute and the Paul-Ehrlich-Institut from Germany.

Were this assumption actually true, commercial vaccines would not exist. According to the current pharmaceutical law in Germany, a vaccine is licensed only if it has been demonstrated that it actually works. The manufacturer is required to provide proof of its effectiveness in experimental and clinical studies. The scientific evidence is examined on the level of the European Union (EU) under the direction of the European Medicines Agency (EMEA). In Germany, the responsibility lies with the Paul Ehrlich institute as the Federal Agency for Sera and Vaccines. That is the legal side of it. Of even higher importance is probably the test in practice. There is clear evidence that the routine introduction of certain vaccines has led to a significant drop in the corresponding diseases. A well-known example is the introduction of the oral polio vaccine in the early 1960s: while almost 4,700 children in the Federal Republic of Germany (FRG) came down with child paralysis (poliomyelitis) in 1961, this number had gone down to less than 50 as early as 1965. Following this success, there have not been any more clusters of poliomyelitis in Germany (see also no. 17). A similar impact had the immunisation against the bacterium Haemophilus influenza type b (Hib) that can cause severe meningitis in infants and toddlers. We know that in the former German Democratic Republic (GDR), where infections were registered very precisely, between 100 and 120 such meningitis cases occurred annually in the years before the reunification. When the Haemophilus vaccination was introduced in Germany in 1990, the annual case number in the former East German states fell rapidly to under 10.

Where there is no pathogen, there is now vaccination – this is a fundamental law in microbiology. Vaccines are produced on the basis of weakened (attenuated) or dead 2 (inactivated) germs, or on the basis of their molecular components. Sometimes, they are produced from other pathogens that are closely related to the disease-causing germs. The body’s immune system is thereby being prepared for the actual infection. Without specific knowledge about the pathogens themselves, however, the systematic development of vaccines would not have been possible. Robert Koch established the essential methodological foundations of bacteriological research. His achievements include the development of solid media for the cultivation of bacteria as well as the introduction of micro-photography that contributed significantly to the widespread use of bacteriology in medical research. As district physician in 1876, he discovered the anthrax spores, the dormant form of the anthrax bacterium, and thus understood the – at the time unexplained – chain of infection and the high robustness of the bacterium against environmental factors. Robert Koch was therefore the first to demonstrate a causal connection between a micro-organism and an infectious disease. Viruses on the other hand could not be made visible for a long time, because they are too small to be seen in the light microscope. This showed clearly the physical limits of light microscopy. Thanks to the development in the 20th century of electron microscopy, which allows a much higher resolution than light microscopy, detailed pictures of numerous viruses are available today. We now even know the genetic code of many pathogens. This knowledge is used for instance to genetically engineer yeast cells to produce the hepatitis B vaccine. This vaccine consists of just one specific surface molecule of the hepatitis B virus, the so-called HBs antigen. Influenza vaccines on the other hand are still produced in a much more traditional way: The influenza viruses are grown in chicken eggs, then killed, and processed to highly purified vaccines.

Whether a vaccination needs to be repeated or not differs from case to case. If, for example, a child has received as part of the basic immunisation schedule two injections with the combined vaccine against measles, mumps and rubella, one can assume that the protection will actually last for life. Things look differently with tetanus, diphtheria, polio, or whooping cough. With immunisations against these diseases one can rely on five to ten years of protection – then they should be renewed. Even shorter is the protection conferred by an influenza vaccination. As the influenza virus mutates enormously fast, vulnerable individuals need to renew their immunisation every year with a newly composed vaccine. That the effect of a vaccine is only temporary does of course not mean that it is useless. Thus the annual influenza immunisation can prevent a life-threatening course of disease in chronically ill patients or in the elderly. Also the immunisation against tetanus that is due every 10 years seems a minor inconvenience in the face of the potentially deadly infection. However, even people who have gone through a disease and recovered may not have developed durable immunity. One can contract tetanus, and also diphtheria or whooping cough, several times in life. There have even been some reports of people contracting measles twice.

Just as no drug is effective in all patients, no single vaccine confers 100 percent protection to the vaccinee,. However, immunisation significantly reduces the likelihood of an illness. Imagine the following scenario: a measles epidemic occurs in a primary school. Half of the children are immunised, the other half not. Statistically, one can expect about 97 or 98 percent of the unprotected pupils to get sick – but only two to three percent of the vaccinated pupils. The influenza vaccination, however, is less effective. Depending on one’s age and state of health, it protects 50 to 90 percent of vaccinees against the flu. The vaccine is usually least effective in old people. Likewise, if a necessary booster vaccination has been missed or immune protection is not yet fully established, the protection often remains incomplete. Thus, the traditional childhood vaccinations at first need to be repeated several times according to a regulated schedule before one can count on a reliable and durable protective effect. There are also immunisations that prevent only a particularly severe course of disease. This is the case with the Bacille Calmette-Guérin (BCG) vaccination against tuberculosis that was routinely applied to infants in most European countries until the late 1990s, but that has meanwhile been taken out of the regular immunisation schedule in most of these countries due to the comparatively low likelihood of contracting the disease. Although the vaccine did not protect the children from a tuberculosis infection as such, it did protect them from its worst complications, which involve the entire body and brain.

So far, there are no scientific studies that show any advantage of non-vaccinated over vaccinated children with regard to their mental or physical development. Nor would this be plausible. Immunisation is directed against around a dozen particularly notorious and dangerous pathogens – the immune system has to deal with hundreds of other pathogens every day. The vaccination itself also stimulates and trains the immune system. Accordingly, it would be highly surprising if vaccinated children in general had a weaker constitution or reduced immune defences. Evidence that would support such a theory does not exist. In addition, it has to be noted that even if one assumed that going through certain diseases was somewhat beneficial, there can be no doubt that infections can influence the development of children negatively and cause complications and even deaths. Exactly this can often be prevented by immunisation.

It is correct that many infections heal without consequences. Nevertheless, even so- called childhood illnesses can in certain cases take a dramatic course. Childhood illness does not mean that the illness is harmless, but that it occurs preferentially in children. The best example is measles: About one in 1,000 children who have measles, develop an inflammation of the brain, the so-called measles encephalitis. This often leads to permanent brain damage or even death. In about one in a million cases such an encephalitis can even occur after vaccination – this is 1,000 times less frequently than after the disease. Also the fever cramps that often occur in measles patients can to a large extent be avoided by the vaccination. While approximately one in 15 measles patients suffers from such cramps, they affect only one in 100 vaccinees. Similar issues apply to childhood diseases such as mumps or rubella. When Mumps occurs in young men, it can sometimes lead to inflammation of the testicles and impaired fertility. Rubella on the other hand, if contracted by a pregnant woman who is not immune against the disease, can cause severe malformations in the unborn child. These severe consequences can be prevented by immunisation in as good as all cases. Finally it has to be said that in the past, the possibility of vaccination did not exist for many diseases, just like there were no seatbelts in the cars, no motorcycle helmets, and no protective bicycle helmets. Today, all these possibilities for protection exist, and people are happy to use them.

Antibodies are indeed transferred during pregnancy from the mother to the unborn child via the bloodstream. With the breastmilk, the infant receives further immune factors. Particularly during the first months of life, this maternal protection provides crucial support to the child’s developing immune system – but it does not cover everything. Since these antibodies are rapidly degraded, the child is left completely without protection as soon as the mother stops breastfeeding. The mother can pass on antibodies against diseases that she has had herself or against which she has been vaccinated. Against certain infections such as whooping cough, however, the immune system does not produce transferable antibodies, not even during the illness – so the baby is not protected against those diseases in any case. Furthermore it is well known that this passive protection is not strongly developed in premature infants, who therefore profit from vaccinations even more. Passive immune protection and vaccinations are not opposing concepts anyway; in some cases they rather complement each other. Thus Swedish paediatricians have found out that children who are breastfed suffer less frequently from severe meningitis caused by the bacterium Haemophilus influenzae type b (Hib), and in addition produce more protective antibodies against this pathogen after receiving a Hib vaccination. Only through a completed vaccination regime, meningitis can almost always be avoided.

For measles, mumps and rubella this has been proven true. A vaccination against these diseases stimulates the mother’s immune system less strongly than a real infection with the wild virus, which is why the baby of a vaccinated mother has proportionally less maternal antibodies. For this reason, paediatricians today generally give the first vaccine against measles, mumps and rubella a little earlier than it was done 20 years ago. For some other diseases, however, there is no such connection. During an infection with whooping cough for example, the mother’s immune system does not produce any transferable antibodies, and consequently, the baby in that case does not benefit from the maternal immune protection. On the contrary, it is known that adults can become infected with whooping cough several times in life and then often transmit the germs unnoticed to their children. According to a study done in the United States in 2007, parents and close relatives are by far the most frequent source of infection, when a newborn child contracts whooping cough. The German standing committee on vaccination (STIKO) at the Robert Koch institute therefore recommends vaccinating possible contacts already before the child is born. For still other diseases such as tetanus or diphtheria, maternal immune protection can be found in babies of vaccinated mothers but not in babies of mothers that had the infection.

Certain infection affects infants considerably more than older children – this is a fundamental reason why babies are immunised against various diseases already at the age of two months. Classic examples are infections with the bacterium Haemophilus influenzae as well as whooping cough. About one in four children with whooping cough develop complications such as pneumonia or respiratory arrest, if they are younger than six months. Later, the rate of complications drops to about one in 20. Infants therefore profit in particular from an immunisation against whooping cough. Already the first dose of the vaccine at the age of two months can reduce by about two thirds the likelihood that the baby needs to be hospitalised because of whooping cough. The booster vaccinations during the first year make the protection against whooping cough complete. That infants in general tolerate vaccination less well than older children is not documented. It is true that in extremely premature babies that are born before the 32nd week of pregnancy, heart and lung activity needs to be monitored after certain vaccinations in order to detect possible complications rapidly. But on the other hand, premature infants are also more vulnerable to infections – the risk-benefit ratio is therefore positive even in those cases. However, by no means all vaccines are administered already at this early age. The immunisation against measles, mumps and rubella, as well as against special bacteria that cause meningitis – the so-called meningococci – is only done around the age of one year.

Whilst it is true that children nowadays are immunised against more illnesses than in the past, the number of foreign molecules, so-called antigens, that are introduced with those vaccines has decreased considerably. Thus the old whooping cough vaccine alone contained around 3,000 such foreign molecules. In contrast, all of today’s vaccines together contain only 150 antigens. The reason for this is that the modern vaccines are highly purified and for the most part contain only a single component of a pathogen. In fact, the child’s immune system needs to deal every day with a much larger number of foreign molecules than the ones it is exposed to by immunisation. Moreover, there are no indications that combination vaccines overload the immune system. However, it is known that certain vaccine components stimulate the immune system less well when given in combination rather than as an individual vaccine, which can make it necessary to have four injections instead of three. But in the end, the number of necessary injections can still be reduced significantly by using combination vaccines. Nowadays, up to six vaccines – against tetanus, diphtheria, whooping cough, Haemophilus influenzae, polio und hepatitis B – can be combined in a single vaccine shot. Frequent criticism regarding the sixfold vaccine is that hepatitis B is predominantly – although by no means exclusively – transmitted through sexual contact, and newborns are therefore unlikely to contract it. However, hepatitis B in newborns is almost always a very severe disease and becomes chronic in 90% of the cases. Practical considerations also play a role in choosing to immunise newborns against hepatitis B. It is known that the vaccination rate in adolescents is generally low, although a hepatitis B infection can lead to severe disease and, when it becomes chronic, even to liver cancer. The German standing committee on vaccination and the World Health Organization therefore recommend immunisation against hepatitis B already at a young age. According to current knowledge, this could achieve longterm, possibly even lifelong, protection in a large proportion of vaccinees.

Certain vaccines can indeed cause mild symptoms resembling the disease – but virtually never the full-blown disease. The best-known example is measles. Since the measles vaccine contains attenuated (weakened), but live, measles virus, it can cause a measles- like rash in about 5% of vaccinees, which occurs about one week after immunisation. However, inflammations of the middle ear or the lung, which can accompany the actual disease, are not caused by the vaccine. Also the dreaded inflammation of the brain (measles encephalitis) is extremely rare after immunisation. It occurs in about one in one million vaccinees, whereas it affects one in a thousand children who have the actual measles. Patients that have developed poliomyelitis due to the oral polio vaccine have become historical in most European countries. The live vaccine which has helped reduce poliomyelitis on a large scale, itself caused a small number of infections every year. However, since 1998, this oral polio vaccine has been replaced in most European countries by an injection that does not contain live virus and cannot cause the disease. Many vaccines consist of dead pathogens or, as for instance the influenza vaccine, only of molecular components of the pathogens; only very few contain attenuated, still living pathogens. Quite apart from the connections mentioned above, immunisations can sometimes be followed by fever, nausea or drowsiness, as well as swelling and redness at the site of injection. But these are general, and usually rapidly subsiding, reactions of the body. They have nothing to do with the infectious disease against which the immunisation is directed.

What is certain is that we nowadays have more vaccinations – and more allergies. But whether one is connected to the other is not documented. Swedish doctors, it is true, have shown a few years ago that children from anthroposophical families were less prone to develop eczemas. Indeed, these children were vaccinated less frequently. However, they also received fewer antibiotics and a different diet, and their parents smoked less. In another study, American allergy specialists observed that children of parents who oppose immunisations suffer less frequently form asthma or hay fever. But also in this study it remained unclear whether there really was a causal connection. Many other studies argue against such a connection. An analysis done by doctors from Rotterdam, for instance, who evaluated all scientific articles published on the topic between 1966 and 2003, showed that especially the methodologically more reliable pieces of research could not find an increased allergy risk following immunisation. An experience made in Germany points into the same direction: In the former GDR, where vaccination was compulsory by law and almost all children were vaccinated, there were hardly any allergies. They increased in East Germany only after the reunification, while at the same time the vaccination rate decreased.

The assumptions are many: Again and again it has been debated in the past years whether autism, diabetes or even multiple sclerosis can be caused by immunisations. To this day, proof of this does not exist; on the contrary, numerous studies argue against it. A group of British scientists, for instance, hypothesised at the end of the 1990s that the measles-mumps-rubella (MMR) vaccine could cause damage to the intestine and thus facilitate the entry of neurotoxic substances into the body. They further hypothesise that this would interfere with the mental development and favour autism. Meanwhile, however, several other studies have disproved this thesis – 10 of the original 13 authors withdrew the interpretation officially. Nevertheless, vaccines without question do have side effects. Thus a total of about 44 million vaccine doses were sold in Germany in 2005; about half of them were for the annual influenza jab. In the same period, doctors and pharmaceutical companies reported just under 1,400 supposed vaccine complications – corresponding to a rate of about three suspected cases per 100,000 doses sold. As shown in a detailed analysis of all suspected complications by the Paul Ehrlich institute in Germany, there was no indication of a possible causal connection with the immunisation in about a third of the reported cases. Furthermore, a large proportion of the reported health problems – for instance high fever – were temporary. In only five vaccinees was a permanent health impairment reported, which may have been caused by the vaccination. In the case of one adult who died after an immunisation, a causal relation with the vaccination could at least not be completely excluded. Actually, a major difficulty in the risk assessments lies in the fact that vaccinations are so common that many health problems can occur after an immunisation by pure chance. A genuine connection does not necessarily exist at all. A few years ago, for example, it was discussed whether vaccinations would favour cot death, since a number of children had just died after an immunisation. Meanwhile, studies rather point towards the opposite. Thus doctors at the university of Magdeburg in Germany have recently performed a comprehensive analysis of around 300 cases of cot death and discovered that the deceased babies had in fact been vaccinated less frequently and later than usual.

Certain vaccines contain formaldehyde, aluminium, phenol or mercury – but only in minute concentrations (below the toxicological threshold). These substances serve the purpose of, for example, killing the vaccine viruses (formaldehyde), enhancing the immune response (aluminium hydroxide) or act as a preservative (phenol). Some years ago two American doctors had proposed the thesis that the rise in autism cases noticed in the United States was linked to the mercury-containing preservative thiomersal that is part of certain vaccines. The World Health Organization WHO, the United States Institute of Medicine, as well as the European Medicines Agency EMEA, however, have meanwhile independently from each other reached the conclusion that the available studies argue against such a link. Nevertheless, some pharmaceutical companies have reacted to the fierce debate: Mercury-free vaccines are now available for all generally recommended immunisations.

It is correct that, the serum of calves, for instance, is necessary as a component of the cell culture medium in which certain vaccine viruses are grown. However, only certified products from BSE-free countries such as New Zealand are allowed for this purpose. Equally strict are the controls for certain protein components, the so-called human albumin that is obtained from the blood plasma of blood donations. These proteins sometimes serve the purpose of stabilising and preserving live vaccines. In order to exclude a transmission of human immunodeficiency virus (HIV) or hepatitis viruses, plasma products are systematically tested for those pathogens. Further along the production cycle there are procedures to kill possibly undetected viruses.

Few doctors are altogether against immunisation. However, there are indeed some who have a critical attitude towards individual vaccinations – which does not mean per se that there are sound scientific reasons for it. Personal experience and religious or philosophical beliefs also play an important role.

However, an approach based on alternative medicine does by no means need to be in conflict with the idea of immunisation. A few years ago, researchers from Freiburg, Germany, condcuted a survey among 200 doctors with a homeopathic orientation. The found out that those doctors administered the “classic” vaccinations against tetanus, diphtheria and polio almost as frequently as their colleagues in conventional medicine. With other immunisations, though, the homeopaths were more reserved.

The German Central Association of homeopathic doctors (DZVhA) emphasised in a statement from 2002 that a discussion about the benefits and disadvantages of immunisations was perfectly legitimate and the decision for or against needed to be made on an individual basis. At the same time, however, the DZVhA confirmed the importance of the German standing committee on vaccination (STIKO) at the Robert Koch institute whose recommendations were “carefully considered and took into account the current state of knowledge with the intention of preventing, categorically, many infectious diseases.”

Some infections such as polio or diphtheria have become extremely rare in Europe. But this is in itself the result of vaccination programmes. Falling vaccination rates would always bring the danger of new epidemics. This is exemplified by the poliomyelitis outbreaks in the years 1978 and 1992 in Dutch municipalities in which immunisations were refused on religious grounds. 110 people contracted polio during the first epidemic, 71 people during the second. Even more dramatic were the diphtheria waves in Russia and the other post-Soviet states, where more than 150,000 people fell ill and more than 6,000 died in the 1990s as a result of falling vaccination rates. In the course of such epidemics, international travel can export infections to Germany [neighbouring countries]. Polio, for instance, still occurs in India and Egypt, popular holiday destinations. But even in Germany, there are recurring epidemics of, for example, measles, such as the one in North Rhine-Westphalia that affected around 1,700 children in 2006. Overall, the measles rate in Germany is still high compared to other European countries. In addition, other pathogens such as the hepatitis B virus or the bacteria causing severe systemic childhood inflammations – the so-called pneumococci – circulate in the population practically all the time. Infants, who contract a pneumococcal inflammation, often need to be hospitalised. However, an extensive study in the United States has shown that the routine pneumococcal vaccination, which has now been recommended for some years also for babies in Germany, can reduce the number of hospitalisations by almost half. Since the beginning of 2007, a completely different kind of immunisation has entered the scene: an immunisation against certain types of so-called papillomaviruses for girls between the age of 12 and 17. The viruses that are often transmitted during sexual intercourse can later in life cause cervical cancer. The majority of those cases could be prevented by the new vaccine.

Today’s treatment options are no doubt better than in the past – but by no means arbitrary. Drugs against viruses are rare; antibiotics do not work against viruses. And even some bacterial diseases are very hard to treat. Thus, among others, tetanus infections, meningitides and whooping cough can be fatal even under modern treatment conditions. In fact, vaccination and therapy are not alternative options, but part of the same chain of protection. Although vaccination does not always prevent the infection, it does prevent its most severe progressions.

Undoubtedly prosperity and hygiene contribute significantly to the prevention of infectious diseases. The provision of clean drinking water and the establishment of good hand hygiene, for example, are essential for the prevention of hepatitis A, typhus and cholera. Nevertheless, an overall connection between hygienic conditions and infectious diseases does not exist. Thus some pathogens, such as the measles, hepatitis B and polioviruses live exclusively inside the human body and are spread from human to human, for example by sexual contact or coughing It is true that for instance measles infections take a particularly severe course in malnourished children. The actual risk of infection, however, is closely linked to how many children are vaccinated against measles. If the immunisation rate is approximately 95%, measles can be completely eliminated. Thus, as a result of consistent immunisation programmes, the entire American subcontinent can be regarded as virtually measles-free. In sub-Saharan Africa, India and south-east Asia, on the other hand, measles is still one of the most frequent causes of death. In 1999, far more than 800,000 children died of measles in those areas. Large- scale vaccination campaigns, in which more than 360 million children were immunised in Africa and Asia, reduced the number of deaths to around 350,000 in 2005. In the long term, the World Health Organization strives to eliminate measles world-wide. This requires further efforts even in Europe. For example in Germany, the vaccination rates have risen in the past years, and more than 90% of children in their first year of school have received the first, and around 84% also the second measles vaccination, according to a German investigation in 2006. However, at least 95% for both shots are necessary for elimination.

Also the businesses in other industries earn money with their products; this is the goal of all companies. However, medicines for chronic patients, which need to be taken the whole life, would probably be more profitable than vaccines, which usually need to be administered only a few times. Sales for the pharmaceutical industry can often lead to considerable public health savings. Thus for every Deutschmark spent in the old West German states on the oral polio vaccination, 90 were saved in therapy and rehabilitation costs. Today’s vaccination against whooping cough reduces the treatment costs by more than 200 million Euros per year. Also the immunisation against hepatitis B – which meanwhile is generally recommended – is estimated to achieve cost savings to the health system in the long run, after initial extra costs for the health insurance companies.

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Acknowledgement

This translation was done with the kind permission of the Robert-Koch institute and the Paul Ehrlich institute.

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