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This article is taken from Dr Vernon Coleman’s Health Letter. It gives general material and opinions for information only and is not to be considered an alternative to professional medical advice. Readers should consult their family doctors or other qualified medical advisers on any matter relating to their health and wellbeing.

Do Vaccines Work And Are They Safe?

Most doctors and nurses genuinely believe that vaccines have helped wipe out some of the deadliest infectious diseases. Many members of the medical profession would put vaccination high on any list of great medical discoveries.

The perceived value of vaccination is so great that even though I have, for many years, been a vociferous critic of some specific vaccines (see section headed Whooping Cough) I have up until now always been reluctant to **** all vaccination programmes as worthless and dangerous.

The mythical power of vaccination programmes has for years constantly been sustained by governments, and bodies, such as the World Health Organisation announcing, apparently with complete conviction, that such and such a disease will be eradicated when the relevant vaccination programme has been completed.

The principle behind vaccination is a convincing one.

The theory is that when an individual is given a vaccine – which consists of a weakened or dead version of the disease against which protection is required – his or her body will be tricked into developing antibodies to the disease in exactly the same way that a body develops antibodies when it is exposed to the disease itself.

But in reality things aren’t quite so simple. How long do the antibodies last? Do they always work? What about those individuals who don’t produce antibodies at all? Vaccination, like so much of medicine, is a far more inexact science than doctors (and drug companies) would like us to think.

Vaccination is widely respected by doctors and others in the health care industry because of the assumption that it is through vaccination that many of the world’s most lethal infectious diseases have been eradicated. But this simply isn’t true. As I have shown in many of my books infectious diseases were conquered by the provision of cleaner drinking water and better sewage facilities. The introduction of vaccination programmes came along either just at the same time or later when the death rates from the major infectious diseases had already fallen. There really isn’t any evidence to show that vaccination programmes have ever been of any real value – either to individuals or to communities.

THE SMALLPOX MYTH

One of the medical profession’s greatest boasts is that it eradicated smallpox through the use of the smallpox vaccine. I myself believed this claim for many years. But it simply isn’t true.

One of the worst smallpox epidemics of all time took place in England between 1870 and 1872 – nearly two decades after compulsory vaccination was introduced. After this evidence that smallpox vaccination didn’t work the people of Leicester in the English midlands refused to have the vaccine any more. When the next smallpox epidemic struck in the early 1890s the people of Leicester relied upon good sanitation and a system of quarantine. There was only one death from smallpox in Leicester during that epidemic. In contrast the citizens of other towns (who had been vaccinated) died in vast numbers.

Obligatory vaccination against smallpox was introduced in Germany in around 1816, largely as a result of state by-laws, but these vaccination programmes had no influence on the incidence of the disease. On the contrary, the smallpox epidemic continued to grow and in 1870 the war with France led to the gravest smallpox epidemic in Germany history. At that point the new German ***** introduced a new national law making vaccination against smallpox an even stricter legal requirement. The police were given the power to enforce the new law.

German doctors (and medical students) are taught that it was the ***** Vaccination Law which led to a dramatic reduction in the incidence of smallpox in Germany. But a close look at the figures shows that the incidence of smallpox had already started to fall before the law came into action. And the legally enforced national smallpox vaccination programme did not eradicate the disease.

Doctors and drug companies may not like it but the truth is that surveillance, quarantine and better living conditions got rid of smallpox – not the smallpox vaccine.

When the World Health Organization campaign to rid the world of smallpox was at its height the number of cases of smallpox went up each time there was a large scale (and expensive) mass vaccination of populations in susceptible countries. As a result of this the WHO changed its strategy. Mass vaccination programmes were abandoned and replaced with surveillance, isolation and quarantine.

For example, in the 1960s Sierra Leone had the highest rate of smallpox in the world. The country got rid of smallpox in just over a year – largely by the simple process of identifying and isolating patients with the disease.

The myth that smallpox was eradicated through a mass vaccination programme is just that – a myth.

It is worth pointing out that Edward Jenner, widely feted as the inventor of the smallpox vaccine, tried out the first smallpox vaccination on his own 10 month old son. His son remained mentally ******* until his death at the age of 21. Jenner refused to have his second child vaccinated.

TUBERCULOSIS

Vaccination against tuberculosis is often given as the reason why this disease stopped being quite the threat to life that it had been in the 18th century.

But again, this isn’t true.

Robert Koch discovered the pathogen that causes TB back in 1883. After that BCG vaccination was introduced and then, subsequently, mass treatment programmes were devised with chemotherapy.

None of these discoveries or introductions had any effect on the incidence of tuberculosis.

Contracting TB doesn’t provide any immunity against a second infection. And if a natural infection doesn’t provide protection then a vaccination certainly won’t provide protection. How on earth can it?

It was noticed decades ago that in the lung sanatoriums that specialised in the treatment of TB patients there was no difference in the survival rates of patients who had been ‘protected’ against TB with BCG vaccination when compared to the survival rates of patients who had received no such ‘protection’.

The tuberculosis vaccination (the Bacillus Calmette-Guerin – known as BCG) consists of a weakened, living bovine mycobacterium. The vaccine was used for many years but a WHO trial in India showed that the vaccine offers no protection against the disease. Indeed, when new cases of tuberculosis increased annually in the areas where people had been vaccinated against the disease the trial seemed to suggest that there might be a link between the vaccine and outbreaks of the disease.

Many countries have now abandoned the TB vaccine – and have no plans to reintroduce it even though the disease is once again a major health problem.

DIPTHERIA

Vaccination against diphtheria was introduced to Germany in 1925. After the introduction of the vaccine the number of cases of diphtheria steadily increased until, shortly after the Second World War, production of the vaccine was halted. There was a decline in the incidence of the disease which coincided with the fact that the vaccination was no longer being used. When the vaccine was subsequently reintroduced the decline in the incidence of the disease slowed down.

As with whooping cough, tetanus and other diseases the incidence, and number of deaths from diphtheria, were in decline long before the vaccine was introduced.

POLIO

Paralysis caused by poliomyelitis is now unheard of in Germany. But every year there are some cases of paralysis caused by the oral polio vaccine.

In America the incidence of polio increased dramatically (by around 50%) after the introduction of mass immunisation. In some States the incidence of polio roughly doubled after the polio vaccine was introduced. The number of deaths from polio had fallen dramatically before the first polio vaccine was introduced. As with other infectious diseases the significance of polio dropped as better sanitation, better housing, cleaner water and more food were all made available in the second half of the nineteenth century. It was social developments rather than medical ones which increased human resistance to infectious diseases.

Proof that the introduction of the polio vaccine wasn’t the success it is often made out to be isn’t difficult to find. In Tennessee, US, the number of polio victims the year before vaccination became compulsory was 119. The year after vaccination was introduced the figure rose to 386. In North Carolina, the number of cases before vaccination was introduced was 78, while the number after the vaccine became compulsory rose to 313. There are similar figures for other American states.

The fact is that polio (like many other infectious diseases) comes in cycles. When a disease is at a high point in its cycle the authorities (egged on by doctors and drug companies) will use this to frighten citizens into agreeing to be vaccinated. And when a disease is at a low point in its natural cycle it is often vaccination programmes which get the credit. This is exactly what happened with polio.

However, whether or not the polio vaccine actually works is, for many people, a relatively unimportant health issue.

Of far more significance is the fact (revealed in my book Why Animal Experiments Must Stop in 1991) that millions of people who were given the polio vaccine as children in the 1950s and 1960s may now be at a greatly increased risk of developing cancer.

Although an early breakthrough in the development of a polio vaccine was made in 1949 with the aid of a human tissue culture, monkey kidney tissue was used when the first practical vaccine was prepared in the 1950s. The monkey tissue was used simply because that was standard laboratory practice, but no one realised that one of the viruses commonly found in monkey kidney cells can cause cancer in human beings.

(As a side issue this is yet another example of the stupidity of using animal tissue in the treatment of human patients. The popularity of using transplants derived from animals suggests that doctors and scientists have learned nothing from this error. I sometimes despair of those who claim to be in the healing profession.)

Bone, brain, liver and lung cancers have all been linked to the monkey kidney virus SV40 and something like seventeen million people who were given the polio vaccine in the 1950s and 1960s are probably now at risk. Moreover, there now seems to be evidence that the virus may be passed on to the children of those who were given the contaminated vaccine. The SV40 virus from the polio vaccine has already been found in cancers which have developed both in individuals who were given the vaccine as protection against polio and in the children of individuals who were given the vaccine. It seems inconceivable that the virus could have got into the tumours other than through the polio vaccine.

The American government was warned of this danger back in 1956 but the doctor who made the discovery was ignored and her laboratory was closed down. Surprise, surprise. It was five years after this discovery before drug companies started screening out the virus. And even then Britain had millions of doses of the infected polio vaccine in stock. There is no evidence that the government withdrew the vaccine. In Britain official records which would identify those who received the contaminated vaccine were all destroyed by the Department of Health in 1987. Oddly enough this means that no one can take legal action against the government. Gosh. Another surprise. How do these ******* sleep at night?

WHOOPING COUGH

Throughout the 1970s and the 1980s I was a critic of a number of vaccines – most notably the whooping cough vaccine. The following essay on the whooping cough vaccine appeared in 1988 in my book The Health Scandal.

The story of the whooping cough vaccine provides us with a remarkable example of dishonesty and deceit in medicine.

There has been controversy about the whooping cough vaccine for many years but in the UK the Department of Health and Social Security has, through the years, consistently managed to convince the majority of medical and nursing staff to support the official line that the vaccine is both safe and effective. The official DHSS line has for years paid little attention to the facts. Put bluntly the DHSS (on behalf of successive governments) has consistently lied about the risks and problems associated with the whooping cough vaccine.

I will explain exactly why I think that governments have lied to their employers (the public) a little later. For the time being I would like to concentrate on the facts.

The first point that should be made is that although official spokesmen claim otherwise, the whooping cough vaccine has never had much of an influence on the number of children dying from whooping cough. The dramatic fall in the number of deaths caused by the disease came well before the vaccine was widely available and was, historians agree, the result of improved public health measures and, indirectly, the use of antibiotics.

It was in 1957 that the whooping cough vaccine was first introduced nationally in Britain – although the vaccine was tried out in the late 1940s and the early 1950s. But the incidence of whooping cough, and the number of children dying from the disease, had both fallen very considerably well before 1957. So, for example, while doctors reported 170,000 cases of whooping cough in 1950 they reported only about 80,000 cases in 1955. The introduction of the vaccine really didn’t make very much, if any, difference to the fall in the incidence of the disease. Even today (1988) thirty years after the introduction of the vaccine, whooping cough cases are still running at about 1,000 a week in Britain.

Similarly, the figures show that the introduction of the vaccine had no effect on the number of children dying from whooping cough. The mortality rate associated with the disease had been falling appreciably since the early part of the twentieth century and rapidly since the 1930s and 1940s – showing a particularly steep decline after the introduction of the sulphonamide drugs. Whooping cough is undoubtedly an extremely unpleasant disease but it has not been a major killer for many years. Successive governments have frequently forecast fresh whooping cough epidemics but none of the forecast epidemics has produced the devastation predicted.

My second point is that the whooping cough vaccine is neither very efficient nor is it safe. The efficiency of the vaccine is of subsidiary interest – although thousands of children who have been vaccinated do still get the disease – the greatest controversy surrounds the safety of the vaccine. The DHSS has always claimed that serious adverse reactions to the whooping cough vaccine are extremely rare and the official suggestion is that the risk of a child being brain damaged by the vaccine is no higher than one in 100,000. Now, leaving aside the fact that I find a risk of one in 100,000 unacceptable, it is interesting to examine this figure a little more closely, for after a little research work it becomes clear that the figure of one in 100,000 is a guess.

Over the last decade or two, numerous researchers have studied the risks of brain damage following whooping cough vaccination and their results make fascinating reading. Between 1960 and 1981, for example, nine reports were published showing that the risk of brain damage varied between one in 6,000 and one in 100,000. The average was a risk of one in 50,000. It is clear from these figures that the DHSS has simply chosen the figure which showed the whooping cough vaccine to be least risky. Moreover, the one in 100,000 figure did not come from any rock solid research. It was itself an estimate – a guess.

These are just a couple of the important facts about the whooping cough vaccine that have been ignored or overlooked or disguised by the DHSS. But they are not the only facts that have been distorted.

Although the DHSS consistently claims that whooping cough is a dangerous disease, the figures show that it is not the indiscriminate killer it is made out to be. Whooping cough causes around four deaths a year in Britain. Compare that to approximately 300 deaths caused by tuberculosis and 100 deaths caused by meningitis. Most of the victims of whooping cough are babies under three months old. That fact is particularly important because the vaccine is never given to babies under three months old.

The truth about the whooping cough vaccine is that it has always been a disaster. The vaccine has already been withdrawn in other countries because of the amount of brain damage associated with its use. In Japan, Sweden and West Germany the vaccine has been omitted from regular vaccination schedules. In America two out of three whooping cough vaccine manufacturers have stopped making the vaccine because of the cost of lawsuits. On 6th December 1985 the Journal of the American Medical Association published a major report showing that the whooping cough vaccine is, without doubt, linked to the development of serious brain damage. And even here in Britain the DHSS has been so worried about the vaccine that for ten years it has been paying research workers at Porton Down to search for ways to make a new, safer, more effective whooping cough vaccine. At long last, after a £5 million research programme, a new vaccine is indeed being tested on children.

The final nail in the coffin lid is the fact that the British Government has already paid out compensation to the parents of some 800 children who have been brain damaged by the whooping cough vaccine. Some parents who accepted damages a few years ago were given £10,000. More recently parents have been getting £20,000.

It is a startling fact that for many years now the whooping cough vaccine has been killing or severely injuring more children than the disease itself. Since 1979 around 800 children (or their parents) have received money from the Government for vaccine produced brain damage. In the same period less than 100 children have been killed by whooping cough. I think that makes the vaccine more dangerous than the disease. And that, surely is quite unacceptable. So, why has the DHSS continued to encourage doctors to use the vaccine?

There are two possible explanations. The first explanation is the more generous of the two and concerns the Government’s responsibility for the health of the community as a whole. The theory here is that by encouraging millions of parents to have their children vaccinated the Government can reduce the incidence of the disease in the community. In the long run this (theoretically) reduces the risk of there being any future epidemics of whooping cough. In other words the government risks the lives of individual children for the good of the next generation.

The second, less charitable explanation is that the DHSS is looking after its own interests by continuing to claim that the whooping cough vaccine is safe enough to use. In 1987 there were 258 sets of parents preparing to sue the DHSS for damages. They claim that the whooping cough vaccine damaged their children. They are claiming something in the region of £250,000 each. If the DHSS withdrew the whooping cough vaccine, it would be admitting that the vaccine was dangerous. And it would obviously lose its court cases. Such an admission would, therefore, cost it 258 times £250,000.

And that would be just the beginning for there are, you will remember, 800 sets of parents who have already received payments from the Government of either £10,000 or £20,000. If the DHSS admitted liability (and those payments did not include an admission of liability) then it is fair to assume that the DHSS would find itself with several hundred more lawsuits and a damages bill running into billions of pounds.

Whatever explanation you consider most accurate the unavoidable fact is that the government (in the form of the DHSS) has consistently lied about the whooping cough vaccine, has distorted the truth and has deceived both the medical profession (for the majority of doctors and nurses who give these injections accept the recommendations made by the DHSS without question) and millions of parents.

The DHSS may have saved itself a tidy sum in damages. But the cost to the nation’s health has been enormous. And this, remember, is merely one more example of the way in which the truth has been distorted by those whom we trust to provide us with honest, accurate advice about medicine and health care.

(The above account of the whooping cough vaccine is taken from The Health Scandal by Vernon Coleman, published by Sidgwick and Jackson in 1988.)

MORE AND MORE VACCINES

As the years have gone by the number of vaccines available has increased steadily. Modern American children receive around thirty vaccinations by the time they go to school.

A decade or two ago the only vaccines available were against a relatively small number of diseases including smallpox, tuberculosis, polio, cholera, diphtheria, tetanus and whooping cough. Today, the number of available vaccines seems to grow almost daily. In the past vaccines were produced against major killer diseases. Today vaccines are produced against diseases such as measles, mumps and chickenpox which have been traditionally regarded as relatively benign inconveniences of childhood.

In the UK the death rate from measles had dropped dramatically decades before the vaccine was introduced. Today the incidence of measles is rising again.

In attempts to persuade parents to have their children vaccinated against measles governments and doctors around the world have thought up an apparently unending – and hysterical – series of scare campaigns. Now that there is a vaccine against it measles has, by a strange coincidence, stopped being an annoying childhood disease and has, instead, become a deadly killer.

Scares often consist of claiming that a major epidemic is just around the corner and that only vaccination can offer protection. I have lost count of the number of whooping cough epidemics which governments have wrongly forecast. Governments and their advisers are either unbelievably stupid or else they are deliberately lying to help boost drug company profits.

Of course, countless scientists around the world have spent vast fortunes trying to create a vaccine against AIDS (in view of the fact that AIDS may not exist – see later in this edition of VCHL – they may find this trickier than expected).

And scientists have apparently developed a banana vaccine by creating genetically engineered banana plants. There are plans to develop bananas which ‘protect’ against hepatitis B, measles, yellow fever and poliomyelitis.

Other scientists have developed a genetically engineered potato which it may be possible to use as a vaccine against cholera. The active part of the potato remains active during the process of cooking and so a portion of genetically engineered chips could soon be a vaccine against cholera. (I am not making this up.)

Naturally, the pharmaceutical industry is constantly searching for more and more new vaccines. I have lost count of the number of times I have read of researchers working on a vaccine to prevent cancer. Every year new flu jabs appear on the market. There are, so I am told, vaccines in the pipeline for just about everything ranging from asthma to earache. There is a planned genetically engineered vaccine which will provide protection against forty different diseases. The vaccine, which will contain the raw DNA of all those different diseases, will be given to newborn babies to provide them with protection for life. Oh, goody.

I don’t know about you but I can no longer keep up with what is going on. I have long since given up trying to work out which vaccines are very dangerous and which are just a bit dangerous – and to whom.

Nor can I keep up with which vaccines might work a bit and which don’t seem to do much good at all. Does anyone know what the hell happens inside the body when all these different vaccinations are given together? Do different vaccines work with or against one another? What about the risk of interactions? Exactly how does the immune system cope when it is suddenly bombarded with so much foreign material?

I am an enthusiastic supporter of the principle of preventive medicine. It is usually much easier to avoid an illness than it is to treat one.

Vaccination programmes are usually sold to the public as though they are an integral part of a general preventive medicine programme.

But over the years I have steadily come around to the view that vaccination programmes cannot truly be described as preventive medicine but are, rather, a part of the interventionist approach to medical care.

DOCTORS REFUSE TO DISCUSS THE ISSUE

One of the big problems with vaccination is that it has, for many years, been nigh on impossible to discuss the issue of vaccination without arousing great antagonism from doctors and politicians. Many parents who have tried to discuss vaccination programmes offered to their children have been startled by the response. Doctors who will discuss other issues in a rational and understanding way suddenly become hysterical when it is suggested that the value of a vaccination programme be discussed. Doctors, nurses and health visitors often put a great deal of pressure on parents to force them to have their children vaccinated. It is common for doctors to refuse to discuss the issue and it is common for doctors to use a great deal of emotional blackmail to force parents to have their children vaccinated. All this is made even more worrying by the fact that these days doctors often have a personal financial interest in making sure that their patients are vaccinated. (For example, doctors in general practice often get a financial bonus if they can show that a high percentage of their patients have been vaccinated.)

Instead of providing members of the public with the facts politicians and civil servants have frequently introduced blatantly misleading and downright dishonest advertising campaigns in an attempt to bully patients and parents into accepting vaccination. Diseases which are often short lived and relatively harmless may be described as deadly and lethal while the side effects associated with particular vaccines are often ignored, minimised, trivialised or even hidden completely.

In my experience it is often extremely difficult to find the truth about a particular vaccine. GPs who rely upon official information (from the government) probably find it difficult to discover the whole truth and I suspect that most of the doctors and nurses who are such enthusiastic supporters and promoters of vaccination programmes do so because they innocently and naively believe what they have been told and have no idea of the real facts.

One of the arguments often put forward in favour of vaccination is that if a large enough number of people are vaccinated then the community will benefit because fewer people will catch the disease in question. The individual who does not get vaccinated (or who refuses to allow his or her child to be vaccinated) will be accused of being irresponsibly selfish. In some parts of the world it is now illegal for parents not to have their children vaccinated. Children in the US have been arrested for not having valid vaccination certificates.

Apart from the fact that it is odd to see doctors and drug companies (most of whom are hardly left wing in their day to day approach to life) embracing this curiously communistic approach to health care (with the rights of the individual being regarded as less important than the future prospects of the community) the big flaw is that all the evidence shows that vaccination just doesn’t work this way.

Survey after survey has shown that the incidence of a disease in a community simply isn’t related to the number of people who have been vaccinated.

FLAWS AND MYTHS

The whole business of vaccination is riddled with flaws and myths.

Here are just a couple of the most obvious ones.

First, vaccines simply aren’t very effective. Much to the annoyance of doctors and drug companies, viruses and other organisms don’t just sit still and remain the same for year after year. They are constantly changing. And new organisms are being formed all the time. Attempts to prevent influenza by giving flu jabs are, in my view, utterly futile. Every year scientists, drug companies and doctors enthuse about the latest anti-flu vaccine. But each year’s new vaccine is based on last year’s brand of flu. And it will not necessarily provide any protection against the latest flu bug.

While your doctor is busy jabbing you and your family with the latest vaccine a new flu bug is probably on its way from China, Australia or South America. The result is that vaccines are, at best, unpredictable and at worst utterly ineffective.

During outbreaks of whooping cough around half the victims are people who have been vaccinated. (At least one important study has shown that whooping cough epidemics mainly occur among children who have had the full vaccination course.) Research from Sweden and Italy has shown that the whooping cough vaccine is effective in 48% and 36% of those to whom it is given. Hardly reassuring when one considers the risks involved.

Measles vaccines are similarly often ineffective. In an attempt to cope with this doctors usually simply suggest giving booster shots. Naturally, this has nothing whatsoever to do with the fact that abandoning the vaccine would damage drug company (and doctor) profits whereas giving booster profits would increase drug company (and doctor) profits.

Measles used to be a relatively mild disease that usually affected children. Today it seems to be a more serious disease which often affects young adults. Measles is now a significant disease among college students who have been vaccinated against it. (Incidentally, there is now some evidence to suggest that trying to stop children getting the typical childhood infections isn’t a good idea for another reason. It seems possible that children who don’t get many infectious diseases in childhood may be more likely to develop cancer later in life. The explanation for this is that those childhood infections help the immune system to develop.)

Failure rates with other vaccines are also high. There is much evidence to show that the polio vaccine may fail (some outbreaks of polio seem more likely to affect the vaccinated than the unvaccinated) and one study showed that a vaccination given to protect against meningitis increased a child’s risk of contracting the disease by five times.Other studies have shown that the vaccine increases susceptibility to complications.

The vaccine against tuberculosis has been estimated to be effective between 0% and 80% of the time. (The Heaf test which is used to measure tuberculin sensitivity can be something of a mystery. False negatives and false positives are possible. A positive test could mean that the patient is allergic to the test, has had a TB infection or is immune to TB. Take your pick.)

Second, the side effects which may be associated with vaccines are invariably worse than those who give and enthuse about the vaccines are prepared to admit. There is no such thing as an entirely safe vaccine. There are today more people in Germany suffering from vaccination damage than there are people suffering from AIDS. (This is probably true for most other so called ‘developed’ countries.) The amount of money being wasted on AIDS research runs into billions of any currency you like to name. (I am not saying that research into this disease is inevitably useless but that the research which is being done is probably useless.) The amount of money being spent on studying vaccine damage is approximately nothing.

Some side effects are relatively mild but nevertheless inconvenient. For example, the flu jab regularly causes symptoms which are virtually indistinguishable from flu itself. Other side effects may be crippling. For example, the side effects which may be associated with the whooping cough vaccine can cause serious, life long damage.

For over two centuries doctors have persisted with vaccination programmes despite the fact that there has never been any convincing evidence to show that they work or, indeed, are safe. Moreover, to their eternal shame, doctors have consistently refused to debate the issue of vivisection and have done everything they could to prevent the public discovering the truth about an activity which has been extremely profitable both for the medical profession and for the drugs industry.

In the 1970s, when I wrote extensively about the hazards of specific vaccination programmes (particularly the whooping cough vaccine), I was widely blamed by doctors and politicians for the fact that many parents were refusing to have their children vaccinated. My only weapon against the propaganda techniques employed by the government was the truth. At the time I was writing a syndicated newspaper column which appeared in a number of local newspapers. Time and time again doctors put pressure on local newspaper editors to encourage them to drop my column on the grounds that by printing the facts about the whooping cough vaccine (as far as I know, no one ever disputed the accuracy of the facts I printed) I was threatening the safety of the nation!

YET MORE FLAWS AND FAILURES

Evidence that vaccines may do more harm than good is supported by experiences with animals. Between 1968 and 1988 there were considerably more outbreaks of foot and mouth disease in countries where vaccination against foot and mouth disease was compulsory than in countries where there were no such regulations. Epidemics always started in countries where vaccination was compulsory. This experience clearly shows that the alleged advantage to the community of vaccinating individuals simply does not exist.

Similar observations were made about the hyena dog, which was in 1989 threatened with extinction. Scientists vaccinated individual animals to protect them against rabies but more than a dozen packs then died within a year – of rabies. This happened even in areas where rabies had never been seen before. When researchers tried using a non-infectious form of the pathogen (to prevent the deaths of the remaining animals) all members of seven packs of dogs disappeared. And yet the rabies vaccine is now compulsory in many parts of the world. Is it not possible that it is the vaccine which is keeping this disease alive?

Horses are regularly and repeatedly vaccinated with a whole range of vaccines. Some vets now believe that these vaccinations damage the immune systems of the animals concerned (though most vets, like most doctors, are frightened to speak out and attack vaccines).

Similarly, what evidence is there to show that the many vaccines given to family pets are of value – other than to the companies making the vaccines and the vets giving the jabs?

Those who eat meat should be aware that cattle (and other animals reared for slaughter) are regularly vaccinated. The meat that is taken from those animals may, therefore, contain vaccine residues in addition to hormones, antibiotics and other drugs.

THE BOTTOM LINE

I have for decades argued that some vaccines may be unnecessary and/or even potentially dangerous in some circumstances, and may sometimes be promoted too enthusiastically by both politicians and doctors. Tragically, many doctors seem to know very little about the vaccines they advocate. In my view, if a doctor wants to vaccinate you or a member of your family you should insist that he confirm in writing that the vaccine is both entirely safe and absolutely essential. You may notice his enthusiasm for the vaccine suddenly diminish.

The first vaccine which really attracted my attention was the whooping cough vaccine. For years now whooping cough has not been a major killer disease – not, at least, in most westernised, developed countries and for many years I have believed – and publicly argued – that the number of children allegedly brain damaged by the vaccine has, during the last decade or two, probably exceeded the number allegedly killed by the disease itself.

Many readers who have tried to discuss vaccines with their doctors have complained that their physicians simply insist that the whooping cough vaccine is perfectly safe and won’t even discuss it with them. I firmly believe that all parents should be told the facts so that they can make up their own minds about the value of any vaccine. Deciding whether or not to have a child vaccinated is a big decision. It isn’t something to be done lightly. The wrong decision can easily lead to a lifetime of regrets. Sadly, however, one big problem is undoubtedly the fact that many doctors simply don’t know very much about the safety or effectiveness of vaccines. They know what the government tells them and they may know what the company which makes the vaccine tells them. But I don’t trust governments and I don’t think that drug companies are always the best source of unbiased information about effectiveness and safety.

In my view all parents should have the right to decide whether or not their child has any vaccine. They should not just be told by their doctor that they must accept his assurance that the vaccine is perfectly safe and completely essential.

‘My doctor implied that I was just being stupid when I said I wasn’t sure that I wanted my child vaccinated,’ complained one reader. ‘His attitude was that it had nothing to do with me and that I should just allow him to do whatever he thought best.’

‘My wife came home crying,’ complained another reader. ‘She had had the temerity to question her doctor about vaccination. He told her that if she refused to have our child vaccinated he would call in the social workers since in his view our refusal to allow vaccination made us unfit to be parents. What really upset me is that my wife hadn’t refused to have our child vaccinated. She just wanted to talk about it.’

This paternalistic attitude seems strong among doctors and other health workers, most of whom seem to prefer to answer any questions with abuse rather than facts.

I believe that all parents should make up their own minds about whether or not to have their children vaccinated. Before you allow your doctor to vaccine your child (or you) ask your doctor some questions. Essential questions to ask include:


How dangerous is the disease for which the vaccine is being given?
How effective is the vaccine?
How dangerous is the vaccine?
Which patients should not be given the vaccine?
And, finally, as I said earlier, I advise patients to ask doctors to give them written confirmation that they have personally investigated the risk-benefit ratio of the vaccine and that, having looked at all the evidence, they believe that the vaccine is safe and essential for that particular patient. How could any doctor object to signing such a confirmation?
I cannot give you specific advice about whether or not you should have your child vaccinated against whooping cough, measles or any other disease. It would be dangerous and irresponsible for me to try to offer you specific advice because we are all different and circumstances change from day to day.

My own personal view is that vaccines are unsafe and worthless. I will not allow myself to be vaccinated again. Readers of VCHL must, however, make their own judgements based on all the available evidence. I strongly recommend that anyone contemplating vaccination discuss the issue with their own medical adviser.

The bottom line is that infectious diseases are least likely to affect (and to ****) those who have healthy immune systems. I no longer believe that vaccines have any role to play in the protection of the community or the individual. Vaccines may be profitable but, in my view, they are neither safe nor effective.

I prefer to put my trust in building up my immune system. (See VCHL Vol 1 No 8 and VCHL Vol 2 No 10.)
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us e
M-M-R II safely and effectively. See full prescribing information
for M-M-R II.
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live)
Suspension for subcutaneous injection
Initial U.S. Approv al: 1978
-------------------------------INDICATIONS AND USAGE-------------------------------
M-M-R II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella in individuals 12 months of
age and older. (1)
-------------------------- DOSAGE AND ADMINISTRATION--------------------------
Administer a 0.5-mL dose of M-M-R II subcutaneously. (2.1)
• The first dose is administered at 12 to 15 months of age. (2.1)
• The second dose is administered at 4 to 6 years of age. (2.1)
------------------------DOSAGE FORMS AND STRENGTHS -----------------------
Suspension for injection (0.5-mL dose) supplied as a lyophilized
vaccine to be reconstituted using accompanying sterile diluent. (3)
---------------------------------- CONTRAINDICATIONS ----------------------------------
• Hypersensitivity to any componentof the vaccine. (4.1)
• Immunosuppression. (4.2)
• Moderate or severe febrile illness. (4.3)
• Active untreated tuberculosis. (4.4)
• Pregnancy. (4.5, 8.1)
-------------------------- WARNINGS AND PRECAUTIONS --------------------------
• Use caution when administering M-M-R II to individuals with a
history of febrile seizures. (5.1)
• Use caution when administering M-M-R II to individuals with
anaphylaxis or immediate hypersensitivity following egg ingestion.
(5.2)
• Use caution when administering M-M-R II to individuals with a
history of thrombocytopenia. (5.3)
• Immune Globulins (IG) and other blood products should not be
given concurrently with M-M-R II. (5.4, 7.2)
----------------------------------ADVERSE REACTIONS----------------------------------
See full prescribing information for adverse reactions occurring duri ng
clinical trialsor the post-marketing period. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-8 7 7 -
888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
-----------------------------------DRUG INTERACTIONS----------------------------------
• Administration of immune globulins and other blood products
concurrently with M-M-R II vaccine may interfere with the
expected immune response. (7.2)
• M-M-R II vaccination may result in a temporary depression of
purified protein derivative (PPD) tuberculin skin sensitivity. (7.3)
-------------------------- USE IN SPECIFIC POPULATIONS--------------------------
• Pregnancy: Do not administer M-M-R II to females who are
pregnant. Pregnancy should be avoided for 1 month following
vaccination with M-M-R II. (4.5, 8.1, 17)
See 17 for PATIENT COUNSELING INFORMATION and FDA
approv ed patient labeling.
Rev ised: 06/2020
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
2.2 Preparation andAdministration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Immunosuppression
4.3 Moderate or Severe Febrile Illness
4.4 Active Untreated Tuberculosis
4.5 Pregnancy
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
5.2 Hypersensitivity to Eggs
5.3 Thrombocytopenia
5.4 Immune Globulins and Transfusions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
7.2 Immune Globulinsand Transfusions
7.3 Tuberculin Skin Testing
7.4 Use with Other Live Viral Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.6 Persistence of Antibody Responses After Vaccination
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Efficacy
14.2 Immunogenicity
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the full prescribing info rma tion
are not listed.
2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
M-M-R® II is a vaccine indicated for active immunization for the prevention of measles, mumps, and
rubella in individuals 12 months of age and older.
2 DOSAGE AND ADMINISTRATION
For subcutaneous use only.
2.1 Dose and Schedule
Each 0.5 mL dose is administered subcutaneously.
The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6
years of age.
The second dose may be administered prior to 4 years of age, provided that there is a minimum
interval of one month between the doses of measles, mumps and rubella virus vaccine, live {1-2}.
Children who received an initial dose of measles, mumps and rubella vaccine prior to their first
birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to
complete the vaccination series [see Clinical Studies (14.2)].
For post-exposure prophylaxis for measles, administer a dose of M-M-R II vaccine within 72 hours
after exposure.
2.2 Preparation and Administration
Use a sterile syringe free of preservatives, antiseptics, and detergents for each injection and/or
reconstitution of the vaccine because these substances may inactivate the live virus vaccine. To
reconstitute, use only the diluent supplied with the vaccine since it is free of preservatives or other
antiviral substances which might inactivate the vaccine.
Withdraw the entire volume of the supplied diluent from its vial and inject into lyophilized vaccine vial.
Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved.
Withdraw the entire volume of the reconstituted vaccine and inject subcutaneously into the outer
aspect of the upper arm (deltoid region) or into the higher anterolateral area of the thigh.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Visually inspect the vaccine before and after
reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a light yellow
compact crystalline plug, when reconstituted, is a clear yellow liquid. Discard if particulate matter or
discoloration are observed in the reconstituted vaccine.
To minimize loss of potency, administer M-M-R II as soon as possible after reconstitution. If not used
immediately, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from
light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.
3 DOSAGE FORMS AND STRENGTHS
M-M-R II vaccine is a suspension for injection supplied as a single dose vial of lyophilized vaccine to
be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How
Supplied/Storage and Handling (16)]. A single dose after reconstitution is 0.5 mL.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component
of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following
administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubellacontaining vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to
neomycin [see Description (11)].
4.2 Immunosuppression
Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due
to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death
as a direct consequence of disseminated measles vaccine virus infection have been reported in
3
immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this
population, disseminated mumps and rubella vaccine virus infection have also been reported.
Do not administer M-M-R II to individuals with a family history of congenital or hereditary
immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
4.3 Moderate or Severe Febrile Illness
Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3F
(>38.5C).
4.4 Active Untreated Tuberculosis
Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
4.5 Pregnancy
Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming
pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information
(17)].
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with
M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and
those with a family history of febrile seizures there is a small increase in risk of febrile seizure following
receipt of M-M-R II vaccine [see Adverse Reactions (6)].
5.2 Hypersensitivity to Eggs
Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives,
swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion
may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine
.The potential risks and known benefits should be evaluated before considering vaccination in these
individuals.
5.3 Thrombocytopenia
Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles,
mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children
with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous
dose of measles, mumps, and rubella vaccine {6-8} [see Adverse Reactions (6)].
5.4 Immune Globulins and Transfusions
Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see
Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus
replication and decrease the expected immune response.
The ACIP has specific recommendations for intervals between administration of antibody containing
products and live virus vaccines.
6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during postapproval use of M-M-R II vaccine or its individual components.
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems
Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System
Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or ****** edema) and
bronchial spasm.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
4
Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing
panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM);
transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis;
polyneuropathy; ocular palsies; paresthesia.
Respiratory System
Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin
Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura;
erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema,
swelling and vesiculation).
Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System
Epididymitis; orchitis.
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy,
including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease
due to measles vaccine in individuals on immunosuppressive drugs [see Contraindications (4.2)].
7.2 Immune Globulinsand Transfusions
Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may
interfere with the expected immune response {9-11} [see Warnings and Precautions (5.4)]. The ACIP has
specific recommendations for intervals between administration of antibody containing products and live
virus vaccines.
7.3 Tuberculin Skin Testing
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually
may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with
tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously
with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
7.4 Use with Other Live Viral Vaccines
M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given
concurrently, M-M-R II vaccine should be given one month before or one month after administration of
other live viral vaccines to avoid potential for immune interference.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
M-M-R II vaccine is contraindicated for use in pregnant women because infection during pregnancy
with the wild-type viruses has been associated with maternal and fetal adverse outcomes.
Increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects have
been observed following infection with wild-type measles during pregnancy. {12,13} Wild-type mumps
infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Infection with wild-type rubella during pregnancy can lead to miscarriage or stillbirth. If rubella infection
occurs during the first trimester of pregnancy, it can result in severe congenital defects, Congenital
Rubella Syndrome (CRS). Congenital rubella syndrome in the infant includes but is not limited to eye
manifestations (cataracts, glaucoma, retinitis), congenital heart defects, hearing loss, microcephaly, and
intellectual disabilities. M-M-R II vaccine contains live attenuated measles, mumps and rubella viruses. It
is not known whether M-M-R II vaccine can cause fetal harm when administered to pregnant woman.
There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant
women.
5
All pregnancies have a risk of birth defect, loss or other adverse outcomes. In the US general
population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data suggest the rates of major birth defects and miscarriage in women who received
M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated
background rates (see Data).
Data
Human Data
A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978
through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine
occurring 30 days before or at any time during pregnancy with known pregnancy outcomes. Of the
prospectively followed pregnancies for whom the timing of M-M-R II vaccination was known, 425 women
received M-M-R II vaccine during the 30 days prior to conception through the second trimester. The
outcomes for these 425 prospectively followed pregnancies included 16 infants with major birth defects, 4
cases of fetal death and 50 cases of miscarriage. No abnormalities compatible with congenital rubella
syndrome have been identified in patients who received M-M-R II vaccine. Rubella vaccine viruses can
cross the placenta, leading to asymptomatic infection of the fetus. Mumps vaccine virus has also been
shown to infect the placenta {14}, but there is no evidence that it causes congenital malformations or
disease in the fetus or infant .
The CDC established the Vaccine in Pregnancy registry (1971-1989) of women who had received
rubella vaccines within 3 months before or after conception. Data on 1221 inadvertently vaccinated
pregnant women demonstrated no evidence of an increase in fetal abnormalities or cases of Congenital
Rubella Syndrome (CRS) in the enrolled women {15}.
8.2 Lactation
Risk Summary
It is not known whether measles or mumps vaccine virus is secreted in human milk. Studies have
shown that lactatingpostpartum women vaccinated with live attenuated rubella vaccine may secrete the
virus in breast milk and transmit it to breast-fed infants.{16,17} In the breast-fed infants with serological
evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one
exhibited mild clinical illness typical of acquired rubella.{18,19}
The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from
the underlying maternal condition. For preventive vaccines, the underlying maternal condition is
susceptibility to disease prevented by the vaccine.
8.4 Pediatric Use
M-M-R II vaccine is not approved for individuals less than 12 months of age. Safety and effectiveness
of measles vaccine in infants below the age of 6 months have not been established [see Clinical Studies
(14)]. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have
not been established.
8.5 Geriatric Use
Clinical studies of M-M-R II did not include sufficient numbers of seronegative subjects aged 65 and
over to determine whether they respond differently from younger subjects.
11 Description
M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose(1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative.
6
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection
which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme
linked immunosorbent assay (ELISA) tests. Results from efficacy studies or effectivenes s studies that
were previously conducted for the component vaccines of M-M-R II were used to define levels of serum
antibodies that correlated with protection against measles, mumps, and rubella [see Clinical Studies (14)].
12.6 Persistence of Antibody Responses After Vaccination
Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-
100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination. {22-28}
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of
fertility.
14 CLINICAL STUDIES
14.1 Clinical Efficacy
Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind
controlled trials. {29-34} These studies also established that seroconversion in response to vaccination
against measles, mumps and rubella paralleled protection. {35-38}
14.2 Immunogenicity
Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated
that M-M-R II vaccine is immunogenic. In these studies, a single injection of the vaccine induced measles
HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of
susceptible individuals.
A study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in
childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live
(previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable
neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus
Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies {39}. When the 6-month-old infants
of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody
titers similar to those of toddlers who were vaccinated previously at 15-months of age.
15 REFERENCES
1. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR
43(RR-1): 1-38, January 28, 1994.
2. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, a n d Co n g e nita l Ru b e lla
Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practice s (ACIP), M M WR
47(RR-8): May 22, 1998.
3. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gel atin , J.
Allergy Clin. Immunol. 91: 867-872, 1993.
4. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Cl i n . In fect. Di s. 2 9 :
855-861, 1999.
5. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 1 0 4 -1 06 ,
1998.
6. Cecinati V, et al. Vaccine administration and the development of immune thrombocyto pe ni c p urp u ra i n ch i ld re n. Hu m an
Vaccines & Immunotherapeutics 9:5, 2013.
7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic
Review of the Literature and Guidance for Management. J Ped 156(4): 2010.
8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. A collaborative approach to investigating th e ri sk
of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine. 2012;30:3042‐6.
9. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MM WR 3 9 (RR-1 5 ): 1 -1 8 ,
November 23, 1990.
7
10. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatri cs,
344-357, 1997.
11. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22,
December 29, 1989.
12. Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801,
November 1993.
13. Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta
Paediatr Scand. 66: 367-372, May 1977.
14. Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the hu m a n p l ace n ta . N En g l J M e d .
1974;290(13):710‐712.
15. Rubella Vaccination during Pregnancy —United States, 1971-1988. JAMA. 1989;261(23):3374–3383.
16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II.
Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666,1982.
17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I.
Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
18. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal i mm un izatio n , J.
Pediatr. 97: 465-467, 1980.
19. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studiesof immunization with living rubella virus: Trialsin children with a strain culture d
from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.
21. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fi bro b la sts: Evi d e n ce fo r
reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
22. Weibel, R.E.; Carlson, A.J.; Villarejos, V.M.; Buynak, E.B.; McLean, A.A.; Hilleman, M.R.: Clinical and Labo ra tory Stu d ie s o f
Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus, Proc. So c. Exp . Bi ol. M e d. 1 6 5 :
323-326, 1980.
23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; et al: An Evaluation of Measles RevaccinationAmong School-Entry Age Ch i ld re n,
31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
24. Unpublished data from the files of Merck Research Laboratories.
25. Davidkin, I.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in a n M M R -Va ccina ted
Cohort: A 20-Year Follow-up, JID 197:950–6, April 2008.
26. LeBaron, W.; Beeler J.; Sullivan, B.; et al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a
Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, March 2007.
27. LeBaron, C.; Forghani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine,
JID 199:552– 60 , February 2009.
28. LeBaron, W.; Forghani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella
Vaccine, JID 200:888–99, September 2009.
29. Hilleman, M.R.; Buynak, E.B.; Weibel, R.E.; et al: Development and Evaluation of the Moraten MeaslesVirusVa cci n e , JAM A
206(3): 587-590, 1968.
30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Clinical and Serologic Aspects in a Fiel d
Evaluation,N. Engl. J. Med. 276: 245-251, 1967.
31. Hilleman, M.R.; Weibel, R.E.; Buynak, E.B.; et al:Live, Attenuated Mumps VirusVaccine 4. ProtectiveEfficacy as Measure d i n
a Field Evaluation, N. Engl. J. Med. 276: 252-258, 1967.
32. Cutts, F.T.; Henderson, R.H.; Clements, C.J.; et al: Principles of measles control, Bull WHO 69(1): 1-7, 1991.
33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; et al: Evaluation Of Live Attenuated Mumps Virus Vaccine, Strain Jeryl Lynn, First
International Conference on VaccinesAgainst Viral and Rickettsial Diseases of Man, World Health Organization, No. 147, M a y
1967.
34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-1 3 6,
February 1972.
35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13: 139-141, January 1961.
36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363,
1970.
8
37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for
Experimental Biology and Medicine, 123: 768-775, 1966.
38. Hilleman M.R., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Appraisal of Efficacy. Amer. J. o f Pu b l ic He a lth ,
52(2):44-56, 1962.
39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Month-Old Infants Born to Mothers in the Measles
Vaccine Era, Pediatrics, 93(6): 939-943, 1994.
16 HOW SUPPLIED/STORAGE AND HANDLING
No. 4681 ⎯ M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 vials of diluent (package B)
Exposure to light may inactivate the vaccine viruses.
Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F, (2°C to 8°C).
Store accompanying diluent in the refrigerator with the lyophilized vaccine or separately at room
temperature (68° to 77°F, 20° to 25°C). Do not freeze the diluent.
Administer M-M-R II vaccine as soon as possible after reconstitution. If not administered immediately,
reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8
hours. Discard reconstituted vaccine if it is not used within 8 hours.
For information regarding the product or questions regarding storage conditions, call 1-800-
MERCK-90 (1-800-637-2590).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Package Insert).
Discuss the following with the patient:
• Provide the required vaccine information to the patient, parent, or guardian.
• Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
• Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine
or other measles-, mumps-, or rubella-containing vaccines.
• Question females of reproductive potential regarding the possibility of pregnancy. Inform female
patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and
Use in Specific Populations (8.1)].
• Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100%
protection from measles, mumps, and rubella infection.
• Instruct patients, parents, or guardians to report any adverse reactions to their health-care
provider. The U.S. Department of Health and Human Services has established a Vaccine
Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events
after the administration of any vaccine, including but not limited to the reporting of events required
by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine
reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at
https://www.vaers.hhs.gov.
For patent information: www.merck.com/product/patent/home.html
Copyright © 1978-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
uspi-v205c-i-2006r009
Do Vaccines Disable the Immune System?
by Randall Neustaedter, O.M.D.

© 1996

Parents watch with proud satisfaction as their infant, just a few months old, begins to reach out into the world--tiny hands grasping at toys and gently twirling locks of their mother's hair. Just when they have begun to take a lively interest in the world, rolling-over, cooing, and smiling, the first illnesses strike.

The baby's runny nose develops into a fever, fussiness, and night-waking. Her previously placid demeanor suddenly changes to obvious discomfort--crying, clinging, refusing to leave her mother's arms. The pediatrician sees red eardrums and prescribes antibiotics. That first infection starts a seemingly endless battle against viral and bacterial illnesses that persists despite repeated treatment with a barrage of different antibiotics. Something is dreadfully wrong. Frequent visits to the pediatrician do nothing to prevent the continuous pattern of illness—antibiotic—illness.

Why do these illnesses begin when babies are three or four months old? What event triggers this frustrating scenario? What happens to babies at two to four months that could initiate this relentless course of symptoms? Perhaps maternal antibodies are beginning to wear out, making babies susceptible to these environmental microbes. But why don't these babies develop their own antibodies in response to the initial viral or bacterial infections? What prevents the immune system from mounting a vigorous response? And why does this pattern of illness with recurrent ear infections occur now, a pattern that seldom occurred prior to thirty years ago? What is weakening the immune function of today's infants?

The Cause of Chronic Illness
Ear infections have become the most common reason for visits to pediatricians. The incidence of asthma has steadily increased in the modern era. During the period 1980 through 1989 the prevalence rate of self-reported asthma in the United States increased 38 percent, and the death rate for asthma increased 46 percent. In the five years from 1985 through 1990, projected estimates for asthma's medical costs increased 53 percent. The total estimated cost of asthma rose from $4.5 billion to $6.2 billion, or 1 percent of all US health-care costs. This dramatic increase has been attributed to increased exposure to environmental pollutants, and to the toxic effect of asthma medications themselves. Could vaccines be weakening the immune system of our populations and causing recurrent infections and allergies at unprecedented levels?

The only event that all infants routinely encounter at two months of age is vaccination with at least five different vaccines (Diphtheria-Tetanus-Pertussis-Polio-Haemophilus). They are repeated at four months. Could this simple fact explain the onset of the recurrent illnesses that plague so many infants? If vaccines stimulate antibody production to fight diseases, why would they weaken the immune system? Is there any evidence that vaccines do cause illness and immune system dysfunction?

One answer came in a careful study of illness patterns observed in babies before and after vaccination, published in Clinical Pediatrics in 1988. If vaccines cause a weakened immune system, then we would expect to see a higher incidence of illness following vaccination. In that study conducted in Israel, the incidence of acute illnesses in the 30 day period following DTP vaccine was compared to the incidence in the same children for the 30 day period prior to vaccine. The three-day period immediately following vaccine was excluded because children frequently develop fever as a direct response to vaccine toxins. A total of 82 healthy infants received DTP, and their symptoms were reported by parents and observed by a pediatrician at weekly intervals. Those babies experienced a dramatic increase in fever, diarrhea, and cough in the month following DTP vaccine compared to their health before the shot.

How do researchers investigate immune system reactions to vaccines? First, they can observe the incidence of serious disease onset soon after vaccination. They can also study immune functions following vaccines given to children and adults. Two research models have been used to discover the possible adverse effect of vaccines on the immune system. Laboratory researchers observe whether vaccines have any negative effect on white blood cells, the body's primary immune defense system. Clinical researchers study illness patterns preceding and following vaccination. All of these investigative channels have reached the same conclusions--vaccines can trigger immune system suppression.

Vaccines are destroying our immune systems. Amazingly, the medical profession ignores the incriminating evidence against vaccines, and continues to inflict more unnecessary and harmful vaccines on our nation's infants. A recent study from the New England Journal of Medicine of May 1996 revealed that tetanus vaccine disables the immune system in *** patients. Tetanus vaccination produced a drop in T cells in 10 of 13 patients, a classic sign of immune deficiency. *** viral replication increased dramatically in response to tetanus vaccine. Finally, white blood cells from 7 of 10 uninfected individuals became more susceptible to *** infection following tetanus vaccination. Despite these findings, the authors made no comment about the immune depleting effect of the vaccine.

Why is the public unaware of these findings? Why has the medical profession kept these reports hidden from the public eye? With typical condescension, Dr. Martin Smith, president of the American Academy of Pediatrics, explained in the Academy's News that the inclusion of this type of information in vaccine brochures would confuse many parents and could even needlessly alarm them. An uninformed patient is compliant.

The cover-up of immune system failure following vaccination is reminiscent of the tobacco industry's continuous denial and misinformation campaign about the dangers of cigarettes. In both instances huge profits are at stake in multibillion-dollar industries. Vaccine manufacturers cannot afford to have their product maligned in a public forum.

Doctors have often stated that broadcasting adverse effects of vaccines to the public would hinder vaccine campaigns. This attitude emerged more than thirty years ago when Dr. Paul Meier testified before a congressional committee concerning the polio vaccine campaign of the 1960s. It is hard to convince the public that something is good. Consequently, the best way to push forward a new program is to decide on what you think the best decision is and not question it thereafter, and further, not to raise questions before the public or expose the public to open discussion of the issues.

The medical profession has been aware of the damaging effects of vaccines on the immune system since their introduction. For example, the ability of pertussis and DTP vaccines to stimulate the onset of paralytic polio was first noted in 1909. In every polio epidemic since then, DTP injections have caused the onset of polio disease.

In 1950, two careful studies were conducted in the state of New York to evaluate the reports of an association between the onset of paralytic polio and recent injections. The findings were published in the American Journal of Public Health. Investigators contacted the families of all children who contracted polio during that year, a total of 1,300 cases in New York City and 2,137 cases in the remainder of New York State. A history of vaccinations received in the previous two months was obtained on each child and from a group of matched controls in the same population. Those studies discovered that children with polio were twice as likely to have received a DTP vaccination in the two months preceding the onset of polio than were the control children.

The association of vaccines with the onset of polio continues in the modern age. During a recent polio epidemic in the Arabian peninsula country of Oman, DTP vaccination again caused the onset of paralytic polio. In that epidemic, 70 children 5 to 24 months old contracted paralytic polio during the period 1988-1989. The report in the British medical journal Lancet confirmed that a significantly higher percentage of these children had received a DTP shot within 30 days of the onset of polio compared to a control group of children without polio, 43 percent of polio victims compared to 28 percent of controls. The DTP vaccine suppresses the body's ability to fight off the polio virus.

The destructive effect of vaccines on the immune system can persist over an extended period of time. One study published in the Journal of Infectious Diseases documented a long-term depressive effect on interferon production caused by the measles vaccine. Interferon is a chemical produced by lymphocytes (a type of white blood cell) that renders the host resistant to infection. Interferon production is stimulated by infection with a virus to protect the body from superinfection by some other micro-organism. In this study, vaccination of one-year-old infants with measles vaccine caused a precipitous drop in the level of alpha-interferon produced by lymphocytes. This decline persisted for one year following vaccination, at which time the experiment was terminated. Thus, this study showed that measles vaccine produced a significant long-term immune suppression.

Autoimmune Reactions to Vaccines
An 11 year old girl received a routine tetanus booster dose and three days later developed blindness in the right eye and light perception only in the left eye. Her optic discs were swollen on exam. Two days later she had partial paralysis of her legs and loss of bladder control, then more widespread sensory loss including a lack of vibrational and positional senses. Seven weeks later she still had some vision loss and decreased muscle power. Within one year she recovered (Lancet, 1992).

A 20 year old woman experienced pain and swelling of her right wrist and fingers 4 days after a hepatitis vaccination. The pain and swelling resolved, but returned again 6 months later with more severe swelling and pain, following a second hepatitis vaccination. Nine years later, X-ray of the hands showed destruction of the bones throughout her wrist joints (Scandinavian Journal of Rheumatology, 1995).

A 4 year old girl developed progressive weakness of the legs, pain in the legs and feet, and gradual inability to walk 10 days after Hib vaccination. On the fifth day she had swallowing difficulties, ****** weakness, and a monotonous voice. Her symptoms gradually improved, and within 3 weeks she could walk with help (Journal of Pediatrics, 1993).

A 42 year old man received tetanus toxoid on three separate occasions over a period of 13 years. Following each vaccination he developed acute nerve symptoms diagnosed as Guillain-Barre syndrome, a disease of the nervous system characterized by rapid onset of motor weakness and loss of sensation.. A nerve biopsy revealed destruction of the myelin nerve sheath. Following his last injection he continued to experience multiple recurrences, and continued to show abnormal findings on examination 15 years later (Journal of Neurological Science, 1978).

What is the effect of long-term immune suppression? Some investigators are concerned that vaccines could be disabling our body's ability to react normally to disease, and creating the climate for autoimmune self-destruction. The many reports of autoimmune phenomena that occur as reactions to vaccination provide incontrovertible proof that tampering with the immune system causes devastating disease.

Federal legislation of 1986 commissioned the Institute of Medicine to establish a Vaccine Safety Committee. The purpose of that committee was to search the medical literature for reports of adverse events associated with the vaccines routinely administered to children, and report their findings. Computer searches revealed 1,800 relevant articles. However, the committee's rigid criteria for establishing a causal relationship between vaccine and adverse event made it nearly impossible for a disease condition to make their short list. Without a case-controlled study proving a relationship, the hundreds of case reports of immune system destruction following vaccines were relegated to coincidence. Case-controlled studies are expensive. They must include tens or hundreds of thousands of children.

Even the Vaccine Safety Committee acknowledged the onset of several autoimmune diseases as a result of vaccination (Guillain-Barre syndrome, a disease that causes muscle weakness and paralysis, following tetanus and polio vaccines; thrombocytopenia, destruction of blood platelets responsible for blood clotting, following MMR; and chronic arthritis following rubella). These types of symptoms have occurred following every vaccine routinely given to children--the suppressed immune system begins to attack the body's own cells, usually the nerves and joints. Thousands of autoimmune incidents following vaccines have been reported in the medical literature and adverse event reporting systems. These autoimmune responses to vaccines have resulted in permanent, chronic disease conditions--deforming arthritis and muscle wasting and paralysis.

In their attempt to explain the repeated occurrence of autoimmune diseases that attack and destroy the myelin sheaths of nerves as a direct result of vaccines, the committee members explain:

It is biologically plausible that injection of an inactivated virus, bacterium, or live attenuated virus might induce in the susceptible host an autoimmune response by deregulation of the immune response, by nonspecific activation of the T cells directed against myelin proteins, or by autoimmunity triggered by sequence similarities of proteins in the vaccine to host proteins such as those of myelin.

Since the committee's report, a large ecological study in New Zealand revealed that an epidemic of diabetes followed a massive campaign to vaccinate children against hepatitis B. This report, published in the New Zealand Medical Journal in 1996 revealed that a 60 percent increase in childhood diabetes occurred in the years following the 1989-1991 vaccination program of children aged 6 to 16. The widespread use of the new Haemophilus meningitis vaccine has similarly resulted in diabetes epidemics. Diabetes is an autoimmune disease that has been frequently observed to occur as a consequence of mumps vaccine. Three European studies reported 22 cases of diabetes that began within 30 days of mumps vaccination. The dramatic rise in vaccine-induced diabetes has led researchers to raise a warning flag. Immunologist Bart Classen has said, "We believe the effects of vaccines on diabetes are of tremendous clinical importance and that trials need to be started immediately to address the effect of vaccines on diabetes and other autoimmune diseases."

Vaccines have become a sacred cow of our culture, unassailable to criticism. Now that we know their devastating effects on the immune system, perhaps we need to take a more cautious approach to the vaccine campaigns.

New vaccines for children are being developed in an unprecedented effort to wipe out childhood diseases. In some cases this effort has strictly monetary goals. For example, the most frequently stated purpose of the chickenpox vaccine is not to protect children from this benign childhood illness, but to keep parents at their jobs rather than missing a few days of work to care for their sick child at home. According to Dr. Philip Brunell, a leading chickenpox vaccine researcher, it is clear that we can reduce the cost of chickenpox by routinely immunizing normal children, primarily by reducing the loss of parental income. Vaccination of the entire population would save an estimated $380 million dollars in lost income and wages. Economic interests have spurred the adoption of a chickenpox vaccine, not our concern for the well-being of children.

This callous disregard for the potential damage inflicted by vaccines characterizes the goals of vaccine manufacturers. The pharmaceutical giant Merck invested over $5 million in chickenpox vaccine development, according to The Wall Street Journal. Dr. Samuel Katz, Duke University's pediatrics chairman and head of a vaccine panel at the National Academy of Sciences, expressed the manufacturer's concerns: Merck isn't going to make back its investment in that vaccine by just distributing it to kids with cancer. They're going to be interested in pushing for use in the normal population.

Profit has always been the goal of vaccine manufacturers. When lawsuits leveled at drug companies began wiping out profits gleaned from the pertussis vaccine, the manufacturers simply stopped production of the vaccine. The United States government stepped in to pay these vaccine-damage claims. Only then did the drug companies agree to resume vaccine production. The formula was simple--no profits, no vaccines.

Now that drug companies are protected from legal action, the race to invent and distribute new vaccines has again switched into high gear. Vaccines for hepatitis, haemophilus, and chickenpox have all been pushed into the recommended schedule for children. This zealous rush to bring new vaccines to market, heedless of the damage inflicted in the name of prevention, could have far-reaching consequences. We may be setting the stage for the unwitting destruction of our population's health, a result that may continue to remain a hidden cause of widespread immune system failure and autoimmune disease.

About the Author
Dr. Neustaedter has practiced homeopathic medicine and Traditional Chinese Medicine for over twenty years. His book, The Vaccine Guide: Making an Informed Choice (North Atlantic Books, 1996), has become a popular resource for parents. He is a licensed acupuncturist and received his Doctorate in Oriental Medicine in Hong Kong. He lives and works in the San Francisco Bay Area.
HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to us e
M-M-R II safely and effectively. See full prescribing information
for M-M-R II.
M-M-R® II (Measles, Mumps, and Rubella Virus Vaccine Live)
Suspension for subcutaneous injection
Initial U.S. Approv al: 1978
-------------------------------INDICATIONS AND USAGE-------------------------------
M-M-R II is a vaccine indicated for active immunization for the
prevention of measles, mumps, and rubella in individuals 12 months of
age and older. (1)
-------------------------- DOSAGE AND ADMINISTRATION--------------------------
Administer a 0.5-mL dose of M-M-R II subcutaneously. (2.1)
• The first dose is administered at 12 to 15 months of age. (2.1)
• The second dose is administered at 4 to 6 years of age. (2.1)
------------------------DOSAGE FORMS AND STRENGTHS -----------------------
Suspension for injection (0.5-mL dose) supplied as a lyophilized
vaccine to be reconstituted using accompanying sterile diluent. (3)
---------------------------------- CONTRAINDICATIONS ----------------------------------
• Hypersensitivity to any componentof the vaccine. (4.1)
• Immunosuppression. (4.2)
• Moderate or severe febrile illness. (4.3)
• Active untreated tuberculosis. (4.4)
• Pregnancy. (4.5, 8.1)
-------------------------- WARNINGS AND PRECAUTIONS --------------------------
• Use caution when administering M-M-R II to individuals with a
history of febrile seizures. (5.1)
• Use caution when administering M-M-R II to individuals with
anaphylaxis or immediate hypersensitivity following egg ingestion.
(5.2)
• Use caution when administering M-M-R II to individuals with a
history of thrombocytopenia. (5.3)
• Immune Globulins (IG) and other blood products should not be
given concurrently with M-M-R II. (5.4, 7.2)
----------------------------------ADVERSE REACTIONS----------------------------------
See full prescribing information for adverse reactions occurring duri ng
clinical trialsor the post-marketing period. (6)
To report SUSPECTED ADVERSE REACTIONS, contact Merck
Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., at 1-8 7 7 -
888-4231 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
-----------------------------------DRUG INTERACTIONS----------------------------------
• Administration of immune globulins and other blood products
concurrently with M-M-R II vaccine may interfere with the
expected immune response. (7.2)
• M-M-R II vaccination may result in a temporary depression of
purified protein derivative (PPD) tuberculin skin sensitivity. (7.3)
-------------------------- USE IN SPECIFIC POPULATIONS--------------------------
• Pregnancy: Do not administer M-M-R II to females who are
pregnant. Pregnancy should be avoided for 1 month following
vaccination with M-M-R II. (4.5, 8.1, 17)
See 17 for PATIENT COUNSELING INFORMATION and FDA
approv ed patient labeling.
Rev ised: 06/2020
FULL PRESCRIBING INFORMATION: CONTENTS
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Dose and Schedule
2.2 Preparation andAdministration
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
4.1 Hypersensitivity
4.2 Immunosuppression
4.3 Moderate or Severe Febrile Illness
4.4 Active Untreated Tuberculosis
4.5 Pregnancy
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
5.2 Hypersensitivity to Eggs
5.3 Thrombocytopenia
5.4 Immune Globulins and Transfusions
6 ADVERSE REACTIONS
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
7.2 Immune Globulinsand Transfusions
7.3 Tuberculin Skin Testing
7.4 Use with Other Live Viral Vaccines
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.4 Pediatric Use
8.5 Geriatric Use
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.6 Persistence of Antibody Responses After Vaccination
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
14.1 Clinical Efficacy
14.2 Immunogenicity
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
Sections or subsections omitted from the full prescribing info rma tion
are not listed.
2
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
M-M-R® II is a vaccine indicated for active immunization for the prevention of measles, mumps, and
rubella in individuals 12 months of age and older.
2 DOSAGE AND ADMINISTRATION
For subcutaneous use only.
2.1 Dose and Schedule
Each 0.5 mL dose is administered subcutaneously.
The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6
years of age.
The second dose may be administered prior to 4 years of age, provided that there is a minimum
interval of one month between the doses of measles, mumps and rubella virus vaccine, live {1-2}.
Children who received an initial dose of measles, mumps and rubella vaccine prior to their first
birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to
complete the vaccination series [see Clinical Studies (14.2)].
For post-exposure prophylaxis for measles, administer a dose of M-M-R II vaccine within 72 hours
after exposure.
2.2 Preparation and Administration
Use a sterile syringe free of preservatives, antiseptics, and detergents for each injection and/or
reconstitution of the vaccine because these substances may inactivate the live virus vaccine. To
reconstitute, use only the diluent supplied with the vaccine since it is free of preservatives or other
antiviral substances which might inactivate the vaccine.
Withdraw the entire volume of the supplied diluent from its vial and inject into lyophilized vaccine vial.
Agitate to dissolve completely. Discard if the lyophilized vaccine cannot be dissolved.
Withdraw the entire volume of the reconstituted vaccine and inject subcutaneously into the outer
aspect of the upper arm (deltoid region) or into the higher anterolateral area of the thigh.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to
administration, whenever solution and container permit. Visually inspect the vaccine before and after
reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a light yellow
compact crystalline plug, when reconstituted, is a clear yellow liquid. Discard if particulate matter or
discoloration are observed in the reconstituted vaccine.
To minimize loss of potency, administer M-M-R II as soon as possible after reconstitution. If not used
immediately, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from
light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.
3 DOSAGE FORMS AND STRENGTHS
M-M-R II vaccine is a suspension for injection supplied as a single dose vial of lyophilized vaccine to
be reconstituted using the accompanying sterile diluent [see Dosage and Administration (2.2) and How
Supplied/Storage and Handling (16)]. A single dose after reconstitution is 0.5 mL.
4 CONTRAINDICATIONS
4.1 Hypersensitivity
Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component
of the vaccine (including gelatin) {3} or who have experienced a hypersensitivity reaction following
administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubellacontaining vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to
neomycin [see Description (11)].
4.2 Immunosuppression
Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due
to disease or medical therapy. Measles inclusion body encephalitis {4} (MIBE), pneumonitis {5} and death
as a direct consequence of disseminated measles vaccine virus infection have been reported in
3
immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this
population, disseminated mumps and rubella vaccine virus infection have also been reported.
Do not administer M-M-R II to individuals with a family history of congenital or hereditary
immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
4.3 Moderate or Severe Febrile Illness
Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3F
(>38.5C).
4.4 Active Untreated Tuberculosis
Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
4.5 Pregnancy
Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming
pregnant within the next month [see Use in Specific Populations (8.1) and Patient Counseling Information
(17)].
5 WARNINGS AND PRECAUTIONS
5.1 Febrile Seizure
There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with
M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and
those with a family history of febrile seizures there is a small increase in risk of febrile seizure following
receipt of M-M-R II vaccine [see Adverse Reactions (6)].
5.2 Hypersensitivity to Eggs
Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives,
swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion
may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine
.The potential risks and known benefits should be evaluated before considering vaccination in these
individuals.
5.3 Thrombocytopenia
Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles,
mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children
with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous
dose of measles, mumps, and rubella vaccine {6-8} [see Adverse Reactions (6)].
5.4 Immune Globulins and Transfusions
Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see
Drug Interactions (7.2)]. These products may contain antibodies that interfere with vaccine virus
replication and decrease the expected immune response.
The ACIP has specific recommendations for intervals between administration of antibody containing
products and live virus vaccines.
6 ADVERSE REACTIONS
The following adverse reactions include those identified during clinical trials or reported during postapproval use of M-M-R II vaccine or its individual components.
Body as a Whole
Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System
Vasculitis.
Digestive System
Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems
Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System
Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or ****** edema) and
bronchial spasm.
Musculoskeletal System
Arthritis; arthralgia; myalgia.
4
Nervous System
Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE) subacute sclerosing
panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM);
transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis;
polyneuropathy; ocular palsies; paresthesia.
Respiratory System
Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin
Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura;
erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema,
swelling and vesiculation).
Special Senses — Ear
Nerve deafness; otitis media.
Special Senses — Eye
Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System
Epididymitis; orchitis.
7 DRUG INTERACTIONS
7.1 Corticosteroids and Immunosuppressive Drugs
M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy,
including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease
due to measles vaccine in individuals on immunosuppressive drugs [see Contraindications (4.2)].
7.2 Immune Globulinsand Transfusions
Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may
interfere with the expected immune response {9-11} [see Warnings and Precautions (5.4)]. The ACIP has
specific recommendations for intervals between administration of antibody containing products and live
virus vaccines.
7.3 Tuberculin Skin Testing
It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually
may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with
tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously
with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
7.4 Use with Other Live Viral Vaccines
M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given
concurrently, M-M-R II vaccine should be given one month before or one month after administration of
other live viral vaccines to avoid potential for immune interference.
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
Risk Summary
M-M-R II vaccine is contraindicated for use in pregnant women because infection during pregnancy
with the wild-type viruses has been associated with maternal and fetal adverse outcomes.
Increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects have
been observed following infection with wild-type measles during pregnancy. {12,13} Wild-type mumps
infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Infection with wild-type rubella during pregnancy can lead to miscarriage or stillbirth. If rubella infection
occurs during the first trimester of pregnancy, it can result in severe congenital defects, Congenital
Rubella Syndrome (CRS). Congenital rubella syndrome in the infant includes but is not limited to eye
manifestations (cataracts, glaucoma, retinitis), congenital heart defects, hearing loss, microcephaly, and
intellectual disabilities. M-M-R II vaccine contains live attenuated measles, mumps and rubella viruses. It
is not known whether M-M-R II vaccine can cause fetal harm when administered to pregnant woman.
There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant
women.
5
All pregnancies have a risk of birth defect, loss or other adverse outcomes. In the US general
population, the estimated background risk of major birth defects and miscarriage in clinically recognized
pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data suggest the rates of major birth defects and miscarriage in women who received
M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated
background rates (see Data).
Data
Human Data
A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978
through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine
occurring 30 days before or at any time during pregnancy with known pregnancy outcomes. Of the
prospectively followed pregnancies for whom the timing of M-M-R II vaccination was known, 425 women
received M-M-R II vaccine during the 30 days prior to conception through the second trimester. The
outcomes for these 425 prospectively followed pregnancies included 16 infants with major birth defects, 4
cases of fetal death and 50 cases of miscarriage. No abnormalities compatible with congenital rubella
syndrome have been identified in patients who received M-M-R II vaccine. Rubella vaccine viruses can
cross the placenta, leading to asymptomatic infection of the fetus. Mumps vaccine virus has also been
shown to infect the placenta {14}, but there is no evidence that it causes congenital malformations or
disease in the fetus or infant .
The CDC established the Vaccine in Pregnancy registry (1971-1989) of women who had received
rubella vaccines within 3 months before or after conception. Data on 1221 inadvertently vaccinated
pregnant women demonstrated no evidence of an increase in fetal abnormalities or cases of Congenital
Rubella Syndrome (CRS) in the enrolled women {15}.
8.2 Lactation
Risk Summary
It is not known whether measles or mumps vaccine virus is secreted in human milk. Studies have
shown that lactatingpostpartum women vaccinated with live attenuated rubella vaccine may secrete the
virus in breast milk and transmit it to breast-fed infants.{16,17} In the breast-fed infants with serological
evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one
exhibited mild clinical illness typical of acquired rubella.{18,19}
The developmental and health benefits of breastfeeding should be considered along with the mother’s
clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from
the underlying maternal condition. For preventive vaccines, the underlying maternal condition is
susceptibility to disease prevented by the vaccine.
8.4 Pediatric Use
M-M-R II vaccine is not approved for individuals less than 12 months of age. Safety and effectiveness
of measles vaccine in infants below the age of 6 months have not been established [see Clinical Studies
(14)]. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have
not been established.
8.5 Geriatric Use
Clinical studies of M-M-R II did not include sufficient numbers of seronegative subjects aged 65 and
over to determine whether they respond differently from younger subjects.
11 Description
M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated
line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo
cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in
chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated
rubella virus propagated in WI-38 human diploid lung fibroblasts. {20,21} The cells, virus pools,
recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and
determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious
doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Each dose is calculated to contain sorbitol (14.5 mg), sucrose(1.9 mg), hydrolyzed gelatin (14.5 mg),
recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin
and other buffer and media ingredients. The product contains no preservative.
6
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection
which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme
linked immunosorbent assay (ELISA) tests. Results from efficacy studies or effectivenes s studies that
were previously conducted for the component vaccines of M-M-R II were used to define levels of serum
antibodies that correlated with protection against measles, mumps, and rubella [see Clinical Studies (14)].
12.6 Persistence of Antibody Responses After Vaccination
Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-
100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination. {22-28}
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of
fertility.
14 CLINICAL STUDIES
14.1 Clinical Efficacy
Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind
controlled trials. {29-34} These studies also established that seroconversion in response to vaccination
against measles, mumps and rubella paralleled protection. {35-38}
14.2 Immunogenicity
Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated
that M-M-R II vaccine is immunogenic. In these studies, a single injection of the vaccine induced measles
HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of
susceptible individuals.
A study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in
childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live
(previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable
neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus
Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies {39}. When the 6-month-old infants
of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody
titers similar to those of toddlers who were vaccinated previously at 15-months of age.
15 REFERENCES
1. General Recommendations on Immunization, Recommendations of the Advisory Committee on Immunization Practices, MMWR
43(RR-1): 1-38, January 28, 1994.
2. Measles, Mumps, and Rubella — Vaccine Use and Strategies for Elimination of Measles, Rubella, a n d Co n g e nita l Ru b e lla
Syndrome and Control of Mumps: Recommendations of the Advisory Committee on Immunization Practice s (ACIP), M M WR
47(RR-8): May 22, 1998.
3. Kelso, J.M.; Jones, R.T.; Yunginger, J.W.: Anaphylaxis to measles, mumps, and rubella vaccine mediated by IgE to gel atin , J.
Allergy Clin. Immunol. 91: 867-872, 1993.
4. Bitnum, A.; et al: Measles Inclusion Body Encephalitis Caused by the Vaccine Strain of Measles Virus. Cl i n . In fect. Di s. 2 9 :
855-861, 1999.
5. Angel, J.B.; et al: Vaccine Associated Measles Pneumonitis in an Adult with AIDS. Annals of Internal Medicine, 129: 1 0 4 -1 06 ,
1998.
6. Cecinati V, et al. Vaccine administration and the development of immune thrombocyto pe ni c p urp u ra i n ch i ld re n. Hu m an
Vaccines & Immunotherapeutics 9:5, 2013.
7. Mantadakis E, Farmaki E, Buchanan GR. Thrombocytopenic Purpura after Measles-Mumps-Rubella Vaccination: A Systematic
Review of the Literature and Guidance for Management. J Ped 156(4): 2010.
8. Andrews N, Stowe J, Miller E, Svanstrom H, Johansen K, Bonhoeffer J, et al. A collaborative approach to investigating th e ri sk
of thrombocytopenic purpura after measles-mumps-rubella vaccination in England and Denmark. Vaccine. 2012;30:3042‐6.
9. Rubella Prevention: Recommendation of the Immunization Practices Advisory Committee (ACIP), MM WR 3 9 (RR-1 5 ): 1 -1 8 ,
November 23, 1990.
7
10. Peter, G.; et al (eds): Report of the Committee on Infectious Diseases, Twenty-fourth Edition, American Academy of Pediatri cs,
344-357, 1997.
11. Measles Prevention: Recommendations of the Immunization Practices Advisory Committee (ACIP), MMWR 38(S-9): 5-22,
December 29, 1989.
12. Eberhart-Phillips, J.E.; et al: Measles in pregnancy: a descriptive study of 58 cases. Obstetrics and Gynecology, 82(5): 797-801,
November 1993.
13. Jespersen, C.S.; et al: Measles as a cause of fetal defects: A retrospective study of ten measles epidemics in Greenland. Acta
Paediatr Scand. 66: 367-372, May 1977.
14. Yamauchi T, Wilson C, Geme JW Jr. Transmission of live, attenuated mumps virus to the hu m a n p l ace n ta . N En g l J M e d .
1974;290(13):710‐712.
15. Rubella Vaccination during Pregnancy —United States, 1971-1988. JAMA. 1989;261(23):3374–3383.
16. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. II.
Maternal-neonatal interactions, J. Infect. Dis. 145: 661-666,1982.
17. Losonsky, G.A.; Fishaut, J.M.; Strussenber, J.; Ogra, P.L.: Effect of immunization against rubella on lactation products. I.
Development and characterization of specific immunologic reactivity in breast milk, J. Infect. Dis. 145: 654-660, 1982.
18. Landes, R.D.; Bass, J.W.; Millunchick, E.W.; Oetgen, W.J.: Neonatal rubella following postpartum maternal i mm un izatio n , J.
Pediatr. 97: 465-467, 1980.
19. Lerman, S.J.: Neonatal rubella following postpartum maternal immunization, J. Pediatr. 98: 668, 1981. (Letter)
20. Plotkin, S.A.; Cornfeld, D.; Ingalls, T.H.: Studiesof immunization with living rubella virus: Trialsin children with a strain culture d
from an aborted fetus, Am. J. Dis. Child. 110: 381-389, 1965.
21. Plotkin, S.A.; Farquhar, J.; Katz, M.; Ingalls, T.H.: A new attenuated rubella virus grown in human fi bro b la sts: Evi d e n ce fo r
reduced nasopharyngeal excretion, Am. J. Epidemiol. 86: 468-477, 1967.
22. Weibel, R.E.; Carlson, A.J.; Villarejos, V.M.; Buynak, E.B.; McLean, A.A.; Hilleman, M.R.: Clinical and Labo ra tory Stu d ie s o f
Combined Live Measles, Mumps, and Rubella Vaccines Using the RA 27/3 Rubella Virus, Proc. So c. Exp . Bi ol. M e d. 1 6 5 :
323-326, 1980.
23. Watson, J.C.; Pearson, J.S.; Erdman, D.D.; et al: An Evaluation of Measles RevaccinationAmong School-Entry Age Ch i ld re n,
31st Interscience Conference on Antimicrobial Agents and Chemotherapy, Abstract #268, 143, 1991.
24. Unpublished data from the files of Merck Research Laboratories.
25. Davidkin, I.; Jokinen, S.; Broman, M. et al.: Persistence of Measles, Mumps, and Rubella Antibodies in a n M M R -Va ccina ted
Cohort: A 20-Year Follow-up, JID 197:950–6, April 2008.
26. LeBaron, W.; Beeler J.; Sullivan, B.; et al.: Persistence of Measles Antibodies After 2 Doses of Measles Vaccine in a
Postelimination Environment, Arch Pediatr Adolesc Med. 161:294-301, March 2007.
27. LeBaron, C.; Forghani, B.; Beck, C. et al.: Persistence of Mumps Antibodies after 2 Doses of Measles-Mumps-Rubella Vaccine,
JID 199:552– 60 , February 2009.
28. LeBaron, W.; Forghani, B.; Matter, L. et al.: Persistence of Rubella Antibodies after 2 Doses of Measles-Mumps-Rubella
Vaccine, JID 200:888–99, September 2009.
29. Hilleman, M.R.; Buynak, E.B.; Weibel, R.E.; et al: Development and Evaluation of the Moraten MeaslesVirusVa cci n e , JAM A
206(3): 587-590, 1968.
30. Weibel, R.E.; Stokes, J.; Buynak, E.B.; et al: Live, Attenuated Mumps Virus Vaccine 3. Clinical and Serologic Aspects in a Fiel d
Evaluation,N. Engl. J. Med. 276: 245-251, 1967.
31. Hilleman, M.R.; Weibel, R.E.; Buynak, E.B.; et al:Live, Attenuated Mumps VirusVaccine 4. ProtectiveEfficacy as Measure d i n
a Field Evaluation, N. Engl. J. Med. 276: 252-258, 1967.
32. Cutts, F.T.; Henderson, R.H.; Clements, C.J.; et al: Principles of measles control, Bull WHO 69(1): 1-7, 1991.
33. Weibel, R.E.; Buynak, E.B.; Stokes, J.; et al: Evaluation Of Live Attenuated Mumps Virus Vaccine, Strain Jeryl Lynn, First
International Conference on VaccinesAgainst Viral and Rickettsial Diseases of Man, World Health Organization, No. 147, M a y
1967.
34. Leibhaber, H.; Ingalls, T.H.; LeBouvier, G.L.; et al: Vaccination With RA 27/3 Rubella Vaccine, Am. J. Dis. Child. 123: 133-1 3 6,
February 1972.
35. Rosen, L.: Hemagglutination and Hemagglutination-Inhibition with Measles Virus, Virology 13: 139-141, January 1961.
36. Brown, G.C.; et al: Fluorescent-Antibody Marker for Vaccine-Induced Rubella Antibodies, Infection and Immunity 2(4): 360-363,
1970.
8
37. Buynak, E.B.; et al: Live Attenuated Mumps Virus Vaccine 1. Vaccine Development, Proceedings of the Society for
Experimental Biology and Medicine, 123: 768-775, 1966.
38. Hilleman M.R., Studies of Live Attenuated Measles Virus Vaccine in Man: II. Appraisal of Efficacy. Amer. J. o f Pu b l ic He a lth ,
52(2):44-56, 1962.
39. Johnson, C.E.; et al: Measles Vaccine Immunogenicity in 6- Versus 15-Month-Old Infants Born to Mothers in the Measles
Vaccine Era, Pediatrics, 93(6): 939-943, 1994.
16 HOW SUPPLIED/STORAGE AND HANDLING
No. 4681 ⎯ M-M-R II vaccine is supplied as follows:
(1) a box of 10 single-dose vials of lyophilized vaccine (package A), NDC 0006-4681-00
(2) a box of 10 vials of diluent (package B)
Exposure to light may inactivate the vaccine viruses.
Before reconstitution, refrigerate the lyophilized vaccine at 36°F to 46°F, (2°C to 8°C).
Store accompanying diluent in the refrigerator with the lyophilized vaccine or separately at room
temperature (68° to 77°F, 20° to 25°C). Do not freeze the diluent.
Administer M-M-R II vaccine as soon as possible after reconstitution. If not administered immediately,
reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8
hours. Discard reconstituted vaccine if it is not used within 8 hours.
For information regarding the product or questions regarding storage conditions, call 1-800-
MERCK-90 (1-800-637-2590).
17 PATIENT COUNSELING INFORMATION
Advise the patient to read the FDA-approved patient labeling (Patient Package Insert).
Discuss the following with the patient:
• Provide the required vaccine information to the patient, parent, or guardian.
• Inform the patient, parent, or guardian of the benefits and risks associated with vaccination.
• Question the patient, parent, or guardian about reactions to a previous dose of M-M-R II vaccine
or other measles-, mumps-, or rubella-containing vaccines.
• Question females of reproductive potential regarding the possibility of pregnancy. Inform female
patients to avoid pregnancy for 1 month following vaccination [see Contraindications (4.5) and
Use in Specific Populations (8.1)].
• Inform the patient, parent, or guardian that vaccination with M-M-R II may not offer 100%
protection from measles, mumps, and rubella infection.
• Instruct patients, parents, or guardians to report any adverse reactions to their health-care
provider. The U.S. Department of Health and Human Services has established a Vaccine
Adverse Event Reporting System (VAERS) to accept all reports of suspected adverse events
after the administration of any vaccine, including but not limited to the reporting of events required
by the National Childhood Vaccine Injury Act of 1986. For information or a copy of the vaccine
reporting form, call the VAERS toll-free number at 1-800-822-7967, or report online at
https://www.vaers.hhs.gov.
For patent information: www.merck.com/product/patent/home.html
Copyright © 1978-2020 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
All rights reserved.
uspi-v205c-i-2006r009
Cancer & vaccination quotes
Quotes  Cancer and vaccines  Leukemia & lymphoma

Polio vaccine contamination with SV40
Childhood diseases prevent cancer:

Another practitioner, Dr. W. B. Clarke of Indiana, finds that "Cancer was practically unknown until compulsory vaccination with cowpox vaccine began to be introduced. I have had to deal with at least two hundred cases of cancer, and I never saw a case of cancer in an unvaccinated person."--Eustace Mullins

In an "In Memoriam" notice in a local paper, in November 1942, it was stated that William Martin Graham, Bowness Farm, Bowness, Wigton, aged four years, had died on 13 November 1941, from inoculation. The cause of death, which occurred five months after inoculation, had been certified as acute lymphatic Leukemia. The Truth About Vaccination and Immunization by Lily Loat

"The chief, if not the sole, cause of the monstrous increase in cancer has been vaccination." - Dr. Robert Bell; V. President International Society for Cancer Research, British Cancer Hospital.

My son was diagnosed with acute lymphablastic leukaemia (ALL) ten days or so post-MMR dose. I realise this is not one of the side-effects that you mentioned. I have been reassured many times that it had nothing to do with triggering ALL. My son is alive, 19 now and persevering against side-effects of treatment 18 years ago. Jessica Mullan, Grand Rapids, Michigan, USA 09.03.07 [2007] Parliament was given false MMR assurance

   Mr. J. Jackson Clarke, M.B. (Lond.), F.R.C.S., &c, the distinguished surgeon, when recently describing experiments in vaccination on the cornea, refers to the resulting "now well-known bodies " which "recall the bodies Russell described in cancer in 1890." Mr. Jackson Clarke further states that the bodies seen in the vaccinated cornea are closely similar in their appearance to those described as protozoa in cancer.
    General Phelps, in a paper read at the Glasgow meeting of the National Anti-Vaccination League, held in November, 1903, says : " Monckton-Copeman and Mann, writing on vaccine lesions in skin, observes : 'Clarke rightly points out that many cells appear similar to those found  in cancer.' " [1921] Vaccination and the State By Arnold Lupton MP.

Dr. Tennison Deane of San Francisco, in his Crime of Vaccination, tells a remarkable story illustrative of this truth.
    Dr. Deane relates that he was summering in Northern California in the late 80's, near a wealthy ranchman who lived with his wife and seven children on a 10,000-acre ranch in a salubrious pine region, 15 miles from the nearest town and having no adjacent neighbors. With him on the ranch at that time was a ***** foreman who also had a wife and five children. Until Dr. Deane appeared on the scene, none of these 16 persons—white nor black—had ever been vaccinated.
    As a zealous young practitioner, very close to his medical school traditions, Dr. Deane quickly warned these ranch-dwellers of their "unprotected" state and was able to persuade six of the sixteen—the farmer's wife and three children, the ***** foreman and his 12-year-old son—to submit to the vaccinating operation. "A year later," writes Dr. Deane, "an epidemic of sore throats broke out in this ranch colony which developed into diphtheria in four of the vaccinated, among them the farmer's wife, and one child died. The unvaccinated recovered rapidly from their sore throats, but the farmer's wife was paralyzed for a year and eleven years later died of cancer."
    It seems that the San Francisco physician was so impressed by this unexpected turn of his well-intentioned vaccinating zeal, that he not only kept tab on the subsequent history of the two families on the northern ranch, but watched the connection between vaccination and other maladies occurring in his general practice. He learned that the other four persons whom he had vaccinated on the ranch all died either of tuberculosis or cancer within four to twenty-two years from the date of vaccination, while none of the unvaccinated in either family died within that period except the white farmer who, he says, "died of old age."
    Dr. Deane relates that for many years after this early experience with vaccination on the Northern California ranch, when a patient came to him with any serious throat, bronchial or pulmonary trouble, he made a point of inquiring into his past history, and invariably he found a back-ground of calf-pus "immunization" against smallpox. Then when he felt he had sufficient data to warrant it, he published The Crime of Vaccination (in 1913), which brought down on him the wrath of his medical colleagues, and made his professional life in San Francisco so unhappy that he voluntarily withdrew from all medical assemblages and finally abandoned all medical practice except surgery. Hale, Annie Riley. The Medical Voodoo. New York: Gotham House, 1936.

"My site has several articles by the Nobel Laureate Alexis Carrel regarding injections of highly dilute poisons, similar to formaldehyde in Salk vaccine, which was 1:4000 concentration. Carrel injected carcinogens at 1:5000 to 1:250000 and caused reliably, cancer in chickens."---Jim West (Harpub) www.geocities.com/harpub  

"The big question everyone seems to avoid is:  Can vaccines cause cancer? There is certainly  evidence connecting contaminated vaccines to AIDS. And *** is a cancer-causing  virus. Robert Gallo, the co-discoverer of *** in 1984, has clearly stated AIDS is an epidemic of cancer.    Animal and avian viruses can contaminate vaccines and have all been studied as cancer-causing  agents. And cancer  and vaccine research would be much more difficult without the use of cell lines, some of which are derived from cancer."--Dr Cantwell

"Had my mother and father known that the poliovirus vaccines of the 1950s were heavily contaminated with more than 26 monkey viruses, including the cancer virus SV40, I can say with certainty that they would not have allowed their children and themselves to take those vaccines.  Both of my parents might not have developed cancers suspected of being vaccine-related, and might even be alive today. "--Dr Urnovitz

"MY DAUGHTER had the MMR booster at four and her arm immediately swelled up and she started to feel unwell. Within six weeks, she was diagnosed as having leukaemia, and the doctors we spoke to accepted that the MMR jab was probably the trigger for the disease by overloading her immune system."--Media letter

"A study by Ronne (Lancet, 5/5/85 1-5) showed that adults who had had natural measles with a rash had a decreased incidence of various cancers, including cervical. Another study showed that women are less likely to contract ovarian cancer if they have had mumps during childhood."--Dr Jayne Donegan

"Vaccination and sulpha drugs have been recognised as being directly responsible for the production of leukemia in humans."---Dr B. Duperrat of the Saint-Louis Hospital in Paris, writing in the French medical journal Presse Medicale, march 12, 1955.

"All vaccination has the effect of directing the three values of the blood into or toward the zone characteristics of cancer and leukaemia...Vaccines do predispose to cancer and leukaemia." Professor L. Vincent - founder of Bioelectronics

"Already published reports, as well as our own observations indicate that smallpox vaccination sometimes produces manifestations of leukemia.  In children and adults observed in the clinics of Cracow, smallpox vaccination has been followed by violent local and general reactions and by leukemia."---Professors Julian Aleksandrowickz and Boguslave Halileokowski of the Medical Academy of Cracow, Poland wrote as reported in Lancet, May 6, 1967.

"Many here voice a silent view that the Salk and Sabin vaccine, being made of monkey kidney tissue....has been directly responsible for the major increase in leukemia in this country"---Dr Klenner, M.D.

"Within a few years of the polio vaccine we started seeing some strange phenomena like the year before the first 300,000 doses were given in the United States childhood leukaemia had never struck in children under the age of two. One year after the first onslaught they had the first cases of children under the age of two that died of leukaemia........ Dr Herbert Radnor observed that in a small area of this little town, in an area where no cases of leukaemia had been expected or at the most one in 4 years according to previous statistics, they suddenly had a rash like an epidemic within a few blocks"---Dr Snead

"He (Moskowitz MD) also suggests a link between whooping cough vaccine and leukaemia — an association he supports with case histories from his own practice and with other clinical data."---Media article

"Most infants have been receiving up to 15 doses of mercury-containing vaccines by the time they are 6 months old. It is almost inconceivable that these heavy burdens of foreign immunologic materials, introduced into the immature systems of children, could fail to bring about disruptions and adverse reactions in these in these systems."--Harold Buttram MD

Polio vaccine contamination with SV40:
"Stanley Kops....has produced proof positive that the oral polio vaccine has always been contaminated with SV-40, a monkey virus which has been linked by the FDA and other organisations with cancers such as mesothelioma and meduloblastoma. Since 1963, we have been assured that polio vaccines have not contained this deadly contaminant. Stanley Kops shows that not only is this not the case, but that the vaccine regulators who are charged with keeping our families safe, have known all along that SV-40 was never removed from vaccines."----Meryl W. Dorey

Childhood diseases prevent cancer [Homeopathy and Measles]
"On the basis of observations by the Vienna surgeon Professor Schmidt, which took place over decades in his practice 16, studies in the last 100 years have shown consistently that people who experienced childhood diseases accompanied by fever were less likely to suffer from cancer in later life 17, 18,19,20."---Anita Petek-Dimmer

— The End —