Information sheet on the six-in-one vaccination

Every vaccination is preceded by a conversation in which you are informed. It is not a formality and not a disclaimer but the precondition for consent being valid at all. This page sums up what you are told before the six-in-one vaccination – and who may legally consent in Austria.

What the six-in-one vaccination is about

The six-in-one vaccination protects against diphtheria, whooping cough, tetanus, Haemophilus influenzae type b, polio and hepatitis B. In Austria it is given in the third and fifth month of life and between the twelfth and the fourteenth.

It is an inactivated vaccine. It contains no organisms capable of multiplying but detoxified toxins, individual surface proteins, killed viruses and a protein produced by genetic engineering – plus an aluminium salt as an adjuvant. The vaccine cannot cause any of the six illnesses.

What the individual components do and what they protect against is set out in detail on the pages diphtheria, whooping cough, tetanus, Haemophilus influenzae b, polio and hepatitis B; the vaccine itself is described on the page Hexyon.

What the conversation has to contain

The requirements in Austria have been shaped by case law and can be summed up in five points. Information that leaves one of them out does not support the consent.

• The illnesses vaccinated against: how common they are, how they run, what consequences they can have.
• The benefit of the vaccination: how reliably it protects and for how long.
• The procedure: how it is given, how many doses are needed, at what intervals.
• Possible side effects: the common and harmless ones as well as the rare and severe, with an indication of how often they occur.
• The consequences of refusing: what it means not to vaccinate.

In addition, there must be an opportunity to ask questions, and enough time should remain between being informed and the vaccination for the matter to be thought over. With plannable vaccinations such as this one, in practice that means: the documents are handed out in advance, the conversation takes place on site, and anyone who does not want to decide can defer it.

A common misunderstanding: the signed form is not the information but its documentation. Legally it is the conversation that counts. A form without a conversation does not replace it; a conversation without a form is valid – only harder to prove.

Who may consent in Austria

This question comes up more often than you would suppose, and the answer is graded.

For a child without the capacity to decide, those with custody consent. For a routine vaccination the consent of one parent is enough; the consenting parent may assume that they are acting for the other as well. Where the parents disagree, the vaccination is not given.

From the age of fourteen a person in Austria counts as capable of deciding in medical matters, provided they understand what is at stake. An adolescent can then consent to a vaccination herself – even against her parents' wishes. Conversely she can also refuse it.

In those who are younger, the capacity to decide is assessed case by case. A twelve-year-old who understands what is involved is included in the conversation; legal consent, however, lies with those who have custody.

For gynaecological practice this point is directly relevant in one place: with the HPV vaccination of adolescents. A fourteen-year-old can consent to it herself. In practice the conversation is nevertheless usually held together, because a decision that is supported at home is the better one.

Why six components in one injection

The commonest objection in the conversation is that six at once are too much for an infant's immune system. It deserves a serious answer and not reassurance.

The number of components the immune system has to deal with is the decisive measure – not the number of illnesses on the label. A six-in-one vaccine today contains fewer than forty individual protein components in total. The smallpox vaccine, with which whole generations were vaccinated, contained around two hundred on its own.

Set against that is what an infant deals with every day anyway. The gut of a newborn is colonised in the first days of life by billions of bacteria, each with numerous surface structures. The air it breathes, the skin, every meal bring more. A vaccine does not stand out on this scale.

The practical reason for the combination is a different one and even more convincing: if the six components had to be given separately, there would be eighteen appointments instead of three. In practice immunisation programmes fail not on effectiveness but on missed appointments – and every additional appointment is an opportunity to miss one.

On top of that, single vaccines for these six components are no longer on the market in Europe. The question of splitting them therefore does not arise as a choice but as the question of whether to vaccinate at all.

The side effects one by one

Very common – in more than one in ten vaccinated children: redness, swelling and tenderness on the thigh; fever; restlessness, more crying, loss of appetite, sleepiness. These reactions appear in the first one to two days and subside by themselves. They are an expression of the immune response and not a sign that something has gone wrong.

Common to uncommon – in one in a hundred to one in a thousand: fever above 39.5 degrees; extensive swelling of the vaccinated leg; unusually shrill, persistent crying; a rash. These reactions too resolve without consequences but should be assessed by a doctor if they are pronounced or last longer than two days.

Rare to very rare – less often than one in a thousand: seizures, mostly in connection with fever and without lasting consequences; allergic reactions. Anaphylactic shock is extraordinarily rare and is the reason why people wait a quarter of an hour at the practice after every vaccination – such reactions occur during this time.

Not established, although regularly claimed: a connection with sudden infant death, with autism, with allergies, diabetes or chronic illness. These questions have been examined in large studies involving millions of children; no connection could be found.

This list looks long. Putting it in context requires the other side: the illnesses vaccinated against run a severe course in a considerable proportion of those affected and a fatal one in some. It is precisely this comparison that is the content of the conversation.

When it is not given or given later

It is postponed with an acute febrile illness – not because of a risk but because the reaction to the vaccination and the signs of the illness could otherwise not be told apart.

It is not given where there has been a documented severe allergic reaction to one of its components or to an earlier dose, and with a severe neurological illness that has not yet been investigated.

Not reasons to postpone, by contrast, are: a cold without fever, a course of antibiotics under way, an allergy to foods or pollen, atopic eczema, asthma, a preterm birth, low weight, a forthcoming operation or ill siblings. This list is here because in practice it regularly leads to unnecessary postponements.

How to read the frequency terms

Every consent sheet contains terms such as “common” or “very rare”. They are defined uniformly across Europe, and knowing that definition makes the difference between an alarming and an informative text.

A second point matters and is rarely stated alongside: these figures describe how often something was observed after a vaccination – not necessarily how often it was caused by it. In a period in which millions of infants are vaccinated, events inevitably occur that would have happened anyway.

Whether there is a connection can only be established by comparison: does the event occur more often in the vaccinated than in the unvaccinated of the same age? It is in exactly this way that the questions about sudden infant death, autism and chronic illness were investigated – and exactly why a clear answer can be given to them.

Anyone who reads a consent sheet and takes fright at a list of serious events is therefore reading something correct incorrectly. The list names what was reported. What was caused is in the studies behind it – and asking about that is one of the most useful questions in the conversation.

How you can prepare

A conversation of this kind goes better when both sides are prepared. Four things help:

Bring the vaccination record. Without it there is no certainty about which dose is due – and an unnecessary repeat is annoying.

Write your questions down. In the conversation they regularly do not come to mind and on the way home they do. There are no stupid questions; the worry about aluminium, about “too much at once” or about sudden infant death belongs asked and not taken home.

Report known reactions. If there was fever, extensive swelling or persistent crying after an earlier dose, that belongs mentioned – it can change what is done.

Keep the evening afterwards free. A child with a fever and a tender leg needs quiet, and so do its parents.

What to do after the vaccination

The injection site can be cooled. An antipyretic in a dose appropriate to the age makes sense if the child is suffering from the fever – it is not given preventively with this vaccination, because it damps down the response slightly without any benefit arising. An exception applies to the meningococcal B vaccination; see Bexsero.

Bathing, moving about and the usual daily routine are unproblematic. The vaccinated leg should not be rested but moved normally – that disperses the swelling faster.

What belongs with a doctor: fever above 39.5 degrees, fever lasting more than 48 hours, a seizure, unusually shrill crying over hours, swelling of the whole leg or striking listlessness. In infants under three months any temperature above 38 degrees is a reason for assessment.

If a side effect occurs

Suspected side effects can and should be reported – by doctors as much as by parents themselves. In Austria the competent authority is the Federal Office for Safety in Health Care; a report can be made through a form and needs no medical confirmation.

The point of this is not bureaucracy. Licensing studies cover a few thousand participants; events occurring once in a hundred thousand cannot become visible in them. They only show themselves when millions of people have been vaccinated – and they only show themselves if reports are made.

Historically this system has worked several times. The first rotavirus vaccine was withdrawn from the market in 1999 after reported cases of intussusception had come to notice – details are on the page rotavirus. An influenza vaccine was restricted after reported cases of narcolepsy. Both are examples of surveillance after licensing not being a ritual.

For parents this means in practice: if something unusual occurs after a vaccination, discuss it – even if you are not sure whether there is a connection. Making that assessment is not your task; reporting observations is.

If you decide against the vaccination

Vaccination is voluntary in Austria. A refusal is documented, and it changes nothing about further care.

Being properly informed does, however, include what a refusal means: the child remains unprotected against six illnesses, several of which run a particularly severe course in infancy. With whooping cough, pauses in breathing in the first months of life are the most feared consequence; with hepatitis B, infection in infancy leads to a chronic course in nine cases out of ten.

A decision can moreover be changed later. A series that has been started is continued, not begun again, and a late start is better than none.

What is documented in the vaccination record

Documentation involves more details than you would suppose, and each has a reason: the date, the trade name of the vaccine, the batch number, the doctor giving it with signature and stamp.

The batch number is the part most likely to be forgotten and, in an emergency, the most important. Should a quality problem ever come to notice in a particular production series, it is only through this number that it can be established who is affected.

The trade name counts because the exact composition follows from it – with combination vaccines that cannot be derived from the number of illnesses alone. If the preparation changes within a series, it is the only way of tracing what was given.

For some time now Austria has additionally had the electronic vaccination record as part of the electronic health file. It has the considerable advantage that it cannot get lost – and a lost vaccination record is the rule in adulthood, not the exception. Anyone who doubts that should ask the next pregnant woman about her rubella protection.

What happens next

The child's vaccinations are given by the paediatrician, and that is also where this conversation takes place. In this practice it is the part before that which matters – the dTpa and influenza vaccinations in pregnancy and the question of what is due in the first year of life. Arranging an appointment.

The same principles apply, incidentally, to being informed about anything in medicine, not only vaccinations. Before an IUD is fitted, before a conisation, before an antenatal test, the same pattern is followed: benefit, procedure, risks, alternatives, consequences of doing nothing – and an opportunity to ask questions. If after a conversation you have the feeling that you have not understood something, that is a reason to ask again and not an occasion to feel ignorant. These conversations exist for that purpose.