Rotavirus vaccine

The vaccine prevents serious rotavirus infections causing vomiting and diarrhoea.
Vaccine-preventable diseases

To whom is the rotavirus vaccine administered?
Which vaccine is used and what does it contain?
Dosage and schedule
What are the contraindications and precautions associated with the vaccine?
What are the benefits of the rotavirus vaccine?
What are the potential adverse effects of the rotavirus vaccine?
History of the rotavirus vaccine in the national vaccination programme

To whom is the rotavirus vaccine administered?

In the national vaccination programme, a free rotavirus vaccination is offered to young children aged from 6 to 31 weeks.

Which vaccine is used and what does it contain?

The product used in the vaccination programme is called RotaTeq.

The vaccine contains live attenuated viruses.
The excipients are sugars, salts, and purified water.
The vaccine contains no adjuvants or preservatives.
The vaccine prevents severe gastrointestinal infections caused by rotaviruses, the symptoms of which are vomiting, diarrhoea and fever.

Dosage and schedule

A single dose is 2 ml.

The vaccines are scheduled to be administered before the child’s risk of contracting a severe rotavirus infection reaches its peak. This schedule also helps to avoid the period associated with the highest risk of intussusception (blockage in the intestine).

THL recommends vaccinating children at the ages of 2, 3 and 5 months. If this is not possible, the rule of thumb is as follows:

The first dose can be administered from the age of 6 weeks on, and it should be administered before the age of 12 weeks (12.0).
The third dose should be given before the child is 32 weeks old (32.0).
The minimum interval between doses should be four weeks.

No boosters are given after the primary vaccination series. Studies indicate that this series still gives excellent protection three years after the last dose.

What are the contraindications and precautions associated with the rotavirus vaccine?

When making decisions about vaccinating a child, consider the general precautions and contraindications associated with vaccines containing live, attenuated pathogens.

If the mother has been given so-called biopharmaceuticals during pregnancy, several international treatment recommendations note that no live vaccines should be administered to the child before the age of 6 months. These children miss out on the rotavirus vaccination, as it is not administered later.

An exception to biopharmaceuticals is certolizumab pegol; following its use, the child’s rotavirus vaccination can be administered as normal.

A rotavirus vaccination may not be given to a child who has

had a severe allergic reaction (anaphylaxis) following a previous dose
weakened immunity because of an illness or its treatment
previously had intussusception (blockage in the intestine)
a congenital malformation of the gastrointestinal tract that may expose them to intussusception
a rare disorder affecting the breaking down of saccharides in the intestine.

Precautions

Postpone the vaccination if the child has a fever, diarrhoea or vomiting.

Suspected hypersensitivity to the active substance or an adjuvant is not necessarily a contraindication. The decision to vaccinate should be made individually in each case. The vaccination can usually be administered under a physician's supervision, as long as an adequate monitoring period is ensured.

Monitor the child’s breathing when administering the vaccine to

very small premature infants born at gestation week 28 or earlier
premature infants whose respiratory system is not sufficiently developed

The family should observe a particularly high level of hand hygiene if one of its members has weakened resistance to infections. Some recipients shed vaccine viruses in their faeces, especially after the first dose. The most intensive shedding takes place during the first week.

What are the benefits of the rotavirus vaccine?

In recent years, vaccinated children under the age of 2 have had less than 10 rotavirus infections requiring hospitalisation. Before the vaccination programme, there were over 500 such cases a year. This means that the vaccine has been more than 98% effective against rotavirus infections requiring hospitalisation.

Thanks to the rotavirus vaccinations, in children aged under 5 years

rotavirus cases requiring hospitalisation have gone down by over 93%
all acute diseases causing diarrhoea and requiring hospitalisation have gone down by 70%.

While they are very rare in Finland anyway, it is likely that the vaccine helps prevent deaths from infections causing vomiting and diarrhoea.

The vaccinations of infants reduce the prevalence of rotavirus infections in the entire population.

The vaccine significantly reduces hospitalisations, healthcare-related infections, use of other health services and parents’ absenteeism from work caused by rotaviruses.

Before the vaccinations were introduced in the national programme, rotaviruses caused diarrhoea outbreaks in Finland every year. During these outbreaks, over 11,000 children aged under 5 required healthcare services. Almost an equal number of children recovered from the disease at home. Every year, rotavirus cases resulted in thousands of hospitalisations and outpatient visits and an estimated 9,000 health centre visits.

While these cases are rare in our country anyway, it is likely that the rotavirus vaccinations make it possible to avoid all dehydration deaths resulting from infections which cause vomiting and diarrhoea in Finland.

The vaccinations of infants reduce the prevalence of rotavirus infections in the entire population.

What are the potential adverse effects of the rotavirus vaccine?

As the vaccine contains live attenuated pathogens, it may cause mild symptoms resembling a rotavirus infection.

Comparisons of vaccinated and unvaccinated children have shown that one out of 33 vaccine recipients has mild, vaccine-related diarrhoea within a month of the vaccination. This only applies to the first dose. In other words, in the first month following the vaccination, vaccine recipients experience 3% more diarrhoea than unvaccinated children.

In most cases, the children experience transient flatulence and spitting up as well as mild generalised symptoms, including irritability or a temperature.

Stomach pain and a rash are relatively rare symptoms.

A similar incidence of haematochezia (blood in the faeces) was observed in both vaccinated infants and those who received a placebo.

Stomach and generalised symptoms are usually not a contraindication for further vaccinations. The vaccination series can be continued once the symptoms have disappeared.

Intussusception and rotavirus vaccinations

Intussusception is a condition in which part of the intestine is pushed inside the intestine section beside it. Its occurrence increases strongly from the age of 2 to 3 months up.

The largest number of intussusception cases are found in infants of approx. 6 months of age. They occur in both children who have received the rotavirus vaccination and unvaccinated children.

In most cases, the reason for the intussusception cannot be determined. It has been thought that the factors which could expose an infant to this condition include:

viral or parasitic infection
enlarged mesenteric lymph node
Meckel’s diverticulum
tumour in the intestinal area
haematoma under the intestinal mucosal barrier
cystic fibrosis
rotavirus vaccination.

Inform the guardian of a vaccinated child of any symptoms indicating intussusception.

A child with any of the following symptoms should be seen by a physician:

severe, recurring and convulsive episodes of pain
vomiting
faeces with blood, water or mucous
bloating of the stomach
deterioration in general condition.

What do we know about the risk of intussusception?

The rotavirus vaccine used in the United States in the late 1990s increased the intussusception risk by 1 to 2 cases per 10,000 vaccination recipients.

Tens of millions of doses of the current rotavirus vaccines have already been administered globally. Based on studies conducted in different countries, the additional risk is estimated to be 1 to 6 cases per 100,000 vaccine recipients.

A Finnish study also found that a low risk of intussusception after the first dose cannot be excluded. The study indicates that at most, the rotavirus vaccinations could cause one additional case of intussusception per cohort. This finding is not statistically significant; in other words, it is also possible that the cases occurred randomly.

Kawasaki disease

Minor indications of a potential Kawasaki disease risk were found in the safety studies of the vaccine. However, no increase in the prevalence of Kawasaki disease in vaccination recipients has been noted in the vaccination programme.