Rotavirus

This page provides a brief summary of the disease and the vaccine that is available to prevent it. Links to more detailed information are provided at the bottom of the page.

After rotavirus vaccination, always remind parents to seek medical attention if their baby develops symptoms of intussusception.

What is rotavirus disease?

Rotavirus is a viral infection which causes diarrhoea and vomiting in babies and young children. It is very infectious. It is the most common cause of gastroenteritis in children in Ireland under the age of 5 years. It is most common in the Spring and Winter.

Most children will recover at home but some need to be admitted to hospital. Every year in Ireland almost 1000 children under the age of 5 are admitted to hospital with rotavirus infection. The average length of time they spend in hospital is 5 days. Babies and young children can now be protected from this disease by the rotavirus oral vaccine.

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How do people get rotavirus disease?

Rotavirus is very infectious and can spread easily. It can be spread through hand to mouth contact, such as from touching toys, surfaces, dirty nappies or can be spread through the air from coughing and sneezing.

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How many cases of rotavirus occur in Ireland?

In Ireland, from 2006-2015 inclusive there was an average of 2,400 cases of rotavirus notified each year in the 0-4 years age group (see figure below). Most of these cases are seen in the less than1 year age group (see figure below).

Figure: Number of rotavirus notifications for 0-4 years, 2006-2015

Source HPSC

 rotavirus graph1

Figure: Age specific incidence rate per 100,000 population of notified rotavirus cases

Source HPSC

Rotavirus graph2

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What are the symptoms of rotavirus disease?

Rotavirus causes diarrhoea which can be severe, stomach cramps, vomiting, dehydration and a low-grade fever. Symptoms occur 1 – 3 days after being exposed to rotavirus infection and can last approximately 3-8 days. Rarely diarrhoea may last for up to 3 weeks. Children with rotavirus disease can spread the infection from 2 days before they become unwell with the infection and up to 10 days after they become unwell.

If 1,000 children get rotavirus:

  • 1,000 get vomiting and diarrhoea
  • 3 will need to be admitted to hospital for treatment.
  • Young children need to stay in hospital for an average of 5 days, if they are admitted.

Children may get rotavirus disease more than once because there are many different rotavirus types, but second infections tend to be less severe than the first infections.

If you are concerned your child may have rotavirus infection, please attend your GP for review.

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Who should get rotavirus oral vaccine?

Rotavirus disease is prevented by vaccination. All children born on or after 1 October 2016 will be given rotavirus oral vaccine at 2 and 4 months of age.

Rotavirus oral vaccine should not be given to babies who are 8 months 0 days and older.

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Are there any reasons why rotavirus oral vaccine should not be given?

Contraindications

  • Anaphylactic reaction to a previous dose of the vaccine
  • Anaphylactic reaction to any constituent of the vaccine
  • A previous history of intussusception
  • Severe Combined Immunodeficiency Disorder (SCID)*
  • A malformation of the gastrointestinal tract which might predispose them to intussusception
  • A hereditary fructose intolerance, sucrose-isomaltase deficiency or glucose-galactose malabsorption
  • Aged 8 months and 0 days and older.

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What is SCID and why is it relevant to rotavirus oral vaccine?

SCID is a rare inherited primary immune deficiency characterised by severe impairment in T-cell development and function.

In Ireland, 1 case is diagnosed every year. It is more common in babies in some Traveller families.

The risk of an Irish infant (non-traveller) being born with SCID is approximately 1:70,000.

The risk of an infant Irish traveller being born with SCID is approximately 1:1200.

SCID can result in the onset of one or more serious and even life-threatening infections within the first few months of life. These infections may include pneumonia, meningitis or septicaemia. 

Children affected by SCID can also become ill from live vaccines, including rotavirus oral vaccine. These vaccines contain viruses that are attenuated (weakened) and do not harm children with a healthy immune system. In children with SCID however, these attenuated viruses and bacteria may cause severe, life-threatening infections.

However the risk from rotavirus vaccine needs to be balanced against the risk of a baby with undiagnosed SCID contracting rotavirus disease.

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How to check if the baby is at risk of SCID and what to do if they are?

Ask the baby’s parent / caregiver the following questions:

  • Are there any diseases in the baby’s family that affect the immune system?
  • Did anyone in either family need a bone marrow transplant as a baby?

If the parent/caregiver answers “No” to these questions rotavirus oral vaccine should be given.

If the parent / caregiver answers “Yes” to either of these questions

  • check if a Full Blood Count was taken at birth and confirm the results.
  • if a FBC was not taken, a full blood count with differential white cell, including lymphocyte count should be ordered.

If the lymphocyte count is below <2.0/109 litre referral to a Paediatrician should be made urgently.

Any baby at risk of SCID should NOT be given rotavirus oral vaccine.

Precautions

Vaccination should be delayed until recovery for babies who are suffering from

  • an acute febrile illness
  • an acute vomiting or diarrhoea illness

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What is rotavirus oral vaccine?

Rotavirus oral vaccine is a live attenuated viral vaccine. There are two vaccines licensed for use in Ireland, one is a two dose schedule (Rotarix, GSK) and the other a three dose schedule (Rotateq, Sanofi Pasteur MSD).

The rotavirus vaccine being used as part of the HSE programme is Rotarix (GSK).

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What does rotavirus oral vaccine protect against?

Rotavirus oral vaccine protects against gastrointestinal diseases caused by rotavirus infection. It will not prevent against diseases caused by other gastrointestinal viral infections, such as norovirus. 

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How safe is rotavirus oral vaccine?

Rotavirus oral vaccine has been shown to be very safe and well tolerated by the majority of babies. Over 300 million doses have been distributed worldwide.

As with all vaccines, there are some possible side effects and contraindications to its use (see below).

Rotavirus oral vaccine should not be given to babies 8 months 0 days and older. This is because of the risk that intussusception might occur in older babies given this vaccine (see below).

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How effective is rotavirus oral vaccine?

Rotavirus oral vaccine is very effective in preventing rotavirus disease in young babies. Since the vaccine was introduced into the immunisation schedule in Australia, they have seen a 70% decline in hospitalisations due to rotavirus gastroenteritis in the under-five year’s age group. Preliminary laboratory data from the UK has also identified a 70% reduction in rotavirus reports since the vaccine programme was implemented there. A European study identified a reduction in hospitalisations from rotavirus infection of between 65 to 84%. It estimated the vaccine effectiveness at between 82-94%.

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What is in rotavirus oral vaccine?

Rotavirus oral vaccine is formulated in a sugary solution.

There is a plunger stopper and a protective tip cap as part of the vaccine kit. These are made of rubber butyl and should not affect those with a latex allergy. The vaccine is not formulated in eggs and therefore should not affect those with an egg allergy.

A full list of vaccine constituents can be found at www.hpra.ie

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Are other countries vaccinating against rotavirus?

Yes, the World Health Organization has recommended rotavirus vaccination and many other countries are providing the vaccine to their citizens. The vaccine was licensed globally in 2006.  Over 300 million doses have been distributed worldwide. Rotavirus was added to the immunisation schedule in Australia in 2007. The UK implemented a national programme in 2013. The USA and 11 other EU countries have also implemented rotavirus vaccination programmes.

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Should a baby who has already been infected with rotavirus still get the vaccine?

Yes. Babies who have recovered from a rotavirus infection may not be immune to all of the virus types present in the vaccine. The vaccine will help better protect the baby against further episodes of infection. So babies who have previ­ously had rotavirus disease should still get the vaccines before age 8 months and 0 days

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Why is rotavirus oral vaccine being introduced into the primary childhood immunisation schedule?

Rotavirus disease is very common and by the age of five most children will have had vomiting and diarrhoea from rotavirus disease. Studies have shown that rotavirus oral vaccine is very effective in preventing rotavirus disease in young babies. The HSE received funding to include the rotavirus oral vaccine in the Primary Childhood Immunisation Schedule for all children born on or after 1 October 2016  . The rotavirus oral vaccine will protect young babies and children from this common disease

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How is the vaccine presented?

The vaccine comes in a box containing 10 individual vaccine doses.

The vaccine comes as a small (1.5 mls) oral suspension in a pre-filled oral applicator.

Each individual vaccine dose is ready to use and does not require any reconstitution

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How should the vaccine appear?

The vaccine dose should be a clear, colourless liquid with no visible particles within it. If any particulate matter is seen in the vaccine, or the vaccine appears anything other than a clear colourless liquid, the vaccine should be clearly marked ‘not for use’, boxed and returned to the HSE National Cold Chain Service (NCCS) when you receive your next delivery.

rotarix

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When should rotavirus oral vaccine be given?

The vaccine should be given at the beginning of the visit, while the baby is still content, and before administering injections. This is because the baby is likely to be most settled at the start of the vaccination schedule, which makes administering it easier. Also, the vaccine is within a sugary solution which is helpful in providing pain relief for the remaining vaccines

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How should the vaccine be given?

The vaccine is an ORAL vaccine.

STEP 1:          Remove protective tip cap from the oral applicator (see diagram)

step 1

STEP 2:          Ensure the baby is sitting in a reclining position.

 

STEP 3:          Insert syringe tip into the baby’s mouth, towards the inner cheek                    

 step3

STEP 4:           Administer vaccine into the baby’s mouth. The syringe containing the vaccine should be aimed down one side and towards the back of the baby’s mouth. The syringe should not be inserted so far back that the baby gags. All the syringe contents should be given to the baby.

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How soon before or after the vaccine can a baby feed?

A baby can feed at any stage before or after the vaccine.

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What is the minimum age a baby can receive rotavirus oral vaccine?

The rotavirus vaccine can be given at any time from 6 weeks. However, the best time to receive the first dose is at 2 months of age

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What is the minimum interval between dose one and dose two of rotavirus vaccine?

The minimum interval between doses of rotavirus vaccine is 4 weeks. The recommended interval is 2 months.

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What is the maximum interval between doses of rotavirus vaccine?

There is no maximum interval. However, no rotavirus vaccine should be given to a baby after 8 months and 0 days.

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What if a baby is late starting the vaccine schedule?

If a baby is late presenting for rotavirus oral vaccine, then they can receive their first dose of vaccine anytime up to the age of 8 months and 0 days.

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What if a baby is late presenting for the second dose of vaccine?

Babies can be given their second rotavirus vaccine as long as they are less than 8 months and 0 days, and there is a minimum of 4 weeks since the first dose of rotavirus vaccine. 

If a baby is 8 months and 0 days of age or older then they should NOT receive any dose of rotavirus oral vaccine.

These recommendations are in line with the CDC recommendations in the USA. 

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Why should babies not be given rotavirus after 8 months and 0 days?

Babies are most at risk of rotavirus infections and its complications, and get best protection from the rotavirus vaccine, if they receive the vaccine at the scheduled 2 and 4 month visits. However, if they are late presenting they should still be offered the vaccine up until 8 months and 0 days. After this they should not receive the vaccine due to the slight elevated risk identified with intussusception and older babies.

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Different guidelines about rotavirus oral vaccine are given elsewhere, so what guidelines should be followed?

The Rotarix SmPC states that the vaccination course should preferably be given before 16 weeks of age, but must be completed by the age of 24 weeks. In the UK, a 2 dose rotavirus oral vaccine course is given at 8 and 12 weeks of age. In the US, a 3 dose rotavirus oral vaccine course is given at 2, 4 and 6 months of age.

As stated in the rotavirus chapter of the Immunisation guidelines for Ireland, where advice differs from PIL or SmPC the recommendations based on current expert advice from should be followed.

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What are the side effects of rotavirus oral vaccine?

The vaccine has a very good safety profile. The following are side effects noted with this vaccine and available in the PIL.

Common (1 in 10 babies)

  • Diarrhoea
  • Irritable

Uncommon (1 in 100 babies)

  • Abdominal pain / Flatulence
  • Dermatitis (skin inflammation)

Very rare (1 in 50,000)

  • Intussusception*
  • Blood in stools
  • Apnoeas in very premature babies born at or before 28 weeks gestation
  • Gastroenteritis in babies with SCID

After rotavirus vaccination, always remind parents to seek medical attention if their baby develops symptoms of intussusception.

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What is intussusception?

Intussusception is a condition where a baby can get a blockage in the bowel. In Ireland, approximately 1 in 1500 babies will get this condition naturally, and it is most common between the ages of 5 months and 1 year. It is thought that for every 100,000 first doses of rotavirus vaccine given, approximately two extra cases of intussusception may be seen. For Ireland, this may mean an extra 1-2 cases per year of intussusception which would be related to the rotavirus vaccine. Intussusception can occur at any time after the vaccine is given.

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How would I know if a baby is developing intussusception?   

Babies with intussusception have pain similar to a severe colic, accompanied with bouts of crying. However, they generally become very pale during episodes, rather than flushed as they might with colic, and they may draw their legs up. The episodes become more frequent over a few hours associated with vomiting or blood in their stools. If this occurs then the baby needs to be urgently referred to hospital for investigation. Treatment in hospital usually involves a non-operative procedure but on some occasions, an operation is required. The sooner a baby is identified and referred to hospital, the less likely they are to need an operation.  

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Should a baby with a history of intussusception in a sibling have the rotavirus oral vaccine?

Intussusceptions may be idiopathic or associated with underlying diseases.

In those with idiopathic intussusception, familial occurrence is rare however all siblings of a child who has had an intussusception are at a slightly higher risk of having an intussusception themselves. Familial occurrence of intussusception as a complication of recognisable familial underlying diseases, such as cystic fibrosis, has been reported. 

The NIAC immunisation guidelines do not include a family history of intussusception in a sibling as a contraindication or a precaution to receiving the rotavirus oral vaccine.

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What if a baby was given a dose of vaccine after 8 months and 0 days?

If a baby receives rotavirus oral vaccine on or after 8 months and 0 days no specific clinical monitoring needs to be performed for the baby. However, the parents should be clear regarding the symptoms of intussusception and the need to seek medical help if concerned.

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What if a baby has received another live vaccine within the past four weeks?

There is no minimum interval of time between other live vaccines and oral rotavirus vaccine. The rotavirus vaccine can be given at any time before or after another live vaccine.

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What if a baby spits out (regurgitates) rotavirus oral vaccine?

If more rotavirus oral vaccine was spat out rather than swallowed, a single replacement dose should be given straight away.

If the baby spits out more than 10-15 minutes after the initial vaccine, then it is considered absorbed and a replacement dose is not needed.

  • If the regurgitation takes place during the clinic visit, give a replacement dose
  • If the baby has left the clinic room, no replacement dose is required

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What if a baby was born prematurely at < 37 weeks gestation?

Preterm infants are at increased risk for hospitalisation from rotavirus gastroenteritis during the first two years of life. In clinical trials, rotavirus vaccine was generally well tolerated in preterm infants, although relatively small numbers were evaluated. The benefits of rotavirus vaccination of preterm infants outweigh the risk of adverse events

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What if a baby was born very prematurely at ≤28 weeks gestation?

Any preterm infants born ≤ 28 weeks who have been discharged from hospital can be given rotavirus oral vaccine.

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What if a baby has already had a confirmed rotavirus vaccine infection?

Even if the baby has had a confirmed rotavirus infection, they are still recommended to receive the vaccine. This is to help better protect against further episodes of infection. 

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What if a baby has a feeding tube in place?

Children with nasogastric feeding tubes should be given the vaccine orally, unless it is absolutely necessary to give it via the tube. Administration of rotavirus vaccine via gastrostomy is acceptable. There is no issue flushing the tube after the vaccine has been administered.

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What if a baby is on anti-reflux medication?

Babies who are required to take anti-reflux medication should still receive the vaccine. The vaccine itself contains antacid to protect it from the acidic stomach environment and therefore the immune response to the vaccine should not be affected by anti-reflux medication.

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Is a history of positive Coombs test a contraindication to rotavirus oral vaccine?

A history of a positive Coombs test disease is not a contraindication to the rotavirus oral vaccine.

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Why do I need to ask about diseases in the baby’s family that affect the immune system?

This question is asked to discover if there is a family history of immunodeficiency diagnosed in early childhood requiring bone marrow transplant.

A family history of immunosuppression due to other diseases e.g. carcinoma  or treatment is not a contraindication to rotavirus vaccine.

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What if a baby has an immunodeficiency other than SCID?

Little safety or efficacy data are available following administration of rotavirus vaccine to other infants who are immunocompromised or potentially immunocompromised. Therefore, although rotavirus vaccine strains are considerably attenuated, their administration to infants with known or suspected immunodeficiency other than SCID should be based on careful consideration of potential benefits and risks. HIV positive infants and those of unknown HIV status should receive the rotavirus vaccine.

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What if a baby is HIV positive?

HIV positive infants and those of unknown HIV status should receive rotavirus vaccine.

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What if a household member of the babies’ family is immunosuppressed (e.g. undergoing cancer treatment)?

The vaccine virus could be transmitted from the infant to severely immunocompromised contacts through faecal material for at least 14 days. However, vaccination of the infant will offer protection to household contacts from wild-type rotavirus disease and this benefit outweighs any risk from transmission of vaccine virus to immunocompromised close contacts. All members of the household should maintain careful hygiene when changing an infant’s nappy.

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Is a family history of autoimmune disease a contraindication to rotavirus oral vaccine?

A family history of autoimmune disease is not a contraindication to the rotavirus oral vaccine.

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Can my child be immunised with rotavirus vaccine while they are in close contact with a pregnant woman?

Yes. There is no problem with this. In fact, immunising the child will protect the pregnant woman from being exposed to diseases like rotavirus. However, as rotavirus vaccine is an oral vaccine, pregnant woment should wash their hands carefully after changing nappies. 

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Can the infant of a woman who has been treated with an immunomodulator during pregnancy receive the rotavirus vaccine?

There is no contraindication to giving rotavirus oral vaccine to  a baby whose mother has been treated with an immunomodulator treatment  while pregnant.

What if the baby’s mother was on immunomodulators while pregnant?

There is no contraindication to rotavirus oral vaccine for a baby whose mother took immunomodulators while pregnant.

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 Can my child be immunised with rotavirus vaccine while they are in close contact with a pregnant woman?

Yes. There is no problem with this. In fact, immunising the child will protect the pregnant woman from being exposed to diseases like rotavirus. However, as rotavirus vaccine is an oral vaccine, pregnant women should wash their hands carefully after changing nappies. 

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Can a baby go swimming after rotavirus oral vaccine?

Yes. You should take the usual hygiene measures when changing your baby’s nappy after rotavirus oral vaccine. If your baby gets diarrhoea as a side effect of the vaccine, your baby  should not go swimming for two weeks after the diarrhoea has settled.

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Where can I find out more?

You can ask for further information regarding immunisation from your G.P., Public Health Nurse or local health office.

In addition the links below provide some more detailed information:

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    This page was updated on 3 April 2017