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Information for Consumers

Published: 9 April 2014

Consumer Educational Materials

Questions and Answers on Rotavirus Vaccination (RotaTeq)

9 April 2014

What is rotavirus and how serious is it?

Rotavirus is the most common cause of severe diarrhoea and dehydration in children under five years of age. In mild infections the child experiences vomiting and watery diarrhoea of limited duration. In severe infections the child may also have fever, and tummy pain that last for many days. In some cases the child may become dehydrated and need hospital treatment. In rare instances in industrialised countries, a child may die due to rotavirus.

Rotavirus is mostly spread by contact with the poo (faeces/stool) of an infected person. It can be spread through toys and door-knobs if these have been touched by someone who has been in contact with rotavirus.

Virtually all children have been infected by the time they reach five years old, regardless of their nationality or level of hygiene.

Rotavirus infection in figures

It has been estimated that 634 of every 100,000 children under three years old are hospitalised because of rotavirus infection in New Zealand1.

Rotavirus infection results in 1 in 43 children being hospitalised and the parents of 1 in 5 children seeking medical advice by the time they are five years old.

What are the symptoms of rotavirus?

The symptoms in children are:

Adults can catch rotavirus but generally have no symptoms.

Whilst hand washing and cleanliness are important ways to stop the spread of germs they are not enough to stop rotavirus infection. This is why the vaccine is being introduced in New Zealand.

How is rotavirus treated?

If your child has rotavirus the most important thing you can do is prevent dehydration. If your baby is less than six months old and has diarrhoea and/or vomiting you should see a doctor urgently. Babies can become dehydrated very quickly.

More information on treating children is available on kids health.

How effective is the rotavirus vaccine?

There are two brands of rotavirus vaccine approved for use in New Zealand: Rotarix and RotaTeq. RotaTeq will be funded from 1 July 2014.

Rotavirus vaccines prevent almost all infants and children from severe disease. The vaccine protects most infants and children from any severity of rotavirus disease.

Vaccine efficacy in figures

Efficacy for RotaTeq was tested in 6,983 infants (3,484 were given vaccine). RotaTeq stopped rotavirus (of any strain) in 71.3% of infants. RotaTeq stopped severe rotavirus in 98.2% of infants2.

Since the introduction of rotavirus vaccination in Australia the number of children under five years of age being hospitalised because of rotavirus has dropped by 70%.

How is RotaTeq (rotavirus) vaccine given?

RotaTeq is a liquid that is given by mouth, not an injection. It can be safely given at the same time as other vaccines. RotaTeq needs to be given three times, the first dose should be given between six and twelve weeks.

The vaccine can be given to children if they have just eaten and if they are breast feeding.

Is RotaTeq suitable for all infants?

RotaTeq vaccine is fine for most infants, but there are some infants who shouldn’t get this vaccine.

Check with your doctor if your child has HIV infection, or is taking medicines which can affect the immune system such as steroids.

Consumer Medicine Information (CMI) for RotaTeq (PDF 128 KB, 4 pages)

What are the side effects of RotaTeq?

Like all vaccines and medicines RotaTeq can cause side effects in some infants. These side effects are usually mild and go away on their own.

Serious side effects are possible, but are very rare.

Mild effects include, mild diarrhoea or vomiting in the week after vaccination.

Serious effects include severe allergic reactions and intussusception (a type of bowel blockage).

More information on events linked to rotavirus vaccine in New Zealand can be found in the Suspected Medicine Adverse Reactions Search (SMARS).

What is intussusception?

Intussusception is a condition where one part of the bowel slides into the next (like a telescope). This can happen ‘naturally’ in some infants every year in New Zealand. The reason why this happens is unknown, but some cases may be caused by an infection.

There is a small risk of intussusception from rotavirus vaccination. The risk is highest in the week after vaccination with the first dose.

Intussusception is treated in hospital. A radiologist (specialised doctor) can usually unfold the intussusception by using air or fluid to push the folded part of the bowel back into its normal position. In about 30% (one third) of cases an operation is needed. After surgery the infant will need to stay in hospital for a few days to recover.

Most infants recover completely with no further problems. However, intussusception can reoccur in up to 10%  (1 in 10) of cases.

Intussusception in figures

In New Zealand it is estimated that there are 65 cases of intussusception for every 100,000 children under one year old3.

The risk after vaccination with RotaTeq has been estimated in the United States around 1 infant in every 100,000 infants vaccinated.

In Australia the risk was estimated at 7 children per 100,000 vaccinated with RotaTeq4.

What should I do if my child has a serious reaction?

Signs of a severe allergic reaction can include hives, swelling of the face and throat, difficulty breathing and a fast heartbeat. These usually start a few minutes to a few hours after vaccination.

If you think your child may have a severe allergic reaction you should call an ambulance.

Signs of intussusception include severe crying and tummy pain, infants might pull their legs up to their chest as if they have colic. Infants may also vomit or have blood in their poo. If this happens call an ambulance. Tell the hospital doctor when your baby got the vaccine.

Afterwards please report the reaction to the Centre for Adverse Reactions Monitoring (CARM).

Does RotaTeq contain mercury?

RotaTeq does not contain mercury (thiomersal) or aluminium.

Have there been any reactions to rotavirus vaccine in New Zealand?

You can find a summary of reports of suspected adverse reactions (adverse events following immunisation) to rotavirus vaccine in the Suspected Medicine Adverse Reaction Search (SMARS).

Search for suspected adverse reactions using SMARS.

Do the benefits of rotavirus vaccination outweigh the risks?

The overall benefits of preventing rotavirus outweigh the small risk of intussusception.

Vaccination is not mandatory in New Zealand. You should weigh up the benefits and risk of harm for your child before giving them any vaccine or medicine. If you need more advice you can talk to your healthcare professional or call the Immunisation Advisory Centre on 0800 466 863.

Benefits versus risks in figures

In Australia introduction of rotavirus vaccination has resulted in a 70% decrease in hospitalisation for rotavirus. In New Zealand, this would reduce the rate of hospitalisation by 444 children per 100,000 per year. In contrast, it is expected that the number of cases of children hospitalised for intussusception could increase by up to 7 children per 100,000 per year.

References
  1. Grimwood K, Huang QS, Cohet C, et al. 2006. Rotavirus hospitalisation in New Zealand children under 3 years of age. Journal of Paediatrics and Child Health 42(4):196–203.

  2. Merck Sharp & Dohme (New Zealand) Limited. 2013. RotaTeq Oral Suspension 3 July 2013. URL: www.medsafe.govt.nz/profs/datasheet/r/RotaTeqsusp.pdf (accessed 7 April 2014).

  3. Chen YE, Beasley S, Grimwood K, et al. 2005. Intussusception and rotavirus associated hospitalisation in New Zealand. Archives of Disease in Childhood 90(10): 1077–1081.

  4. Carlin JB, Macartney K, Lee KJ, et al.2013. Intussusception risk and disease prevention associated with rotavirus vaccines in Australia’s national immunisation program. Clinical Infectious Diseases 57(10): 1427–1434.

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