Rotavirus Vaccine

Vaccine

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The rotavirus vaccine used in the UK (Rotarix) gives protection against rotavirus infections that cause vomiting and severe diarrhoea in infants and children.

Babies receive two doses, at 8 weeks and 12 weeks, alongside the other routine vaccines given at these times (see the UK vaccination schedule).

It is an oral vaccine, not an injection. A few drops of liquid (1.5ml) are given from a dropper into the mouth.

It was introduced into the UK schedule in July 2013. Worldwide, vaccines including the one used in the UK (Rotarix) have been shown in clinical trials to be 90-100% effective in preventing severe rotavirus gastroenteritis and 74-85% effective in preventing rotavirus infection of any severity.

Some babies who are vaccinated will still get rotavirus infection, but the disease is usually mild. In the three years after the vaccine was introduced in the UK, reported cases of rotavirus fell by over 70%.

 

Infants should receive their first dose of this vaccine between 6 weeks of age and 14 weeks, 6 days of age.

Second doses should be given after a minimum of 4 weeks from the first dose, but before 23 weeks, 6 days of age to infants. 

Rotarix (see the patient information leaflet) should not be given to infants:

  • under 6 weeks of age
  • over 24 weeks and 0 days of age
  • with a confirmed anaphylactic reaction to a previous dose or any components of the vaccine
  • with severe immunodeficiency disorder
  • with a history of certain gastrointestinal and bowel disorders

 

All vaccines go through rigorous testing and regulatory processes that can take up to 15 years to ensure they are safe and effective. Like all medicines, vaccines can cause side effects, but not everyone gets them.

Common side effects - affecting up to 1 in 10 people at each dose include:

  • diarrhoea
  • feeling irritable or restless

Uncommon side effects - affecting up to 1 in 100 people at each dose include:

  • pain in the stomach
  • wind
  • bringing up food
  • loss of appetite
  • skin inflammation

Very rare side effects - affecting fewer than 1 in 10,000 people at each dose include:

  • very small increased risk of a rare condition called intussusception, although most children with intussusception are treated without complications and make a full recovery. Intussusception is where part of the bowel folds in on itself (like a collapsible telescope), causing an obstruction. It needs urgent medical attention because it can be life-threatening. The symptoms are severe stomach pain, vomiting, and sometimes passing what looks like a red jelly. This will appear as blood in the baby’s nappy.

As with any vaccine, medicine or food, there is a very small chance of a severe allergic reaction (anaphylaxis). Anaphylaxis is different from less severe allergic reactions because it causes life-threatening breathing and/or circulation problems. It is always extremely serious but can be treated with adrenaline. Health care workers who give vaccines know how to do this.

In the UK between 1997 and 2003 there were a total of 130 reports of anaphylaxis following ALL immunisations.  During this six year period, around 117 million doses of vaccines were given in the UK. This means that the overall rate of anaphylaxis is around 1 in 900,000.

If you are concerned about any reactions that occur after vaccination, consult your doctor. In the UK you can report suspected vaccine side effects to the Medicines and Healthcare products Regulatory Agency (MHRA) through the Yellow Card Scheme . You can also contact the MHRA to ask for data on Yellow Card reports for individual vaccines . See more information on the Yellow Card scheme and monitoring of vaccine safety.

 

The rotavirus vaccine used in the UK is called Rotarix. Apart from the active ingredients (the antigens), it also contains about a gram of sugar to give it a pleasant taste. As a result, it should not be given to infants who have fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency.

The rotavirus strain in this vaccine is grown in the laboratory using animal cell strains, but does not contain porcine gelatine.

Other brands of the rotavirus vaccine used in other countries may contain different ingredients. If you are not in the UK, ask for the patient information leaflet for the vaccine you are offered.

 

More detail about who should get this vaccine

A history of certain gastrointestinal and bowel disorders may make this vaccine unsuitable for some infants. These include those with:

  • a history of intussusception, where part of the bowel folds in on itself (like a collapsible telescope)
  • gastrointestinal malformation that could predispose them to intussusception

Research from some countries suggest that two extra cases of intussusception may occur for every 100,000 first doses of Rotarix that are given. This would happen within seven days of vaccination. When compared to the number of cases that happen anyway - 120 per 100,000 children - this is a very low additional risk and should be compared to the benefits of the vaccine in preventing severe rotavirus infection.

The first dose of Rotarix is always given before 15 weeks of age, as the side effect of intussusception seems unlikely to occur if the vaccine doses start at this age. This also reduces the chance of the vaccine being wrongly blamed for cases of intussusception that sometimes occur naturally at around five months of age. There are strict rules about the age at which rotavirus vaccine should be given to babies, to avoid the risk of intussusception.

See these studies for more information:

The vaccine contains live human rotavirus that has been weakened (attenuated), so that it stimulates the immune system but does not cause disease in healthy people. However it should not be given to people who are clinically immunosuppressed, either due to drug treatment or underlying illness. This is because the vaccine strain could replicate too much and cause a serious infection. This includes babies whose mothers have had immunosuppressive treatment while they were pregnant or breastfeeding.

For more information see the MHRA's Drug Safety Update (April 2016) .

Impact of the rotavirus vaccine

In the UK, experts predicted that the rotavirus vaccine would:

  • halve the number of rotavirus cases seen by GPs each year. Before a vaccine was introduced, 130,000 UK children a year visited their GP with rotavirus infection;
  • cut the number of hospital admissions by two thirds. Before a vaccine was introduced, around 12,700 UK children a year were hospitalised with rotavirus infection.

The graph below shows what has happened in the UK since the rotavirus vaccine was introduced in July 2013. In 2014, 2015 and 2016 the number of reported cases of rotavirus fell by over 70% compared to previous years. Rotavirus infections tend to peak between January and March, but in these years there was no significant peak in cases.

For more information see the 2015 study showing the rapid decline in rotavirus infection from Public Health England and Imperial College London.

Rotavirus cases 2006

Click here for an accessible text version of this graph

 Source: Public Health England Rotavirus data 2006 to 2015 and 2007 to 2016

 

Page last updated: Monday, February 20, 2023