Rotavirus Vaccine

Key vaccine facts

The rotavirus vaccine used in the UK is called Rotarix. It gives protection against rotavirus infections that can cause vomiting and severe diarrhoea in infants and children.

Babies receive two doses. The first is given at 8 weeks and the second at 12 weeks alongside the other routine vaccines given at these times. See the UK vaccination schedule.

It is an oral vaccine, not an injection, so it is administered using a few drops of liquid (1.5ml) from a dropper into the mouth.

The vaccine was introduced into the UK schedule in July 2013. Vaccines for rotavirus, including Rotarix, have been shown in clinical trials to be 90-100% effective in preventing severe rotavirus 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. Reported cases of rotavirus fell by over 70% three years after the vaccine was introduced in the UK.

Who should get this vaccine

Infants should receive their first dose of the rotavirus vaccine between 8 weeks of age and 12 weeks of age.

Two doses should be given, with the second dose being given after 4 weeks after the first dose. Ideally, the two doses should be completed before 16 weeks of age, but they must be completed by 24 weeks of age.

Infants may receive their first dose from 6 weeks of age in exceptional circumstances, such as pre-travel, but it is not routinely recommended before 8 weeks of age.

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 / suspected SCID screening (see more information below)
with a history of certain gastrointestinal and bowel disorders (see more information below)
who have not received their first dose before 14 weeks and 6 days of age.

Safety and side effects

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

Some studies also suggest a very small, and extremely rare, increased risk of intussusception within 7 days of vaccination (up to 6 cases of intussusception per 100,000 first doses of the vaccine). This 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. Most children with intussusception are treated without complications and make a full recovery.

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. Healthcare 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 these six years, 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.

Ingredients

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 cells but does not contain porcine gelatine.

Other brands of the rotavirus vaccine used in other countries, such as RotaTeq, may contain different ingredients. If you are not in the UK, ask for the patient information leaflet for the vaccine you are offered. See more information below about RotaTeq.

More information about the vaccine

More detail about who should get this vaccine

More detail about intussusception

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.

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 the rotavirus vaccine should be given to babies, to avoid the risk of intussusception.

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.

More detail about the vaccine

The vaccine contains live human rotavirus that has been weakened (attenuated), so 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) .

SCID screening

Babies should have the results of their screening for Severe Combined Immunodeficiency (SCID) checked before the rotavirus vaccine is given if they live in an area of England where screening happens. If SCID is suspected, the vaccine should not be given. However, if no SCID result is available, the vaccine should be given.

SCID screening was added to the routine newborn screening test at five days of age, in six areas across England in September 2021 – these include babies born in the regions served by screening labs in Newcastle, Manchester, Sheffield, Birmingham, Great Ormond Street Hospital and Guys and St Thomas Hospital. This is part of an evaluation that will find out if screening for SCID will work in England the same as it has in many other countries.

SCID screening is used to identify babies with a rare genetic condition that affects the immune system. This could pose a risk to them if they receive live vaccines, like the rotavirus vaccine. Babies in non-screening areas will be assigned a ‘SCID screening not offered’ result.

The rotavirus vaccine should also not be given to babies of mothers that used medication that impacts the immune system (immunosuppressive biological therapy) during their pregnancy because this could influence the infant’s immune status.

Other rotavirus vaccines available

Alongside Rotarix, another vaccine is licensed to protect against Rotavirus but is not currently used in the UK. RotaTeq is used in some countries and is delivered as a three-dose course. Where possible, infants should receive the same vaccine for each of their doses. See the RotaTeq patient information leaflet for more information.

Impact of the rotavirus vaccine

In the UK, when the rotavirus vaccine was introduced, experts predicted that the 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 introducing a vaccine, around 12,700 UK children were hospitalised with rotavirus infection a year.

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.