This vaccine gives protection against type A rotavirus infections that cause vomiting and severe diarrhoea in infants and children. It was introduced into the UK schedule in July 2013. The vaccine is over 85% effective at protecting against severe rotavirus infection in the first two years of life. Some babies who are vaccinated will still get rotavirus infection, but the disease is usually milder. See more information on Rotavirus.
It is an oral vaccine, not an injection. A few drops of liquid (1.5ml) are given from a dropper into the mouth. Babies receive two doses, at two months and three months, alongside the other routine vaccines given at these times (see the UK vaccination schedule).
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) .
In 2014, 2015 and 2016 the number of reported cases of rotavirus fell by over 70% in the UK (see More information below).
In the short film below, Dr Andrew Prendergast talks about rotavirus infection and why it is important to vaccinate against the disease.
The rotavirus strain used in the vaccine is grown in the laboratory using animal cell-lines. See more information on animal cell-lines.
As it is an oral vaccine, it also contains about a gram of sugar (sucrose) to give it a pleasant taste.
The Rotavirus vaccine used in the UK does not contain the preservative thiomersal (mercury).
Common (up to 1 in 10 doses of the vaccine):
Less common (up to 1 in 100 doses of the vaccine):
Very rare side effects (fewer than 1 in 10,000 doses of the vaccine):
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 serious but can be treated with adrenaline. In the UK between 1997 and 2003 there were a total of 130 reports of anaphylaxis following ALL immunisations, but all of these people survived. Around 117 million doses of vaccines were given in the UK during this period, making the overall rate around 1 in 900,000. Depending on the cause of the reaction, and following expert guidance, the person may be able to have vaccinations in the future.
Reactions listed under ‘possible side effects’ or ‘adverse events’ on vaccine product information sheets may not all be directly linked to the vaccine. See Vaccine side effects and adverse reactions for more information on why this is the case.
See more information on the monitoring of vaccine safety.
Experts predicted that the rotavirus vaccine would:
The graph below shows that 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 three 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 vaccines, such as Rotarix which is used in the UK, may be associated with a very small increased risk of a rare condition called intussusception, particularly if the vaccine is given later than recommended. In this condition, part of the bowel folds in on itself (like a collapsible telescope), causing an obstruction. It occurs naturally in some children under one year old (about 120 cases in every 100,000 children), with a peak at around 5 months of age. Intussusception needs urgent medical attention because it can be life-threatening. The symptoms are severe stomach pain, vomiting, and sometimes passing what looks like redcurrant jelly (blood in the baby’s nappy). Most children with intussusception are treated without complications and make a full recovery.
Research from some countries suggests that 2 extra cases of intussusception may occur for every 100,000 first doses of Rotarix that are given (within 7 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 (an increase to 122 per 100,000), 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 peak naturally at around 5 months of age. For this reason, 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: