Rotarix vaccine manufactured by GlaxoSmithKline is recommended for rotavirus, a typically benign illness that almost all children get before age 5. 2 doses of this vaccine are recommended and administered as oral drops at 2 and 4 months of age.
Disease versus Vaccine Risk Summary
Risk of Hospitalization and Death from Rotavirus in Europe
| Risk of hospitalization from rotavirus in Europe | Approx 1 in 271 (0.37%) |
| Risk of death from rotavirus in Europe (pre-vaccine, 2006) | Approx 1 in 102,000 (0.0001%) |
Risks from Each Dose of Rotavirus Vaccine Rotarix
2 doses recommended, at 2 and 4 months
| Frequency | Observed Side Effects |
|---|---|
| Post-marketing |
|
| Up to 1 in 10,000 (0.01%) |
|
| Up to 1 in 100 (1%) |
|
| Up to 1 in 10 (1% to 10%) |
|
Warnings and Precautions – Avoid If:
| WHO Vigiaccess Adverse Events Reporting System: As of Oct 2024, 89,863 adverse events have been reported for all rotavirus vaccines. |
What is rotavirus?
Rotavirus is a highly contagious RNA virus in the Reoviridae family. It is known as the leading cause of acute gastroenteritis and diarrhoea in children worldwide. In Ireland, cases peak between March and May, affecting young children, especially those in crèches and hospitals. Susceptibility is highest from 6 to 24 months, though nearly all children are infected and gain immunity by age five. Infants under three months are often asymptomatic due to maternal antibodies. The virus spreads through contact with infected body fluids, with most cases managed at home through proper hydration.
Rotavirus tends to have a more severe impact in low-income regions where children are often at a higher risk due to factors like poor sanitation, limited healthcare access, and lower availability of clean water.
What is the risk of getting rotavirus in Ireland?
Every child will develop rotavirus at least once by the age of five and develop immunity to future infections.
What is the risk of death from rotavirus in Ireland?
Before the introduction of the vaccine it was estimated that 3.6 million rotavirus infections occurred annually among the 23.6 million children younger than 5 years of age in the EU. This included 231 deaths, >87,000 hospitalisations and almost 700,000 outpatient visits.
The risk before the vaccine was introduced in 2006 equates to approx 1 in 102,000 (0.0001%) chance of your child under 5 dying , approx 1 in 6.5 (15.25%) chance of contracting rotavirus annually and approx 1 in 271 (0.37%) chance of hospitalisation
Does Rotarix guarantee protection from rotavirus?
No. As with all vaccines protection from the disease cannot be guaranteed.
The vaccine was introduced in an attempt to relieve pressure on hospitals. However, a follow up study to examine the impact of rotavirus vaccine on hospital admissions showed no significant change in paediatric hospital admissions amongst 0–16 year olds
Additional vaccine safety concerns
Like all medicines, vaccines come with side effects, sometimes very serious. Parents need to research every vaccine and ensure benefits outweigh the risks.
- See Disease versus Vaccine Risk Summary at the top of this page for list of possible side effects from Rotarix.
- Rotarix is a live virus vaccine and has potential for transmission of vaccine virus following vaccination.
- Risk of intussusception (a bowel obstruction in which one segment of bowel becomes enfolded within another segment).
- “Severe allergic reactions can occur to any vaccine but they are very rare and are usually seen in less than 1 in 10,000 people who are vaccinated” [Menitorix PIL, 11/2016]
- As of Oct 2024, 89,863 adverse events (including 1891 deaths and 339 SIDS deaths) have been reported on the World Health Organisation Vigiaccess database for all rotavirus vaccines including Rotarix.
What are the vaccine ingredients?
| Vaccine | Ingredients as listed on patient information leaflet |
|---|---|
| Rotarix Rotavirus |
Active substances: Human rotavirus strain (live, attenuated) (produced on vero cells)
Other ingredients: dextran, [popup_anything id=”4649″], and [popup_anything id=”3109″], Dulbecco’s modified eagle medium (DMEM) – [popup_anything id=”3623″], [popup_anything id=”4327″], magnesium sulfate, ferric (III) nitrate, [popup_anything id=”4787″], sodium pyruvate, D-[popup_anything id=”4648″], concentrated vitamin solution, L-cystine, L-tyrosine, amino acids solution, L-glutamine, calcium chloride, sodium hydrogenocarbonate and [popup_anything id=”4792″]) |