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Rotarix

Common name:

RV1, rotavirus vaccine

Protects against rotavirus.

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Overview

Rotarix® is an oral vaccine given at 6 weeks and 3 months of age. 

For safety reasons, the first dose of Rotarix can only be given to babies younger than 15 weeks of age. The last dose of Rotarix can only be given to babies younger than 25 weeks of age.

The vaccine contains live weakened rotavirus.

In countries like New Zealand, a course of either Rotarix vaccine will protect around babies in 10 from severe rotavirus infection and needing to be admitted to hospital because of rotavirus infection.

Responses to vaccine

Rotarix (RV1)

Responses to vaccine

Common responses

  • Mild diarrhoea or vomiting
  • Mild abdominal pain

Rare responses

  • Intussusception (bowel obstruction)

As with any medicine, very rarely, severe allergic reactions occur following immunisation. For this reason we ask people to wait 20 minutes after receiving vaccines.

References

  • Anderson EJ, Weber SG. Rotavirus infection in adults. Lancet Infect Dis. 2004;4(2):91-9.
  • Ansari SA, Sattar SA, Springthorpe VS, Wells GA, Tostowaryk W. Rotavirus survival on human hands and transfer of infectious virus to animate and nonporous inanimate surfaces. J Clin Microbiol. 1988;26(8):1513-8.
  • Burnett E, Jonesteller CL, Tate JE, Yen C, Parashar UD. Global impact of rotavirus vaccination on childhood hospitalizations and mortality from diarrhea J Infect Dis. 2017;215(11):1666-72.
  • Buyse H, Vinals C, Karkada N, Han HH. The human rotavirus vaccine Rotarix™ in infants. Hum Vaccin Immunother. 2014;10(1):19-24.
  • Carlin JB, Macartney KK, Lee KJ, Quinn HE, Buttery J, Lopert R, et al. Intussusception risk and disease prevention associated with rotavirus vaccines in Australia’s National Immunization Program. 2013;57(10):1427-34.
  • Dennehy P. Treatment and prevention of rotavirus infection in children. Curr Infect Dis Rep. 2013;15(3):242-50.
  • Gray J. Rotavirus vaccines: safety, efficacy and public health impact. J Intern Med. 2011;270(3):206–14.
  • Grimwood K, Huang QS, Cohet C, Gosling IA, Hook SM, Teele DW, et al. Rotavirus hospitalisation in New Zealand children under 3 years of age. J Paediatr Child Health. 2006;42(4):196-203.
  • Hsieh Y-C, Wu F-T, Hsiung CA, Wu H-S, Chang K-Y, Huang Y-C. Comparison of virus shedding after lived attenuated and pentavalent reassortant rotavirus vaccine. Vaccine. 2014;32(10):1199-204.
  • Institute of Environmental Science and Research Ltd (ESR). Rotavirus in New Zealand, 2015. Porirua: ESR; 2016. Available from: https://surv.esr.cri.nz/PDF_surveillance/Rotavirus/2015Rotavirus.pdf.
  • Kramer A, Schwebke I, Kampf G. How long do nosocomial pathogens persist on inanimate surfaces? A systematic review. BMC Infect Dis. 2006;6(1):130.
  • Marshall GS. Rotavirus disease and prevention through vaccination. Pediatr Infect Dis J. 2009;28(4):351-64.
  • Milne RJ, Grimwood K. Budget impact and cost-effectiveness of including a pentavalent rotavirus vaccine in the New Zealand Childhood Immunization Schedule. Value Health. 2009;12(6):888-98.
  • Ministry of Health. Immunisation Handbook 2017 2nd Edition [Internet]. Wellington: Ministry of Health; 2018 [cited 2020 July 24]. Available from http://www.health.govt.nz/publication/immunisation-handbook-2017
  • Rosillon D, Buyse H, Friedland LR, Ng S-P, Velazquez FR, Breuer T. Risk of intussusception after rotavirus vaccination: Meta-analysis of postlicensure studies. Pediatr Infect Dis J. 2015;34(7):763-8.
  • Soares-Weiser K, Bergman H, Henschke N, Pitan F, Cunliffe N. Vaccines for preventing rotavirus diarrhoea: Vaccines in use (Review). Cochrane Database Syst Rev. 2019(3. Art. No.: CD008521).
  • Stringer MD, Pablot SM, Brereton RJ. Paediatric intussusception. Br J Surg. 1992;79(9):867-76.
  • World Health Organization. Rotavirus vaccine and intussusception: Report from an expert consultation. Wkly Epidemiol Rec. 2011;86(30):317-8.
In Depth

Vaccine type: live attenuated (oral)

Schedule and administration

  • Rotarix is given to babies as two oral doses at the 6 week and 3 month immunisation visits.
  • Rotarix is given orally, only, and should never be injected.
  • The first dose must be given before 15 weeks of age (up to and including 14 weeks 6 days old). If dose one not given by this age, then no doses can be given. Subsequent doses of Rotarix must not be given once a baby is aged 25 weeks or older (latest is 24 weeks and 6 days).
  • Rotarix can be administered concurrently with other vaccines, including all the National Immunisation Schedule vaccines.
  • It is recommended to give Rotarix before injected vaccines as the sugar solution helps to mitigate any pain caused by these injections.
  • A dose does not have to be re-administered if the infant spits it out, regurgitates or vomits immediately after administration.
  • Infants can have breast milk, formula or food before and after immunisation.

Special considerations

Further medical advice should be sought for any baby suspected or known to have a weakened immune system, for example due to HIV/AIDS or treatment with long term steroids, or any baby who has cancer or who is undergoing treatment for cancer.

Catch-up doses

Catch-up of the first Rotarix dose can only be given to babies younger than 15 weeks of age, i.e. up to and including the age of 14 weeks 6 days. If the first dose is not given BEFORE 15 weeks of age, NO doses can be given.

A second dose of Rotarix can only be given to babies younger than 25 weeks of age, i.e. up to and including the age of 24 weeks 6 days. NO Rotarix doses can be given to babies aged 25 weeks or older.

Special vaccine storage and preparation considerations

No special considerations, store as per cold chain between +2°C to +8°C.

Vaccine safety

One or two babies in 10 may have mild vomiting or diarrhoea during the 7 days after immunisation. However, studies suggest these symptoms may be unrelated to rotavirus vaccine because around the same number of babies who received a placebo liquid not containing rotavirus also developed these symptoms. The weakened rotavirus from the vaccines may be found in stools for up to 28 days after the first immunisation and up to 15 days after the second dose. However, after changing nappies caregivers only need to follow standard hygiene measures, i.e. wash their hands using soap and water and dry them well, or use liquid hand gel.

The risk of intussusception after a rotavirus vaccine is very small and the risks from rotavirus infection are much larger. Generally, the benefits of immunisation against rotavirus are considered to exceed the risk of intussusception.

Although the risk of intussusception after rotavirus immunisation is very small, it is recommended that parents seek medical advice if their baby develops intermittent crying/screaming episodes, pull their knees towards their chest and vomit, or develop pink or red coloured jelly-like stools.

Vaccine should not be given to any baby who:

  • Has severe combined immunodeficiency (SCIDS)
  • Has previously had intussusception and with condition that predisposes the infant to intussusception
  • Had a severe allergic reaction (anaphylaxis) to any component in the vaccine or to a previous doses of the vaccine

Rotarix should be postponed for any baby with moderate to severe fever, vomiting or diarrhoea.

Babies in hospital, including those in neonatal units, can be immunised. The vaccine can be administered to a baby who lives with someone who is immunocompromised or receiving immunosuppressive therapy. After changing nappies caregivers are recommended to follow standard hygiene measures, i.e. wash their hands using soap and water and dry them well, or use liquid hand gel. 

Vaccine effectiveness

In countries like New Zealand, a course of Rotarix vaccines will protect around 8 babies in 10 from severe rotavirus infection and needing to be admitted to hospital because of rotavirus infection

here has been an over 90% reduction in rotavirus hospitalisations in industrialised and resource-deprived countries. As of January 2015, at least 75 countries worldwide had implemented rotavirus vaccination as part of the national immunisation schedule. 

Prior to the introduction of rotavirus vaccine to the New Zealand Immunisation Schedule in 2014, 500–800 hospital admissions in children aged under 5 years annually were related to rotavirus gastroenteritis in the years 2010–2014. In 2015, after the introduction of rotavirus vaccine, the annual rate of rotavirus hospital admissions fell to less than 100.

Last updated: Jul 2020