Immunisation Provider Guidelines - Rotavirus immunisation
State and Territory information:
Rotavirus immunisation was included on the National Immunisation Program (NIP) from 1 July 2007.The NIP will provide free rotavirus vaccine to all children born on or after 1 May 2007.
PDF printable version of Immunisation Provider Guidelines - Rotavirus immunisation (PDF 200 KB)
About rotavirus immunisation
Rotavirus immunisation was included on the National Immunisation Program (NIP) from 1 July 2007.The NIP will provide free rotavirus vaccine to all children born on or after 1 May 2007.Summary of program eligibility
All children born on or after 1 May 2007- vaccination commencing July 2007.Rationale for recommended ages
Administration of a course of rotavirus immunisation is recommended as part of the routine National Immunisation Program in the first 6 months of life.Immunisation of older infants and children is not recommended as there is currently inadequate safety data and theoretical concerns regarding use in older age groups.
The efficacy and safety of both rotavirus vaccines, Rotarix® and RotaTeq®, have been evaluated in large clinical trials in which infants received the vaccines within specified age limits. Consequently, both brands are recommended by the Therapeutic Goods Administration (TGA) for use in Australia, but only in babies between 2 to 6 months of age.
Rotavirus
Children can be infected with rotavirus several times during their lives. The spectrum of illness ranges from mild, watery diarrhoea of limited duration to severe, dehydrating diarrhoea with vomiting and fever which can result in death. The clinical features of rotavirus gastroenteritis are generally non-specific and confirmation of rotavirus infection can only be made by laboratory testing of faecal specimens. Infections occurring in the first 3 months of life are generally asymptomatic. The peak incidence of rotavirus disease causing severe diarrhoea and dehydration is between 6 and 24 months of age.In Australia, it is estimated that there are approximately 10,000 hospitalisations due to rotavirus in children less than 5 years of age each year. In addition to hospitalised children, an estimated 115,000 children under 5 years of age visit a GP, and 22,000 children require an emergency department visit. On average, there is one death due to rotavirus each year in Australia.
Indigenous Australian infants and children are hospitalised with rotavirus gastroenteritis about 3-5 times more commonly than non-indigenous children.
Rotavirus infections follow a seasonal pattern in temperate Australia with peak incidence in mid to late winter. Disease peaks are unpredictable in northern tropical and arid regions of Australia.
Vaccines
Two rotavirus vaccines are licensed for use in Australia:- Rotarix® (GlaxoSmithKline); and
- RotaTeq® (CSL Limited/Merck and Co, Inc).
Both vaccines are live attenuated vaccines and must be given orally:
- Rotarix® is presented in a powdered form. Reconstitution with the provided diluent makes a 1mL oral dose.
- RotaTeq® is presented as a 2mL oral dose.
Vaccine efficacy
Both vaccines have been shown to have similar efficacy against rotavirus gastroenteritis of any severity of around 70%. The efficacy against severe rotavirus gastroenteritis and against hospitalisation for rotavirus gastroenteritis is higher, ranging from 85 to 100% in clinical trials in many different countries. Vaccination was also highly effective in preventing Emergency Department and clinic/GP visits.Transport, storage and handling
All vaccine service providers should be familiar with and adhere to the National Vaccine Storage Guidelines "Strive for Five". This publication can be accessed free of charge from http://www.immunise.health.gov.au/internet/immunise/publishing.nsf/Content/provider-store.After reconstitution, Rotarix® should be administered promptly or kept in a refrigerator (2-8ºC). If not used within 24 hours, the vaccine should be discarded.
Dosage and administration
Both rotavirus vaccines are for administration by the oral route only. Under no circumstances should rotavirus vaccines be injected.
There are differences in the composition and number of doses required for each vaccine. Rotarix® vaccine is a live, attenuated single strain of human rotavirus of the serotype G1P1a[8]. RotaTeq® is a live attenuated human-bovine reassortant vaccine of five vaccine types (G1, G2, G3, G4 and P1a[8]).
Rotavirus vaccine can be administered at the same time as the other vaccines on the childhood immunisation schedule at either 2 and 4 months of age (Rotarix®) or 2, 4 and 6 months of age (RotaTeq®).The interval separating the doses should be no less than 4 weeks (see Table 1).
Table 1: Age limits for administration of oral Rotavirus vaccines
 | Number of Doses | Age of routine administration | Age limits for dosing | Minimum interval between doses | ||
|---|---|---|---|---|---|---|
| | | 1st dose | 2nd dose | 3rd dose | |
Rotarix® (GlaxoSmithKline) | 2 oral doses (1 mL/dose) | 2 and 4 months | 6–14* weeks | 10–24* weeks | None | 4 weeks |
RotaTeq® (CSL Biotherapies /Merck & Co Inc) | 3 oral doses (2 mL/dose) | 2, 4 and 6 months | 6–12† weeks | 10–32† weeks | 14–32† weeks | 4 weeks |
*The upper age limit for receipt of the first dose of Rotarix is 14.9 weeks; that is up to the anniversary of the 15th week of age. The upper age limit for receipt of the second dose of Rotarix is 24.9 weeks; that is up to the anniversary of the 25th week.
†The upper age limit for receipt of the first dose of RotaTeq is 12.9 weeks; that is up to the anniversary of the 13th week of age. The 2nd dose of vaccine should preferably be given by 28 weeks of age to allow for minimum interval of 4 weeks prior to receipt of 3rd dose, and the upper age limit for either the second or third doses is 32.9 weeks; that is by the anniversary of the 33rd week.
Readminstration of the vaccine is not necessary following regurgitation, spitting out, or vomiting of a rotavirus vaccine. This is because there are limited data available on the safety of administering higher than the recommended dose of rotavirus vaccines. There are no studies of the efficacy of a partially administered dose(s).
Interchangeability of rotavirus vaccines
Completion of a course of rotavirus vaccine should be with vaccine from the same manufacturer whenever possible. There are no studies that address the interchangeability of the two available rotavirus vaccines. However, if either dose 1 or 2 of vaccine is given as RotaTeq®, a third dose of rotavirus vaccine should be given, provided that the upper age limit and inter-vaccine interval as defined above in "Dosage and Administration" are met.Vaccine side effects
Vaccine recipients developed gastrointestinal symptoms such as diarrhoea or vomiting in the week after rotavirus vaccination more commonly than placebo recipients (increased risk of up to 3%). Fever was not significantly more common in rotavirus vaccine recipients compared with placebo recipients in clinical trials of both available vaccines.Contraindications and precautions
Contraindications
Rotavirus vaccine should not be given to any infant who has hypersensitivity to any component of the vaccine or an anaphylactic reaction to a previous dose of either vaccine.Precautions
- Acute gastroenteritis
Infants with moderate to severe acute gastroenteritis should not be immunised until after recovery from their acute illness, as there is a theoretical concern that vaccine immunogenicity and efficacy could be compromised during a moderate to severe acute illness.
- Moderate to severe illness
As with other vaccines, infants with a moderate to severe illness should be vaccinated after recovery. In addition to the factors mentioned above, this avoids superimposing potential adverse events related to immunisation on the concurrent illness
- Underlying conditions predisposing to severe rotavirus gastroenteritis
Conditions predisposing to severe or complicated rotavirus gastroenteritis include metabolic disorders or chronic gastrointestinal disease, such as Hirschsprung's disease, malabsorption syndromes or short gut syndrome.
- Infants with impaired immunity
There are no studies of the safety or efficacy of the rotavirus vaccines in infants with impaired immunity. The theoretical risk for vaccine virus-associated disease in immune-impaired vaccinated infants is considered likely to be less than their risk from being exposed to disease from natural infection. Risks and benefits of vaccination should be considered in the context of the infant's specific immune impairment with appropriate specialist advice.
- Infants living in households with persons with impaired immunity
Infants living in households with persons who have impaired immunity should be vaccinated. The theoretical risk for vaccine virus-associated disease in contacts with impaired immunity is considered less than their risk of being exposed to disease from natural infection.
- Recent administration of antibody-containing blood products
Infants who have recently received antibody-containing blood products and are at an eligible age should be immunised. The interval between immunisation and receipt of the blood product should be as long as possible, but without delaying administration of vaccine beyond the suggested age limits for dosing (as per Table 1).
- Exposure of pregnant women to vaccinated infants
Infants living in households of pregnant women can receive rotavirus vaccines. Most women will have pre-existing immunity to rotavirus but avoidance of wild-type infection through the vaccination of infant contacts may benefit adults, including pregnant women, and outweighs any theoretical concern regarding exposure to vaccine viruses.
For more information, please refer to the 9th Edition Australian Immunisation Handbook, available at http://immunise.health.gov.au/internet/immunise/publishing.nsf/Content/home
Notification to the Australian Childhood Immunisation Register (ACIR)
All vaccines administered to children less than seven years of age should be notified to the ACIR, in order to maintain a complete immunisation history for the child on the register.Initially, rotavirus immunisation will not be linked to eligibility for Maternity Immunisation Allowance and Child Care Benefit. Linkage may be reviewed after the program is established.
General Practice Immunisation Initiatives (GPII) scheme
For further information about the ACIR or the GPII Scheme visit the Medicare Australia website (www.medicareaustralia.gov.au). Alternatively, phone the ACIR enquiries line on 1800 653 809 (free call) or the GPII enquiries line on 1800 246 101 (free call).Further information
You should contact your State or Territory Health Department for further information on the program specific to your State or Territory:State/Territory Contact Number
Australian Capital Territory: 02 6205 2300New South Wales: Public Health Unit (under 'Health' in the White Pages)
Northern Territory: 08 8922 8044
Queensland: 07 3234 1500
South Australia: 08 8226 7177
Tasmania: 1800 671 738 (Tasmania only)
Victoria: 1300 882 008
Western Australia: 08 9321 1312
Further information is also available from the Immunise Australia Program website at www.immunise.health.gov.au
Note: This information is correct as at 5 July 2007.
Page last modified: July, 2007
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