Rubella
Information about rubella disease, vaccines and recommendations for vaccination from the Australian Immunisation Handbook.
Recently added
This page was added on 07 June 2018.
Updates made
This page was updated on 28 June 2023. View history of updates
Vaccination for certain groups of people is funded under the National Immunisation Program.
Overview
What
Rubella is a viral illness that spreads from person to person by respiratory secretions. Rubella is usually mild and self-limiting, but exposure during pregnancy can result in fetal infection and congenital rubella syndrome.
Who
Rubella-containing vaccine is recommended for:
- children ≥12 months of age
- adolescents and adults born during or since 1966 who have not received 2 doses of rubella-containing vaccine, particularly
- healthcare workers
- childhood educators and carers
- women of child-bearing age who are seronegative for rubella
How
Rubella-containing vaccine is recommended for children at 12 months of age as MMR (measles-mumps-rubella) vaccine and at 18 months of age as MMRV (measles-mumps-rubella-varicella) vaccine.
All adolescents and adults born during or since 1966 should have either:
- documented evidence of 2 doses of rubella-containing vaccine given at least 4 weeks apart and with both doses given ≥12 months of age, or
- serological evidence of immunity to measles, mumps and rubella
Why
Congenital rubella syndrome includes a range of birth defects (for example, deafness, intellectual disability, cataracts and cardiac abnormalities). World Health Organization regions have set goals for control and elimination of rubella and congenital rubella syndrome.
Recommendations
Children
-
All children aged ≥12 months are recommended to receive 2 doses of rubella-containing vaccine.
The vaccines usually received at each schedule point are:
- 12 months of age — MMR
- 18 months of age — MMRV
Rubella-containing vaccine is funded through the NIP for children aged ≥12 months. For details see the National Immunisation Program Schedule.
Age at 1st dose
Age at 1st dose
MMR vaccine is not routinely recommended for infants <12 months of age. See Measles.
Children as young as 2 months of age can receive MMR vaccine in certain circumstances, including travel to measles-endemic areas (see Measles). If an infant receives MMR vaccine at <12 months of age, they still need to receive 2 vaccine doses at ≥12 months of age.
MMRV as 1st dose is not recommended
MMRV as 1st dose is not recommended
MMRV vaccine is not recommended as the 1st dose of rubella-containing vaccine in children <4 years of age. This is due to a small but increased risk of fever and febrile seizures when MMRV vaccine is given as the 1st dose of rubella-containing vaccine in this age group. See Adverse events.
If MMRV vaccine is inadvertently given as dose 1 of rubella-containing vaccine, the dose does not need to be repeated (providing it was given at ≥12 months of age). The scheduled 18-month dose of MMRV should still be given at the usual time. See Table. Minimum acceptable age for the 1st dose of scheduled vaccines in infants in Catch-up vaccination. Advise parents and carers about the small but increased risk of fever and febrile seizures (compared with that expected after MMR vaccine).
For more details about MMRV vaccine to prevent varicella disease, see Varicella.
Catch-up vaccination for rubella
Catch-up vaccination for rubella
Children who have not received rubella-containing vaccine at the recommended schedule points may need an alternative schedule.
See Catch-up vaccination for more details, including minimum intervals between doses.
Adolescents and adults
-
All adolescents and adults born during or since 1966 should have either:
- documented evidence of 2 doses of rubella-containing vaccine given at least 4 weeks apart and with both doses given at ≥12 months of age, or
- serological evidence of immunity to measles, mumps and rubella
See Serological testing for immunity to rubella.
Rubella-containing vaccine is funded through the NIP adolescents and adults aged ≤20 years who have been incompletely vaccinated or do not have evidence of immunity to mumps. For details see the National Immunisation Program Schedule.
This is particularly important to ensure that women of child-bearing age are immune to rubella. See Women of child-bearing age who are seronegative for rubella are recommended to receive rubella-containing vaccine.
All males born during or after 1966 (particularly those born from 1966 up to the 1990s) are recommended to have their vaccination records reviewed to ensure that they have received 2 doses of MMR vaccine. These males are more likely than females to have not received 2 doses of rubella-containing vaccine. See Epidemiology.
Adolescents and adults who have been incompletely vaccinated or do not have evidence of immunity to rubella are recommended to receive rubella-containing vaccine. See Catch-up vaccination for more details, including minimum intervals between doses.
People aged ≥14 years are not recommended to receive MMRV vaccine
People aged ≥14 years are not recommended to receive MMRV vaccine
MMRV vaccine is not recommended for use in people ≥14 years of age. No data are available on safety, immunogenicity or efficacy in this age group.
If a person ≥14 years of age is inadvertently given a dose of MMRV vaccine, this dose does not need to be repeated.
Occupational groups
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Healthcare workers are recommended to have received 2 doses of rubella-containing vaccine. This is for their own protection and to avoid the risk of transmitting rubella to pregnant women.1
Healthcare workers do not need to receive rubella-containing vaccine if they have either:
- documented evidence of 2 doses of rubella-containing vaccine given at least 4 weeks apart and with both doses given at ≥12 months of age, or
- serological evidence of immunity to measles, mumps and rubella
See Serological testing for immunity to rubella, and Recommended vaccines for people at increased risk of certain occupationally acquired vaccine-preventable diseases in Vaccination for people at occupational risk.
View recommendation details -
Childhood educators and carers are recommended to have received 2 doses of rubella-containing vaccine given at least 4 weeks apart. This is for their own protection and to avoid the risk of transmitting rubella to pregnant women.1
People who work in childhood education and care do not need to receive rubella-containing vaccine if they have either:
- documented evidence of 2 doses of rubella-containing vaccine with doses given at least 4 weeks apart and with both doses given ≥12 months of age, or
- serological evidence of immunity to measles, mumps and rubella
See Serological testing for immunity to rubella, and Recommended vaccines for people at increased risk of certain occupationally acquired vaccine-preventable diseases in Vaccination for people at occupational risk.
View recommendation details
Women of child-bearing age
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Immunisation providers should make every effort to identify and immunise non-pregnant seronegative women of child-bearing age. This includes women who have had children. See Serological testing for immunity to rubella.
The following women are more likely to be seronegative for rubella:
- women born overseas (especially in Asia, Pacific islands, sub-Saharan Africa and South America) who entered Australia after the age of routine vaccination
- Aboriginal and Torres Strait Islander women living in rural and remote regions
- non–English speaking women
- women ≥35 years of age
- Australian-born Muslim women2-7
Seronegative women are recommended to receive MMR vaccine. Vaccinated women should avoid pregnancy for 28 days after vaccination.
Although 2 doses of MMR vaccine are routinely recommended, women who show rubella immunity after 1 dose of rubella-containing vaccine do not need another dose. Exceptions are:
- women who remain seronegative after 1 dose (see Serological testing for immunity to rubella)
- women who need protection against measles and mumps (see Measles and Mumps)
Serological testing after vaccination
Serological testing after vaccination
Vaccinated women of child-bearing age are recommended to be tested for seroconversion 6 to 8 weeks after vaccination (see Serological testing for immunity to rubella).
Women who have negative or very low antibody levels after vaccination are recommended to have a 2nd dose. However, antibody levels that remain low after a 2nd documented vaccination are unlikely to improve with further vaccinations.8
Serological testing for immunity to rubella
-
Serological testing for immunity to rubella (and measles, mumps and varicella) is not recommended before or after routine administration of the 2-dose childhood schedule of these vaccines.
However, serological testing for rubella immunity can be done:
- if it is uncertain whether the person has a history of natural immunity
- if it is uncertain whether the person has received 2 doses of rubella-containing vaccine
- if a woman is planning pregnancy or pregnant (see also Vaccination for women who are planning pregnancy, pregnant or breastfeeding)
Rubella serological assays
Rubella serological assays
Commercial assays for testing immunity to rubella vary according to the method used to determine the positive cut-off value. Antibody levels found by a licensed assay to be above the standard positive cut-off for that assay can be considered evidence of past exposure to rubella virus.9
Interpreting serological results
Interpreting serological results
Rubella vaccine induces immune responses that are similar in quality, but lesser in quantity, than responses after natural disease.8 Measuring antibody levels by commercial assays is not a perfect correlate of protection in vaccinated people.8 Although people with low levels of vaccine-induced antibodies are often protected, some people with measurable antibodies can be reinfected.
If a person is rubella IgG seronegative, they should receive rubella-containing vaccine according to the relevant recommendations.
Further testing and vaccination is not usually needed for people who remain seronegative after 2 doses. When interpreting serological testing results, it may be useful to discuss the results with the laboratory that performed the test, to ensure that decisions are based on all relevant clinical information.
Negative serology after 2 documented doses of rubella-containing vaccine may be a false negative (that is, an antibody titre too low to be detected using routine commercial assays). If there is difficulty interpreting results, consult experts or refer the sera to a reference laboratory, particularly for women of child-bearing age. See Women of child-bearing age who are seronegative for rubella are recommended to receive rubella-containing vaccine.
Advise all women of child-bearing age of the result of their antibody test, because it is a clinically significant test.
Screening pregnant women for rubella antibodies
Screening pregnant women for rubella antibodies
All women who are planning pregnancy or have recently become pregnant should be screened for rubella antibodies, irrespective of a previous positive rubella antibody result.8,10 Women found to be seronegative for rubella immunity during antenatal testing should receive rubella-containing vaccine after delivery and before discharge from the maternity unit. These women should be tested for rubella immunity 6–8 weeks after vaccination.9
Very occasionally, patients who are seronegative may be reported as seropositive due to error. Specimens from pregnant women need to be stored for 12 months to allow for parallel serological testing if required.11
Vaccines, dosage and administration
Rubella vaccines available in Australia
The Therapeutic Goods Administration website provides product information for each vaccine.
See also Vaccine information and Variations from product information for more details.
Combination vaccines
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Sponsor:Merck Sharp & Dohme (Australia)Administration route:Intramuscular injection, Subcutaneous injection
Registered for use in people aged ≥12 months.
MMR — measles-mumps-rubella combination vaccine
Lyophilised pellet in a monodose vial with separate diluent.
Each 0.5 mL reconstituted dose contains:
- ≥1000 tissue culture infectious dose 50% (TCID50) of live attenuated measles virus (Enders’ attenuated Edmonston strain)
- ≥12,500 TCID50 of live attenuated mumps virus (Jeryl Lynn B level strain)
- ≥1000 TCID50 of live attenuated rubella virus (Wistar RA 27/3 strain)
- 14.5 mg sorbitol
- 1.9 mg sucrose
- 14.5 mg hydrolysed porcine gelatin
- ≤0.3 mg recombinant human albumin
- <1 ppm fetal bovine serum
- 25 µg neomycin
For Product Information and Consumer Medicine Information about vaccineName visit the Therapeutic Goods Administration website.
View vaccine details -
Sponsor:GlaxoSmithKline AustraliaAdministration route:Intramuscular injection, Subcutaneous injection
Registered for use in people aged ≥12 months.
MMR — measles-mumps-rubella combination vaccine
Lyophilised pellet in a monodose vial with a pre-filled diluent syringe.
Each 0.5 mL reconstituted dose contains:
- ≥103.0 cell culture infectious dose 50% (CCID50) of live attenuated measles virus (Schwarz strain)
- ≥103.7 CCID50 of live attenuated mumps virus (RIT 4385 strain, derived from the Jeryl Lynn strain)
- ≥103.0 CCID50 of live attenuated rubella virus (Wistar RA 27/3 strain)
- lactose
- neomycin sulphate
- sorbitol
- mannitol
- phenylalanine
For Product Information and Consumer Medicine Information about Priorix visit the Therapeutic Goods Administration website.
View vaccine details -
Sponsor:GlaxoSmithKline AustraliaAdministration route:Intramuscular injection, Subcutaneous injection
Registered for use in people aged ≥9 months.
MMRV — measles-mumps-rubella-varicella combination vaccine
Lyophilised pellet in a monodose vial with a pre-filled diluent syringe.
Each 0.5 mL reconstituted dose contains:
- ≥103.0 cell culture infectious dose 50% (CCID50) of live attenuated measles virus (Schwarz strain)
- ≥104.4 CCID50 of live attenuated mumps virus (RIT 4385 strain, derived from the Jeryl Lynn strain)
- ≥103.0 CCID50 of live attenuated rubella virus (Wistar RA 27/3 strain)
- ≥103.3 plaque-forming units of live attenuated varicella-zoster virus (Oka strain)
- lactose
- neomycin
- sorbitol
- mannitol
For Product Information and Consumer Medicine Information about Priorix-tetra visit the Therapeutic Goods Administration website.
View vaccine details -
Sponsor:Merck Sharp & Dohme (Australia)Administration route:Intramuscular injection, Subcutaneous injection
Registered for use in children aged 12 months to 12 years.
MMRV — measles-mumps-rubella-varicella combination vaccine
Lyophilised powder in a monodose vial with a pre-filled diluent syringe.
Each 0.5 mL reconstituted dose contains:
- ≥103.00 culture infectious dose 50% (TCID50) of live attenuated measles virus (Enders’ attenuated Edmonston strain)
- ≥104.30 TCID50 of live attenuated mumps virus (Jeryl Lynn B level strain)
- ≥103.00 TCID50 of live attenuated rubella virus (Wistar RA 27/3 strain)
- ≥103.99 plaque-forming units of live attenuated varicella-zoster virus (Oka/Merck strain)
- 20 mg sucrose
- 11 mg hydrolysed porcine gelatin
- 2.5 mg urea
- 16 mg sorbitol
- 0.38 mg monosodium L-glutamate
- 0.25 mg recombinant human albumin
- 5 µg neomycin
- residual components of MRC-5 cells
- 0.5 µg bovine serum albumin
For Product Information and Consumer Medicine Information about ProQuad visit the Therapeutic Goods Administration website.
View vaccine details
Dose and route
The dose of Priorix and M-M-R-II (MMR) vaccine for both children and adults is 0.5 mL given by either subcutaneous or intramuscular injection.
The dose of ProQuad and Priorix-tetra (MMRV) vaccine for children <14 years of age is 0.5 mL given by subcutaneous or intramuscular injection.12
Co-administration with other vaccines
People can receive MMR or MMRV vaccine at the same time as other live attenuated parenteral vaccines or other inactivated vaccines,13 using separate syringes and injection sites. If a person does not receive MMR or MMRV vaccine at the same time as other live attenuated parenteral vaccines, wait at least 4 weeks between vaccinations.14,15
Measles, mumps and rubella vaccines are not available separately as an alternative to MMR vaccine. However, a monovalent varicella vaccine is available (see Varicella).
If a person receives MMR vaccine at the same time as monovalent varicella vaccine, use separate syringes and injection sites. Do not mix MMR vaccine and monovalent varicella vaccine together before injection.
Interchangeability of MMR-containing vaccines
The 2 brands of MMR vaccine are interchangeable, so the 2nd MMR vaccine dose does not have to be the same brand as the 1st.
The same principle applies to the 2 MMRV vaccines,13 although they are not routinely recommended in a 2-dose schedule.
Contraindications and precautions
Contraindications
Anaphylaxis to vaccine components
MMR and MMRV vaccines are contraindicated in people who have had:
- anaphylaxis after a previous dose of any MMR-containing vaccine
- anaphylaxis after any component of an MMR-containing vaccine
See Anaphylaxis in Adverse events for more details about MMR vaccination for people with a known egg allergy.
Pregnant women
MMR-containing vaccines are contraindicated in pregnant women.
Vaccinated women should avoid pregnancy for 28 days after vaccination.9 This is due to the theoretical risk of transmitting the rubella component of the vaccine to a susceptible fetus. However, there are no reports of vaccine-induced congenital rubella syndrome.16
Active surveillance in the United States, the United Kingdom and Germany indicates that no cases of vaccine-induced congenital rubella syndrome occurred among more than 500 women who were inadvertently given rubella vaccine during pregnancy, and whose pregnancies continued.17
In an Iranian study performed after mass vaccination with a measles-rubella vaccine, 117 susceptible women were inadvertently vaccinated while pregnant or became pregnant within 3 months after vaccination. There were no abnormalities related to congenital rubella syndrome among the infants born to these women.18
Based on this evidence, the vaccine is not considered to be teratogenic. Women do not need to consider ending a pregnancy after inadvertent vaccination.16,19
See also Vaccination for women who are planning pregnancy, pregnant or breastfeeding.
Breastfeeding women can receive MMR vaccines. The rubella vaccine virus may be secreted in human breast milk, and rare cases of transmission of vaccine virus through breast milk have been reported. However, symptoms in the newborn have been absent or mild.20-22 Post-partum vaccination of women who are not immune to rubella does not need to be delayed because of breastfeeding.
There is no risk to pregnant women from contact with people who have recently been vaccinated. The vaccine viruses is not transmitted from vaccinated people to susceptible contacts.16
See also Vaccination for women who are planning pregnancy, pregnant or breastfeeding and Table. Vaccines that are contraindicated in pregnancy: live attenuated vaccines for more details.
People who are immunocompromised
MMR-containing vaccines contain live attenuated viruses and are contraindicated in people who are immunocompromised. This means that MMR-containing vaccines are contraindicated in:
- people who are significantly immunocompromised because of a medical condition(s)
- people receiving high-dose systemic immunosuppressive therapy, such as chemotherapy, radiation therapy or oral corticosteroids
See Vaccination for people who are immunocompromised and Varicella for more information.
For more details on using live attenuated vaccines in people receiving corticosteroid therapy, see Table. Recommended timing of live vaccine doses in adults and children taking corticosteroids in Vaccination for people who are immunocompromised.
Precautions
Vaccination after receiving immunoglobulin or a blood product
A recent blood transfusion with washed red blood cells is not a contraindication to MMR or MMRV vaccines.
People who have received an immunoglobulin-containing blood product should wait 3–11 months before receiving a rubella-containing vaccine. This is because the immunoglobulin may impair the expected immune response to the vaccine.15,23
The interval between receiving the blood product and the vaccine depends on the amount of immunoglobulin in each product.15 See Table. Recommended intervals between immunoglobulins or blood products, and measles-mumps-rubella, measles-mumps-rubella-varicella or varicella vaccination and Vaccination for people who have recently received normal human immunoglobulin and other blood products.
People may receive MMR vaccine at the same time as anti-D immunoglobulin, but at different injection sites. They can also receive MMR vaccine at any time after anti-D immunoglobulin. Anti-D immunoglobulin does not interfere with the antibody response to the vaccine.
Immunoglobulin or blood product administration after vaccination
People who have received a rubella-containing vaccine should not receive immunoglobulin-containing products for 3 weeks after vaccination, unless the benefits of receiving the blood product outweigh the benefits of vaccination. If the person receives an immunoglobulin-containing product within 3 weeks after a rubella-containing vaccine, the vaccinated person should be either:
- revaccinated later at the appropriate time, as indicated in Table. Recommended intervals between immunoglobulins or blood products, and measles-mumps-rubella, measles-mumps-rubella-varicella or varicella vaccination, or
- tested for immunity 6 months later and then revaccinated if seronegative
People may receive anti-D immunoglobulin at any time after receiving MMR vaccine.
People with HIV
The following people with HIV may receive MMR vaccine:9,24-28
- asymptomatic children >12 months of age with an age-specific CD4+ count of ≥15%
- adults with a CD4+ cell count ≥200 cells per μL
See People with HIV in Vaccination for people who are immunocompromised.
There have been no studies on combination MMRV vaccines in asymptomatic people with HIV or people with an age-specific CD4+ count of ≥15%. Therefore, it is recommended that these groups receive only MMR vaccine (and monovalent varicella vaccine — see Varicella).26,28,29
No data are available on the safety, immunogenicity or efficacy of MMRV vaccines in children with HIV. These children should receive MMR vaccine and monovalent varicella vaccine, not MMRV vaccine.9,23
People receiving corticosteroid therapy
People on low-dose systemic corticosteroids can receive MMR-containing vaccines. Low-dose systemic corticosteroid therapy includes:
- children on doses of ≤2 mg per kg per day for less than 1 week
- people on doses of 1 mg per kg per day or alternate-day regimens for longer periods
People receiving high-dose corticosteroids can receive MMR-containing vaccines after they have stopped corticosteroid therapy for at least 1 month (see Contraindications).30
Some experts suggest temporarily stopping lower doses of steroids 2–3 weeks before vaccination with live viral vaccines, if possible.23,30
See also Vaccination for people who are immunocompromised.
Household contacts of people who are immunocompromised
Household contacts of people who are immunocompromised should ensure that they are age-appropriately vaccinated against, or are immune to, measles, mumps, rubella and varicella.
Household contacts of people who are immunocompromised can safely receive rubella-containing vaccines, because the vaccine viruses are not transmissible from vaccinated people to others.9
If using MMRV vaccine, see Varicella for details about varicella vaccine virus transmission.
People receiving long-term aspirin or salicylate therapy
There is no need to avoid salicylates before or after receiving MMR or MMRV vaccine.
People taking long-term salicylate therapy (aspirin) can receive MMRV vaccine if needed. The benefit is likely to outweigh any possible risk of Reye syndrome after vaccination with a varicella-containing vaccine (see Varicella).
People with a history of thrombocytopenia
Thrombocytopenia is a rare adverse event associated with MMR vaccination (see Adverse events).31-33
In children who have had an episode(s) of idiopathic thrombocytopenia purpura (ITP), the risk of vaccine-associated thrombocytopenia after a dose of MMR vaccine is uncertain.9,33 However, a systematic review concluded that MMR vaccination, either a 1st or 2nd dose, did not lead to a recurrence of ITP.34 In children due for their 2nd dose, serological testing can be used to determine whether the child needs the extra dose of MMR or MMRV vaccine.
People with possible IFNAR1 deficiency
IFNAR1 deficiency is a rare inherited condition affecting some people of Western Polynesian heritage including Tongan, Samoan and Niuean. It is associated with severe illness and death from certain viral infections and also potentially from some live attenuated viral vaccines including the measles, mumps and rubella (MMR) vaccine.35 Currently, diagnosis of IFNAR1 deficiency prior to vaccination is challenging and there is no established treatment.
Healthcare providers need to be aware that children of Western Polynesian heritage who present for medical attention and are very unwell in the 1-2 weeks following MMR vaccine may need further investigation by an immunologist to assess for an immune deficiency. Any suspected adverse event following immunisation should be reported. Family members of individuals who have had a severe reaction to a live attenuated viral vaccine, or are related to someone with known IFNAR1 deficiency, should be referred to an immunologist before having the MMR vaccine. Children who have safely received a first dose of MMR vaccine are highly unlikely to have IFNAR1 deficiency.35
Advice on vaccination of children or adults who have been diagnosed with IFNAR1 or any other specific immune deficiency should be sought from their immunologist, noting that disease from wild-type measles and mumps is probably more severe than from the vaccine-strain viruses.35
Personal or close family history of seizures or convulsions
Children with a personal or close family history of seizures or convulsions can receive MMR or MMRV vaccine.
Ensure that the parents or carers understand that the child may develop a fever 6–14 days after vaccination.9 Advise parents or carers about how to manage the fever with paracetamol and other measures (see Adverse events following immunisation in After vaccination).
MMRV vaccines are only recommended for use as the 2nd dose of rubella-containing vaccine. This is because the risk of fever and febrile convulsions is higher if children receive MMRV vaccine as their 1st dose. See Recommendations and Adverse events.
Tuberculin skin testing after MMR vaccination
The measles virus inhibits the response to tuberculin. Tuberculin-positive people may become tuberculin-negative for 4–6 weeks after measles infection, and measles-containing vaccines have a similar effect.9,36 Because of this, a tuberculin skin test (TST; Mantoux) may be unreliable for at least 4–6 weeks in people who have received MMR vaccine.
There are no studies on if and how MMR or MMRV vaccination affects the results of interferon-gamma release assays used for testing for M. tuberculosis infection.37
Adverse events
Adverse events after receiving a rubella-containing vaccine are generally mild and well tolerated.8 Adverse events are much less common after the 2nd dose of MMR or MMRV vaccine than after the 1st dose.
A history of rubella is not a contraindication to vaccination. People who are already immune to rubella have no increased risk of side effects from vaccination.8,9
Fever and febrile convulsions
MMR vaccines
People who receive MMR vaccine may develop a fever between 7–10 days (range 5–12 days) after vaccination. This can last 2–3 days. The fever may be associated with malaise and/or a non-infectious rash. Up to 15% of young children receiving MMR vaccine develop a high fever (>39.4°C).9,38
An increased risk of febrile seizures of about 1 case per 3000–4000 doses occurs during the same time period.9
This time frame coincides with the period of peak measles vaccine virus replication.
Inform vaccine recipients, or their parents or carers, about:
- possible symptoms occurring 5–12 days after vaccination
- how to manage the symptoms, including using paracetamol for fever
See Adverse events following immunisation in After vaccination.
MMRV vaccines
In clinical trials, people who received MMRV vaccine had higher rates of fever than people who received MMR vaccine and monovalent varicella vaccine at the same time but at separate sites.39-42 Rates of fever were highest in young children who received MMRV vaccine as their 1st dose.
Post-marketing studies in the United States identified an approximately 2-fold increased risk of fever and febrile convulsions 7–10 days43 (or 5–12 days)44 after vaccination in children who received MMRV vaccine as a 1st dose. MMRV recipients were compared with recipients of separate MMR and varicella vaccines. MMRV vaccination resulted in 1 additional febrile seizure for every 2300 doses compared with separate MMR and varicella vaccination.43 Children in these studies were mostly 12–23 months of age.
In the United States, post-marketing studies did not find an increase in fever or febrile convulsions after children received the 2nd dose of ProQuad (MMRV) vaccine. However, most 2nd-dose recipients were aged 4–6 years, an age at which the incidence of febrile convulsions is low.45 This side effect profile is expected to be similar in children who receive Priorix-tetra.
Rare adverse events
Anaphylaxis
Anaphylaxis after receiving an MMR vaccine is very rare (1.8–14.4 per million doses).9
Although no cases of anaphylaxis were reported in MMRV vaccine clinical trials, the incidence is likely to be similar to that of MMR vaccine.
Anaphylaxis after vaccination is probably due to anaphylactic sensitivity to gelatin or neomycin, not an egg allergy. Measles and mumps (not rubella or varicella) vaccine viruses are grown in chick embryo tissue cultures, but measles- and mumps-containing vaccines have negligible amounts of egg ovalbumin. See Variations from product information and Vaccination for people who have had an adverse event following immunisation.
People with an egg allergy can safely receive an MMR or MMRV vaccine.31,46,47 Skin testing is not needed before vaccination.31
Thrombocytopenia
Thrombocytopenia has been very rarely associated with the rubella or measles component of MMR vaccine. It is usually self-limiting and occurs in 3–5 per 100,000 doses of MMR vaccine.31-33 This is considerably less frequent than after natural measles, mumps and rubella infections.33
Any association with MMRV vaccine is expected to be similar.
Encephalopathy
It is uncertain whether people can develop encephalopathy after MMR vaccination. If they do, it is at least 1000 times less frequent than encephalopathy as a complication from natural infection.38
Lymphadenopathy, arthralgia and parotitis
Other rare adverse events attributed to MMR vaccine include:9
- transient lymphadenopathy
- arthralgia
- parotitis (see Mumps)
Some studies have reported arthralgia as an adverse event among people receiving rubella vaccine. However, other studies report similar rates between those receiving vaccine and placebo.8 A 2011 Institute of Medicine report concluded that there is inadequate evidence to accept or reject a causal relationship between MMR vaccine and chronic arthralgia or arthritis.48
Conditions not linked to MMR vaccination
MMR vaccine is not associated with:
- autism
- autistic spectrum disorder
- inflammatory bowel disease
No credible scientific evidence supports a link between MMR and these conditions. Most proponents of the link have retracted this claim.48,49 There is a substantial body of evidence to refute these claims.50-53
Nature of the disease
Rubella is caused by an enveloped togavirus from the genus Rubivirus. The rubella virus has an RNA genome.
The rubella virus is relatively unstable. It is inactivated by:16
- lipid solvents
- trypsin
- formalin
- extremes of heat and pH
- light
Pathogenesis
The incubation period for rubella is 14–21 days.
Transmission
Rubella spreads from person to person by respiratory secretions, possibly including aerosol transmission.16,55 People are infectious from 1 week before the rash appears (see Symptoms of rubella) until 4 days after.55
Rubella virus can reinfect people who already have natural or vaccine-induced antibodies to rubella.8
Clinical features
Symptoms of rubella
Rubella is generally a mild and self-limiting disease.16,55 It can cause:
- a transient, generalised, erythematous, maculopapular rash
- lymphadenopathy involving the post-auricular and suboccipital glands
Clinical diagnosis is unreliable because the symptoms are often fleeting and other viruses can cause similar symptoms. In particular, the rash is not unique to rubella, and it may be absent.16,55
Up to 50% of rubella virus infections are subclinical or asymptomatic.16 This means that a history of rubella can only be confirmed by serological evidence of previous infection.16
Complications of rubella
Rubella occasionally causes arthritis and arthralgia. People may experience other complications, such as neurologic disorders and thrombocytopenia, but these are rare.8
Congenital rubella syndrome
Rubella infection in pregnancy can result in fetal infection, causing congenital rubella syndrome (CRS) in many cases.
Up to 90% of infants born to women who had rubella infection in the 1st trimester of pregnancy have abnormalities (often multiple) that are characteristic of CRS.8,56,57
The risk of damage declines to 10–20% by 16 weeks gestation. After this stage of pregnancy, fetal damage is rare, but has been reported when mothers were infected up to 20 weeks gestation.8
The characteristics of CRS include:8
- intellectual disabilities
- cataracts
- deafness
- cardiac abnormalities
- intrauterine growth retardation
- inflammatory lesions of the brain, liver, lungs and bone marrow
CRS can include any combination of these defects. Deafness and pigmentary retinopathy commonly occur alone if infection occurs after the first 8 weeks of pregnancy. Some infected infants may appear normal at birth, but defects, especially sensorineural deafness, may be detected later.58
Occasionally, some infants have been born with CRS after their mother was reinfected during pregnancy. However, fetal damage is very rare in pregnant women who have detectable antibodies.9,19,56,59
Epidemiology
Rubella in Australia
Endemic rubella is well controlled in Australia.60 The incidence of rubella has fallen rapidly since rubella vaccine was registered in 1970. Notifications of rubella have been low since the National Measles Control Campaign in late 1998 resulted in high vaccine coverage, which has been maintained.61
Since 2003, rubella notifications in Australia have been less than 0.3 per 100,000 population. In 2014, the notification rate was 0.1 per 100,000 population (17 notifications).62
From 2008 to 2012, the age distribution of cases shifted, with comparatively more cases seen in adult age groups, particularly the 20–29 years age group.63 Males >30 years of age are more likely to be notified with rubella than older females,63 and demonstrate lower seroprotection than females in population-based serosurveys.64 This is because males were not included in the school-based rubella vaccination program between 1971 and 1993.65 For this reason, all adult males, as well as females, who do not have a documented history of receiving 2 doses of MMR vaccine should receive rubella-containing vaccine (see Recommendations). Vaccination will both protect the individual and prevent transmission in the community.
Mass vaccination campaigns starting in the 1970s have successfully reduced the incidence of congenital rubella syndrome (CRS) since 1977.2,3,10 Between 2004 and 2014, 5 confirmed cases of CRS were reported in Australia, all in children whose mothers were born overseas.62,66
A study in 2000 showed that about 2.5% of women of child-bearing age in Australia were seronegative for rubella.4 However, susceptibility was higher among certain groups of women, particularly overseas-born women (see Women of child-bearing age in Recommendations).4
Global elimination of rubella and congenital rubella syndrome
Several World Health Organization (WHO) regions have set goals to eliminate rubella and CRS. The Pan American Health Organization has declared elimination in its region.67
The WHO Western Pacific Region (WPRO) has set goals for increased rubella and CRS control efforts. As of 2016, all WPRO Member States have introduced rubella vaccination into their national immunisation programs.68 As with measles, achieving rubella and CRS elimination will need strong immunisation and surveillance efforts. This includes identifying rubella virus genotypes to confirm the absence of an endemic strain.69
Vaccine information
Monovalent rubella vaccine is not available in Australia. People receive rubella vaccine as either MMR or MMRV vaccine.
Immunogenicity
A single dose of rubella-containing vaccine produces an antibody response in more than 95% of vaccine recipients.19 But antibody levels are lower than in people who have had natural infection.8,9
A 2nd vaccine dose aims to confer immunity in those who fail to seroconvert to the 1st dose.
Clinical trials of MMR vaccine compared with MMRV vaccine were mainly done in children 12 months to 6 years of age. MMRV vaccines produce similar rates of seroconversion to all 4 vaccine components as MMR and monovalent varicella vaccines given at the same time at separate injection sites.39-42
Vaccine effectiveness
Outbreaks of rubella in populations that are vaccinated against rubella are rare. A 1981 study from an outbreak at a United States university showed vaccine effectiveness against clinical rubella of 97%.70 Another study among Italian military recruits showed vaccine effectiveness of 94.5% after rubella vaccination.71
Duration of immunity
Vaccine-induced antibodies persist for at least 16 years in the absence of endemic disease.9,72,73 Protection against clinical rubella appears to be long term in those who seroconvert.8,19
Transporting, storing and handling vaccines
Transport according to National vaccine storage guidelines: Strive for 5.74 Store at +2°C to +8°C. Do not freeze. Protect from light.
Both MMR and MMRV vaccines must be reconstituted. Add the entire contents of the diluent container to the vial containing the pellet. Shake until the pellet completely dissolves.
Use reconstituted Priorix (MMR), M-M-R II (MMR) and Priorix-tetra (MMRV) vaccines as soon as practicable. If reconstituted vaccine must be stored, hold at +2°C to +8°C for no more than 8 hours.
Use reconstituted ProQuad (MMRV) vaccine immediately. If it must be stored, hold at:
- +2°C to +8°C for no more than 2.5 hours, or
- +20°C to +25°C for no more than 1 hour.
Public health management
Notifying rubella
Rubella is a notifiable disease in all states and territories in Australia.
State and territory public health authorities can provide advice about the public health management of rubella, including management of cases and their contacts.
Managing rubella cases
Rubella-containing vaccine does not protect people if they receive it after they have been exposed to rubella.9 However, if the exposure did not result in infection, the vaccine will protect the person against future infection.
People with confirmed rubella should not go to school or work, and should avoid contact with women of child-bearing age for at least 4 days after onset of the rash.75
Managing suspected rubella contacts
Identify all contacts of people with suspected rubella infection, especially those who are pregnant (see NHIG as prophylaxis below).
Exposed healthcare workers without proof of immunity should not go to work for 21 days from exposure or for at least 4 days after onset of the case’s rash.75
Contacts >12 months of age without proof of immunity should receive 1 dose of MMR vaccine (or MMRV vaccine, if appropriate). However, this will not prevent rubella disease if the person has already been exposed.
If the contact refuses vaccination, they should avoid further contact with the case until at least 4 days after onset of the case’s rash.
Seronegative women of child-bearing age should receive rubella vaccine and be tested for seroconversion 6 to 8 weeks after vaccination (see Recommendations).
NHIG as prophylaxis
Using normal human immunoglobulin (NHIG) as post-exposure prophylaxis in non-immune pregnant contacts may reduce the risk of rubella infection to the non-immune adult. In such cases, give NHIG (0.5mL up to 160kg; and 1mL >160kg) given intramuscularly within 5 days of rubella exposure.76 Serological follow-up of NHIG recipients is essential, and should continue for up to 2 months.
Variations from product information
People with egg allergy
The product information for Priorix, M-M-R II and Priorix-tetra states that people with a history of anaphylactic or anaphylactoid reactions to egg should not receive these vaccines.
The Australian Technical Advisory Group on Immunisation (ATAGI) recommends that these people can receive Priorix, M-M-R II, Priorix-tetra or ProQuad.9
Women planning pregnancy
The product information for M-M-R II and ProQuad recommends that women of child-bearing age should avoid pregnancy for 1 month after vaccination.
ATAGI recommends that these women should avoid pregnancy for 28 days after vaccination,9 as for Priorix and Priorix-tetra.
People taking salicylates
The product information for ProQuad and Priorix-tetra states that people should avoid taking salicylates for 6 weeks after vaccination. This is because Reye syndrome has been reported after using salicylates during natural varicella infection.
ATAGI recommends that non-immune people on long-term salicylate therapy can receive varicella-containing vaccines, because the benefit is likely to outweigh any possible risk of Reye syndrome after vaccination.
Recommended ages for MMR vaccines
The product information for M-M-R II and Priorix states vaccine is for use in children ≥12 months of age.
ATAGI recommends that children ≥9 months can receive both MMR vaccines in certain circumstances, including travel to highly endemic areas and during outbreaks.
Recommended ages for MMRV vaccines
The product information for ProQuad states that this vaccine is for use in children 12 months to 12 years of age. The product information for Priorix-tetra states that children ≥9 months of age can receive this vaccine.
ATAGI recommends that children up to 14 years of age can receive both MMRV vaccines. ATAGI also recommends that MMRV vaccine should not be used routinely as the 1st dose of MMR-containing vaccine in children aged <4 years.
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Page history
Updates to guidance in NHIG as prophylaxis in Public Health Management section to reflect most up-to-date information.
Information added to contraindications and precautions regarding vaccination of people with possible IFNAR1 deficiency.
NCIRS editorial changes.
Changes to 4.18.4 Vaccines; 4.18.5 Transport, storage and handling; and 4.18.11 Adverse events
4.18.4 Vaccines
Amendment of text to align with new product information. In particular the source of animal derived gelatin was updated to specify porcine gelatin. (Refer also Chapters, 4.9 Measles, 4.11 Mumps, 4.21 Typhoid, 4.22 Varicella and Appendices 3 & 4).
Correction of text due to incorrect nomenclature (Refer also Chapter, 4.9 Measles, 4.11 Mumps and 4.22 Varicella).
4.18.5 Transport, storage and handling
Amendment of text to align with new product information on storage of vaccine at various temperatures (Refer also Chapters, 4.9 Measles and 4.11 Mumps).
4.18.11 Adverse events
Addition of text on egg allergy to Adverse Events to be consistent with other chapters (Refer also Chapters, 4.9 Measles, 4.11 Mumps, 4.18 Rubella and 4.22 Varicella).
Updates to guidance in NHIG as prophylaxis in Public Health Management section to reflect most up-to-date information.
Information added to contraindications and precautions regarding vaccination of people with possible IFNAR1 deficiency.
NCIRS editorial changes.
Changes to 4.18.4 Vaccines; 4.18.5 Transport, storage and handling; and 4.18.11 Adverse events
4.18.4 Vaccines
Amendment of text to align with new product information. In particular the source of animal derived gelatin was updated to specify porcine gelatin. (Refer also Chapters, 4.9 Measles, 4.11 Mumps, 4.21 Typhoid, 4.22 Varicella and Appendices 3 & 4).
Correction of text due to incorrect nomenclature (Refer also Chapter, 4.9 Measles, 4.11 Mumps and 4.22 Varicella).
4.18.5 Transport, storage and handling
Amendment of text to align with new product information on storage of vaccine at various temperatures (Refer also Chapters, 4.9 Measles and 4.11 Mumps).
4.18.11 Adverse events
Addition of text on egg allergy to Adverse Events to be consistent with other chapters (Refer also Chapters, 4.9 Measles, 4.11 Mumps, 4.18 Rubella and 4.22 Varicella).