Significant revisions since the last chapter update are highlighted in the CIG Table of Updates which is available on the PHAC website.
For additional information, refer to previously published National Advisory Committee on Immunization (NACI) Statements and Statement Updates.
Rubella (German measles) is caused by rubella virus, a ribonucleic acid (RNA) virus of the Togaviridae family. For more information about rubella virus refer to the PHAC website.
Rubella virus is highly communicable and is transmitted by droplet spread or direct contact with nasopharyngeal secretions of infected people. Transplacental transmission from an infected mother to her fetus during pregnancy may result in Congenital Rubella Syndrome (CRS) in the infant. Infants with CRS may shed the virus in their urine and nasopharyngeal secretions for 1 year or more. The incubation period for rubella is from 14 to 17 days (range, 14 to 21 days). The period of communicability extends from 1 week before to at least 4 days after the onset of rash. People who recover from rubella have lifetime immunity.
People of any age who have not been successfully vaccinated or have not had rubella disease are at risk of being infected. In Canada, routine infant immunization programs have resulted in sustained high rates of immunity in the general population, but the risk of limited transmission resulting from importation still exists. Individuals with the greatest risk of exposure to the Rubella virus include travelers to destinations outside of the Region of the Americas, where rubella incidence may be higher.
Historically, the incidence of rubella peaked in the spring and winter months in temperate zones; rubella is now limited to sporadic cases and outbreaks.
Spectrum of clinical illness
Rubella results in a transient erythematous rash, post-auricular and suboccipital lymphadenopathy, arthralgia and low-grade fever. As symptoms are non-specific, it may be mistaken for infection due to other viruses including parvovirus, adenovirus, or enterovirus. Adult infection is frequently accompanied by transient polyarthralgia or polyarthritis. Serious complications in children and non-pregnant adults are rare, and up to 50% of infections are subclinical.
Rubella infection during pregnancy often gives rise to CRS, which can result in miscarriage, stillbirth or fetal malformations, including congenital heart disease, cataracts, deafness and mental retardation. Fetal infection can occur at any stage of pregnancy, but the risk of fetal damage following maternal infection is particularly high in the earliest months after conception (85% in the first trimester) with progressive diminution of risk thereafter, and it is very uncommon after the 20th week of pregnancy. Infected infants who appear normal at birth may later show eye, ear or brain damage. Congenital infection may give rise to such problems as diabetes mellitus and panencephalitis later in life.
Rubella occurs worldwide; however, during the last two decades, rubella vaccination programs have greatly reduced rubella incidence rates in many industrialized countries. In Canada, routine infant immunization programs have resulted in sustained high rates of immunity in the general population and a massive decrease in incidence. Like rubella, CRS has been eliminated in Canada, although sporadic cases do occur through prenatal infection acquired in endemic areas. There have been no cases of CRS due to a rubella exposure in Canada since 2000.
For more information about rubella disease in Canada, refer to the Public Health Agency of Canada rubella web page.
In Canada, rubella vaccine is only available in combination with measles and mumps vaccine (MMR) or measles, mumps and varicella vaccine (MMRV). In some other countries, measles vaccine alone is given and rubella vaccination is not offered.
For complete prescribing information, consult the product leaflet or information contained within the product monograph available through Health Canada's Drug Product Database. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for a list of vaccines available for use in Canada and their contents.
The duration of protection following immunization with rubella-containing vaccine is not known, but studies indicate that the duration of both cellular and humoral immunity exceeds 20 years. Asymptomatic rubella re-infection, manifest by a rise in antibody, has been observed in some vaccinees. Asymptomatic re-infection has also been observed in women with naturally acquired immunity associated with very low antibody titres. There are no data regarding the efficacy of MMRV vaccine.
In clinical trials, 95% or more of vaccinees aged 12 months and older developed serologic evidence of rubella immunity after a single dose of rubella-containing vaccine. Antibody titres are generally lower than those observed in natural rubella infection. Long-term persistence of anti-measles, anti-mumps, anti-rubella and anti-varicella antibodies following MMRV vaccinations are under evaluation.
One dose of rubella-containing vaccine should be given for routine immunization of children and for immunization of children and adolescents who missed rubella immunization on the routine schedule. MMRV vaccine may be used in children aged 12 months to 12 years. While a single dose is recommended for rubella protection, two doses are required for measles, mumps and varicella protection.
Adults who do not have documented evidence of receiving rubella-containing vaccine on or after their first birthday, or laboratory evidence of immunity, or a history of laboratory confirmed rubella infection should be immunized with one dose of MMR vaccine.
Rubella immunization recommendations differ from measles and mumps recommendations. Because the available preparations all contain measles, mumps and rubella, extra rubella vaccinations may be administered when following the recommendations for measles and mumps vaccination. Refer to Booster doses and re-immunization for additional information.
Individuals who have one or more of the following are considered immune to rubella. Individuals who do not have ANY of the following are considered susceptible to rubella:
The following groups are priorities for rubella immunization:
A second dose of MMR or MMRV vaccine (as appropriate for age and risk factors) may be recommended for measles and mumps protection (MMR and MMRV) and varicella protection (MMRV) in certain people. Although a second dose of the rubella component is not considered necessary for elimination of CRS, it is not harmful and may benefit the 1% to 5% of people who do not respond to primary immunization. Refer to Measles Vaccine, Mumps Vaccine and Varicella (Chickenpox) Vaccine in Part 4 for additional information and to Schedule.
Children and adults lacking adequate documentation of immunization should be considered unimmunized and started on an immunization schedule appropriate for their age and risk factors, unless known to be immune based on laboratory testing. MMR or MMRV vaccine as appropriate may be given regardless of possible previous receipt of the vaccine because additional adverse events associated with repeated immunization have not been demonstrated. Refer to Immunization of Persons with Inadequate Immunization Records in Part 3 for additional general information.
Immunity to measles, mumps and rubella should be reviewed in women of reproductive age, and vaccination should be recommended to non-pregnant susceptible women. Ideally, the immunization status of women intending to become pregnant should be reviewed and vaccines updated as necessary prior to conception. Women should delay pregnancy by 4 weeks following vaccination with a live vaccine.
MMR and MMRV vaccines should not be given during pregnancy because of the theoretical risk of disease transmission to the fetus; however, there is no evidence demonstrating a teratogenic or other risk from such vaccines. In one study, there was no evidence of CRS in any of the offspring of 226 women inadvertently vaccinated during pregnancy. Inadvertent immunization with MMR vaccine is not a reason for pregnancy termination. In some situations, potential benefits of MMR vaccination may outweigh risks such as during measles or rubella outbreaks, in which case vaccination may be considered based on recommendations from public health officials.
Women who are breastfeeding can be vaccinated with MMR vaccine.
Susceptible residents of long-term care facilities should receive measles, mumps and rubella-containing vaccine, as well as all routine immunizations appropriate for their age and risk factors. Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional general information.
In general, immunocompromised persons should not receive live vaccines because of the risk of disease caused by the vaccine strains. When considering immunization of an immunocompromised person with a live vaccine, approval from the individual's attending physician should be obtained before vaccination. For complex cases, referral to a physician with expertise in immunization or immunodeficiency is advised. Refer to Immunocompromised persons in Measles Vaccine in Part 4 for additional information.
Susceptible household contacts of immunocompromised people should receive a rubella-containing vaccine as appropriate for age and risk factors.
People with conditions such as autism spectrum disorders or demyelinating disorders (including multiple sclerosis) should receive all routinely recommended immunizations, including MMR or MMRV vaccine. Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information.
Protection against rubella is important for people planning travel to rubella-endemic areas. Susceptible travellers should receive one dose of rubella-containing vaccine. Refer to rubella incidence rates in WHO member countries for additional information.
Refer to Immunization of Travellers in Part 3 for additional general information.
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals. In many countries outside of Canada, mumps and rubella vaccines are in limited use and measles vaccine alone is given. A Canadian study showed that more than one-third of new immigrants and refugees, particularly women, were susceptible to measles, mumps, or rubella.
Unless known to be immune to rubella because of prior serology or documentation of a dose of rubella-containing vaccine, rubella-containing vaccine should be given to persons new to Canada; pre-immunization serology is not needed, as it adds cost and immunising a woman who already is immune is not harmful. Non-pregnant foreign-born women of childbearing agefrom countries where rubella-containing vaccine is not in use should be vaccinated as soon as possible on arrival in Canada. Susceptible women who are pregnant should receive MMR vaccine after delivery. Refer to Immunization of Persons New to Canada in Part 3 for additional general information.
It is recommended that all health care workers be immune to rubella. Health care workers who do not have documented evidence of receiving one dose of rubella-containing vaccine on or after their first birthday, or laboratory evidence of immunity, or a history of laboratory confirmed rubella disease should receive one dose of MMR vaccine. Susceptible people who work with children (e.g. child care workers, teachers, health care workers) are priorities for rubella immunization, especially non-pregnant susceptible women of childbearing age. Refer to Immunization of Workers in Part 3 for additional general information.
Post-exposure MMR vaccination does not prevent or alter the clinical severity of rubella after exposure; however, it should be given to susceptible individuals because exposure may not result in infection, and the MMR vaccine will induce protection against subsequent exposures. There is no evidence of increased risk of adverse reactions from immunization with MMR vaccine if an individual is already immune to one or more components of the vaccine or infected by rubella virus.
Passive immunization with human immune globulin (Ig) is not effective in preventing rubella. Ig given soon after exposure to rubella may modify or suppress symptoms but may not prevent infection, including congenital infection. Therefore, the routine use of Ig in susceptible women exposed to rubella early in pregnancy is not indicated.
During rubella outbreaks, susceptible people should be given MMR vaccine promptly without prior serologic testing. In consultation with public health officials, it may be appropriate to vaccinate pregnant women.
Each dose is 0.5 ml.
Route of administration
MMR vaccine should be administered subcutaneously; MMRV can be administered subcutaneously or intramuscularly. Refer to Vaccine Administration Practices in Part 1 for additional information.
Children (12 months to 12 years of age)
For routine immunization of children aged 12 months to 12 years, one dose of rubella-containing vaccine (MMR or MMRV) should be administered at 12 to 15 months of age.
Adolescents (13 to 17 years of age)
Rubella-susceptible adolescents should receive one dose of MMR vaccine.
Adults (18 years of age and older)
Rubella-susceptible adults should receive one dose of MMR vaccine.
Re-immunization with rubella-containing vaccine after documented receipt of one dose of rubella-containing vaccine is not necessary. However, if a booster dose is given, it is not harmful and may benefit individuals who did not respond to primary immunization.
Serologic testing is not routinely recommended before or after receiving rubella-containing vaccine.
Pregnant women without documented evidence of prior immunization with a rubella-containing vaccine should be serologically screened for rubella antibodies. Those found to be susceptible should be vaccinated with one dose of MMR vaccine in the immediate post-partum period, before discharge from hospital (unless they have received Rh immune globulin [RhIg] - refer to Rh immune globulin and MMR vaccine in Immunization in Pregnancy and Breastfeeding in Part 3). Women who have been appropriately immunized post-partum do not need to be serologically screened for rubella antibodies either post-immunization or in subsequent pregnancies. Women who have been found to be serologically positive in one pregnancy do not need to be screened again in subsequent pregnancies.
M-M-R® II: This vaccine should be held at +10°C or colder during shipment. Freezing during shipment will not affect potency of the vaccine. The vaccine should be protected from light. Before reconstitution, the vial of vaccine should be stored at +2°C to +8°C or colder. The diluent may be stored in the refrigerator or at room temperature and must not be frozen.
PRIORIX®: This vaccine should be stored in a refrigerator at +2°C to +8°C and protected from light. The diluent may be stored separately at room temperature.
PRIORIX-TETRA®: This vaccine and diluent should be stored in a refrigerator at +2°C to +8°C and care should be taken not to freeze them. The vaccine should be protected from light.
Refer to Storage and Handling of Immunizing Agents in Part 1 for additional general information.
Live vaccines given by the parenteral route may be administered concomitantly with all other vaccines during the same visit using different injection sites and separate needles and syringes. In general, if two live parenteral vaccines are not administered concomitantly, there should be a period of at least 4 weeks before the second live parenteral vaccine is given. Exceptions are varicella-containing vaccines, such as MMRV vaccine. Refer to Varicella Vaccine chapter in Part 4 for additional information.
Oral and intranasal vaccines can be given at the same time as, or any time before or after any other live vaccine, regardless of the route of administration of the other live vaccine.
Refer to Timing of Vaccine Administration in Part 1 for additional general information.
Refer to Vaccine Safety in Part 2 for additional general information.
Adverse events following MMR immunization occur much less frequently and are significantly less severe than those associated with natural disease. Adverse reactions are less frequent after the second dose of vaccine and tend to occur only in those not protected by the first dose. Six to 23 days after MMR immunization, approximately 5% of immunized children experience malaise and fever (with or without rash) lasting up to 3 days. Parotitis, rash, lymphadenophy, and joint symptoms also occur occasionally after MMR immunization.
Pain and redness at the injection site, low-grade fever or both occur in 10% or more of vaccinees. Rash, including measles-like, rubella-like and varicella-like rash, as well as swelling at the injection site and moderate fever (greater than 39°C) occur in 1% to less than 10% of vaccinees. As varicella-like rashes that occur within the first two weeks after immunization may be caused by wild-type virus, health care providers should obtain specimens using viral transport media from a lesion of the vaccinee to ensure that varicella disease is not confused with a reaction to vaccination.
Acute transient arthritis or arthralgia may occur 1 to 3 weeks after immunization with rubella-containing vaccine, lasts for about 1 to 3 weeks, and rarely recurs. This is more common in post-pubertal females, among whom arthralgia develops in 25% and arthritis in 10% after immunization with rubella-containing vaccine. There is no evidence of increased risk of new onset, chronic arthropathies or neurologic conditions.
Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association. As with other vaccines, anaphylaxis following vaccination with MMR or MMRV vaccine may occur but is very rare.
Immune Thrombocytopenic Purpura (ITP)
Rarely, ITP occurs within 6 weeks after immunization with MMR or MMRV vaccine. In most children, post-immunization thrombocytopenia resolves within three months without serious complications. In individuals who experienced ITP with the first dose of MMR or MMRV vaccine, serologic status may be evaluated to determine whether an additional dose of vaccine is needed. The potential risk to benefit ratio should be carefully evaluated before considering administration of the second dose in such cases.
Encephalitis has been reported in association with administration of measles vaccine in approximately 1 per million doses distributed in North America, which is much lower than that observed with natural measles disease (1 per 1,000 cases).
Recent studies have found a higher risk of febrile seizures with the first dose of a MMRV vaccine (ProQuad®, not authorized for use in Canada) when compared to the concomitant administration of MMR and univalent varicella vaccine. Data from the United States (US) estimated that the risk of febrile seizures in the 5 to 12 days following the first dose of this MMRV vaccine is 1 for every 2,600 vaccinated children aged 12 to 23 months. Experience with the MMRV vaccine available in Canada is more limited; however, one study showed an additional risk of febrile seizures with MMRV vaccine compared to MMR and univalent varicella vaccines given as two separate products administered concomitantly. The risk with the vaccine used in Canada was smaller than the risk found with the US product. Close surveillance and further investigation are underway.
In the mid to late 1990s, researchers from the United Kingdom reported an association between MMR vaccine and inflammatory bowel disease, and MMR vaccine and autism. Rigorous scientific studies and reviews of the evidence have been done worldwide, and there is now considerable evidence proving that these claims were false. In 2010, the original study suggesting a link between the MMR vaccine and autism was retracted.
Vaccine providers are asked to report the following AEFI in particular, through local public health officials:
Refer to Reporting Adverse Events Following Immunization (AEFI) in Canada and Vaccine Safety in Part 2 for additional information about AEFI reporting.
MMR and MMRV vaccines are contraindicated in persons with a history of anaphylaxis after previous administration of the vaccine and in persons with proven immediate or anaphylactic hypersensitivity to any component of the vaccine (with the exception of egg allergy [refer below]) or its container. Refer to Contents of Immunizing Agents Available for Use in Canada in Part 1 for a list of vaccines available for use in Canada and their contents. For rubella-containing vaccines, potential allergens include:
In situations of suspected hypersensitivity or non-anaphylactic allergy to vaccine components, investigation is indicated, which may involve immunization in a controlled setting. Consultation with an allergist is advised.
The measles and mumps components of MMR and MMRV vaccines are produced in chick embryo cell culture and may contain traces of residual egg and chicken protein. The trace amount of egg and chicken protein in the vaccine appears to be insufficient to cause an allergic reaction in egg-allergic individuals. Skin testing is not recommended prior to vaccination as it does not predict reaction to the vaccine. MMR or MMRV vaccine can be administered in the routine manner to people who have a history of anaphylactic hypersensitivity to hens' eggs. Prior egg ingestion is not a prerequisite for immunization with egg protein-containing vaccine. For all vaccines, immunization should always be performed by personnel with the capability and facilities to manage adverse events post-vaccination. Refer to Anaphylactic Hypersensitivity to Egg and Egg-Related Antigens in Part 2 for additional information.
Children with a known or suspected family history of congenital or hereditary immunodeficiency that is a contraindication to vaccination with live vaccine should not receive live vaccines unless their immune competence has been established.
MMRV vaccine is contraindicated in persons with impaired immune function, including primary or secondary immunodeficiency disorders. Refer to Immunocompromised persons.MMR and MMRV vaccines are generally contraindicated during pregnancy but not while breastfeeding. Refer to Pregnancy and breastfeeding.
MMR vaccine is contraindicated in individuals with active, untreated tuberculosis. While tuberculosis may be exacerbated by natural measles infection there is no evidence that MMR vaccine has such an effect. Nonetheless, anti-tuberculous therapy for active TB disease is advisable before administering MMR vaccine and it may be prudent to avoid this vaccine in those with active TB disease until treatment is underway. Consultation with an expert in infectious diseases is recommended.
A history of febrile seizures or a family history of convulsions is not a contraindication to the use of MMRV vaccine.
Administration of MMR or MMRV vaccine should be postponed in persons with a severe acute illness. Persons with a minor or moderate acute illness (with or without fever) may be vaccinated.
It is recommended to avoid the use of salicylates (e.g., acetylsalicylic acid [ASA]) for 6 weeks after immunization with MMRV vaccine because of an association between wild-type varicella, salicylate therapy and Reye's syndrome.
Refer to Contraindications, Precautions and Concerns in Part 2 for additional general information.
Systemic antiviral therapy (such as acyclovir, valacyclovir, famciclovir) should be avoided in the peri-immunization period, as it may reduce the efficacy of varicella-containing vaccine such as MMRV. On the basis of expert opinion, it is recommended that people taking long-term antiviral therapy should discontinue these drugs, if possible from at least 24 hours before administration of MMRV vaccine and should not restart antiviral therapy until 14 days after.
The measles component in measles-containing vaccines can temporarily suppress tuberculin reactivity, resulting in false-negative results. If tuberculin skin testing or an Interferon Gamma Release Assay (IGRA) test is required, it should be done on the same day as immunization or delayed for at least 4 weeks after measles vaccination. Vaccination with measles-containing vaccine may take place at any time after tuberculin skin testing has been administered.
Passive immunization with human immune globulin (Ig) or receipt of most other blood products can interfere with the immune response to live vaccines. Refer to Blood Products, Human Immune Globulin and Timing of Immunization in Part 1 for additional information for recommended intervals between the administration of immune globulin (Ig) preparations or other blood products and MMR and MMRV vaccines.
On the basis of expert opinion, the MMR vaccines authorized in Canada may be used interchangeably. Refer to Principles of Vaccine Interchangeabilityin Part 1 for additional general information.
Centers for Disease Control and Prevention. Progress Toward Elimination of Rubella and Congenital Rubella Syndrome-the Americas, 2003-2008. MMWR Morb Mortal Wkly Rep 2008;57(43):1176-9.