Canadian Immunization Guide: Part 4 - Active Vaccines
Updated: August 2016
- Key Information
- Immunizing Agents Available for Use in Canada
- Immunogenicity, Efficacy and Effectiveness
- Recommendations for Use
- Vaccination of Specific Populations
- Serologic Testing
- Administration Practices
- Storage and Handling of Immunizing Agents
- Safety and Adverse Events
- Selected References
Key Information (refer to text for details)
- Up to 50% of rubella infections are subclinical; if a woman develops rubella during pregnancy, it can result in Congenital Rubella Syndrome (CRS) in the infant.
- Rubella vaccine is available as measles-mumps-rubella (MMR) or measles-mumps-rubella-varicella (MMRV) vaccine.
- Over 97% of individuals develop immunity after 1 dose of rubella vaccine.
- Reactions to MMR vaccine are generally mild and transient and include pain and redness at the injection site, fever less than 39°C, and rash. Reactions to MMRV vaccine include: pain and redness at the injection site and fever less than 39°C in 10% or more of vaccine recipients; measles-like, rubella-like or varicella-like rash, swelling at the injection site and fever greater than 39°C in less than 10% of vaccine recipients.
- When the first dose is administered to children 12 to 23 months of age as MMRV vaccine, there is a higher risk of fever and febrile seizures in the 7 to 10 days after vaccination when compared to separate administration of MMR and univalent varicella vaccine at the same visit.
- Rubella-containing vaccine is recommended for routine immunization of children and for immunization of children and adolescents who missed rubella immunization on the routine schedule.
- Rubella-containing vaccine is recommended for all susceptible adults.
- Rubella immunization should be prioritized for the following susceptible individuals:
- Non-pregnant women of childbearing age - especially foreign-born, and staff and students in educational settings
- People who work with children (for example, child care workers, teachers)
- Health care workers
- Travellers to rubella-endemic areas
- Routine childhood immunization: 1 dose of any rubella-containing (MMR or MMRV) vaccine should be administered at 12 to 15 months of age. While a single dose is recommended for rubella protection, 2 doses of measles, mumps and varicella-containing vaccines are required for protection against these infections.
- Susceptible children, adolescents and adults: 1 dose of MMR vaccine. MMRV vaccine may be used in healthy children aged 12 months to less than 13 years.
- Rubella occurs worldwide and is highly communicable.
- Rubella during pregnancy can result in CRS in the infant.
Rubella (German measles) is caused by rubella virus, a ribonucleic acid (RNA) virus of the Togaviridae family. For additional information about the rubella virus, refer to the Pathogen Safety Data Sheet.
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 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 of rubella exists.
Persons at greatest risk of exposure to rubella
Individuals with the greatest risk of exposure to the rubella virus include travellers to destinations outside of the Region of the Americas, where rubella incidence may be higher.
Seasonal and temporal patterns
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. 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 significant decrease in incidence. Like rubella, CRS has been eliminated in Canada, although sporadic cases occur through prenatal infection acquired in endemic areas. There have been no cases of CRS due to a rubella exposure in Canada since 2000. Updates on the epidemiology of rubella in Canada are published in the weekly PHAC Measles & Rubella Monitoring Report.
For more information about rubella, including disease description, distribution and epidemiology, refer to the PHAC rubella website.
Immunizing Agents Available for Use in Canada
- M-M-R®II (live, attenuated combined measles, mumps and rubella vaccine), Merck Canada Inc. (MMR)
- PRIORIX® (live, attenuated, combined measles, mumps and rubella vaccine), GlaxoSmithKline Inc. (MMR)
- PRIORIX-TETRA® (live, attenuated combined measles, mumps, rubella and varicella vaccine), GlaxoSmithKline Inc. (MMRV)
- ProQuad™ (live attenuated combined measles, mumps, rubella and varicella vaccine), Merck Canada Inc. (MMRV)
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.
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.
Immunogenicity, Efficacy and Effectiveness
In clinical trials, 95% or more of vaccine recipients 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.
Efficacy and effectiveness
The duration of protection following immunization with rubella-containing vaccines 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 vaccine recipients. 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.
Recommendations for Use
Healthy children (12 months to less than 18 years of age)
- Healthy children (12 months to less than 13 years of age)
For routine immunization of children, 1 dose of rubella-containing vaccine should be administered at 12 to 15 months of age, using either MMR or MMRV vaccine. MMRV vaccine may be used in children aged 12 months to less than 13 years. While a single dose is recommended for rubella protection, 2 doses of measles, mumps and varicella-containing vaccines are required for protection against these infections.
Catch-up and accelerated schedules
- Healthy children (12 months to less than 13 years of age)
Children who did not receive rubella immunization on the routine schedule should receive 1 dose of rubella-containing vaccine, using either MMR or MMRV vaccine.
- Adolescents (13 to less than 18 years of age)
Rubella-susceptible adolescents (refer to Susceptibility and immunity for criteria for immunity) should receive 1 dose of MMR vaccine.
Healthy adults (18 years of age and older)
Rubella-susceptible adults (refer to Susceptibility and immunity for criteria for immunity) should receive 1 dose of MMR vaccine.
Refer to Immunization of Adults in Part 3 for additional information about routinely recommended immunization for adults as well as vaccines recommended for adults in specific risk situations.
Second dose of vaccine
A second dose of MMR or MMRV vaccine (as appropriate for age and risk factors) may be recommended for measles, mumps or varicella protection in certain people. Although a second dose of the rubella component in the vaccine 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.
Susceptibility and immunity
Individuals who have ANY of the following are considered immune to rubella:
- Documented evidence of immunization with a rubella-containing vaccine on or after the first birthday
- A history of laboratory confirmed rubella infection
- Laboratory evidence of immunity
Booster doses and re-immunization
Re-immunization with rubella-containing vaccine after documented receipt of 1 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.
Post-exposure immunization and outbreak control
Post-exposure vaccination with MMR vaccine or human immune globulin (Ig) does not prevent or alter the clinical severity of rubella after exposure. However, MMR vaccine 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. There are no data on the use of MMRV vaccine in post-exposure situations.
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.
Vaccination of Specific Populations
Persons with inadequate immunization records
Children and adults who are susceptible to rubella, including those lacking adequate documentation of immunization, should be started on an immunization schedule appropriate for their age and risk factors. Rubella-containing vaccine 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 information.
Pregnancy and breastfeeding
Immunity to measles, mumps and rubella should be reviewed in women of reproductive age, and vaccination should be recommended to susceptible non-pregnant women. Women should delay pregnancy by at least 4 weeks following vaccination with MMR vaccine.
MMR and MMRV vaccines are contraindicated in pregnancy because of the theoretical risk of disease transmission to the fetus. However, there is no evidence demonstrating a teratogenic risk from the vaccine and termination of pregnancy should not be recommended following inadvertent immunization with either of these vaccines on the basis of fetal risks following maternal immunization. There was no evidence of CRS in any of the offspring of 226 women inadvertently vaccinated during pregnancy. In some situations, potential benefits of vaccination with MMR vaccine may outweigh risks such as during measles or rubella outbreaks, in which case vaccination may be considered based on recommendations from public health officials. Pregnant women who are susceptible to rubella should have vaccination offered post-partum.
Susceptible women who are breastfeeding should be vaccinated with MMR vaccine.
Refer to Blood Products, Human Immune Globulin and Timing of Immunization in Part 1 for information about rubella vaccination of post-partum women who have received Rh immune globulin (RhIg). Refer to Immunization in Pregnancy and Breastfeeding in Part 3 for additional information.
Patients in health care institutions
Susceptible residents of long-term care facilities should receive measles, mumps and rubella-containing vaccine as appropriate for their age and risk factors. Post-partum women susceptible to rubella should be vaccinated before discharge. Refer to Immunization of Patients in Health Care Institutions in Part 3 for additional information.
Persons with chronic diseases
Refer to Measles Vaccine in Part 4 for additional information. Refer to Immunization of Persons with Chronic Diseases in Part 3 for additional general information about vaccination of people with chronic diseases.
People with conditions such as autism spectrum disorders or demyelinating disorders, including multiple sclerosis, should receive all routinely recommended immunizations, including rubella-containing vaccine.
In general, immunocompromised people 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. MMRV vaccine has not been studied in persons with impaired immune function, including primary or secondary immunodeficiency disorders, and is not recommended for this group. Refer to Measles Vaccine in Part 4 for additional information.
Susceptible household contacts of immunocompromised people should be considered a priority to receive a rubella-containing vaccine as appropriate for age and risk factors.
Protection against rubella is important for people planning travel to rubella-endemic areas. Rubella-susceptible travellers (refer to Susceptibility and immunity for criteria for immunity) to rubella-endemic areas should receive 1 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 information.
Persons new to Canada
Health care providers who see persons newly arrived in Canada should review the immunization status and update immunization for these individuals as necessary. 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 serologic testing or documentation of receipt of a dose of rubella-containing vaccine, rubella-containing vaccine should be given to persons new to Canada; pre-immunization serologic testing is not needed. Rubella-susceptible people should be immunized with rubella-containing vaccine as soon as possible after entry to Canada. Non-pregnant, foreign-born women of childbearing age from countries where rubella-containing vaccine is not in use should be a priority. Susceptible women who are pregnant should receive MMR vaccine after delivery. Refer to Immunization of Persons New to Canada in Part 3 for additional information.
It is recommended that all health care workers be immune to rubella. Health care workers who do not meet the definition of rubella immunity (refer to Susceptibility and immunity for criteria for immunity) should receive 1 dose of MMR vaccine. Susceptible people who work with children (for example, 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 information.
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 1 dose of MMR vaccine in the immediate post-partum period, before discharge from hospital (unless they have received RhIg – refer to Blood Products, Human Immune Globulin and Timing of Immunization in Part 1). 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.
Each dose of rubella-containing vaccine is 0.5 mL.
Route of administration
MMR vaccine should be administered subcutaneously (SC). MMRV should be administered according to the product monograph.
Refer to Vaccine Administration Practices in Part 1 for additional information about pre-vaccination and post-vaccination counselling, vaccine preparation and administration technique, and infection prevention and control.
Concurrent administration with other vaccines
MMR vaccine may be administered concomitantly with, or at any time before or after, inactivated vaccines, live oral vaccines, or live intranasal influenza vaccine (LAIV).
MMR vaccine may be administered together with other routinely provided live parenteral vaccines. If not given concomitantly, a minimum interval of 4 weeks is recommended between administration of MMR and other live parenteral vaccines. This recommendation is to address the risk of interference from the vaccine given first on the vaccine given later.
Different injection sites and separate needles and syringes must be used for concomitant parenteral injections. Refer to Timing of Vaccine Administration in Part 1 for additional information about concomitant administration of rubella-containing vaccine with other vaccines.
Storage and Handling of Immunizing Agents
Refer to Storage and Handling of Immunizing Agents in Part 1 for storage and handling recommendations for rubella-containing vaccines.
Safety and Adverse Events
Common and local adverse events
Adverse events following immunization with MMR vaccine occur less frequently and are 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 individuals not protected by the first dose. Six to 23 days after immunization with MMR vaccine, 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 immunization with MMR vaccine.
Pain and redness at the injection site or fever less than 39°C occur in 10% or more of vaccine recipients. Rash, including measles-like, rubella-like and varicella-like rash, as well as swelling at the injection site and fever greater than 39°C occur in 1% to less than 10% of vaccine recipients. As varicella-like rashes that occur within the first 2 weeks after immunization may be caused by wild-type virus (varicella virus circulating in the community), health care providers should obtain specimens from the vaccine recipient to determine whether the rash is due to natural varicella infection or to the vaccine-derived strain.
Acute transient arthritis or arthralgia may occur 1 to 3 weeks after immunization with rubella-containing vaccines. It lasts for about 1 to 3 weeks, and rarely recurs. It 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.
Less common and serious or severe adverse events
Serious adverse events are rare following immunization and, in most cases, data are insufficient to determine a causal association. Anaphylaxis following vaccination with MMR or MMRV vaccine may occur but is very rare.
Immune Thrombocytopenic Purpura
Rarely, immune thrombocytopenic pupura (ITP) occurs within 6 weeks after immunization with MMR or MMRV vaccine. In most children, post-immunization thrombocytopenia resolves within 3 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 for protection. The potential risk to benefit ratio should be carefully evaluated before considering vaccination 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 the incidence observed with natural measles disease (1 per 1,000 cases).
Between the ages of 12 to 23 months, when the first dose of vaccine for measles and varicella is administered as MMRV vaccine, there is a higher risk of fever and febrile seizures in the 7 to 10 days after vaccination when compared to separate administration of MMR and varicella vaccine at the same visit. For information about febrile seizures following the administration of MMRV vaccine, refer to Measles Vaccine in Part 4.
Other reported adverse events and conditions
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 to refute those claims. In 2010, the original study suggesting a link between the MMR vaccine and autism was found to be fraudulent and was retracted.
Guidance on reporting Adverse Events Following Immunization
Vaccine providers are asked to report the following adverse events following immunization (AEFI) in particular, through local public health officials:
- Febrile seizures within 30 days after vaccination with MMR or MMRV vaccine.
- Varicella that is moderate (50 to 500 lesions) or severe (more than 500 vesicular lesions or associated complications or hospital admission) and occurs within 7 to 21 days of vaccination with MMRV vaccine.
- Any serious or unexpected adverse event felt to be temporally related to vaccination. An unexpected AEFI is an event that is not listed in available product information but may be due to the immunization, or a change in the frequency of a known AEFI.
Refer to Reporting Adverse Events Following Immunization (AEFI) in Canada and Vaccine Safety in Part 2 for additional information about AEFI reporting.
Contraindications and precautions
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 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.
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.
Although 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 or 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. Refer to Pregnancy and breastfeeding.
Measles-containing vaccines are contraindicated in individuals with active, untreated tuberculosis (TB) as a precautionary measure. While TB may be exacerbated by natural measles infection there is no evidence that measles-containing vaccines have such an effect. Nonetheless, anti-tuberculous therapy for active TB disease is advisable before administering measles-containing vaccines and it may be prudent to avoid live viral vaccines 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 seizures 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.
The use of salicylates (medications derived from salicylic acid, such as acetylsalicylic acid [ASA]) should be avoided 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 information.
Systemic antiviral therapy
Systemic antiviral therapy (such as acyclovir, valacyclovir, famciclovir) should be avoided in the peri-immunization period, as it may affect the reproduction of the vaccine virus and consequently 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 vaccine administration.
Tuberculin skin testing or Interferon Gamma Release Assay (IGRA)
The measles component in measles-containing vaccines can temporarily suppress tuberculin reactivity, resulting in false-negative results. If tuberculin skin testing or an 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 performed and read.
Human immune globulin or other blood products
Passive immunization with human immune globulin (Ig) or receipt of most other blood products can interfere with the immune response to MMR and MMRV vaccines. Refer to Blood Products, Human Immune Globulin and Timing of Immunization in Part 1 for recommended intervals between the administration of Ig preparations or other blood products and MMR and MMRV vaccines.
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