Vaccine Information

Entry last updated: May 28, 2004

- Understanding the Disease
- Available Vaccines
- History of the Vaccine
- Who Should and Should Not Receive the Vaccine
- Dose Schedule
- Effectiveness of the Vaccine
- Known Side Effects
- Related Issues
- Key References and Sources of Additional Information
- State Vaccine Requirements
- Important Facts for Parents to Know
- Frequently Asked Questions
- CDC Vaccine Information Statement

Understanding the Disease

Rubella is caused by a virus that is transmitted from person to person in mucus droplets coughed or sneezed into the environment. Rubella usually is a mild illness. Symptoms include low-grade fever and swollen lymph nodes in the back of the neck followed by a generalized rash. Complications may include joint pain, a temporary decrease in platelets, and encephalitis (inflammation of the brain). Temporary arthritis may also occur, particularly in adolescents and adult women.

Rubella in expectant women often leads to congenital rubella syndrome (CRS) in their fetuses. This is a devastating disease characterized by deafness, mental retardation, cataracts and other eye defects, heart defects, and diseases of the liver and spleen that may result in a low platelet count with bleeding under the skin. The incidence and severity of congenital defects are greater if infection occurs during the first month of gestation. Up to 85% of expectant mothers infected in the first trimester will have a miscarriage or a baby with CRS.

The World Health Organization estimated that, in 1999, 110,000 infants were born with CRS worldwide. Although most CRS occurs in developing countries, it also continues to occur in the U.S., mostly among unimmunized Hispanics.

Before a vaccine was available, there was a rubella outbreak in the U.S. (1963 to 1964), during which 12 million people developed the disease. Because many of those infected were expectant mothers, 11,000 fetuses died and 20,000 babies were born with permanent disabilities as a result of exposure to the virus. The number of cases of rubella fell very sharply once the rubella vaccine was licensed in 1969; today there are fewer than 1,000 cases of rubella reported each year in the U.S. on average and less than 10 cases of congenital rubella syndrome.

Available Vaccines

The rubella vaccine is available as:

• MMR (Measles-Mumps-Rubella)
• Rubella (alone)

Product: M-M-R� II
Manufacturer: Merck
Year licensed: 1971

Product: Meruvax� II (Rubella)
Manufacturer: Merck
Year licensed: 1969. This vaccine is thimerosal-free.

All MMR vaccines are available containing no thimerosal. For information on the thimerosal content in the MMR vaccine, see the Food and Drug Administration at www.fda.gov/cber/vaccine/thimerosal.htm#t3 or Johns Hopkins University's Institute for Vaccine Safety at www.vaccinesafety.edu/thi-table.htm

History of the Vaccine

The first vaccines for rubella were licensed in 1969. Today rubella vaccine is generally given in combination with measles and mumps vaccines (MMR).

Originally, just one dose of the MMR vaccine was recommended. In 1989, the American Academy of Family Physicians, the American Academy of Pediatrics, and the Centers for Disease Control and Prevention�s Advisory Committee on Immunization Practices, changed the recommendation to two doses, primarily to immunize the small percent of people who do not respond to the measles component of the MMR vaccine. This change and a higher vaccination rate have nearly eliminated these three diseases in the United States.

Who Should and Should Not Receive this Vaccine

Who should receive the MMR vaccine?

• All infants 12 months of age or older
• Susceptible adults who do not have documented evidence of measles immunity, such as a physician-diagnosed case of measles, a blood test showing the presence of measles antibody, or proof of receiving measles vaccine.

Immunity against measles is particularly important for adults at high risk for measles exposure, including college students and health care workers. People born before 1957 who are not in one of these high-risk categories are generally considered immune to measles through environmental exposure.

Because of the risk of CRS, it is particularly important that post-pubertal women be�immune to�rubella. Routine screening of pregnant women for rubella immunity is recommended and susceptible individuals should be vaccinated when it is known that they are not pregnant.�Vaccination in�case of susceptible pregnant women is�often�given immediately after giving birth.

People susceptible to rubella working in educational institutions and childcare centers should be immunized to prevent transmission of rubella virus to pregnant women, as well as for their own protection.

Frequently, it is believed that members of the following groups should not receive the vaccine. In fact, susceptible members may still receive the vaccine:
- Women who are breast feeding
- Individuals who have HIV infection but no symptoms of AIDS
- Susceptible children whose mothers or other household members are pregnant, as immunizing these contacts presents no risk to the pregnant individual

Who should not receive the MMR vaccine?

• People with serious allergies to gelatin or any of the other components of the vaccine
• Women who are pregnant or trying to conceive. Moreover, women should not become pregnant within 28 days after immunization with MMR.
• Immunocompromised persons (with the exception of HIV-infected persons who have no symptoms of AIDS, as noted above) and persons receiving cancer chemotherapy or high doses of steroids
• People receiving blood products (except washed red blood cells) such as immune globulin should have the MMR vaccine deferred for 3 to 11 months depending on the blood product and dosage administered.
• People who are moderately or severely ill should consult with their physician before receiving any vaccine.

Who should receive the rubella vaccine?

• People who cannot receive one or both of the other vaccines included in MMR
• People who have proof of immunity to one or both of the diseases that MMR prevents may receive the rubella vaccine, though MMR is usually recommended

Who should not receive the rubella vaccine?

• People with serious allergies to gelatin or any of the other components of the vaccine
• Women who are pregnant or trying to conceive. Moreover, women should not become pregnant within 28 days of receiving the rubella vaccine.
• Immunocompromised persons (with the exception of HIV-infected persons who have no symptoms of AIDS, as noted above) and persons receiving cancer chemotherapy or high doses of steroids
• People receiving blood products (except washed red blood cells) such as immune globulin should have the MMR vaccine deferred for 3 to 11 months depending on the blood product and dosage administered.
• People who are moderately or severely ill should consult with their physician before receiving any vaccine.

This vaccine is recommended by:

• Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention
• American Academy of Pediatrics
• American Academy of Family Physicians

The complete childhood immunization schedule can be found at:
www.cdc.gov/nip/recs/child-schedule.PDF

The summary of adolescent/adult immunization recommendations can be found at: www.cdc.gov/nip/recs/adult-schedule.pdf

Dose Schedule

The rubella vaccine is usually given with the measles and mumps vaccines in persons 12-15 months of age and older.

Two doses of MMR vaccine administered on or after the first birthday are recommended for all children. The first dose is generally given at 12 to 15 months of age, and the second dose is generally given at four to six years of age. There must be a minimum of four weeks between doses. The second dose of MMR provides an added safeguard against all three diseases, but is recommended primarily to prevent outbreaks of measles.

Susceptible women should receive the rubella vaccine or MMR at least 28 days before getting pregnant to prevent congenital rubella syndrome (CRS)�a devastating disease that affects the babies of susceptible women exposed to rubella during their pregnancy. CRS can result in neonatal deafness, mental retardation, cataracts and other eye defects, heart defects, and liver and spleen disease.

Effectiveness of the Vaccine

Ninety-five percent of those who receive the MMR or rubella vaccine at one year of age or older are immune after the first dose. Immunity is lifelong.

Known Side Effects

Nearly all children who get the MMR vaccine (more than 80%) will have no side effects. Most children who have a side effect will have only a mild reaction, such as soreness, redness or swelling where the shot was given, mild rash, mild to moderate fever, swelling of the lymph glands, and temporary pain, stiffness, or temporary swelling in the joints.

In about 5% to 15% of children given MMR, a fever in excess of 103 degrees F may occur�usually beginning about 7 to 12 days after the vaccine has been administered.

About 15% of women who receive the rubella vaccine or MMR will develop acute arthritis or swelling of the joints. This condition is usually very short-lived.

In rare cases (about 3 children out of 10,000 given MMR, or 0.03% of recipients) a moderate reaction such as seizure related to high fever may occur.

In extremely rare cases (far less than 1 child out of 10,000 given MMR), children have a serious reaction, such as lowered consciousness, coma, or hypersensitivity (anaphylaxis)�swelling inside the mouth, difficulty breathing, low blood pressure, and rarely, shock. Even more rarely, children may have low blood platelets that can lead to a temporary bleeding problem that is described in more detail in the �Related Issues� section below. Since 1990, there have been 11 case reports of anaphylaxis in those who received the vaccine. Thirty to 40 million children were vaccinated during this time period. No children who experienced such a reaction died as a result.

MMR side effects are largely due to the measles vaccine that it contains. Adverse reactions to the rubella vaccine may include arthritis or joint swelling as described above.�

Related Issues

Persons exposed to infants with congenital rubella syndrome, particularly post-pubertal women for whom rubella immunity is critical, should be aware that these infants may shed rubella virus for at least one year.

There are hypotheses that the MMR vaccine causes autism. However, the best available science indicates that the development of autism is unrelated to use of the MMR or any other vaccine. One small study seemed to postulate such a link but has subsequently been disproved by many other, larger studies. Ten of the thirteen authors of that study later retracted from their suggestion of�a link between MMR vaccine and autism.

Researchers estimate that about one in every 22,000 MMR vaccinations could result in a child developing a temporary bleeding disorder called idiopathic thrombocytopenic purpura (ITP). ITP is rarely dangerous -- generally much less serious than measles, mumps, or rubella -- and is easily treated. A recent study found that children who had ITP and later received the MMR vaccine had no vaccine-associated recurrences. ITP can also occur as a result of rubella infection.

The following provide additional information on the safety of the MMR vaccine:

• Centers for Disease Control and Prevention, National Immunization Program. (2001). Vaccines and autism theory [Web page]. Available online: www.cdc.gov/nip/vacsafe/concerns/autism
• Halsey NA and Hyman SL. (2001). Measles-mumps-rubella vaccine and autistic spectrum disorder: Report from the New Challenges in Childhood Immunizations Conference. Pediatrics, 107(5), e84.
• Institute of Medicine. (2001). Immunization safety review: Measles-Mumps-Rubella vaccine and autism. Washington, DC: National Academy Press. Available online: http://books.nap.edu/html/mmr/
• Miller E, Waight P, Farrington CP, Andrews N, Stowe J, and Taylor B. (2001). Idiopathic thrombocytopenic purpura and MMR vaccine. Archives of Disease in Childhood, 84(3), 227-229
• Prober CG. (1999). Evidence shows genetics, not MMR, determines autism. AAP News, 15(12), 24. Available online: www.aap.org/new/autism2.htm
• Rodier PM. (2000). The early origins of autism. Scientific American, 282(2), 56-63.
• Stratton K, Gable A, Shetty P, and McCormick M (Eds.). (2001). Immunization safety review: Measles-mumps-rubella vaccine and autism. Washington DC: National Academy Press. Available online: www.nap.edu/books/0309074479/html/
• Taylor B, Miller E, Farrington CP, Petropoulos MC, Favot-Mayaud I, Li J, and Waight PA. (1999). Autism and measles, mumps, and rubella vaccination: No epidemiological evidence for causal association. Lancet, 353(9169), 2026-2029.
• Wakefield AJ, Murch SH, Anthony A, Linnell J, Casson DM, Malik M, Berelowitz M, Dhillon AP, Thomson MA, Harvey P, Valentine A, Davies SE, and Walker-Smith JA. (1998). Ileal-lymphoid-modular hyperplasia, non-specific colitis, and pervasive developmental disorder in children. Lancet, 351(9103), 637-641.

Key References and Sources of Additional Information

• American Academy of Pediatrics (AAP), Committee on Children with Disabilities. (2001). The pediatrician�s role in the diagnosis and management of autistic spectrum disorder in children. Pediatrics, 107(5), 1221-1226.
• AAP, Committee on Infectious Diseases. (2003). Rubella. In LK Pickering (Ed.), Red Book: Report of the Committee on Infectious Diseases (26th ed., pp. 536-541). Elk Grove Village, IL: Author.
• Barlow WE, Davis RL, and Glasser JW. (2001). The risk of seizures after receipt of whole-cell pertussis or measles, mumps, and rubella vaccine. New England Journal of Medicine, (345), 656-61.
• Centers for Disease Control and Prevention (CDC). (1998). Measles, mumps, and rubella: Vaccine use and strategies for elimination of measles, rubella, and congenital rubella syndrome, and control of mumps: Recommendations of the Advisory Committee on Immunization Practices (ACIP). Morbidity and Mortality Weekly Report, 47(RR-8), 1-57.
• CDC. (2003). Measles, mumps, and rubella vaccines: What you need to know [Vaccine Information Statement (VIS)].
• CDC. (2004). Rubella. In Epidemiology and prevention of vaccine-preventable diseases (�The Pink Book�) (8th ed.). Atlanta: Author.
• CDC. (2000). Rubella among Hispanic adults�Kansas, 1998, and Nebraska, 1999. Morbidity and Mortality Weekly Report, 49(11), 225-228.
• CDC, National Immunization Program. (2000). Rubella (German measles). In Vaccine-preventable childhood diseases [Online fact sheet].
• Cutts FT and Vynnycky E. (1999). Modeling the incidence of congenital rubella syndrome in developing countries. International Journal of Epidemiology, 28(6), 1176-1184.
• Danovaro-Holliday MC, LeBaron CW, Allensworth C, Raymond R, Borden TG, Murray AB, Icenogle JP, and Reef SE. (2000). A large rubella outbreak with spread from the workplace to the community. Journal of the American Medical Association. 284(21), 2733-2739.
• Duclos P and Ward BJ. (1998). Measles vaccines: A review of adverse events. Drug Safety,19(6), 435-454.
• Grabenstein JD. (1999).  Moral considerations with certain viral vaccines. Christianity and Pharmacy, 2(2), 3-6.
• Humiston SG and Good C. (2000). Vaccinating your child: Questions and answers for the concerned parent. Atlanta: Peachtree Publishers.
• Offit PA and Bell LM. (1999). Vaccines: What every parent should know (Rev. ed.). New York: IDG Books.
• Patja A, Davidkin I, Kurki T, Kallio MJ, Valle M, and Peltola H. (2000). Serious adverse events after measles-mumps-rubella vaccination during a fourteen-year prospective follow-up. Pediatric Infectious Disease Journal, 19(12), 1127-1134.
• Siegel M, Fuerst HT, and Peress NS. (1966). Comparative fetal mortality in maternal viral diseases: A prospective study on rubella, measles, mumps and chickenpox and hepatitis. New England Journal of Medicine, 274, 768-771.

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