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Who is at Highest Risk for Complications from Rubella Vaccine?


Complications from rubella vaccine

Contraindications to receiving the MMRII vaccine documented in Merck’s package insert include:1

  • Persons who have experienced a severe allergic reaction or anaphylaxis to any MMR vaccine component, including gelatin and neomycin, should not be vaccinated with MMR;
  • Pregnant women should not receive this vaccine, and women seeking to become pregnant should avoid becoming pregnant for three months following MMR vaccination;
  • Individuals receiving immunosuppressive therapy. Vaccination with MMR should be delayed for three months following the administration of human immune globulin, blood, or plasma;
  • Persons with leukemia, lymphoma, blood dyscrasias and other malignant neoplasms affecting the lymphatic systems or bone marrow;
  • Individuals with febrile respiratory illness or other active febrile infection should avoid MMR vaccine;
  • MMR and other measles-containing vaccines are not recommended for HIV-infected persons with evidence of severe immunosuppression;
  • Persons with a family history of hereditary or congenital immunodeficiency should not be vaccinated with MMR until the immune competence of the recipient has been determined;
  • Individuals with untreated tuberculosis should not be vaccinated with MMR vaccine.

Merck’s MMRII package insert also warns that caution should be taken when administering the vaccine to individuals with a history of cerebral injury, family or personal history of convulsions, or any other condition where stress related to fever should be avoided. A person with thrombocytopenia may exacerbate their condition by receiving the MMR vaccine.

Both live measles and mumps vaccine are manufactured in chick embryo cell culture. Extreme caution should be taken when vaccinating individuals with a history of anaphylaxis or immediate hypersensitivity to eggs. Merck advises careful evaluation of the risks and benefits when considering vaccination in this population.

Rubella vaccine virus has been found in the breast milk of nursing mothers and there is  documentation that the virus can be transferred to infants. Serological evidence of rubella infection and a case of mild clinical illness typical with an acquired rubella infection has also been documented in a nursing infant. Because of these findings, Merck cautions the use of MMR vaccine in nursing women.

IMPORTANT NOTE: Even though the CDC’s Advisory Committee on Immunization Practices (ACIP) states that Merck’s MMRII vaccine can be administer at the same time as other viral and bacterial vaccines, Merck’s MMRII package information insert states that other live virus vaccines—such as varicella2 should NOT be given at the same time as MMR vaccine but rather should be administered one month prior or one month after MMR vaccination.3

Additionally, Merck’s package insert does not recommend giving MMRII at the same time as DTP (diphtheria, tetanus, and pertussis) and/or OPV (oral poliovirus vaccine) even though the Advisory Committee on Immunization Practices (ACIP) has stated that simultaneous administration of the entire recommended vaccine series is acceptable.4

MMRII vaccine is approved for use in persons 12 months of age and older. Despite recommendations by the CDC’s Advisory Committee on Immunization (ACIP) that children between 6 and 12 months traveling or residing abroad be vaccinated with MMR prior to international travel,5 Merck’s MMRII package insert states that effectiveness and safety has not been established in this population.6 Studies have determined that early vaccination of an infant often results in vaccine failure due to both the infant’s immature immune system response as well as the presence of maternal antibodies that interfere with vaccination. Early vaccination can result in reduced antibodies that persist, despite revaccination.7

Contraindications to receiving MMR-V (ProQuad) vaccine documented in Merck’s package insert include:8

  • Persons who have experienced a severe allergic reaction or anaphylaxis to any MMR-V vaccine component, including gelatin and neomycin, should not be vaccinated with MMR-V;
  • Febrile illness or active untreated tuberculosis;
  • Persons with acquired or primary immunodeficiency status and individuals receiving immunosuppressive therapy. Vaccination with MMR-V should be delayed for three months following the administration of human immune globulin, blood, or plasma;
  • Individuals with a family history of hereditary or congenital immunodeficiency;
  • Pregnant women;
  • Persons with leukemia, lymphoma, blood dyscrasias and other malignant neoplasms affecting the lymphatic systems or bone marrow.

Merck’s MMR-V (ProQuad) package insert warns of a higher incidence of fever and febrile seizures in children between the ages of 12- and 23-months following administration of MMR-V when compared with children who received separate doses of MMR and varicella vaccines. Caution is advised when administering MMR-V in children with a history of seizures, cerebral injury, or any other medical condition where stress from fever should be avoided.

Both live measles and mumps vaccine are manufactured in chick embryo cell culture. Extreme caution should be taken when vaccinating individuals with a history of anaphylaxis or immediate hypersensitivity to eggs. Merck advises careful evaluation of the risks and benefits when considering vaccination in this population.

Merck’s MMR-V vaccine package insert reports that transmission of varicella vaccine virus may occur between vaccine recipients and susceptible contacts, including high risk individuals, resulting in both the development or non-development of varicella-like rash. As a result, Merck cautions that vaccine recipients should attempt to avoid close contact with high risk individuals. This population includes pregnant women who lack a positive history of illness or vaccination, and their newborn infants, any infants born prior to 28 weeks gestation, and any immunocompromised individuals.

Merck also advises careful evaluation of the risks and benefits of vaccination with MMR-V in children with thrombocytopenia or history of the blood disorder as no clinical data on the development or exacerbation of this condition exists. Thrombocytopenia has been reported following vaccination with MMRII, measles vaccine, varicella vaccine and again following an additional dose of both measles and MMRII vaccines.

The safety and efficiency of MMR-V has not been determined in children who are infected with human immunodeficiency virus (HIV).

Children between 12 months and 12 years of age who receive MMR-V vaccine should avoid the use of salicylate (aspirin) or salicylate-containing products for six weeks following vaccination due to the risk of Reyes Syndrome.

MMR-V is approved for use in children 12 months to 12 years of age. Children under 12 months or those older than 12 years should not receive MMR-V vaccine.

IMPORTANT NOTE: NVIC encourages you to become fully informed about Rubella and the Rubella vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

« Return to Vaccines & Diseases Table of Contents

References

1 Merck, Sharp & Dohme Corp. Measles, Mumps and Rubella Virus Vaccine, Live Package Insert. U.S. Food and Drug Administration Dec. 14, 2020.

2 Merck, Sharp & Dohme Corp. Package Insert - Varivax (Frozen). U.S. Food and Drug Administration Sept. 16, 2020.

3 Merck, Sharp & Dohme Corp. Measles, Mumps and Rubella Virus Vaccine, Live Package Insert. U.S. Food and Drug Administration Dec. 14, 2020.

4 Merck, Sharp & Dohme Corp. Measles, Mumps and Rubella Virus Vaccine, Live Package Insert. U.S. Food and Drug Administration Dec. 14, 2020.

5  McLean HQ, Fiebelkorn AP, Temte JL. et al. Prevention of Measles, Rubella, Congenital Rubella Syndrome, and Mumps, 2013: Summary Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR June 2013; 62(RR04):1-34.

6 Merck, Sharp & Dohme Corp. Measles, Mumps and Rubella Virus Vaccine, Live Package Insert. U.S. Food and Drug Administration. Dec. 14, 2020.

7 Niewiesk S. Maternal Antibodies: Clinical Significance, Mechanism of Interference with Immune Responses, and Possible Vaccination Strategies Front Immunol September 2014; 5: 446.

8  Merck, Sharp & Dohme Corp. Package Insert - Refrigerator-Stable Formulation - ProQuad. U.S. Food and Drug Administration Sept. 17, 2020.


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