Live measles, mumps & rubella virus vaccine.
M-M-R II vaccine is a sterile lyophilized preparation of (1) Measles Virus Vaccine Live, an attenuated line of measles virus, derived from Enders' attenuated Edmonston strain and propagated in chick embryo cell culture; (2) Mumps Virus Vaccine Live, the Jeryl Lynn (B level) strain of mumps virus propagated in chick embryo cell culture; and (3) Rubella Virus Vaccine Live, the Wistar RA 27/3 strain of live attenuated rubella virus propagated in WI-38 human diploid lung fibroblasts. The cells, virus pools, recombinant human serum albumin and fetal bovine serum used in manufacturing are tested and determined to be free of adventitious agents.
After reconstitution, each 0.5 mL dose contains not less than 3.0 log10 TCID50 (tissue culture infectious doses) of measles virus; 4.1 log10 TCID50 of mumps virus; and 3.0 log10 TCID50 of rubella virus.
Excipients/Inactive Ingredients: Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), porcine hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), approximately 25 mcg of neomycin and other buffer and media ingredients. The product contains no preservative.
Pharmacology: Mechanism of Action: M-M-R II vaccination induces antibodies to measles, mumps, and rubella associated with protection which can be measured by neutralization assays, hemagglutination-inhibition (HI) assays, or enzyme linked immunosorbent assay (ELISA) tests. Results from efficacy studies or effectiveness studies that were previously conducted for the component vaccines of M-M-R II were used to define levels of serum antibodies that correlated with protection against measles, mumps, and rubella [see Clinical Studies as follows].
Persistence of Antibody Responses After Vaccination: Neutralizing and ELISA antibodies to measles, mumps, and rubella viruses are still detectable in 95-100%, 74-91%, and 90-100% of individuals respectively, 11 to 13 years after primary vaccination.
Clinical Studies: Clinical Efficacy: Efficacy of measles, mumps, and rubella vaccines was established in a series of double-blind controlled trials. These studies also established that seroconversion in response to vaccination against measles, mumps and rubella paralleled protection.
Immunogenicity: Clinical studies enrolling 284 triple seronegative children, 11 months to 7 years of age, demonstrated that M-M-R II vaccine is immunogenic. In these studies, a single injection of the vaccine induced measles HI antibodies in 95%, mumps neutralizing antibodies in 96%, and rubella HI antibodies in 99% of susceptible individuals.
A study of 6-month-old and 15-month-old infants born to mothers vaccinated with a measles vaccine in childhood, demonstrated that, following infant and toddler vaccination with Measles Virus Vaccine, Live (previously US-licensed, manufactured by Merck), 74% of the 6-month-old infants developed detectable neutralizing antibody titers while 100% of the 15-month-old infants vaccinated with Measles Virus Vaccine, Live or M-M-R II vaccine developed neutralizing antibodies. When the 6-month-old infants of immunized mothers were revaccinated at 15 months with M-M-R II vaccine, they developed antibody titers similar to those of toddlers who were vaccinated previously at 15-months of age.
Toxicology: Nonclinical Toxicology: Carcinogenesis, Mutagenesis, Impairment of Fertility: M-M-R II vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.
M-M-R II is a vaccine indicated for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.
For subcutaneous use only.
Dose and Schedule: Each 0.5 mL dose is administered subcutaneously.
The first dose is administered at 12 to 15 months of age. A second dose is administered at 4 to 6 years of age.
The second dose may be administered prior to 4 years of age, provided that there is a minimum interval of one month between the doses of measles, mumps and rubella virus vaccine, live.
Children who received an initial dose of measles, mumps and rubella vaccine prior to their first birthday should receive additional doses of vaccine at 12-15 months of age and at 4-6 years of age to complete the vaccination series [see Pharmacology: Clinical Studies: Immunogenicity under Actions].
For post-exposure prophylaxis for measles, administer a dose of M-M-R II vaccine within 72 hours after exposure.
Preparation and Administration: Use a sterile syringe free of preservatives, antiseptics, and detergents for each injection and/or reconstitution of the vaccine because these substances may inactivate the live virus vaccine. To reconstitute, use only the diluent supplied with the vaccine since it is free of preservatives or other antiviral substances which might inactivate the vaccine.
PREFILLED SYRINGE OF DILUENT: To reconstitute the vaccine, inject the entire content of the syringe into the vial of lyophilized vaccine and gently agitate to mix thoroughly. Withdraw the entire contents of the reconstituted vaccine vial into the same syringe and inject the entire volume.
If two needles are provided: use one needle to reconstitute the vaccine and the other for its administration to the person to be vaccinated.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Visually inspect the vaccine before and after reconstitution prior to administration. Before reconstitution, the lyophilized vaccine is a light yellow compact crystalline plug, when reconstituted, is a clear yellow liquid. Discard if particulate matter or discoloration are observed in the reconstituted vaccine.
To minimize loss of potency, administer M-M-R II as soon as possible after reconstitution. If not used immediately, the reconstituted vaccine may be stored between 36°F to 46°F (2°C to 8°C), protected from light, for up to 8 hours. Discard reconstituted vaccine if it is not used within 8 hours.
Hypersensitivity: Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) or who have experienced a hypersensitivity reaction following administration of a previous dose of M-M-R II vaccine or any other measles, mumps and rubella-containing vaccine. Do not administer M-M-R II vaccine to individuals with a history of anaphylaxis to neomycin [see Description].
Immunosuppression: Do not administer M-M-R II vaccine to individuals who are immunodeficient or immunosuppressed due to disease or medical therapy. Measles inclusion body encephalitis (MIBE), pneumonitis and death as a direct consequence of disseminated measles vaccine virus infection have been reported in immunocompromised individuals inadvertently vaccinated with measles-containing vaccine. In this population, disseminated mumps and rubella vaccine virus infection have also been reported.
Moderate or Severe Febrile Illness: Do not administer M-M-R II vaccine to individuals with an active febrile illness with fever >101.3°F (>38.5°C).
Active Untreated Tuberculosis: Do not administer M-M-R II vaccine to individuals with active untreated tuberculosis (TB).
Pregnancy: Do not administer M-M-R II to individuals who are pregnant or who are planning on becoming pregnant within the next month [see Pregnancy under Use in Pregnancy & Lactation; Patient Counselling Information].
Febrile Seizure: There is a risk of fever and associated febrile seizure in the first 2 weeks following immunization with M-M-R II vaccine. For children who have experienced a previous febrile seizure (from any cause) and those with a family history of febrile seizures there is a small increase in risk of febrile seizure following receipt of M-M-R II vaccine [see Adverse Reactions].
Hypersensitivity to Eggs: Individuals with a history of anaphylactic, anaphylactoid, or other immediate reactions (e.g., hives, swelling of the mouth and throat, difficulty breathing, hypotension, or shock) subsequent to egg ingestion may be at an enhanced risk of immediate-type hypersensitivity reactions after receiving M-M-R II vaccine. The potential risks and known benefits should be evaluated before considering vaccination in these individuals.
Thrombocytopenia: Transient thrombocytopenia has been reported within 4-6 weeks following vaccination with measles, mumps and rubella vaccine. Carefully evaluate the potential risk and benefit of vaccination in children with thrombocytopenia or in those who experienced thrombocytopenia after vaccination with a previous dose of measles, mumps, and rubella vaccine [see Adverse Reactions].
Family History of Immunodeficiency: Vaccination should be deferred in individuals with a family history of congenital or hereditary immunodeficiency until the individual's immune status has been evaluated and the individual has been found to be immunocompetent.
Immune Globulins and Transfusions: Immune Globulins (IG) and other blood products should not be given concurrently with M-M-R II [see Immune Globulins and Transfusions under Interactions]. These products may contain antibodies that interfere with vaccine virus replication and decrease the expected immune response.
The Advisory Committee on Immunization Practices (ACIP) has specific recommendations for intervals between administration of antibody containing products and live virus vaccines.
Use in Children: M-M-R II vaccine is not approved for individuals less than 12 months of age. Safety and effectiveness of measles vaccine in infants below the age of 6 months have not been established [see Pharmacology: Clinical Studies under Actions]. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established.
Use in the Elderly: Clinical studies of M-M-R II did not include sufficient numbers of seronegative subjects aged 65 and over to determine whether they respond differently from younger subjects.
Pregnancy: Risk Summary: M-M-R II vaccine is contraindicated for use in pregnant women because infection during pregnancy with the wild-type viruses has been associated with maternal and fetal adverse outcomes.
Increased rates of spontaneous abortion, stillbirth, premature delivery and congenital defects have been observed following infection with wild-type measles during pregnancy. Wild-type mumps infection during the first trimester of pregnancy may increase the rate of spontaneous abortion.
Infection with wild-type rubella during pregnancy can lead to miscarriage or stillbirth. If rubella infection occurs during the first trimester of pregnancy, it can result in severe congenital defects, Congenital Rubella Syndrome (CRS). Congenital Rubella Syndrome in the infant includes but is not limited to eye manifestations (cataracts, glaucoma, retinitis), congenital heart defects, hearing loss, microcephaly, and intellectual disabilities. M-M-R II vaccine contains live attenuated measles, mumps and rubella viruses. It is not known whether M-M-R II vaccine can cause fetal harm when administered to pregnant woman. There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant women.
All pregnancies have a risk of birth defect, loss or other adverse outcomes. In the US general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Available data suggest the rates of major birth defects and miscarriage in women who received M-M-R II vaccine within 30 days prior to pregnancy or during pregnancy are consistent with estimated background rates (see Data as follows).
Data: Human Data: A cumulative assessment of post-marketing reports for M-M-R II vaccine from licensure 01 April 1978 through 31 December 2018, identified 796 reports of inadvertent administration of M-M-R II vaccine occurring 30 days before or at any time during pregnancy with known pregnancy outcomes. Of the prospectively followed pregnancies for whom the timing of M-M-R II vaccination was known, 425 women received M-M-R II vaccine during the 30 days prior to conception through the second trimester. The outcomes for these 425 prospectively followed pregnancies included 16 infants with major birth defects, 4 cases of fetal death and 50 cases of miscarriage. No abnormalities compatible with congenital rubella syndrome have been identified in patients who received M-M-R II vaccine. Rubella vaccine virus can cross the placenta, leading to asymptomatic infection of the fetus. Mumps vaccine virus has also been shown to infect the placenta, but there is no evidence that it causes congenital malformations or disease in the fetus or infant.
The CDC established the Vaccine in Pregnancy registry (1971-1989) of women who had received rubella vaccines within 3 months before or after conception. Data on 1221 inadvertently vaccinated pregnant women demonstrated no evidence of an increase in fetal abnormalities or cases of Congenital Rubella Syndrome (CRS) in the enrolled women.
Lactation: Risk Summary: It is not known whether measles or mumps vaccine virus is secreted in human milk. Studies have shown that lactating postpartum women vaccinated with live attenuated rubella vaccine may secrete the virus in breast milk and transmit it to breast-fed infants. In the breast-fed infants with serological evidence of rubella virus vaccine strain antibodies, none exhibited severe disease; however, one exhibited mild clinical illness typical of acquired rubella.
The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for M-M-R II, and any potential adverse effects on the breastfed child from M-M-R II or from the underlying maternal condition. For preventive vaccines, the underlying maternal condition is susceptibility to disease prevented by the vaccine.
The following adverse reactions include those identified during clinical trials or reported during post-approval use of M-M-R II vaccine or its individual components.
Body as a Whole: Panniculitis; atypical measles; fever; syncope; headache; dizziness; malaise; irritability.
Cardiovascular System: Vasculitis.
Digestive System: Pancreatitis; diarrhea; vomiting; parotitis; nausea.
Hematologic and Lymphatic Systems: Thrombocytopenia; purpura; regional lymphadenopathy; leukocytosis.
Immune System: Anaphylaxis, anaphylactoid reactions, angioedema (including peripheral or facial edema) and bronchial spasm.
Musculoskeletal System: Arthritis; arthralgia; myalgia.
Nervous System: Encephalitis; encephalopathy; measles inclusion body encephalitis (MIBE); subacute sclerosing panencephalitis (SSPE); Guillain-Barré Syndrome (GBS); acute disseminated encephalomyelitis (ADEM); transverse myelitis; febrile convulsions; afebrile convulsions or seizures; ataxia; polyneuritis; polyneuropathy; ocular palsies; paresthesia.
Respiratory System: Pneumonia; pneumonitis; sore throat; cough; rhinitis.
Skin: Stevens-Johnson syndrome; acute hemorrhagic edema of infancy; Henoch-Schönlein purpura; erythema multiforme; urticaria; rash; measles-like rash; pruritus; injection site reactions (pain, erythema, swelling and vesiculation).
Special Senses - Ear: Nerve deafness; otitis media.
Special Senses - Eye: Retinitis; optic neuritis; papillitis; conjunctivitis.
Urogenital System: Epididymitis; orchitis.
Corticosteroids and Immunosuppressive Drugs: M-M-R II vaccine should not be administered to individuals receiving immunosuppressive therapy, including high dose corticosteroids. Vaccination with M-M-R II vaccine can result in disseminated disease due to measles vaccine in individuals on immunosuppressive drugs [see Immunosuppression under Contraindications].
Immune Globulins and Transfusions: Administration of immune globulins and other blood products concurrently with M-M-R II vaccine may interfere with the expected immune response [see Immune Globulins and Transfusions under Precautions]. The ACIP has specific recommendations for intervals between administration of antibody containing products and live virus vaccines.
Tuberculin Skin Testing: It has been reported that live attenuated measles, mumps and rubella virus vaccines given individually may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin skin test with tuberculin purified protein derivative (PPD) is to be done, it should be administered before, simultaneously with, or at least 4 to 6 weeks after vaccination with M-M-R II vaccine.
Use with Other Live Viral Vaccines: M-M-R II vaccine can be administered concurrently with other live viral vaccines. If not given concurrently, M-M-R II vaccine should be given one month before or one month after administration of other live viral vaccines to avoid potential for immune interference.
M-M-R II is supplied as a single-dose vial of lyophilized vaccine and a syringe of diluent.
To maintain potency, M-M-R II must be stored between -50°C and +8°C (-58°F to +46°F). Use of dry ice may subject M-M-R II to temperatures colder than -50°C (-58°F).
Protect the vaccine from light at all times, since such exposure may inactivate the viruses.
Before reconstitution, store the lyophilized vaccine at 2°C to 8°C (36°F to 46°F). The diluent may be stored in the refrigerator with the lyophilized vaccine or separately at room temperature. Do not freeze the diluent.
It is recommended that the vaccine be used as soon as possible after reconstitution. Store reconstituted vaccine in the vaccine vial in dark place at 2°C to 8°C (36°F to 46°F) and discard if not used within 8 hours.
J07BD52 - measles, combinations with mumps and rubella, live attenuated ; Belongs to the class of morbilli viral vaccines.
MMR II vaccine (inj)
(single-dose vial) 0.5 mL x 1's
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