MMR

Disclaimer: This guide is for informational purposes only. By providing the information contained herein we are not diagnosing, treating, curing, mitigating, or preventing any type of disease or medical condition. Before beginning any type of natural, integrative or conventional treatment regimen, it is advisable to seek the advice of a licensed healthcare professional. May contain affiliate links. Product photos/descriptions provided by company websites. This is not medical advice.


Pharmaceutical Name

Trade (marketing or proprietary) name: M-M-R® II, PRIORIX

Generic (nonproprietary or active ingredient) name: Measles, Mumps, and Rubella Virus Vaccine Live Suspension for intramuscular or subcutaneous injection

Indication and Usage

Reason the product has been approved for sale on the market.

The FDA approved this vaccine for active immunization for the prevention of measles, mumps, and rubella in individuals 12 months of age and older.

Manufacturer Insert

Manufacturer Insert Icon
M-M-R® II
Manufacturer Insert Icon
PRIORIX

Ingredients

Also known as “excipients” for vaccines.

M-M-R II vaccine is a sterile lyophilized preparation of:

  • Measles Virus Vaccine Live, an attenuated line of measles virus, derived from Enders’ attenuated Edmonston strain and propagated in chick embryo cell culture;
  • Mumps Virus Vaccine Live, the Jeryl Lynn™ (B level) strain of mumps virus propagated in chick embryo cell culture; and
  • 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 approximately 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.

Each dose is calculated to contain sorbitol (14.5 mg), sucrose (1.9 mg), hydrolyzed gelatin (14.5 mg), recombinant human albumin (≤0.3 mg), fetal bovine serum (<1 ppm), approximately 25 mcg of neomycin and other buffer and media ingredients. The product contains no preservative.

PRIORIX contains the Schwarz strain of live attenuated measles virus, the RIT 4385 strain of live attenuated mumps virus (derived from the Jeryl Lynn strain), both propagated in
chick-embryo fibroblasts from embryonated eggs of specific pathogen-free flocks and the Wistar RA 27/3 strain of live attenuated rubella virus propagated in MRC-5 human diploid cells. The 3 virus strains are cultured in media containing amino acids, a small amount of neomycin sulfate and bovine serum albumin and are stabilized after multiple washing steps in media free from antibiotics and albumin. The attenuated measles, mumps and rubella viruses are then mixed with a stabilizer prior to lyophilization.

After reconstitution, each approximately 0.5-mL dose contains not less than 3.4 log10 Cell
Culture Infective Dose 50% (CCID50) of measles virus, 4.2 log10 CCID50 of mumps virus, and 3.3 log10 CCID50 of rubella virus. Each dose also contains 32 mg of anhydrous lactose, 9 mg of sorbitol, 9 mg of amino acids, and 8 mg of mannitol. Each dose may also contain residual
amounts of neomycin sulphate (≤25 mcg), ovalbumin (≤60 ng), and bovine serum albumin
(≤50 ng), from the manufacturing process.

Contraindications

Per the FDA, contraindications are conditions in a recipient that increases the risk for a serious adverse reaction. Product should not be administered when a patient has a listed contraindication.

M-M-R II

Hypersensitivity: Do not administer M-M-R II vaccine to individuals with a history of hypersensitivity to any component of the vaccine (including gelatin) {3} 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.

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 {4} (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.

PRIORIX

Severe Allergic Reactions: Do not administer PRIORIX to individuals with a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine or after a previous dose of any measles, mumps, and rubella virus-containing vaccine.

Immunosuppression: Due to the risk of disseminated vaccine virus infection, do not administer PRIORIX to individuals with severe humoral or cellular (primary or acquired) immunodeficiency.

Pregnancy: Do not administer PRIORIX to individuals who are pregnant. Pregnancy should be avoided for 1 month after vaccination.

Warnings and Precautions

Per the FDA, warnings are clinically significant adverse reactions or risks. According to the CDC, a precaution is a condition in a recipient that might increase the risk for a serious adverse reaction, might cause diagnostic confusion, or might compromise the effectiveness of the product. In general, a product should be deferred when a precaution is present.

M-M-R II

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.

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.

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. 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.

PRIORIX

Allergic Vaccine Reactions: Appropriate medical treatment used to manage immediate allergic reactions must be available in the event an acute anaphylactic reaction occurs following administration of PRIORIX.

Febrile Seizures: There is a risk of febrile seizure following immunization with PRIORIX.

Thrombocytopenia: Thrombocytopenia and thrombocytopenic purpura have been reported following vaccination with PRIORIX.

Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including PRIORIX. Procedures should be in place to avoid injury from fainting.

Latex: The tip caps of the prefilled syringes of diluent contain natural rubber latex, which may cause allergic reactions.

Risk of Vaccine Virus Transmission: Live attenuated rubella vaccine virus has been detected in the nose and throat of individuals 7 to 28 days after vaccination with a rubella virus containing vaccine.

Manufacturer-Listed Adverse Reactions

Per the CDC, adverse reactions are an undesirable medical condition that has been demonstrated to be caused by a vaccine. Evidence for the causal relation is usually obtained through randomized clinical trials, controlled epidemiologic studies, isolation of the vaccine strain from the pathogenic site, or recurrence of the condition with repeated vaccination (i.e., rechallenge); synonyms include side effect and adverse effect.

M-M-R® II can cause: Panniculitis, Atypical Measles, Fever, Syncope (Fainting), Headache, Dizziness, Malaise (Discomfort), Irritability. Vasculitis, Pancreatitis, Diarrhea, Vomiting, Parotitis, Encephalitis, Encephalopathy, Measles inclusion body encephalitis (MIBE), Subacute sclerosing panencephalitis (SSPE), Nausea, Thrombocytopenia, Purpura, Lymphadenopathy, Leukocytosis, Anaphylaxis, Anaphylactoid reactions, Angioedema, Peripheral or facial edema, Bronchial spasm, Arthritis, Arthralgia, Myalgia, Urticaria (Hives), Erythema multiforme, Measles-like rash, Papillitis, Orchitis, Epididymitis, Papillitis, Optic neuritis, Retinitis, Otitis media, Nerve deafness, Pruritus, Ataxia, Polyneuritis, Polyneuropathy, Ocular palsies, Paresthesia, Pneumonitis, Sore throat, Cough, Guillain-Barré Syndrome (GBS), Acute disseminated encephalomyelitis (ADEM), Transverse myelitis, Febrile convulsions, Afebrile convulsions or seizures, Pneumonia, Stevens-Johnson syndrome, Rhinitis (stuffy/runny nose), Acute hemorrhagic edema of infancy, Henoch-Schönlein purpura, Conjunctivitis (pink eye), Injection site reactions (pain, erythema, swelling and vesiculation.

PRIORIX can cause: Thrombocytopenia, thrombocytopenic purpura, Vasculitis (including Henoch-Schönlein purpura and Kawasaki syndrome), Anaphylactic reactions, Meningitis, measles-like illness, mumps-like illness (including orchitis, epididymitis, and
parotitis), Arthralgia, arthritis, Encephalitis, cerebellitis, cerebellitis-like symptoms (including transient gait disturbance and transient ataxia), Guillain-Barré syndrome, transverse myelitis, peripheral neuritis, afebrile seizures, syncope, and Erythema multiforme.

Limitation of Vaccine Effectiveness

Vaccination with PRIORIX may not protect all susceptible individuals.

Specific Populations

Pregnancy

M-M-R II/PRIORIX vaccine contains live attenuated measles, mumps and rubella viruses. 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. Post-marketing surveillance has identified one case of CRS following inadvertent vaccination of a pregnant woman with a measles, mumps, and rubella virus containing vaccine from an unknown manufacturer. There are no adequate and well-controlled studies of M-M-R II vaccine administration to pregnant women.

Breastfeeding

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.

Fertility

M-M-R II/PRIORIX vaccine has not been evaluated for carcinogenic or mutagenic potential or impairment of fertility.

Pediatric

M-M-R II/PRIORIX 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. Safety and effectiveness of mumps and rubella vaccine in infants less than 12 months of age have not been established.

Mechanism of Action

This is the specific biochemical interaction through which a drug or vaccine substance produces its pharmacological effect. This section also includes the minimum protective level designated for a certain disease.

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.

Humoral immune responses against measles, mumps, and rubella viruses induced by PRIORIX were measured by enzyme-linked immunosorbent assays (ELISAs). IgG antibodies measured by the ELISAs used in clinical studies of PRIORIX have been shown to correlate with the presence of neutralizing antibodies that have been associated with protection.

Analytical Deep Dive


What is informed consent?

Alternatives

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MUST READ: Physicians for Informed Consent for Measles, Mumps, and Rubella Disease Information.

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