MUMPSVAX®

MSD

Mumps Virus Vaccine, Live, Attenuated

Mumps Prophylaxis

Description: This vaccine is prepared from the Jeryl Lynn (B Level) strain, named after the patient from whom the virus was initially recovered.

Mumpsvax is a sterile lyophilized preparation of the Jeryl Lynn (B level) strain of mumps virus. The virus was adapted to and propagated in cell cultures of chick embryo, free of avian leukosis, virus and other adventitious agents according to the general procedures used to prepare Enders' measles virus vaccine, live, attenuated. The vaccine is tested for safety and efficacy.

The reconstituted vaccine is for s.c. administration. When reconstituted as directed, the dose of injection contains not less than the equivalent of 5 000 TCID50 (tissue culture infectious doses) of the US Reference Mumps Virus. Each dose contains approximately 17.5 µg of neomycin base (present as sulfate). The product contains no preservative. Sorbitol and hydrolized gelatin are added as stabilizers.

Action And Clinical Pharmacology: Usually, mumps is a mild disease. However, it may occasionally be severe and produce serious complications. For example, meningoencephalitis has been estimated to occur in about 10% of patients, and unilateral orchitis in about 20 to 30% of postpubertal males. Postinfectious encephalitis, oophoritis, pancreatitis, muscular weakness, myelitis, myocarditis, facial neuritis, arthritis, hepatitis, and deafness may also occur. The relationship of endocardial fibroelastosis in infants, and mumps in the mother during pregnancy, has not been conclusively established. Mumpsvax produces a modified, non-communicable mumps infection in susceptible persons. Extensive clinical trials have demonstrated that the vaccine is highly immunogenic and well tolerated. A single injection has been shown to induce mumps neutralizing antibodies in approximately 97% of susceptible children and approximately 93% of susceptible adults. The pattern of antibody response closely resembles that observed for natural mumps. Although the antibody level is significantly lower than that following natural infection, it is protective and long lasting. Vaccine-induced antibody levels have been shown to persist for at least 15 years with a rate of decline comparable to that seen in natural infection. If the present pattern continues, it will provide a basis for the expectation that immunity following vaccination will be permanent. However, continued surveillance will be required to demonstrate this point. Indications And Clinical Uses: Mumpsvax induces protective antibodies in essentially all nonimmune recipients, provides protection against natural mumps in most cases and has not been shown to cause significant systemic or local reactions. Evidence indicates that the mumps virus infection initiated by the vaccine is not contagious. For immunization against mumps in children 12 months of age or older, and adults. It is not recommended for infants less than a year old because they may retain maternal mumps neutralizing antibodies which may interfere with the immune response. Mumps vaccine is recommended for asymptomatic HIV infected children. Evidence indicates that the vaccine will not offer protection when given after exposure to natural mumps. Passively acquired antibody can interfere with the response to live, attenuated virus vaccines. Therefore, administration of mumps virus vaccine should be deferred until approximately 3 months after passive immunization. Revaccination: Based on available evidence, there is no reason to routinely revaccinate children vaccinated originally when 12 months of age or older. However, persons should be revaccinated if there is evidence to suggest that initial immunization was ineffective. Use with other vaccines: There are no data available concerning simultaneous use of Mumpsvax with monovalent or trivalent poliovirus vaccine, live, oral or with killed poliovirus vaccines. However, serologic evidence shows that when M-M-R containing the HPV-77 rubella strain is given simultaneously with trivalent poliovirus vaccine, live, oral, antibody responses can be expected to be comparable to those which follow administration of the vaccines at different times. From this it follows that when Mumpsvax is given simultaneously with either monovalent or trivalent poliovirus vaccine, live, oral, Attenuvax and/or Meruvax II, antibody responses can be expected to be comparable to those which follow administration of the vaccines at different times. Contra-Indications: Hypersensitivity to neomycin. Each dose of reconstituted vaccine contains approximately 17.5 µg of neomycin base (present as sulfate). Any febrile respiratory illness or other active febrile infection. Active untreated tuberculosis. Patients receiving therapy with ACTH, corticosteroids, irradiation, alkylating agents or antimetabolites. This contraindication does not apply to patients who are receiving corticosteroids as replacement therapy, e.g., for Addison's disease. Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems. Primary immunodeficiency states, including cellular immune deficiencies, hypogammaglobulinemic and dysgammaglobulinemic states. Also, individuals with symptomatic AIDS. Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated. Hypersensitivity to eggs, chicken or chicken feathers: This vaccine is essentially devoid of potentially allergenic substances derived from host tissues (chick embryo). However, because the attenuated virus in this vaccine is propagated in cell cultures of chick embryo, there is a potential risk of hypersensitivity reactions in patients allergic to eggs, chicken or chicken feathers. Widespread use of the vaccine for more than a decade has resulted in only rare, isolated reports of minor allergic reactions attributed to allergens of this kind, possibly related to the vaccine. Significantly, when children with known allergies to eggs, chicken and chicken feathers were given a similarly prepared vaccine in a clinical study, none experienced reactions other than those reactions previously observed in nonallergic children. Pregnancy: Do not give Mumpsvax to pregnant females; the possible effects of the vaccine on fetal development are unknown at this time. When vaccination of postpubertal females is undertaken, pregnancy at the time of vaccination must be ruled out and in addition, the possibility of pregnancy occurring in the 3 months following vaccination must be eliminated by medically acceptable methods. Precautions: For s.c. use; do not give i.v. Mumpsvax may be given simultaneously with monovalent or trivalent poliovirus vaccine, live, oral, with Attenuvax and/or Meruvax II. Mumpsvax should not be given less than 1 month before or after administration of other live virus vaccines. Adequate treatment provisions including epinephrine, should be available for immediate use should an anaphylactoid reaction occur. Vaccination should be deferred for at least 3 months following blood or plasma transfusions, or administration of human immune serum globulin. It has been reported that attenuated live mumps virus vaccine may result in a temporary depression of tuberculin skin sensitivity. Therefore, if a tuberculin test is to be done, it should be administered either before or simultaneously with Mumpsvax. As for any vaccine, vaccination with Mumpsvax may not result in seroconversion in 100% of susceptible persons given the vaccine. Adverse Reactions: Because of the slightly acidic pH (6.2 to 6.6) of the vaccine, patients may complain of burning and/or stinging of short duration at the injection site. Mild fever occurs occasionally. Fever above 39.4°C is uncommon. Parotitis has been reported to occur in very low incidence, and orchitis rarely in persons who were vaccinated. In most instances investigated, prior exposure to natural mumps was established. In other instances, whether or not this was due to vaccine or to prior natural mumps exposure or to other causes has not been established. Reports of purpura and allergic reactions such as wheal and flare at the injection site or urticaria have been extremely rare. Forms of optic neuritis, including retrobular neuritis and papillitis may infrequently follow viral infections, and have been reported to occur 1 to 3 weeks following inoculation with some live virus vaccines. Very rarely encephalitis, febrile seizures, deafness and other nervous system reactions have occurred in vaccinees. A cause-effect relationship has not been established. Clinical experience with the vaccine thus far indicates that CNS reactions such as meningoencephalitis, facial paresis, aphasia, ataxia and dystonia have occurred rarely within 4 days to 4 weeks following vaccine administration. A cause-effect relationship has not been established. In patients who have previously received killed mumps vaccine, it is possible that local reactions may occur at the site of injection with live mumps vaccine. This has not been reported with Mumpsvax. Shipment, Storage and Reconstitution: During shipment, to insure that there is no loss of potency, maintain the vaccine at 10°C or less. Prior to reconstitution, store the vaccine in a refrigerator at 2 to 8°C. Protect from light. To reconstitute, use only the diluent supplied, since it is free of preservatives or other antiviral substances which might inactivate the vaccine. First withdraw the entire volume of diluent into the syringe to be used for reconstitution. Inject all the diluent in the syringe into the vial of lyophilized vaccine, and agitate to mix thoroughly. Withdraw the entire contents into a syringe and inject the total volume of restored vaccine s.c. It is important to use a separate sterile syringe and needle for each individual patient to prevent transmission of hepatitis B and other infectious agents from one person to another. Use only the diluent supplied and reconstitute the vaccine just before using. Use the vaccine as soon as possible after reconstitution. Protect the vaccine from light at all times since such exposure may inactivate the virus. Store the reconstituted vaccine in a dark place at 2 to 8°C and discard if not used within 8 hours. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The vaccine's color when reconstituted is clear yellow. Dosage And Administration: The dosage of vaccine is the same for all persons. After suitably cleansing the immunization site, inject total volume (about 0.5 mL) of reconstituted vaccine s.c., preferably into the outer aspect of the upper arm. Do not inject i.v. Do not give immune globulin concurrently with Mumpsvax. Caution: A sterile syringe free of preservatives, antiseptics, and detergents should be used for each injection of the vaccine because these substances may inactivate the live virus vaccine. A 25 gauge, 15 mm needle is recommended. Availability And Storage: Boxes of 10 single-dose vials of vaccine and boxes of 10 vials of diluent. Diluent may be stored at room temperature.