Characteristics of the medicine
M-M-RVAXPRO is a measles, mumps and rubella vaccine. It is available as a powder and solvent for suspension for injection. The active ingredient consists of attenuated (weakened) viruses of the respective diseases.
Therapeutic indications
M-M-RVAXPRO is indicated for vaccination against measles, mumps and rubella in individuals 12 months of age and older. The medicine can only be obtained with a prescription.
How to use
M-M-RVAXPRO is to be injected subcutaneously (just under the skin) in the upper arm or thigh by a doctor or nurse. Individuals aged 12 months or older should be given one dose. A second dose can be given at least 4 weeks after the first dose. The additional dose is intended for individuals who have not responded to the first dose for any reason. No information is available on the safety and efficacy of M-M-RVAXPRO in newborns and infants below 12 months.
Mechanisms of action
M-M-RVAXPRO is a vaccine. Vaccines work by "teaching" the immune system (the body's natural defense system) to defend itself against a disease. MM-RVAXPRO contains small amounts of attenuated forms of the viruses that cause measles, mumps, and rubella. When a person is vaccinated, the immune system recognizes the attenuated virus as "foreign" and produces antibodies against that virus. If exposed to the virus in the future, the immune system will be able to produce antibodies more quickly. The antibodies will help the body protect itself from disease. caused by these viruses.
MM-RVAXPRO is very similar to another licensed presentation of the measles, mumps and rubella (MMR II) vaccine, with one small difference: if the existing presentation is made with a protein (albumin) extracted from human serum (the liquid part of the blood), MM-RVAXPRO is instead produced with the same protein, but obtained using the so-called "recombinant DNA technology" (a technique whereby a yeast endowed with a gene [DNA] is produced which makes it capable of produce human albumin).
Studies carried out
The MM-RVAXPRO study compared the efficacy of the medicine to that of the previous presentation of measles, mumps and rubella vaccine in 1 279 children. The ability of the vaccine to induce virus response in immune system Another study in another 1,997 children evaluated one of the vaccine components (mumps) more specifically, showing that the level used in MM-RVAXPRO provides sufficient protection against the disease.
Benefits found following the studies
MM-RVAXPRO provided the same level of immune response as the measles, mumps and rubella vaccine containing serum albumin. The response rates obtained (indicating how the immune system responded to the virus) were as follows: 98 , 3% for measles, 99.4% for mumps and 99.6% for rubella.
Associated Risks
The most common side effects in children treated with M-M-RVAXPRO were fever (38.5 ° C or higher) and injection site reactions (redness, pain, swelling). For the full list of side effects reported with M-M-VAXPRO, see the package leaflet.
M-M-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps or rubella vaccine, or to any of the ingredients, including neomycin (an antibiotic).
M-M-RVAXPRO should not be administered during pregnancy, in the presence of any illness with fever (more than 38.5 ° C), untreated active tuberculosis or when the patient is suffering from any disease affecting the immune system. For the complete list of restrictions, see the package insert.
Reasons for approval
The Committee for Medicinal Products for Human Use (CHMP) decided that M-M-RVAXPRO's benefits are greater than its risks for the combined measles, mumps and rubella vaccination in individuals from 12 months of age. The CHMP therefore recommended the granting of the "Marketing Authorization" for M-M-RVAXPRO.
Measures taken to ensure safe use of the medicinal product
The company that makes M-M-RVAXPRO will continue to monitor side effects to see if the use of recombinant albumin in the production process of M-M-RVAXPRO causes unwanted effects such as allergic reactions.
Further information
On May 5, 2006, the European Commission granted Sanofi Pasteur MSD SNC a "Marketing Authorization" for M-M-RVAXPRO, valid throughout the European Union.
For the full evaluation version (EPAR) of M-M-RVAXPRO, click here.
Last update of this summary: 05-2006
The information on M-M-RVAXPRO Vaccine published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
