MM-RVAXPRO

Characteristics of the medicinal product

MM-RVAXPRO is a measles, mumps and rubella vaccine. It is available as a powder and solvent for suspension for injection. The active ingredient is constituted by attenuated (weakened) viruses of the respective diseases.

Therapeutic indications

MM-RVAXPRO is indicated for vaccination against measles, mumps and rubella in subjects aged 12 months or older. The medicine can only be obtained with a prescription.

Method of use

MM-RVAXPRO should be injected by a doctor or nurse subcutaneously (just under the skin) in the upper arm or thigh. Individuals from 12 months or more should be given a 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 MM-RVAXPRO in neonates and infants under 12 months.

Mechanisms of action

MM-RVAXPRO is a vaccine. Vaccines act 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. In the event of exposure to the virus in the future, the immune system will be able to produce antibodies more quickly. Antibodies will help the body protect itself against diseases caused by these viruses.

MM-RVAXPRO is very similar to another authorized presentation of the measles, mumps and rubella vaccine (MMR II), with one small difference: whether the existing presentation is produced 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 that produces a yeast with a gene [DNA] that makes it able to produce human albumin).

Studies carried out

The study on MM-RVAXPRO compared the efficacy of the medicine with that of the previous presentation of measles, mumps and rubella vaccine in 1 279 children. the ability of the vaccine to induce the response to viruses in the immune system was evaluated. Another study conducted on another 1 997 children evaluated more specifically one of the components of the vaccine (mumps), 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 (which indicate how the immune system responded to the virus) are the following states: 98.3% for measles, 99.4% for mumps and 99.6% for rubella.

Associated risks

The most common side effects in children treated with MM-RVAXPRO were fever (38.5 ° C or higher) and reactions at the injection site (redness, pain, swelling). For the complete list of side effects detected with MM-VAXPRO, see the package leaflet.

MM-RVAXPRO should not be used in people who may be hypersensitive (allergic) to any measles, mumps or rubella vaccine, or to any of the excipients, including neomycin (an antibiotic).

MM-RVAXPRO should not be administered during pregnancy, in the presence of any disease with fever (more than 38.5 ° C), active untreated tuberculosis or when the patient is suffering from any disease affecting the immune system. For the complete list of limitations, see the package leaflet.

Grounds for approval

The Committee for Medicinal Products for Human Use (CHMP) decided that the benefits of MM-RVAXPRO outweigh the risks for the combined measles, mumps and rubella vaccination in individuals starting at 12 months of age. The CHMP therefore recommended that it be granted marketing authorization for MM-RVAXPRO.

Measures taken to ensure the safe use of the medicine

The company that produces MM-RVAXPRO will continue to monitor side effects to see if the use of recombinant albumin in the MM-RVAXPRO production process causes undesirable effects such as allergic reactions.