Measles, mumps and rubella vaccine

LICENSED INDICATION, verbatim §4.1: 'PRIORIX is indicated for active immunisation of children from the age of 9 months or older, adolescents and adults against measles, mumps and rubella. For use in children between 9 to 12 months of age see sections 4.2, 4.4 and 5.1.' || VERBATIM UK SPC §4.2 (PRIORIX powder and solvent for solution for injection in a pre-filled syringe): 'The use of PRIORIX should be based on official recommendations. Individuals 12 months of age or older: The dose is 0.5 ml. A second dose should be given according to official recommendations. PRIORIX may be used in individuals who have previously been vaccinated with another monovalent or combined measles, mumps and rubella vaccine. Infants between 9 and 12 months of age: Infants in their first year of life may not respond sufficiently to the components of the vaccines. In case an epidemiological situation requires vaccinating infants in their first year of life (e.g. outbreak or travel to endemic regions), a second dose of PRIORIX should be given in the second year of life, preferably within three months after the first dose. Under no circumstances should the interval between doses be less than four weeks. Infants less than 9 months of age: The safety and efficacy of PRIORIX in infants under 9 months of age has not been established. Method of administration: PRIORIX is for subcutaneous injection, although it can also be given by intramuscular injection, in the deltoid region or in the anterolateral area of the thigh. The vaccine should preferably be administered subcutaneously in patients with thrombocytopenia or any coagulation disorder.' || NO MAXIMUM IS STATED. The SPC prints no maximum dose, and none is shown on this page. The only quantitative limit anywhere in its posology section is the four-week minimum interval between doses quoted above — that is a minimum interval, not a dose ceiling. || SINGLE-BRAND SOURCE: the page lists two brands (MMR VaxPro, Priorix) and only the Priorix SPC has been recovered. Priorix matches the page exactly on drug, route, indication and population, so its posology is published here with its brand named in the dose text — but MMR VaxPro's own SPC must be consulted before the volume, schedule or age limits are applied to that product. || THE SCHEDULE IS NOT IN THE SPC: the SPC defers the dosing schedule to 'official recommendations' twice and gives no vaccination ages beyond those quoted above. The routine UK schedule ages have NOT been taken from this source and must be read from the current national immunisation schedule. || Some sections of the product information we used were incomplete — check the full SPC. || ADMINISTRATION PRECAUTION (§4.4): 'Alcohol and other disinfecting agents must be allowed to evaporate from the skin before injection of the vaccine since they can inactivate the attenuated viruses in the vaccine.' || EGG PROTEIN (§4.4): the measles and mumps components are produced in chick embryo cell culture and may contain traces of egg protein; individuals who have experienced anaphylaxis after egg ingestion should be vaccinated with extreme caution with adequate treatment for anaphylaxis on hand. Record the name and batch number of the administered product for traceability.

AGE GATES, from the SPC's indications and posology sections. Licensed from 9 months of age. Individuals 12 months of age or older: 'The dose is 0.5 ml.' Infants between 9 and 12 months of age: the SPC gives no separate dose volume for this band — it gives only the schedule rule, namely that infants in their first year may not respond sufficiently, that vaccination in the first year is for situations where the epidemiology requires it (e.g. outbreak or travel to endemic regions), and that a second dose should then be given in the second year of life, preferably within three months of the first. Infants less than 9 months of age: 'The safety and efficacy of PRIORIX in infants under 9 months of age has not been established.' No maximum dose is stated in the SPC and none is recorded here. Figures are PRIORIX's; MMR VaxPro's own SPC was not fetched.