AIFA. Vaccines. They do not contain latex

Comunicazione AIFA – 22/02/2018

To respond to a need particularly felt by people allergic to latex, the Italian Medicines Agency conducted an in-depth analysis directly with the companies holding the Marketing Authorization (AIC) on the absence of latex/latex/natural rubber in the various components of the pre-filled syringes (e.g. cap, piston, stopper) of the influenza vaccines authorized for the 2017-2018 season.

This information is in fact extremely important for those allergic to latex who need vaccination coverage, who, in the event of the presence of latex, even in traces, would be exposed to the risk of allergic reactions.

The European Commission guidelines on excipients in the labeling and package leaflet of medicinal products  provide for the insertion of a warning in the Package Leaflet in the event that the latex is present in any quantity, regardless of the route of administration of the medicinal product, while, in the event of the absence of latex, the insertion of specific declarations is not required; In any case, AIFA deemed it useful to contact all the MA holding companies, asking to certify, where not specified in the Summary of Product Characteristics (SPC) and in the FI, the absence of latex in the components of the pre-filled syringes.

Based on the statements provided in response by the owners of the AIC e di quanto riportato nell’RCP/FI di questi vaccini, l’Agenzia fornisce quindi le seguenti informazioni di riepilogo allo scopo di contribuire ulteriormente all’uso sicuro e corretto dei vaccini influenzali stagionali anche nei soggetti con storia di reazioni allergiche severe al latex:

* The company advises patients who are extremely sensitive to latex to consult their doctor before administering the vaccine.