AIFA has published information on the absence of latex/natural rubber from the different components of the immediate packaging (pre-filled syringes: e.g. cylinder, piston and seal, tip cover, protective needle cover cap, etc.; glass vials: e.g. stopper, cap; oral tubes and applicators) of mandatory and free vaccines as well as of non-mandatory, free and actively offered vaccines provided for in Law no. 119/2017 and authorised in Italy. This follows the necessary checks with marketing authorisation holders (MAHs).

This information is extremely important for those people who are allergic to natural rubber latex and need to receive a vaccine. In fact, the presence of latex, even in traces, in the vaccine would expose such people to the risk of allergic reactions.

The European Commission guideline on excipients in the labelling and package leaflet of medicinal products for human use provides for the inclusion of a warning (‘The container of this medicinal product contains latex rubber. May cause severe allergic reactions’) in the package leaflet (PL), should latex/natural rubber be present in any quantity, regardless of the route of administration of the medicinal product.

If latex/natural rubber is not present, the inclusion of a specific warning in the PL is not required.

In addition to these provisions, AIFA has considered it appropriate to contact the MAHs of the above-mentioned vaccines, asking to confirm the absence of latex/natural rubber from the different components of the immediate packaging, in case no specific warning is included in the Summary of Product Characteristics (SmPC) and Patient Leaflet.

Based on the statements made by the MAHs and on the information included in the SmPC/PL of these vaccines, AIFA provides summary information ("Related documents"). 

Please note that not all vaccines (and/or their packs and formulations) may be currently marketed in Italy.

The asterisk (*) indicates those vaccines for which the presence of latex/natural rubber cannot be excluded.

Published on: 17 February 2021