Absence of latex in the primary packaging of influenza vaccines
AIFA communication - 02/22/2018
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 and of what is reported in the SPC/FI of these vaccines, the Agency therefore provides the following summary information in order to further contribute to the safe and correct use of seasonal influenza vaccines even in subjects with a history of severe allergic reactions to latex:
| Holder AIC | Commercial name | Latex presence | Source of Information |
| Abbott | Influvac S Batrevac |
Does not contain latex* – The possibility that they may have come into contact with instruments containing it is not excluded | Owner communication AIC |
| Glaxo Smith Kline Biologicals SA. | Fluarix Tetra Fluarix Trivalent (not marketed in Italy) |
Does not contain latex - Not used in the manufacturing process | Owner communication AIC |
| Sanofi Pasteur Europe | Intance Vaxigrip Tetra Vaxigrip (not marketed in Italy) |
Does not contain latex - Not used in the manufacturing process | Owner communication AIC |
| Seqirus GMBH | Afluria (not marketed in Italy) | Does not contain latex - Not used in the manufacturing process | Owner communication AIC |
| Seqirus SRL | Fluad Agrippal S1 Influwells Subunit |
“Latex Sensitive Individuals: The safe use of [name of the vaccine] in individuals sensitive to latex; however, it is represented that no natural rubber latex was found in the protective cap of the syringe.” | Paragraph 4.4 of the SPC and paragraph 2 of the FI |
* The company advises patients who are extremely sensitive to latex to consult their doctor before administering the vaccine.
