Influenza vaccines, possible traces of latex in the components of pre-filled syringes or nasal applicators of 7 flu vaccines produced by three pharmaceutical companies for the 2019-2020 season. An event that is not ruled out by the Italian Medicines Agency (Aifa) and which can be dangerous for latex allergies, which in the presence of this substance even in traces, would be exposed to the risk of allergic reactions. The agency's invitation to allergy sufferers is therefore to consult the doctor before the vaccine is given.
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«The message published by Aifa is intended only for the packaging of influenza vaccines to protect those with allergies to this substance. This is to allow even more allergy sufferers adequate vaccination by informing them about latex-free products. However, no contamination in influenza vaccines », however, stated the Agency. Possible traces of latex they do not concern the vaccines themselves but rather external components such as actually parts of the syringes such as the cylinder, piston, needle cap and tip cap, or they could have been determined by contact during the production process.
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The information campaign is ongoing #antinfluenzale. Watch out for seasonal problems and fight us #fakenews. Follow the instructions for vaccines on vaccines #AIFA, @MinisteroSalute and @istsupsan pic.twitter.com/3uS8u1kPys
– AIFA (@Aifa_ufficiale) November 13, 2019
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Nothing to do with cases like the Fluad Flu vaccine from Novartis, of which 2014 was partially withdrawn following the reporting of various suspected deaths following the administration of the product. In terms of gate risk, AIFA has in fact conducted an in-depth study with the companies that have a vaccine license (AIC) to protect allergy sufferers. Based on the EU guidelines, there is already a warning in the product information sheet if the latex is present in any amount. In the absence of latex, however, the introduction of specific declarations is not required.
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However, in order to better protect allergic persons, AIFA has asked to certify the presence or not of latex in the components of the primary packaging, unless stated in the brochure, to contact all the companies concerned. The verification showed that the presence of latex is not excluded for 7 vaccines. This is the company Mylan IRE HEALTHCARE LIMITED with the vaccine "Influvac S tetrà" for which AIFA states that "it does not contain latex" but "it cannot be excluded that the vaccine came into contact with production with tools containing latex"; company Mylan Italia S.r.l. with the "Influvac S *" vaccine; company Seqirus srl with the vaccines Agrippal S1, Fluad, Influpozzi subunit, Innoflu *, Flucelvax tetra. For these last vaccines "it cannot be ruled out that the needle guard and the protective caps in the syringes do not contain latex". Therefore, AIFA recommends latex-sensitive patients to consult their physician before the vaccine is given. The goal, therefore, Aifa notes, is to provide "summary information to further contribute to the safe and correct use of seasonal flu vaccines even in people with a history of severe allergic latex reactions.
THIS IS THE DETAIL OF VACCINES
– Influvac S tetra * (Mylan Ire Healthcare Limited) «does not contain latex – the possibility that the vaccine will not be excluded during the production process in contact with latex-containing instruments. Latex-sensitive patients are advised to consult a physician before administering the vaccine ».
– I donfluvac S * (Mylan Italia S.r.l.) «does not contain latex – the possibility that the vaccine will not be excluded during the production process in contact with instruments containing latex. Latex-sensitive patients are advised to consult a physician before administering the vaccine ».
– Fluarix tetra * (Glaxo Smith Kline Biologicals Sa) "does not contain latex – not used in the production process".
– Wax grip tetra * (Sanofi Pasteur Europe) "does not contain latex – not used in the production process".
In the case of Agrippal S1 *, Fluad *, Influpozzi subunit *, Innoflu * and Flucelvax tetra * (Seqirus srl) «it cannot be excluded that the needle covers and the protective caps in the syringes do not contain latex. Latex-sensitive patients are advised to consult a physician before administering the vaccine ». Finally, Fluenz tetra * (AstraZeneca AB) does not contain "latex – not used in the production process".
Last updated at 21.16
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