Update: Fluad, Sandovac
The batches of Fluad and Sandovac influenza vaccines temporarily suspended two weeks ago due to a suspected quality defect (white particles in the bulk of the vaccine) were re-released on Nov. 9, 2012. The review by the Italian Medicines Agency (Agenzia Italiana del Farmaco, AIFA) responsible in the EU concluded that there is no additional risk associated with the use of these batches.
According to the documentation submitted by the marketing authorization holder, the white particles are aggregates (small clumps) of normal protein components of the vaccine. Such aggregates may be formed during the manufacture of the vaccine, but dissolve when the syringe is used correctly (gentle shaking before injection, the pre-filled syringe should be at room temperature).
Flu vaccines are licensed in Austria for the prevention of influenza (flu). Fluad has been used for influenza prevention in persons 65 years of age and older and in persons with chronic diseases since 2000, and Sandovac has been used in adults and children since 1999.
Situation in Austria
In Austria, the following preparations were affected:
- Fluad Injection Suspension in a Prefilled Syringe.
- Sandovac Injection suspension in a prefilled syringe
The BASG has not received any adverse event reports for the above vaccines in the current vaccination season. The vaccines can therefore be used again with immediate effect.
BASG recommendation for users
- Users are urged to follow the recommendations of the valid technical information.