The Italian Medicines Agency (AIFA) announced yesterday it was recalling two lots and suspending the use of the Swiss Biopharma’s seasonal flu vaccine after reports that three people died and one suffered severe adverse effects soon after being injected with a dose of Fluad.
The agency is awaiting the outcome of an investigation of lots 142701 and 143301 of Fluad but said in a statement it was banning the use “as a precautionary measure.”
In a statement sent to Biopharma-Reporter.com, Novartis said it had been notified by AIFA of the suspension adding “no causal relationship to the vaccine has been established.
“Patient safety is our first priority and we take these reports very seriously. A review of the two batches has confirmed that they are in conformity with all production and quality standards. Novartis is working closely with AIFA for further assessment.”
Since its approval in 1997, the firm says the product has a “robust safety history” with over 65 million doses of the trivalent, surface antigen, inactivated influenza virus vaccine have been administered worldwide. Despite this, the vaccine was temporarily banned by AIFA in 2012 after tests found a batch contained protein particles.
Last month Novartis agreed to sell its flu vaccine division to CSL Limited for $275m (€216m), which includes three manufacturing sites in Holly Springs, North Carolina, Liverpool, UK, and Marburg, Germany, with the deal is likely to go through in mid-2015.
Fluad is made by growing individual influenza virus strains in the allantoic cavity of embryonated hens’ eggs. These are then harvested and clarified separately by centrifugation and filtration prior to inactivation with formaldehyde.
The inactivated virus is then concentrated and purified by zonal centrifugation, before removing most of the internal proteins by centrifugation in the presence of cetyltrimethylammonium bromide (CTAB).
Fluad is adjuvanted with MF59, an immunologic adjuvant that uses squalene. According to Novartis, this gives a superior antibody response, as compared to conventional vaccines by offering varying degrees of cross-protection.