Two batches of Fluad made by Swiss Pharma giant Novartis were recalled by the Italian Medicines Agency (AIFA) last week after reports that three people had died and one suffered severe adverse effects soon after receiving a dose of the seasonal flu vaccine.
Yesterday, the National Network of Pharmacovigilance reported an 83 year old patient suffering from a serious condition has died following the administration of the vaccine, pushing the total number of deaths related to the two batches to 13.
The European Medicines Agency (EMA) has begun working with AIFA in the investigation of lots 143,301 and 142,701 of the vaccine, along with an analysis of the 13 patients who have died.
“There is so far no evidence to suggest a causal link between the vaccine and the reported adverse events,” the European agency has said, and the suspension of the vaccine is “a precautionary measure.”
The EMA’s statement mirrors that of Novartis which told our sister publication Biopharma-Reporter.com on Friday that “a review of the two batches has confirmed that they are in conformity with all production and quality standards,” and that the firm is working closely with the regulatory bodies for further assessment.
Over 65 million doses of Fluad – a seasonal flu vaccine containing the immunologic adjuvant MF59 - have been administered worldwide since Novartis received approval in 1997. The vaccine was temporarily banned by AIFA in 2012, after unknown protein particles were found in a batch.
In October, Novartis agreed to sell its flu vaccine division to CSL Limited for $275 (€214m), but the deal - which includes three facilities in the US, UK and Germany - is not set to go through until mid-next year.
Of the 13 deaths, eight occurred less than 24 hours after Fluad was administered, and nine involved patients who were over 80 years of age.
The issue will be discussed in greater detail at the EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) which begins today.