November 28, 2014
Regarding the precautionary suspension of two batches of Fluad in Italy, Novartis underlines that no causal relationship to the vaccine has been established to date.
Fluad is approved for vaccination of elderly patients (65+) and often prescribed to patients who suffer from pre-existing underlying medical conditions and have a weaker immune system. Serious medical events and deaths are unfortunately quite common in this patient population and hence a coincidental timely association with vaccination is not unusual.
The two suspended batches comprising of 500,000 doses were distributed solely in Italy after having passed all required safety and quality testing, including review by regulatory authorities before release to market.
Worldwide, more than 7 million doses of Fluad have been distributed. No unusual frequency of adverse events has been reported through the extensive pharmacovigilance system.
Fluad is an important vaccine to protect the elderly from influenza. They are at high risk of serious complications from influenza infections. In Europe alone, the death toll is estimated at 40,000 each year. Fluad was licensed in 1997 and has a solid safety history. The vaccine has been tested in clinical trials with 70,000 patients and more than 65 million doses have been distributed to date.