Serious adverse events of Novartis flu vaccine Fluad

By William Chin, PhD, Scientific Coordinator, EUCRAF

On the 28th Nov 2014, EMA has reported that the agency is working closely with the Italian medicines agencyExternal link icon(AIFA) to investigate the cause of serious adverse events in elderly patients who had received Fluad, Novartis’ adjuvanted seasonal influenza vaccine. This issue is currently being discussed in the PRAC meeting this week. To date, 13 deaths were reported in Italy within 48 hours of taking Fluad. For now, there is no direct correlation between the between the administration of vaccine and the reported adverse events. Two batches of Fluad amounting to approximately 500,000 doses solely distributed in Italy, have been put on a precautionary hold. Novartis confirmed that all Fluad batches have passed extensive analytical and safety testing and fulfill all required quality standards. Italian officials now say tests on the flu vaccine show the product is safe. Fluad has been approved for more than a decade in Europe to enhance the immune response in older adults, helping to overcome their naturally occurring immune vulnerability and enabling effective protection against influenza. Fluad is not approved in the United States.

This week (3-5 Dec 2014), EUCRAF is conducting a seminar entitled Particulars of specific product classes: monoclonal antibodies, vaccines, ATMPs and blood products. Michael Pfleiderer (Head of the field virus vaccines at Paul Ehrlich Institut, Chairman of the Vaccine Working Party, Chairman of the Pandemic Task Force, Chairman of the CHMP/BWP Influenza ad hoc Working Group) will be addressing the pre- and post-authorisation requirements for pandemic vaccines. 


1. EMA News, Investigation into reports of serious adverse events following use of Fluad

2. Fierce Vaccines, Novartis' Fluad off the hook in Italy following 19 deaths

3. The Daily Beast, Did This Flu Vaccine Kill 13?

4. Novartis, Safety and efficacy of Fluad vaccinations in Italy