Deaths after Fluad flu vaccine and the epidemic of panic in Italy

As the flu season reaches its peak, we report the detrimental effects of poorly managed risk communication.1

On 27 November 2014, the Italian Medicines Agency suspended, as a precautionary measure, the use of two batches of Fluad flu vaccine after three post-vaccination deaths (in people aged 87, 79, and 68 years) reported through the Network of Pharmacovigilance were deemed to be associated with the vaccine.2

Authorities performed investigations on the identified vaccine batches, to assess their safety, and on the case reports, to assess the nature of the association. On 1 December the vaccine’s characteristics were found to comply with quality standards, and on 4 December the European Medicines Agency’s pharmacovigilance risk assessment committee concluded that there was no evidence of an association between the reported deaths and the vaccine. On 23 December, the final results on toxicity and sterility were negative and the two batches were re-introduced.3

We estimate that, by pure statistical chance, 15-20 people die every day in Italy during the two month flu vaccination campaign within 48 hours of vaccination. These figures help us to understand that the three deaths in question fell well within the daily expected numbers of deaths in the vaccinated elderly population. In the following weeks, the number of deaths reported as suspected adverse reactions increased, probably as a result of the massive media coverage,4 which is also likely to have boosted the public’s hesitancy to be vaccinated. A survey conducted by the Union of Italian Physicians reported that, since this episode, uptake of flu vaccination has decreased by 80%, resulting in an estimated decrease of 25-30% on the overall 2014 national immunisation campaign.

We wonder whether it is time to rethink pharmacovigilance regulations on vaccines to prevent outbreaks of generalised panic from compromising immunisation campaigns and negatively affecting disease related outcomes, thereby generating extremely serious health and economic losses for individuals and society.5 6