Two batches of Novartis’ Fluad have been suspended from use whilst Italian authorities investigate 13 deaths that occurred in Italy in November
The Italian medicines agency, AIFA, have suspended the use of two batches of Novartis’ influenza vaccine Fluad after the death of 13 adults, 8 of whom were above the age of 80, between the 7th and 25th of November. The suspension is a precautionary measure undertaken by the AIFA as the majority of the deaths occurred within 24 hours of after receiving the vaccine.
A statement from the AIFA is quick to place these deaths in context however. They suggest that, were Fluad a threat to all those over the age of 65 given the injection, we’d expect to see 22+ deaths a day reported even if just 10% of adverse effects are reported. In a statement released last week, Novartis followed a similar theme stating that “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.”
But in the statement from the AIFA, they state that the statistics suggest ‘variations in the quality of the vaccine.’ However, the Wall Street Journal reports that preliminary results from the Italian Institute of Health have shown no manufacturing deficits within the two batches. Novartis is expected to provide a status report on “all quality controls repeated on lots seized and a clinical evaluation of the possible cause-effect relationships” imminently.
This comes two years after a “data-handling discrepancy” from Novartis caused some of their vaccines to be voluntarily held for several months.