Italy is investigating the deaths of several people who took an influenza vaccine as the total death toll climbed to 11.
An additional eight fatalities possibly related to Novartis AG’s Fluad vaccine have been identified, Bloomberg reports. As a precaution, two batches of the drug were suspended after three people died within 48 hours of getting the shot.
“At the moment it’s not possible to confirm that there is a direct link between taking the vaccine and the reported deaths,” the Italian Pharmaceutical Agency said in a statement. “More complete information is necessary and a thorough analysis of the cases must be conducted.”
Novartis said Fluad, which was approved in 1997, has a “robust” history of safe usage and that there was “no causal relationship” found between the deaths and the vaccine.