Italy's drug regulator has a growing investigation on its hands, and Novartis ($NVS) is in the middle of it. The number of people who have died in the country after receiving one of the Swiss pharma giant's flu vaccines has risen by 10 just days after Italy issued a partial ban on the product.
Thirteen people have now died shortly after getting Novartis' Fluad shot, news.com.au reports. The death toll has climbed since Thursday, when Italian authorities suspended batches 142701 and 143301 of the vaccine as a precaution after alerts of an initial three fatalities. The deaths include people who received doses from those lots as well as people who received doses from other lots, the Italian Pharmaceutical Agency said on Friday, according to Bloomberg.
Still, there's no proof the vaccines caused the deaths, the agency said in a statement. "At the moment it's not possible to confirm that there is a direct link between taking the vaccine and the reported deaths," it said, as quoted by Bloomberg. "More complete information is necessary and a thorough analysis of the cases must be conducted."
As Novartis spokeswoman Liz Power told FiercePharma, all Fluad batches have passed "extensive" analytical and safety testing and fulfill all required quality standards. The European Medicines Agency (EMA) will begin looking into things Monday, according to news.com.au.
While Novartis says Fluad--approved in 1997--has a "robust" safety history, it's not the first time Italian regulators have banned it. Just over two years ago, they temporarily blocked distribution of the jab--along with the company's Agrippal, Influpozzi and adjuvanted Influpozzi--on safety worries after finding particles in vials.
Novartis' flu vaccines--which Australia's CSL recently agreed to pick up for $275 million--have also recently come under Italian scrutiny on pricing concerns. This summer, police alleged the Basel-based drugmaker inflated the cost of an additive to two vaccines, multiplying it 6 times over--and costing the country potentially upward of €16 million ($22 million).
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Editor's note: This story has been updated to include a statement from a Novartis spokeswoman.