After last weeks suspension of Novartis’ Fluad flu vaccine, Italy’s pharmaceutical watchdog AIFA now say that tests on the vaccine show the product to be safe.
The fatalities that occured shortly after Fluad vaccinations were administered grew from 3 to 19 within a few days. Two batches of the vaccine, 142701 and 143301, were suspended pending tests.
“the results of the tests confirm the safety of the anti-flu vaccine,” the Italian Medicines Agency said in a statement seen by Reuters. “Tests on the batches in question came back “completely negative.”
As Novartis spokeswoman Liz Power told FierceVaccines, all Fluad batches have passed “extensive” analytical and safety testing and fulfill all required quality standards.
However,Fierce Vaccines adds: But this wasn’t the first time Italy’s officials had banned Fluad, approved in 1997. In October 2012, they suspended use of the shot–along with the company’s Agrippal, Influpozzi and adjuvanted Influpozzi–on safety concerns after finding particles in vials.
It also wasn’t the first time this year that Novartis’ flu vaccines had hit Italy’s radar. 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).
Of course, Novartis’ flu lineup will soon be CSL’s to worry about, thanks to a recent $275 million sale that, combined with an earlier, multibillion-dollar asset swap with GlaxoSmithKline ($GSK), will help Novartis exit the vaccine arena completely.
And CSL has had its own recent safety issues to contend with: A study found that convulsions in children immunized with a flu shot from the Australian company in 2010 were caused by an excessive immune response to viral components in the vaccine, Bloomberg reports.