Switzerland, Canada clear Novartis flu vaccines after tests

Switzerland's suspension of Novartis flu vaccines Agrippal and Fluad was short-lived--and Canada's was even shorter. Both countries have lifted their bans on the immunizations, saying their own lab analyses, plus information from Novartis, confirmed their safety.

The two countries suspended use of the shots in a wave of regulatory moves that began in Italy. At issue were particles found in vaccine vials. Swissmedic and Health Canada both said that the particles were found to be normal clumps of protein particles--a.k.a. "stray aggregates," per Swissmedic--and thus no threat to patient safety.

"We have always remained confident in the safety and efficacy of our vaccines," the Swiss drugmaker said in an emailed statement. "[N]ow we're working with the Swiss and Canadian [a]uthorities to resume full distribution as soon as possible.

Novartis said it's also "working diligently" with other regulators "to address their questions and resume distribution." Among those would be Italy's drug safety authority, which said it's still reviewing tests of the four vaccines it banned last week, including Influpozzi and adjuvanted Influpozzi in addition to Fluad and Agrippal. Officials said they are "cautiously positive" about lifting that ban, at least on some lots, Reuters reports.

Meanwhile, Austrian health officials said they're continuing to recommend against the vaccines' use, at least for now, Reuters says. Meanwhile, Germany had already retracted approval of some lots of the vaccines--known as Begripal and Fluad in that country--so those lots can't be distributed. Of course, that could all change--and will, if Novartis has its way.

- read the Novartis release
- see the Reuters news
- here's more from FierceVaccines

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