Italy suspends Novartis vaccine after four patients die

Tests are on to find if there is a causal link; Swiss pharmaceutical boasts of the drug’s safety record

By Moushumi Sharma
Published: Monday 01 December 2014

 Fluad is an influenza vaccine for the elderly and has been administered to patients worldwide since it was approved in 1997

Italy has suspended the use of a flu vaccine after four people—two men and two women aged between 67 and 87—who were administered doses died.

Fluad, an influenza vaccine for the elderly, is manufactured by the Swiss firm Novartis. The drug has been suspended as a precautionary measure in Italy and the country’s pharmaceutical watchdog, Agenzia Italiana del Farmaco (Italian Medicines Agency), or AIFA, claims that tests are being conducted to establish a link, if any, reports BBC. “At this point, it is not clear if there is a causal relationship or a link to the vaccination. A full picture will be formed only after a full analysis of all aspects, including the general health of the patients, their ages and probable conditions they might have had,” BBC quotes AIFA.

Novartis, meanwhile, has refuted such a link. “Patient safety is our priority and Novartis evaluates all reports of adverse events with utmost seriousness and attention. A review on the two batches of Fluad in question confirmed compliance with all production and quality standards. Novartis is working with health authorities to respond to the questions raised,” states a press release by the Swiss pharma giant.

Novartis says the vaccine was approved in 1997 and has been in use since. The company vouches for its safety history, claiming 65 million doses of Fluad have been administered successfully worldwide, with clinical trials involving more than 70,000 people. Influenza claims 40,000 lives every year in Europe alone, according to a press release.

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