Italy Bans Novartis Flu Vaccines, Citing Side Effects

24 october 2012, by Eva von Schaper (Bloomberg)

Italy’s Health Ministry asked consumers not to use Novartis AG (NOVN)’s flu shots until further notice because of “potentially dangerous” side effects.

Novartis informed the government of a buildup of proteins in the Agrippal and Fluad vaccines, the ministry said in an e- mailed statement today.

The company didn’t provide enough information “to clarify the exact composition of the buildup, nor the impact of the defect on quality, on the stability of the vaccine, and the consequence on security and the efficacy” of the shots, according to the statement.

The vaccines present “quality defects that are potentially dangerous for public health,” the ministry said.

Italy’s medicines agency AIFA “has established the need for further tests regarding the quality and security” of the vaccines, according to an earlier statement from the ministry.

Novartis has given Italian authorities “an assessment which supports the quality, efficacy and the safety of the vaccines,” Eric Althoff, a spokesman for the Basel, Switzerland-based company, said in an e-mailed statement.

“The company will continue to work with the Italian minister of health and AIFA to understand the reasons for their decision.”

About 488,000 doses are subject to the ban, the health ministry said. Vaccines generate 5 percent of Novartis’ total sales, according to a report by Helvea SA analysts including Odile Rundquist.

Seasonal flu shots make up about a quarter of that revenue, the report states.

The ministry planned a news conference for 5:45 p.m. Rome time today.