Novartis didn’t provide enough information for officials to know the exact makeup of the proteins found in the Agrippal and Fluad shots, or their impact on the quality and safety of the vaccine, Italy’s Health Ministry said today in a statement. There have been no reports of illness because of the particles, officials said.
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.
The suspension adds to Novartis’s manufacturing woes. The company in January temporarily closed a factory in Lincoln, Nebraska, that makes the Excedrin headache remedy, the Lamisil gel for athlete’s foot, and Sentinel, an anti-flea product for dogs, because of quality concerns.
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.”
While particles can occur in the manufacturing process, the company “is confident that there is no impact on safety or efficacy of the vaccine,” Novartis said in a statement released later today. “To date, data from the ongoing seasonal vaccination campaign have revealed no safety signals.”
About 488,000 doses are subject to the ban, the Italian health ministry said.
Novartis notified Italy of the vaccine issues verbally on Oct. 18, and followed up with a written notification the next day, Anna Rosa Marra, an official with AIFA, said at a news conference in Rome. The company knew of the particle buildup since July 11, officials said.
Renato Balduzzi, the health minister, said he or members of his staff will meet with Novartis executives tomorrow for explanations, including of why there was a delay in notifying authorities of the problem. Novartis was due to supply 3 million doses of flu vaccine to Italy, and the country will sign contracts with other producers, Balduzzi said.
Swissmedic, the Swiss drug regulator, suspended distribution of the vaccines as a precaution after the Italian decision, the agency said in a statement today. There’s no danger to recipients of the vaccine, the agency said. It’s unclear if shots distributed in Switzerland have the same problem, according to the statement.
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.
Novartis fell 0.7 percent to close at 57.20 Swiss francs in Zurich trading. The company reports quarterly earnings tomorrow.
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