Untimely Deaths

12.02.14 5:00 AM ET

Did This Flu Vaccine Kill 13?

Italy’s government says it can’t prove a link between Novartis’s Fluad and the elderly Italians who died within 48 hours of getting it—but is removing two batches of the vaccine anyway.

At a sidewalk café in Rome’s Testaccio neighborhood, a group of eighty-something women are debating whether to get a flu shot over a Monday morning cappuccino. The benefits are obvious, says 83-year-old Mariacristina Poggio, who sums it up succinctly: “I could die from the flu without it.” But her friend, 81-year-old Maria Teresa Falcinelli, has a different point of view. “Better to die from the flu than the vaccine,” she says. “At least it would be natural, not suicide.”

Extreme? Maybe. But the women have a right to be concerned. Since Nov. 7, 13 elderly people have died in Italy within 48 hours of taking anti-influenza vaccines made by the Swiss pharmaceutical company Novartis. Some were elderly with underlying conditions like hypertension and diabetes. Others were active octogenarians. The youngest victim was 67 years old. The oldest was 87. Novartis issued a statement underscoring that there is “no causal relationship” between the vaccines and the deaths, touting the vaccine’s “robust” safety history.

But the Italian version of the Federal Drug Administration, called AIFA, is treating the implied correlation with an abundance of caution. It has opened a formal probe into the deaths, and local authorities in half of the seven affected regions have launched criminal manslaughter investigations. AIFA suspended two batches of Novartis’s Fluad vaccine with the lot numbers 142701 and 143301, and cautioned anyone with vaccines at home to check their medicine cabinets. On Monday, the health ministry announced that going forward, all state-administered flu vaccines would be Vaxigrip, made by the French pharmaceutical firm Sanjoli.

Elizabeth Power, a spokeswoman for Novartis, confirmed to The Daily Beast that the vaccines had been removed. “Two batches of Novartis influenza vaccine Fluad, comprising approximately 500,000 doses solely distributed in Italy, have been put on a precautionary hold following reports of 13 deaths in that country,” she said. “Extensive analysis has found no causal link between vaccination and these serous adverse events.”

Novartis has complied with initial requests by the Italian health authorities, Power said, confirming that “all Fluad batches have passed extensive analytical and safety testing and fulfill all required quality standards.” Preliminary results performed by Italian authorities “have not detected any manufacturing defect,” she added.

The Italian health ministry said it could not prove a direct correlation between the flu vaccine and the deaths. Only one autopsy has been definitive, and it proved that a 68-year-old man who collapsed 24 hours after getting the vaccine died of a ruptured aorta, not as a complication of the injection. The remaining autopsies have yet to be completed. “It isn’t possible to confirm a direct link between taking the vaccine and the reported deaths,” AIFA said in a statement, adding that more tests and studies on the victims’ medical backgrounds are underway.

In the United States, pharmaceutical companies cannot be sued for complications resulting from vaccines, thanks to a 1986 Supreme Court ruling that gave immunity to pharmaceutical companies. No such protection exists in Italy.

Fluad is not approved in the United States, according to Power. “More than 7 million doses of Fluad have been distributed this year worldwide,” she said, “with no safety signal detected.”

Novartis told The Daily Beast that Fluad is designed for elderly patients over 65 with underlying cardiovascular and other chronic diseases, which makes them particularly vulnerable to sudden clinical events independent of vaccination. “Due to the high level of natural deaths in the target population, estimated at 500,000 per year in Italy alone, and the high number of vaccines distributed, timely association between natural deaths and vaccinations do occur,” Power said.

Italy’s health ministry has cautioned people not to assume that flu shots are risky. “Before triggering an alarm, we must have all the evidence of examinations. The first tests are not offering evidence of a correlation,” Italy’s minister of health, Beatrice Lorenzin, said Sunday. She also voiced concern about a delay by local health authorities in reporting the possible link between the vaccinations and the deaths. “In some cases, it has taken 15 days to report the deaths and circumstances, which I would like to shorten to 48 hours,” she said. “We need to strike a balance between creating false alarms and letting any urgent medical matters fall through the cracks.”

Sergio Pecorelli of AIFA said people should still get flu vaccines, citing the fact that more than 8,000 Italians die each year from flu complications. He also noted that in some communities like Naples, where more than 200,000 people over the age of 65 are registered by the national health system to have been immunized by Dec. 1, less than half have yet come forward. Sports-medicine doctor Ivo Pulcini echoed several doctors in Rome when he told Italian television that he had decided to suspend vaccines because of the fear his patients expressed. In Bari, the regional health secretary, Filippo Anelli, said he was already preparing for an uptick in flu hospitalizations with vaccination rates down. “From December onward, we risk a lack of hospital beds for flu patients as a result of a rebound effect because of those who have not been vaccinated,” he said.

Italy’s health ministry says there are more than 3.5 million doses of Novartis’s Fluad in circulation as part of the country’s flu-vaccine campaign. Luca Pani, head of AIFA, told reporters Monday that 1 million doses have been already been used in Italy, a sign that there has not been widespread contamination in the production process. The vaccines undergo nearly 40 individual controls before packaging, he said, and each batch then undergoes an additional 14 tests in accordance with international safety standards. Still, he said he expects Novartis to provide further documentation to calm fears. Novartis now has until Dec. 8 to provide an explanation. “The company will provide a status report on all quality controls on the lots seized and a clinical evaluation of the possible cause-effect relationships,” Pani said.

Rome’s mayor, Ignazio Marino, told reporters at a Monday press conference that failing to vaccinate is more dangerous than any perceived risks, joking, “I was vaccinated with Fluad, and I’m here to tell you about it.”