Italy examines 13 deaths in Novartis flu jab probe

Thirteen people in Italy may have died after taking a flu vaccine made by Swiss pharmaceuticals giant Novartis, according to the latest estimate from Italian authorities.

Italy examines 13 deaths in Novartis flu jab probe
Photo: Sebastien Bozon/AFP

Italy’s drug regulator, the Italian Pharmaceutical Agency (AIFA), said in a statement on Sunday that it was investigating an additional ten cases, on top of three reported late last week.

The most recent fatality was an 83-year-old from Umbria, the agency said.

The agency last week banned the use of two batches of the Fluad vaccine after three people died within 48 hours of receiving it.

Out of the other 12 cases, two each were in Sicily, Puglia, Tuscany, Emilia Romagna and Lombardy, while there was one each in Molise and Lazio.

AIFA said that a detailed investigation by the Pharmacovigilance Risk Assessment Committee at the European Medicines Agency would get underway on Monday and was expected to be completed by Thursday.

Basel-based Novartis said in a statement last week that it had been notified by AIFA "of the precautionary suspension of two lots of Fluad in Italy following reports of the serious adverse effects events after vaccination" and that “no causal relationship to the vaccine has been established."

A review of the two batches "has confirmed that they are in conformity with all production and quality standards," the company added.

The suspected batches were produced at a Novartis plant in the Tuscan city of Siena.

Novartis said Fluad had been used since 1997, during which time over 65 million doses have been successfully administered throughout the world, "which confirms the data gathered during clinical studies which involved over 70,000 patients."

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Switzerland’s Novartis to help make Pfizer-BioNTech Covid vaccine

Swiss pharmaceuticals giant Novartis said Friday it had signed an initial agreement to help produce the Pfizer-BioNTech vaccine against Covid-19, as countries scramble to boost supplies.

Switzerland's Novartis to help make Pfizer-BioNTech Covid vaccine
Novartis will help manufacture Pfizer vaccine. Photo by AFP.

The rare act of cooperation — in an industry usually marked by cut-throat competition — comes after French pharma group Sanofi announced earlier this week that it would also team up with rivals Pfizer and BioNTech to help produce 125 million doses of their jab.

The two-dose vaccine, which is based on mRNA technology, has been shown to be around 95 percent effective and has been approved for use by the World Health Organization and in some 50 countries.

But it is in limited supply as nations around the world race to immunise their populations against the coronavirus, which has killed nearly 2.2 million people in just over a year.

Novartis said in a statement that it would use its sterilised manufacturing facilities at its site in Stein, Switzerland to help produce the Pfizer-BioNTech jabs.

Under the agreement, the company said it would “take bulk mRNA active ingredient from BioNTech and fill this into vials under aseptic conditions for shipment back to BioNTech for their distribution to healthcare system customers around the world”.

Once a final agreement is reached, Novartis said it expected to begin production in the second quarter of the year, with initial shipment of finished product expected in the third quarter.

Steffen Lang, Head of Novartis Technical Operations, stressed that the company was “committed to leverage our manufacturing capabilities to help support the supply of COVID-19 vaccines and therapeutics around the world”.

“We expect this to be the first of a number of such agreements,” he said in the statement.

Novartis said it was already in “advanced discussions” with a number of other companies about with other production tasks, including of mRNA, therapeutic protein and raw material production for Covid vaccines and therapeutics.