Watchdog clears Novartis in flu jab scare

Europe's drugs watchdog says it has found no evidence to link the Novartis flu vaccine Fluad to a scare in Italy, where 19 people are reported to have died after being given the jab.

Watchdog clears Novartis in flu jab scare
Photo: Sebastien Bozon/AFP

The European Medicines Agency (EMA) said on Wednesday that its Pharmacovigilance Risk Assessment Committee (PRAC) concluded "there is no evidence that Fluad . . . has caused serious events including deaths" in Italy.

EMA said that four million doses of Fluad, produced by Basel-based Novartis, had been distributed for the current vaccination campaign in Italy, and the vaccine had also been used in Austria, Germany and Spain.

"Fluad is used in older people (65 years of age and older), especially in those who have a number of illnesses at the same time and are at an increased risk of health complications," the statement noted.

"After the review of the cases reported, the PRAC concluded that there was no evidence for a causal relation between the reported fatal events and the administration of Fluad."

On Monday, the Italian Pharmaceutical Agency (AIFA) said it had been notified of 19 deaths among people who had died following vaccination with Fluad.

But it said preliminary tests ruled out any contamination in two batches of the drug that were taken out of circulation the previous week.

Novartis says there is no evidence to link the deaths to the vaccine, which has been in use since 1997 and of which 65 million doses have been given to people around the world.

EMA, citing World Health Organization (WHO) figures, said flu caused about three to five million cases of severe illness worldwide each year, resulting in between 250,000 and 500,000 deaths.

"Influenza vaccines are the most effective way to prevent the disease and the serious complications it can cause," the London-based agency said.

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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.