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NOVARTIS

Germany bans Novartis flu vaccine

Germany became the fourth country on Thursday to ban sales of flu vaccines made by Swiss pharmaceutical giant Novartis, following embargoes by Italy, Switzerland and Austria.

Germany bans Novartis flu vaccine
Photo: USACE Europe District

Announcing the latest ban, German health authorities said four batches of the Begripal flu vaccine — also marketed as Agrippal — and one batch of the Fluad vaccine were no longer for sale.

Novartis insisted earlier on Thursday that both vaccines were safe despite concerns over impurities.

"Novartis confirms its confidence in the safety and efficacy of its seasonal influenza vaccines," the company said in a statement.

On Wednesday, Italian, Swiss and Austrian authorities stopped sales of the vaccines pending tests into possible side effects.

The alarm was first raised in Italy after white particles were seen in syringes carrying the vaccines, but Novartis stressed that "these particles can occur in the vaccine manufacturing process," adding it was "confident that there is no impact on the safety or efficacy of the vaccine."

The company said it had voluntarily provided Italian health authorities with its assessments "supporting the quality, efficacy and safety" of the vaccines, and that it would continue working with them in a bid to understand their decision to put a freeze on the vaccines.

Shortly after the Italian decision, the Swiss national drug agency Swissmedic also ordered an "immediate halt" of the vaccines owing to "possible impurities".

Their decision was followed by the Austrian health ministry which said on Thursday it had pulled the vaccines because of "possible quality problems" as a "purely a precautionary measure".

"There are currently no indications of any danger to patients," the health ministry said, before recommending alternative medication.

Testing was under way on the vaccines in question, the ministry said, "but this process will take some time," it added.

In Switzerland, where the ban affects some 160,000 vaccine doses, according to Swissmedic, the country risks being unprepared for the winter round of jabs.

Switzerland's Office of Public Health said it had expressly asked pharmaceutical companies to supply flu vaccines but there was still a shortage and the Novartis ban could "aggravate the situation."

Novartis meanwhile stressed that it was "fully committed to providing high quality vaccines to patients and will continue to work with the authorities to make vaccines available."

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NOVARTIS

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. 

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