US govt pays Sanofi Pasteur $192m for bulk flu antigen

By Gareth Macdonald

- Last updated on GMT

Related tags: Sanofi, Influenza vaccine, Influenza

The US Department of Health and Human Services (HHS) has accepted a
bulk stock of H5N1 influenza virus antigen, consisting of both
hemagglutinin and neuraminidase, worth $192m (€123m) from French
vaccines specialist Sanofi Pasteur.

The stockpile will be used to produce around 39 million doses of a vaccine against the clade 2.2 strain of the avian type A H5N1 virus. This emergent serotype, which was first identified in migratory Barheaded geese in Qinghai Lake, China in 2005, currently predominates in bird populations in Europe, Africa and the Middle East. Sanofi began working with the HHS in 2004 when it was awarded a $97m contract to produce two million doses of bulk vaccine derived from the H5N1 viral strain. Subsequently, the Lyon-headquartered firm fulfilled a series of bulk orders, most recently in 2007 when it was paid $127m (€81m) for a supply of vaccine. Albert Garcia, an epidemiologist at Sanofi told in-PharmaTechnologist.com that: "the antigen had been produced last year at Sanofi's plant in Swiftwater [Pennsylvania] using the same egg-based technology that is used to manufacture seasonal influenza vaccine."Expands vaccine manufacturing capacity ​ In June last year, Sanofi completed a $150m (€108.6m) expansion of the Swiftwater facility, increasing production capacity to more than 100 million doses a year. Prior to that, the firm announced plans to invest €200m in a new formulation and filling unit at its vaccines facility in Rouen, France, More recently, Sanofi said that it is to build a new production plant in Shenzhen, China. While the facility is primarily intended to produce seasonal influenza vaccine for the local population when it becomes operation in 2012, it will also be used as part of the firm's global response plan should a pandemic virus emerge. Mr Garcia said that, in addition to its ongoing pandemic preparedness program, Sanofi was expanding production capacity because "it anticipates a considerable increase in the demand for seasonal influenza vaccine."​ He added that the firm's manufacturing facilities: "can switch instantaneously to produce any pandemic strain upon WHO request." Cell culture to expedite production rates ​ In March, the HHS released its fifth pandemic preparedness update, detailing efforts to expand US production capacity to 600m doses within six months of the emergence of a pandemic. The HHS also reported moves to stimulate the development of cell culture-based vaccine manufacturing methods, specifically that it has entered into a series of agreements designed to push the technology forward. Sanofi is one of the firms that is developing the technology, others include GlaxoSmithKline, Solvay and Novartis. Mr Garcia explained that Phase I studies of Sanofi's PER.C6 cell culture system have been completed and that Phase II assessments were ongoing. He added that while significant progress was being made, cell culture influenza vaccine production: "will not replace the traditional egg-based technology within the next 10 years​."

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