Novartis ($NVS) has started shipping vaccines for customers in the U.S. in advance of the next flu season, which doesn't include a quadrivalent offering like many of its competitors. But the shipments will include Flucelvax, which now has an FDA-licensed American plant that's poised for production whenever flu shots are needed quickly.
Novartis says it plans to ship a minimum of 30 million doses of its cell-culture Flucelvax vaccine and egg-based Fluvirin in preparation for the 2014-2015 flu season, which typically begins in October.
In June, Novartis received a green light from the FDA to begin manufacturing the seasonal Flucelvax as well as pandemic flu vaccines at a facility in Holly Springs, NC, becoming the country's first pandemic-ready site--just in time for the upcoming flu season.
Though Novartis doesn't have a quadrivalent vaccine--which has brought in big sales gains for companies like AstraZeneca ($AZN), GlaxoSmithKline ($GSK) and Sanofi ($SNY)--it has pitched Flucelvax as a preservative and antibiotic-free alternative to rival vaccines.
Approved for use in adults 18 years of age and older, Flucelvax is manufactured with cell-culture technology, a different production method for flu vaccines compared to the traditional egg-based production method. A major benefit of cell-culture production is that it can be easily ramped up for large-scale production of vaccines in response to pandemics.
The Centers for Disease Control and Prevention recommends routine seasonal influenza vaccination for nearly everyone 6 months of age and older. But with vaccination rates for adults well below target levels, according to the CDC, it remains to be seen how Novartis will fare in a tight market-share battle with an adult-only flu vaccine.
Novartis may soon be shedding Flucelvax altogether. After striking a $7.1 billion sale with GlaxoSmithKline, the Swiss company is giving up most of its vaccines business. In a separate sales process, the company also plans to get rid of its flu jab unit.
- read the press release