Gordon Naylor, the president of CSL’s new flu vaccines unit Seqirus, has said the company will rely on the launch of Fluad, emerging markets growth and a switch to quadrivalent flu vaccines as it presses toward “industry leadership.” This week, the budding unit got big news on one of those fronts, as the FDA approved the company’s Flucelvax Quadrivalent flu vaccine.
With the approval, Seqirus joins the likes of Sanofi ($SNY), GlaxoSmithKline ($GSK) and AstraZeneca ($AZN) offering quadrivalent flu jabs. However, Seqirus’ shot is the only cell culture quadrivalent flu jab now available for people four and up, giving the company a manufacturing strength as the process is faster than egg-based flu vaccines and can be quickly scaled during a pandemic.
The newly approved vaccine will be manufactured at Seqirus’ plant in Holly Springs, NC, a $1 billion site the company picked up when it bought Novartis’ flu vaccines business for $275 million last summer. When Naylor spoke with FierceVaccines in March, he said the site had “a great deal” of “unrealized potential” that the company will now likely put to work.
In fact, the North Carolina site and the technology used there were supported by the U.S. government as a measure to ensure a strong flu vaccine supply during pandemics and outbreaks, Seqirus said in its statement. It’s unique in the United States, the company added.
Flucelvax Quadrivalent will be available for the 2016-2017 flu season; the company has a capacity for 100 million to 130 million doses of quadrivalent flu vaccine annually.
Seqirus has been manufacturing the vaccine "at risk" to this point, Brent MacGregor, SVP of commercial operations, told FierceVaccines, and plans to bring 9 million doses to the market in the first year. He added that the company plans to increase that number “significantly” in the coming years. Seqirus expects to sell its first doses around July or August.
The new FDA approval is Seqirus’ second since its formation last October; in December, it won approval for Fluad, the first publicly available adjuvanted flu vaccine in the U.S., and a shot it picked up from Novartis. The FDA approved that vaccine for people 65 and older.
Currently, Sanofi is the world’s largest flu vaccine provider.
- here’s the release
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