- Seqirus, a vaccine business owned by Australian biotech CSL, expects production of its influenza vaccine Flucelvax Quadrivalent at a North Carolina manufacturing plant to double now that the Food and Drug Administration has approved the company's new cell-based manufacturing process.
- CSL became the world's second largest flu vaccine manufacturer in 2016 with the launch of Seqirus, a unit that combined its existing vaccine arm, bioCSL, with Novartis' global flu vaccine business, which the biotech bought in 2014 for $275 million.
- During CSL's last fiscal year ending June 30, Seqirus revenue rose 23% year over year to $900 million. Driving that growth were seasonal flu vaccine sales in the U.S., as well as the launch of three flu shots: Fluad, Afluria Quadrivalent and Flucelvax Quadrivalent.
The most recent flu season was one of the worst in a decade. A Centers for Disease Control and Prevention database found that between Oct.1 and Feb. 3, the weekly percentage of outpatient visits to healthcare providers for flu-like illness ranged from 1.3% to 7.7% — often cresting well above the national baseline of 2.2%. In fact, the percentage stayed above that baseline for at least 11 consecutive weeks during the flu season.
Key to the outbreak was that vaccines were less effective against one influenza A strain, H3N2.
Regulators are already working to figure out why the vaccines weren't very successful, and to ensure the 2018-19 flu season isn't as severe. The FDA said early this year it would team up with the Centers for Medicare and Medicaid Services to comb through a database of 4 million patients to better understand the details of their vaccinations and whether or not they were hospitalized.
"This work, which is still underway, will try to better understand why overall effectiveness with both the cell-based and egg-based vaccines was less than optimal," FDA Commissioner Scott Gottlieb said in a February statement. "We're also looking at the difference in effectiveness in people 65 years and older who were vaccinated with high-dose influenza vaccine and adjuvanted influenza vaccine to see if effectiveness was better than in those vaccinated with standard dose vaccines."
While regulators look for answers, manufacturers face pressure to produce not only better vaccines but more of them.
CSL is hoping Seqirus' newly approved production process will help in that regard. Globally, most flu vaccines are created using chicken eggs. Seqirus itself uses egg- and cell-based processes to manufacture its products.
Both methods have their advantages, according to Gordon Naylor, president of Seqirus. Yet early data coming out of the last U.S. flu season suggests that the cell-based variety may have produced better vaccines.
"So it may be helpful in addressing the issue ... where sometimes you have a lower level of matching between the circulating influenza virus and what the vaccine's been made to protect against," Naylor said of cell-based vaccine production in an interview with BioPharma Dive.
He noted, however, that it's early to draw any definitive conclusions from the data. "We're encouraged by what we've seen, and we'll continue to investigate further," he said, "and so what we may have here is this interesting situation where it may be a more effective vaccine using cells and we've actually been able to significantly increase the output of this vaccine."
Seqirus' Holly Springs, North Carolina-based manufacturing plant came to be through a flu vaccine partnership with the U.S. Biomedical Advanced Research and Development Authority, better known as BARDA. Flucelvax Quadrivalent is the only seasonal flu vaccine it produces, though the site also plays a role in safeguarding the U.S. should a flu pandemic occur.
The plant's new manufacturing process improves the way cells are grown, including a change in the media, and should allow for double the output of Flucelvax Quadrivalent without adding new equipment, according to Naylor.