CSL Seqirus scores $30M government contract to produce and test avian flu vaccine candidate

CSL Seqirus, one of the world’s top flu vaccine companies, scored a $30.1 million deal from the Biomedical Advanced Research and Development Authority (BARDA) to deliver an avian flu vaccine candidate for use in a phase 2 clinical study. While the virus doesn't appear to pose an immediate human threat, the project will allow the government to be prepared for a potential pandemic scenario.

So far, BARDA has observed cases of avian influenza in wild birds in about 45 states, and in poultry chains in about 35 of them. The flu has moved from bird to human in just a few cases, but it's still enough of a concern from BARDA's perspective to warrant the research, Lorna Meldrum, VP of commercial operations, international and pandemic response at CSL Seqirus, said in an interview.

Under the partnership, CSL Seqirus will make the vaccine candidate in bulk, put it in syringes, and run a clinical trial to test its immunogenicity and safety. That means that if a pandemic strikes, “the U.S. is already a long way along” in its preparations, Meldrum said.

While a few avian influenza cases were observed last winter and through the summer, the virus has not been seen spreading from human to human. If authorities noticed that type of transmission, that would be a "big warning sign," Meldrum said.

“The next pandemic is probably going to be an influenza pandemic,” Meldrum said, citing the last 100 years of history, during which four influenza pandemics proliferated around the globe.

That’s why CSL Seqirus maintains its partnership with BARDA and governments around the world, Meldrum said. The company nabbed a “ready to respond” designation earlier this year, meaning if a pandemic were to occur, CSL Seqirus would “immediately switch” from its seasonal flu shot production at its Holly Springs, North Carolina, plant and be ready to make 150 million pandemic influenza vaccine doses within 6 months.

“We have all the ingredients that you need to make a flu vaccine [at Holly Springs],” Meldrum said. “We have a trained workforce. We have all our [standard operating procedures] in line; we have all our regulatory documents. So, we’re like a machine that you just flick the switch, and then we’re up and running."