Spare a little sympathy for our flu vaccine makers.
“For flu, hunting variants is such a challenge in vaccine manufacturing,” said Chris Larkins, SVP of Global Operations at Seqirus, one of the leading producers of flu vaccines worldwide. “The World Health Organization [WHO] has a tough job of predicting which species will emerge. In production, we develop and launch a new product every six months for both the southern and northern hemispheres. It’s exciting, but extremely challenging. Production windows are tight – we produce 90% of the supply in a six month period. It is an intensive production process and there is no safety stock.”
“It was all used in about 12 weeks,” added David Ross, VP of Commercial Operations, North America at Seqirus. “There’s nothing like that challenge in manufacturing and distribution.”
However, none of these difficulties are new to Seqirus. The company’s origins date back to 1916, when parent company CSL Ltd. was founded in Melbourne, Australia, as Commonwealth Serum Laboratories. Seqirus was founded in 2015 when CSL purchased the Novartis influenza vaccines company, which includes a manufacturing site in Holly Springs, North Carolina. CSL employs approximately 27,000 people worldwide, including 3,300 for Seqirus, in 20 countries.
Flu took a backseat during the pandemic, but it remains a significant health threat. “Flu is a contagious respiratory illness with effects ranging from potentially minor symptoms to death,” Ross said. “The populations most at risk of death are children under three years of age and adults over 65 years of age, as well as people with co-morbidities. The burden on public health in the US is between 10 million and 40 million cases, with 150,000 to 700,000 hospitalizations and 12,000 to 50,000 deaths annually.”
As COVID slowly becomes endemic, that annual flu impact will return as a top priority, which is where Seqirus’ mRNA vaccine research comes in handy. “Seqirus has developed a self-amplifying mRNA (sa-mRNA) flu vaccine, the next generation of mRNA technology,” explains Larkins. “There are many potential benefits of the self-reinforcing approach. Compared to traditional mRNA vaccines, our sa mRNA vaccine may have better immunological efficacy overall, with the potential to develop effective vaccines with a smaller dose, which could have a major impact on its safety.”
“One of the things COVID did was educate the public about vaccine technologies,” Ross said. “We see that as an opportunity to continue to educate people about vaccine protection. For more than 80 years, the primary vaccine technology has been based on eggs grown in chicken eggs. But there are some limitations to that. Because a human virus is grown in an egg, it can adapt, leading to a less effective vaccine. We now have technology platforms, including our cell-based technology, designed to exactly match the WHO-selected strain, and added our MF59 adjuvant to the vaccine to boost the immune system response.”
For some people, an mRNA vaccine can be a hard sell after some controversies surrounding the COVID vaccines. “For us, it’s about evidence-based information,” Ross continued. “The best way to fight misinformation is to focus on the science and share all the information.”
“I think it’s important for people to know that flu vaccines have been around for a long time,” Larkins added. “Seqirus has been at the forefront of developing several vaccines for different age groups, including cell-based vaccines for enhanced efficacy and more effective production. We have three factories worldwide, one of which focuses on cell-based vaccines. When Seqirus was founded, we were producing five million doses per year from our cell-based facility in the US, which we have now been able to optimize to produce more than 50 million doses per year. By making our vaccines in bioreactors, we can improve our volumes and efficiency because it is easy to turn production up or down.”
The timing could be just right as people refocus on illnesses like the flu. “COVID has, and rightly so, occupied the minds of just about everyone,” Ross said. “But the flu is still devastating. As the only company fully focused on flu, our organization is very proud of what we have done and very excited about our differentiated portfolio of flu vaccines to keep the population safe, including the most vulnerable. “We’re expanding,” Larkins added. “In addition to our existing three production sites, we are adding a fourth in Melbourne, Australia. It is under construction and will go into production in early 2026. It will be the only cell-based facility in the Southern Hemisphere.”
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