Seqirus Completes $156 Million Expansion to Holly Springs Manufacturing Facility, Optimizing Global Manufacturing Capabilities for Seasonal and Pandemic Influenza Vaccines

SUMMIT, N.J., June 6, 2022 /PRNewswire/ -- Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced the completion of an expansion to the company's manufacturing facility in Holly Springs, N.C., supporting the formulation and fill-finish of its cell-based influenza vaccines in pre-filled syringes for global communities. The new pre-filled syringe line has received FDA approval and will support influenza vaccine production for the 2022/23 Northern Hemisphere season and beyond. Additionally, it will enhance the site's ability to respond to an influenza pandemic. The expansion, which began in 2018, cost $156 million dollars to complete and will support more than 80 additional highly skilled jobs in the Holly Springs community.

The expanded manufacturing facility and new pre-filled syringe line will allow Seqirus to increase its capacity to supply the U.S. market with FLUCELVAX^® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine in the U.S. for individuals six months of age and older.¹

"According to the World Health Organization (WHO), seasonal influenza can lead to up to 650,000 deaths globally each year," said Steve Marlow, General Manager, Seqirus.² "As one of the world's leading influenza vaccine manufacturers, we're continuously looking for opportunities to advance capabilities and support efficient, sustained supply of new and existing technologies. Today's milestone is evidence of that commitment."

With this expansion, the Holly Springs facility now has two state-of-the-art fill-finish lines. The new fill-finish line will support more efficient production of FLUCELVAX^® QUADRIVALENT. Cell-based influenza vaccines are designed to produce an exact match to WHO-selected influenza virus strains by avoiding egg-adapted changes. In seasons where egg adaptation occurs, studies suggest cell-based vaccines may have the potential to be more effective than traditional, egg-based flu vaccines.³  

"As demand for differentiated influenza vaccines grows, it is paramount that we expand our manufacturing capacity," said Dave Ross, Vice President, North America Commercial Operations at Seqirus. "This new line gives us the ability to more efficiently streamline our production process, allowing us to better meet the needs of our customers and, in turn, better meet the needs of public health."

FLUAD^® QUADRIVALENT, which is specifically developed for adults 65 years and older using the company's MF59^® adjuvant, is also produced at the Holly Springs facility.⁴

The Holly Springs manufacturing facility, the largest cell-based influenza vaccine producer in the world and the first-of-its-kind in the U.S., was purpose-built through a public-private partnership established in 2009 with the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS). This facility expansion enhances the site's regular seasonal influenza vaccine production, as well as to surge production to respond to a potential influenza pandemic.

The Holly Springs facility is part of Seqirus' global manufacturing and supply network supporting seasonal influenza vaccine production and pandemic preparedness, including sites in Liverpool, UK, Parkville, Australia, as well as a new state-of-the-art facility currently under construction in Tullamarine, Australia.

Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.⁵ Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.⁵ Because transmission of influenza viruses to others may occur one day before symptoms develop and up to 5 to 7 days after becoming sick, the disease can be easily transmitted to others.⁵ Estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2019/20 influenza season, there were an estimated 405,000 influenza-related hospitalizations in the U.S.⁶ The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.7 Since it takes about two weeks after vaccination for antibodies to develop in the body that help protect against influenza virus infection, it is recommended that people get vaccinated before influenza begins spreading in their community.⁷ The CDC recommends that people get vaccinated by the end of October.⁷

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, and leading R&D capabilities, Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world. 

CSL (ASX:CSL) (USOTC:CSLLY) is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our two businesses, CSL Behring and Seqirus – provides lifesaving products to patients in more than 100 countries and employs more than 25,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest. For inspiring stories about the promise of biotechnology, visit CSLBehring.com/Vita and follow us on Twitter.com/CSL.   

For more information visit www.seqirus.com and www.csl.com. 

This press release is issued from Seqirus USA Inc. in Summit, New Jersey, USA and is intended to provide information about our global business. Please be aware that information relating to the approval status and labels of approved Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of Seqirus products. 

This press release may contain forward-looking statements, including statements regarding future results, performance or achievements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. 

USA-CRP-22-0013

MEDIA CONTACTS
Maria Tortoreto
+1 (201) 248-5208
[email protected]

Jennifer Bailey
+1 (910) 635-7523
[email protected] 

FLUCELVAX^® QUADRIVALENT (Influenza Vaccine)
IMPORTANT SAFETY INFORMATION

What is FLUCELVAX^® QUADRIVALENT (Influenza Vaccine)?
FLUCELVAX QUADRIVALENT is a vaccine that helps protect people aged 6 months and older from the flu. Vaccination with FLUCELVAX QUADRIVALENT may not protect all people who receive the vaccine.

Who should not get FLUCELVAX QUADRIVALENT?
You should not get FLUCELVAX QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine.

Before receiving FLUCELVAX QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:

• Have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks of getting a flu vaccine. The decision to give FLUCELVAX QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
• Have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine.
• Have ever fainted when receiving a vaccine.

What are the most common side effects of FLUCELVAX QUADRIVALENT?

• Pain, redness, swelling, or a raised hardened rea where the vaccine was given
• Headache
• Overtiredness with low energy
• Muscle aches
• Feeling unwell (malaise)

Additional side effects seen in children include:

• Tenderness or bruising where vaccine was given
• Sleepiness
• Irritability
• Diarrhea
• Changes in eating habits

These are not all of the possible side effects of FLUCELVAX QUADRIVALENT. You can ask your healthcare provider for more information and for advice about any side effects that concern you.

To report SUSPECTED ADVERSE REACTIONS, contact Seqirus 1 855 358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.

FLUAD^® QUADRIVALENT (Influenza Vaccine, Adjuvanted)
IMPORTANT SAFETY INFORMATION

What is FLUAD^® QUADRIVALENT?
FLUAD QUADRIVALENT is a vaccine that helps protect against flu. FLUAD QUADRIVALENT is for people age 65 years and older. Vaccination with FLUAD QUADRIVALENT may not protect all people who receive the vaccine.

Who should not get FLUAD QUADRIVALENT?
You should not get FLUAD QUADRIVALENT if you have had a severe allergic reaction to any of the ingredients in the vaccine in the past, including egg protein, or a severe allergic reaction to a previous influenza vaccine.

Before receiving FLUAD QUADRIVALENT, tell your healthcare provider about all medical conditions, including if you:

• Have ever had Guillain-Barré syndrome (severe muscle weakness) within six weeks after getting a flu shot. The decision to give FLUAD QUADRIVALENT should be made by your healthcare provider, based on careful consideration of the potential benefits and risks.
• Have problems with your immune system or are taking certain medications that suppress your immune system, as these may reduce your immune response to the vaccine.
• Have ever fainted when receiving a vaccine.

What are the most common side effects of FLUAD QUADRIVALENT?

• Pain or tenderness where the shot was given
• Headache
• Tiredness

These are not all of the possible side effects of FLUAD QUADRIVALENT. You can ask your healthcare provider for a complete list of possible side effects.

What do I do if I have side effects?
Ask your healthcare provider for advice about any side effects that concern you. To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov. You are also encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Before receiving vaccine, please see the full Prescribing Information for FLUAD QUADRIVALENT. The information provided here is not comprehensive. To learn more, talk about FLUAD QUADRIVALENT with your healthcare provider or pharmacist.

FLUAD^® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.

¹FLUCELVAX^® QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: Seqirus INC; 2021.
²World Health Organization (WHO). Up to 650 000 people die of respiratory diseases linked to seasonal flu each year. Retrieved from: https://www.who.int/news/item/13-12-2017-up-to-650-000-people-die-of-respiratory-diseases-linked-to-seasonal-flu-each-year. Accessed June 2022.
³Rajaram, S., Boikos, C., Gelone, D.K., Gandhi, A.  Influenza vaccines: the potential benefits of cell-culture isolation and manufacturing. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7036483/. Accessed June 2022.  
⁴FLUAD QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus INC; 2019.
⁵CDC (2021). Key Facts about Influenza. Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed June 2022.
⁶CDC. (2021). Estimated Influenza Illnesses, Medical visits, Hospitalizations, and Deaths in the United States – 2019-2020 Influenza Season. Retrieved from: https://www.cdc.gov/flu/about/burden/2019-2020.html. Accessed June 2022.
⁷CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed June 2022.

SOURCE Seqirus