Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that the company’s manufacturing facility in Holly Springs, North Carolina, has successfully achieved all criteria required to establish domestic manufacturing capability for cell-based seasonal and pandemic influenza vaccines as outlined by 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).1 With this recognition, the U.S. government confirms that Seqirus has established and will maintain the required pandemic readiness to deliver 150 million doses of cell-based pandemic influenza vaccine within six months of an influenza pandemic declaration in the U.S.
Seqirus has taken numerous steps toward achieving this status, further proving itself capable of delivering innovative pandemic solutions at industrial scale and speed. Seqirus developed the first and only adjuvanted, cell-based influenza A(H5N1) monovalent pandemic vaccine, which was originally approved by the U.S. Food and Drug Administration (FDA) in 2020 in a single dose, prefilled syringe and subsequently approved in 2021 in a multi-dose vial formulation.2
“Serving as a primary partner to the U.S. government in support of its pandemic preparedness plans is both an honor and a tremendous responsibility,” said Marc Lacey, Executive Director, Pandemic Response Solutions, Seqirus. “This achievement is due to the success of our longstanding public-private partnership with BARDA to establish domestic cell-based manufacturing capacity. We are incredibly proud of what we have accomplished in service of addressing the ever-present threat of an influenza pandemic. We have specifically designed our platform technologies to be scalable, supporting both our seasonal and pandemic vaccine manufacturing needs, and we look forward to a continued productive partnership for many years to come.”
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 this public-private partnership with BARDA. The site maintains ongoing seasonal vaccine production and delivery of pre-pandemic annual lots to the U.S. government and is equipped to quickly transition from seasonal to pandemic vaccine production to respond to an influenza pandemic. Seqirus has made many investments in the facility in recent years, including the expansion of a new fill-finish line, which is currently underway. These investments serve to strengthen the company’s continuous efforts to increase manufacturing capacity and decrease production time.
To support rapid response in the event of an influenza pandemic or other public health emergency, Seqirus is prepared to supply the U.S. government with influenza vaccines and adjuvants, including:
- AUDENZ™ (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted), the first-ever adjuvanted, cell-based influenza vaccine designed to help protect individuals six months of age and older against influenza A(H5N1) in the event of a pandemic2
- Data was recently published in the peer-review medical journal Vaccines supporting the immunogenicity, safety and lot-to-lot consistency of AUDENZ™ in adults (18 years and above) and children (six months to 18 years)3,4 - The company’s proprietary MF59® adjuvant, which when added to an influenza vaccine, is designed to enhance and broaden the body’s immune response by creating broad, cross-reactive antibodies5
Beyond pandemic preparedness, the joint investment enables Seqirus to sustain the production of differentiated seasonal influenza vaccines, including:
- FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based quadrivalent influenza vaccine for individuals six months of age and older without contraindication6
- FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the first and only adjuvanted quadrivalent seasonal influenza vaccine for adults 65 years of age and older7
Seqirus and BARDA Build on Longstanding, Successful Partnership
Seqirus has a longstanding partnership with BARDA. The company’s manufacturing facility in Holly Springs, North Carolina, the largest cell-based influenza vaccine producer in the world and the first such domestic facility, was built through a public-private partnership established in 2006 with BARDA. The partnership utilizes a highly scalable method of production and is currently positioned to deliver up to 150 million influenza vaccine doses to support an influenza pandemic response, in addition to its seasonal influenza vaccine production.
About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life- threatening complications in some people.8 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.8 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.8 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.9 The CDC recommends annual vaccination for individuals aged 6 months and older, who do not have any contraindications.10 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.11 The CDC recommends that people get vaccinated by the end of October.11
About Pandemic Influenza
Pandemic influenza, is a contagious airborne respiratory disease which is unpredictable in timing and severity.12 The risk of influenza-associated morbidity and mortality is greater with pandemic influenza than with seasonal influenza because there is likely to be little or no pre-existing immunity to the virus in the human population.13 Four influenza pandemics have occurred over the past century, with the 1918 pandemic being the most severe in recent history, estimated to have killed up to 50 million people worldwide.14 According to the CDC, a novel influenza A virus such as the highly pathogenic avian A(H5N1) strain can cause severe disease and have a high mortality rate.15 If the influenza A(H5N1) virus were to change and become easily transmissible from person to person while retaining its capacity to cause severe disease, the consequences for public health could be severe.15
About Seqirus
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.
About CSL
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.
Intended Audience
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.
Forward-Looking Statements
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-PAN-22-0001
MEDIA CONTACT
Maria Tortoreto
+1 (201) 248-5208
Maria.Tortoreto@Seqirus.com
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AUDENZTM (Influenza A(H5N1) Monovalent Vaccine, Adjuvanted)
Important Safety Information
INDICATION AND USAGE
AUDENZ is an inactivated vaccine indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine.
AUDENZ is approved for use in persons 6 months of age and older at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine.
CONTRAINDICATIONS
Do not administer AUDENZ to anyone with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, or after a previous dose of an influenza vaccine.
WARNINGS AND PRECAUTIONS
- Hypersensitivity reactions can occur. Appropriate medical treatment and supervision must be available to manage possible severe allergic reactions (e.g., anaphylaxis) following administration of the vaccine.
- If Gullain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give AUDENZ should be based on careful consideration of potential benefits and risks.
- Vaccination with AUDENZ may not protect all recipients. Immunocompromised persons, including those receiving immunosuppressive therapy, may have a diminished immune response to AUDENZ.
ADVERSE REACTIONS
- In adults 18 through 64 years of age, the most common ≥ 10% solicited local and systemic reactions reported in clinical trials were injection site pain (64%), fatigue (25%), headache (25%), malaise (22%), myalgia (14%), arthralgia (10%), and nausea (10%).
- In adults 65 years of age and older, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (36%), fatigue (20%), malaise (16%), headache (16%), and arthralgia (10%).
- In infants and children, 6 months through 5 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were tenderness (56%), irritability (30%), sleepiness (25%), change in eating habits (18%), and fever (16%).
- In children 6 through 17 years of age, the most common (≥ 10%) solicited local and systemic reactions reported in clinical trials were injection site pain (68%), myalgia (30%), fatigue (27%), malaise (25%), headache (22%), loss of appetite (14%), nausea (13%), and arthralgia (13%).
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1 855 358 8966 or VAERS at 1 800 822 7967 or www.vaers.hhs.gov.
Before administration, please see the full Prescribing Information for AUDENZ.
FLUCELVAX® QUADRIVALENT (Influenza Vaccine)
IMPORTANT SAFETY INFORMATION for HCPs
INDICATION AND USAGE
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and types B contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 6 months of age and older.
CONTRAINDICATIONS
Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reactions (e.g. anaphylaxis) to any component of the vaccine.
WARNINGS AND PRECAUTIONS
- If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
- Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Procedures should be in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
- After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
- Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.
ADVERSE REACTIONS
- In children 6 months through 3 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (27.9%), erythema (25.8%), induration (17.3%) and ecchymosis (10.7%). The most common systemic adverse reactions were irritability (27.9%), sleepiness (26.9%), diarrhea (17.9%) and change of eating habits (17.4%).
- In children 2 through 8 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were tenderness (28.7%), pain (27.9%) and erythema (21.3%), induration (14.9%) and ecchymosis (10.0%). The most common systemic adverse reactions were sleepiness (14.9%), headache (13.8%), fatigue (13.8%), irritability (13.8%) and loss of appetite (10.6%).
- In children and adolescents 9 through 17 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were injection site pain (21.7%), erythema (17.2%) and induration (10.5%). The most common systemic adverse reactions were headache (18.1%) and fatigue (17.0%).
- In adults 18 through 64 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (45.4%), erythema (13.4%) and induration (11.6%). The most common systemic adverse reactions were headache (18.7%), fatigue (17.8%) and myalgia (15.4%).
- In adults ≥65 years of age who received FLUCELVAX QUADRIVALENT, the most commonly reported injection-site adverse reactions were pain (21.6%) and erythema (11.9%).
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or www.vaers.hhs.gov.
Before administration, please see the full US Prescribing Information for FLUCELVAX QUADRIVALENT.
FLUCELVAX ® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.
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FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted)
IMPORTANT SAFETY INFORMATION for HCPs
INDICATIONS AND USAGE
FLUAD QUADRIVALENT is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD QUADRIVALENT is approved for use in persons 65 years of age and older.
This indication is approved under accelerated approval based on the immune response elicited by FLUAD QUADRIVALENT. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
CONTRAINDICATIONS
Severe allergic reaction to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine.
WARNINGS AND PRECAUTIONS
- If Guillain-Barré Syndrome (GBS) has occurred within six weeks of previous influenza vaccination, the decision to give FLUAD QUADRIVALENT should be based on careful consideration of the potential benefits and risks.
- Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- The immune response to FLUAD QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.
- Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT. Ensure procedures are in place to avoid injury from falling associated with syncope.
ADVERSE REACTIONS
- The most common (≥ 10%) local and systemic reactions in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%).
Other adverse events may occur. For a comprehensive list of local and systemic adverse reactions, please see full prescribing information.
To report SUSPECTED ADVERSE REACTIONS, contact Seqirus at 1- 855-358-8966 or VAERS at 1-800-822-7967 and www.vaers.hhs.gov.
Before administration, please see the full Prescribing Information for FLUAD QUADRIVALENT.
FLUAD® QUADRIVALENT is a registered trademark of Seqirus UK Limited or its affiliates.
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1 This project has been supported in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. HHSO100200600012C, HHSO100200700030C, HHSO100200900101C, HHSO100201000061C and HHSO10020100003I.
2 AUDENZ™ (Influenza A (H5N1) Monovalent Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc; 2021.
3 Peterson J, Van Twuijver E, Versage E, Hohenboken M. Phase 3 Randomized, Multicenter, Placebo-Controlled Study to Evaluate Safety, Immunogenicity, and Lot-to-Lot Consistency of an Adjuvanted Cell Culture-Derived, H5N1 Subunit Influenza Virus Vaccine in Healthy Adult Subjects. Vaccines. 2022; 10(4):497.
4 Versage E, van Twuijver E, Jansen W, Theeuwes A, Sawlwin D, Hohenboken M. Analyses of Safety Profile and Homologous Antibody Responses to a Mammalian Cell-Based, MF59-Adjuvanted, A/H5N1, Pandemic Influenza Vaccine across Four Phase II/III Clinical Trials in Healthy Children, Adults, and Older Adults. Vaccines. 2021; 9(12):1468. https://doi.org/10.3390/vaccines9121468
5 Banzhoff A, Pellegrini M, Del Giudice G, Fragapane E, Groth N, Podda A. (2008). MF59-adjuvanted vaccines for seasonal and pandemic influenza prophylaxis. Influenza Other Respir Viruses. 2008;2(6):243-249
6 FLUCELVAX® QUADRIVALENT [package insert]. (2021). Holly Springs, NC: Seqirus Inc.
7 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. (2020). Holly Springs, NC: Seqirus Inc.
8 CDC. (2021). Key Facts about Influenza (Flu). Retrieved from: https://www.cdc.gov/flu/about/keyfacts.htm. Accessed May 2022.
9 CDC. (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 May 2022.
10 CDC. (2021). WG Considerations and Proposed Influenza Vaccine Recommendations, 2021-22. Retrieved from: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-06/03-influenza-grohskopf-508.pdf. Accessed May 2022.
11 CDC. (2021). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed May 2022.
12 CDC. (2016). Pandemic Basics. Retrieved from: https://www.cdc.gov/flu/pandemic-resources/basics/index.html. Accessed May 2022.
13 WHO. (2021). How pandemic influenza emerges. Retrieved from: https://www.euro.who.int/en/health-topics/communicable-diseases/influenza/pandemic-influenza/how-pandemic-influenza-emerges. Accessed May 2022.
14 WHO. (2017). Pandemic Influenza Risk Management: A WHO guide to inform and harmonize national and international pandemic preparedness and response. Retrieved from: https://apps.who.int/iris/bitstream/handle/10665/259893/WHO-WHE-IHM-GIP-2017.1-eng.pdf;jsessionid=4421F16879D2F8B96481F8D0C745C7F3?sequence=1. Accessed May 2022.
15 CDC. (2015). Highly Pathogenic Asian Avian Influenza A(H5N1) in People. Retrieved from: https://www.cdc.gov/flu/avianflu/h5n1-people.htm. Accessed May 2022.