SUMMIT, N.J., April 15, 2019 /PRNewswire/ -- Seqirus, a leading innovator in influenza protection, today announced it will file an Annual Strain Update with the U.S. Food and Drug Administration (FDA) in the coming weeks, including the decision to manufacture its cell-based influenza vaccine (FLUCELVAX® QUADRIVALENT) for the 2019/20 season using a cell-based candidate vaccine virus (CVV) for all four influenza strains recommended by the World Health Organization (WHO).1 This decision makes the entire production process exclusively cell-based.
CVVs are provided each season by the WHO Global Influenza Surveillance and Response System (GISRS) and associated laboratories. The manufacturing seeds produced from these CVVs are used to grow large quantities of virus, in either eggs or cells, enabling the mass production of influenza vaccine matched to the WHO-recommended strains.2
According to a recent study, which evaluated the degree of match of egg-based and cell-based CVVs to the circulating seasonal virus strain over the past 12 seasons, cell-based H3N2 CVVs have been more closely matched to the circulating virus than the egg-based H3N2 CVVs.3
"Egg-based vaccines are the standard of care and continue to play a critical role in the fight against influenza, but it's important to continuously evolve approaches to vaccine development," said Gordon Naylor, President of Seqirus. "While we continue to manufacture and distribute egg-based vaccines globally, cell-based influenza vaccines represent a significant advancement in influenza protection. Seqirus is proud to continue to innovate this promising technology as part of our leading role on the front line of influenza prevention and pandemic preparedness."
Seqirus, the world's largest cell-based influenza vaccine manufacturer, produces FLUCELVAX QUADRIVALENT at its Holly Springs facility in North Carolina. The Holly Springs facility was purpose-built in partnership with the U.S. Biomedical Advanced Research and Development Authority (BARDA) to help combat pandemic threats.4 When production first began in 2014, the site utilized egg-based CVVs in its cell-based manufacturing process.5,6 In 2016, the WHO began to recommend cell-based CVVs and the FDA issued an approval for Seqirus to use them in the production of cell-based influenza vaccines.7
Seqirus incorporated a cell-based H3N2 CVV in FLUCELVAX QUADRIVALENT for the 2017/18 season and cell-based CVVs for both B strains in the 2018/19 season.8 The inclusion of a cell-based CVV for the remaining A strain in the 2019/20 season formulation will complete the transition to an exclusively cell-based product. This achievement complements other innovations that have enabled the site to more than quadruple production in the last three years, as demand has increased in the U.S. and Seqirus prepares to launch the product in Europe next season.9
"We've taken a stepwise approach to the introduction of this latest advancement to our cell-based technology, enabling us to continue to scale up manufacturing at Holly Springs. It will help us to fully realize the potential of our cell-based technology and enhance our ability to deliver on our commitment to public health," said Naylor.
The introduction of cell-based CVVs into the global influenza system was the result of a multi-year collaboration involving the WHO Collaborating Centre for Surveillance, Epidemiology and Control of Influenza at the U.S. Centers for Disease Control and Prevention (CDC), the WHO Collaborating Centre for Reference and Research on Influenza in Melbourne, Australia, and scientists at Seqirus and its predecessor company.
"Major advances in influenza prevention require significant global collaboration between industry and public health agencies. We thank the many partners involved in advancing promising technologies and remain committed to our shared goal of reducing the number of lives lost to influenza each season," said Naylor.
About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. To reduce the risk of more serious outcomes, such as hospitalization and death, resulting from influenza, the CDC encourages annual vaccination for all individuals aged 6 months and older.10 Because transmission 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.11 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases death.11 The CDC estimates that 959,000 people in the United States were hospitalized due to influenza-related complications during the 2017-2018 influenza season.12 Since it takes about 2 weeks after vaccination for antibodies to develop in the body that protect against influenza virus infection, it is best that people get vaccinated to help protect them before influenza begins spreading in their community.10
Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The CSL Group of companies employs more than 22,000 people with operations in more than 60 countries.
Seqirus was established on 31 July 2015 following CSL's acquisition of the Novartis influenza vaccines business and its subsequent integration with bioCSL. 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.
Seqirus operates state-of-the-art production facilities in the U.S., the UK and Australia, and manufactures influenza vaccines using both egg-based and cell-based technologies. It has leading R&D capabilities, a broad portfolio of differentiated products and a commercial presence in more than 20 countries.
FLUCELVAX® QUADRIVALENT (Influenza Vaccine) Important Safety Information
FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. FLUCELVAX QUADRIVALENT is approved for use in persons 4 years of age and older.
- Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine.
Warnings & Precautions
- Guillain-Barré Syndrome (GBS): If GBS 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.
- Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
- Syncope: 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.
- Altered Immunocompetence: After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response.
- Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.
Most Common Adverse Reactions
- The most common (≥10%) local and systemic reactions in adults 18-64 years of age were injection site pain (45.4%), headache (18.7%), fatigue (17.8%), myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).
- The most common (≥10%) local and systemic reactions in adults ≥65 years of age were injection site pain (21.6%) and injection site erythema (11.9%).
- The most common (≥10%) local and systemic reactions in children 4 to <6 years of age were tenderness at the injection site (46%), injection site erythema (18%), sleepiness (19%), irritability (16%), injection site induration (13%), and change in eating habits (10%).
- The most common (≥10%) local and systemic reactions in children 6 through 8 years of age were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%), and myalgia (12%).
- The most common (≥10%) local and systemic reactions in children and adolescents 9 through 17 years of age were pain at the injection site (58%), headache (22%), injection site erythema (19%), fatigue (18%), myalgia (16%), and injection site induration (15%).
Please see accompanying US full Prescribing Information for FLUCELVAX QUADRIVALENT.
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1 WHO. (2019). Addendum to the recommended composition of influenza virus vaccines for use in the 2019–2020 northern hemisphere influenza season. Retrieved from: https://www.who.int/influenza/vaccines/virus/recommendations/201902_recommendation_addendum.pdf?ua=1
Accessed April 2019.
2 Ambrozaitis A, et al. (2009). A novel mammalian cell-culture technique for consistent production of a well-tolerated and immunogenic trivalent subunit influenza vaccine. Vaccine. 2009;27:6022–6029. doi:10.1016/j.vaccine.2009.07.083.
3 Rajaram S., Van Boxmeer J., Leav B., et al. (2018). Retrospective evaluation of mismatch from egg-based isolation of influenza strains compared to cell-based isolation and the possible implications for vaccine effectiveness. Presented at IDWeek 2018, October 2018.
4 This project has been funded in whole or in part with Federal funds from the Office of the Assistant Secretary for Preparedness and Response, Biomedical Advanced Research and Development Authority, under contract numbers HHSO100200600012C, HHSO100200700030C, HHSO100200900101C and HHSO100201200003I.
5 WHO. (2016). Improving influenza vaccine virus selection, Report of the 4th WHO Informal Consultation Hong Kong. Retrieved from: http://www.who.int/influenza/resources/publications/Influenza_vaccine_virus_selection_report/en/ Accessed April 2019.
6 U.S. Department of Health & Human Services. Supplement Approval. (2016). Retrieved from: https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM522280.pdf Accessed April 2019.
7 WHO. (2017). Recommended composition of influenza virus vaccines for use in the 2017-2018 northern hemisphere influenza season. Retrieved from: http://www.who.int/influenza/vaccines/virus/recommendations/201703_recommendation.pdf?ua=1 Accessed April 2019.
8 CDC. (2018). Advisory Committee on Immunization Practices (ACIP) Presentation Slides: June 2018 Meeting. Retrieved from: https://www.cdc.gov/vaccines/acip/meetings/slides-2018-06.html Accessed April 2019.
9 Seqirus USA Inc. Data on file.
10 CDC. (2018). Key facts about seasonal flu vaccine. Retrieved from: http://www.cdc.gov/flu/protect/keyfacts.htm Accessed April 2019.
11 CDC. (2018). How flu spreads. Retrieved from: https://www.cdc.gov/flu/about/disease/spread.htm Accessed April 2019.
12 CDC. (2018). Estimated influenza illnesses, medical visits, hospitalizations, and deaths in the United States — 2017–2018 influenza season. Retrieved from: https://www.cdc.gov/flu/about/burden/2017-2018.htm Accessed April 2019.