United States

Seqirus receives FDA approval for FLUCELVAX QUADRIVALENT™ (Influenza Vaccine) for people four years of age and older

Cambridge, MA — 05/23/2016

  • First and only cell culture-based influenza vaccine in the United States to help offer protection against four influenza virus strains for people aged four years and older1,2
  • Manufactured in America’s only full-scale cell culture influenza vaccine manufacturing facility, in Holly Springs, NC, to help build pandemic preparedness in the US 3
  • FLUCELVAX QUADRIVALENT is the second FDA approval for Seqirus since the formation of the company in July of 2015, and will be available during the 2016-2017 flu season.

Seqirus announced today that the US Food and Drug Administration (FDA) has approved FLUCELVAX QUADRIVALENT™ (Influenza Vaccine), the first four-strain, cell culture-derived, inactivated seasonal influenza vaccine for people aged four years and older.1,2 FLUCELVAX QUADRIVALENT helps protect against the two influenza A viruses and two B viruses recommended by the World Health Organization (WHO) and the FDA for the current influenza season.2

“As the first and only cell culture-derived seasonal influenza vaccine in the US to offer four-strain flu protection for people aged four years and older, FLUCELVAX QUADRIVALENT will provide healthcare providers and their patients with an important option to further broaden their influenza coverage,” said Gordon Naylor, President of Seqirus.1,2 “We are pleased to offer FLUCELVAX QUADRIVALENT, which is produced at our full-scale cell culture influenza vaccine manufacturing facility in North Carolina, to our valued customers during the 2016-2017 flu season.”

The traditional seasonal influenza vaccine is a trivalent formula consisting of two strains of influenza A viruses and a single strain of influenza B virus.4 However, since 1985, two distinct lineages of influenza B virus have co-circulated with varying dominance. The use of a four-strain influenza vaccine like FLUCELVAX QUADRIVALENT may now provide protection against both B lineages, which may lead to a decrease in the influenza burden.5

Each year in the US, an average of 200,000 people are hospitalized due to flu complications.6 To reduce morbidity and mortality resulting from influenza, the Centers for Disease Control and Prevention (CDC) encourages annual vaccination for all individuals aged six months and older.7

“Despite strong recommendations for everyone in the US six months of age and older to be vaccinated against the flu every year, fewer than half of eligible people did so in the 2014-2015 season. This includes children, the group with the highest incidence during community outbreaks,” said Dr. Gary S. Marshall, Chief of Pediatric Infectious Diseases at the University of Louisville. “Even healthy people are at risk—they should be vaccinated to protect themselves and to prevent transmission to others.”

FLUCELVAX QUADRIVALENT is produced using the same full-scale cell culture manufacturing technology as its predecessor FLUCELVAX™ (Influenza Vaccine), which allows the potential for rapidly increased production of flu shots in response to outbreaks or pandemic. Cell culture technology does not depend on eggs for manufacturing, and the vaccine is produced in sterile bioreactors.8 The change to using cells rather than eggs represented the first major development in influenza vaccine manufacturing technology since vaccine production began in the 1930s.9,10

FLUCELVAX QUADRIVALENT is manufactured in a state-of-the-art facility in Holly Springs, North Carolina. Development of the technology and manufacturing facility that produces FLUCELVAX QUADRIVALENT was supported by the US government to help ensure that flu shots are available when needed to help combat public health threats, such as pandemics.3

Demonstrated Immunogenicity in Children and Adults Builds on a Platform of Influenza Protection
FLUCELVAX QUADRIVALENT™ (Influenza Vaccine) is an evolution of FLUCELVAX (Influenza Vaccine), a cell-based trivalent influenza vaccine. Because both vaccines are manufactured using the same process and have overlapping compositions, the clinical efficacy and safety data from clinical trials with FLUCELVAX is relevant to FLUCELVAX QUADRIVALENT.2

In clinical studies of adults aged 18 to 49 years, FLUCELVAX has been shown to be efficacious against influenza caused by vaccine-like strains (83.8%) and by all circulating influenza strains (69.5%).2 Its quadrivalent formulation was also shown to be immunogenic against the flu in adults aged 18 years and older (Study 1) and children aged 4 through 17 (Study 2).2 FLUCELVAX QUADRIVALENT produced stronger antibody responses to the influenza B virus strain, which was not contained in the trivalent comparator flu vaccine, and is well-tolerated with a safety profile similar to its comparator vaccines.2 It also leverages the safety database demonstrated by its predecessor FLUCELVAX in more than 11,000 people.2

About Seasonal Influenza
Influenza is a common, highly contagious infectious disease that can cause severe illness and life-threatening complications in many people. Because transmission to others may occur one day before symptoms develop and up to five to seven 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 On average, more than 200,000 people are hospitalized due to influenza-related complications in the US each year.6

FLUCELVAX QUADRIVALENT is an inactivated vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.2 FLUCELVAX QUADRIVALENT is approved for use in persons four years of age and older.2



  • Do not administer FLUCELVAX QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine. 2

Warnings & Precautions

  • Guillain-Barré Syndrome: The 1976 swine influenza vaccine was associated with an elevated risk of Guillain-Barré syndrome (GBS). Evidence for a causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. If GBS has occurred after receipt of a prior influenza vaccine, the decision to give FLUCELVAX QUADRIVALENT should be based on careful consideration of the potential benefits and risks. 2
  • Preventing and Managing Allergic Reactions: Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine. 2
  • Syncope: Syncope (fainting) can occur in association with administration of injectable vaccines, including Flucelvax. 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. 2
  • Altered Immunocompetence: After vaccination with FLUCELVAX QUADRIVALENT, immunocompromised individuals, including those receiving immunosuppressive therapy, may have a reduced immune response. 2
  • Limitations of Vaccine Effectiveness: Vaccination with FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease. 2

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%) and myalgia (15.4%), injection site erythema (13.4%), and induration (11.6%).2
  • 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%).2
  • The most common (≥10%) local and systemic reactions in children 4 to <6 years of age after first dose of vaccine 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%).2
  • The most common (≥10%) local and systemic reactions in children 6 through 8 years of age after first dose of vaccine were pain at the injection site (54%), injection site erythema (22%), injection site induration (16%), headache (14%), fatigue (13%) and myalgia (12%).2
  • 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%).2

Please see www.seqirus-us.com for US Full Prescribing Information for FLUCELVAX QUADRIVALENT.

About Seqirus
Seqirus is the new global company created in July 2015 from the combined strength and expertise of bioCSL Inc. and the influenza vaccines business formerly owned by Novartis AG. As the second largest influenza vaccine provider in the world, Seqirus is driven by the promise it shares with parent company, CSL Limited, to provide medicines that help to protect and save lives.

Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally, with extensive research and production expertise and manufacturing plants in the US, Europe and Australia and a commercial presence in 20 countries.

Seqirus is part of CSL Limited (ASX:CSL), headquartered in Melbourne, Australia. The Group employs more than 16,000 people with operations in more than 30 countries.

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


Media Contact:

Tori Marks
Corporate Affairs, Seqirus
Phone: +1 919 324 4135
Monica Galimberti
Corporate Affairs, Seqirus
Mobile: +39 335 7440521


 1 U.S. Food and Drug Administration. “FDA approves first seasonal influenza vaccine manufactured using cell culture technology.” Available at: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm328982.htm. Accessed April 2016.
 2  FLUCELVAX QUADRIVALENT (Influenza Vaccine) [prescribing information]. Cambridge, MA: Seqirus, Inc. 2016.
 3 US Department of Health & Human Services. A milestone in protection from influenza. US Department of Health and Human Services website. Available at: http://www.hhs.gov/news/press/2014pres/06/20140617a.html. Accessed April 2016.
 4 Centers for Disease Control and Prevention (CDC). Key Facts About Seasonal Flu Vaccine. Available at: http://www.cdc.gov/flu/protect/keyfacts.htm. Accessed April 2016.
 5 Hartvickson R, et al. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. International Journal of Infectious Diseases. 2015;41:65-72. http://dx.doi.org/10.1016/j.ijid.2015.11.004.
 6 Thompson WW, Shay DK, Weintraub E, et al. Influenza-associated hospitalizations in the United States. JAMA. 2004;292(11):1333-1340.
 7Centers for Disease Control and Prevention (CDC). Flu vaccination coverage. Available at: http://www.cdc.gov/flu/fluvaxview/coverage-1415estimates.htm. Accessed April 2016.
 8Ambrozaitis A, et al. 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.
 9Center for Infectious Disease Research & Policy (CIDRAP). The compelling need for game-changing influenza vaccines: an analysis of the influenza vaccine enterprise and recommendations for the future. Available at: http://www.cidrap.umn.edu/sites/default/files/public/downloads/ccivi_report.pdf. Accessed April 2016.
10 US Department of Health & Human Services. HHS Awards Contracts Totaling More Than $1 Billion To Develop Cell­Based Influenza Vaccine. Available at: http://archive.hhs.gov/news/press/2006pres/20060504.html. Accessed April 2016.
11Centers for Disease Control and Prevention (CDC). Key Facts about Influenza (Flu) & Flu Vaccine. Updated 2015. Available at: http://www.cdc.gov/flu/keyfacts.htm. Accessed April 2016.

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