Seqirus, a global leader in influenza prevention and a business of CSL Limited (ASX:CSL), today announced that it has begun to ship its portfolio of innovative cell-based, adjuvanted and egg-based seasonal influenza vaccines across the U.S. in preparation for the 2022/23 influenza season. The company is prepared to supply more than 55 million doses of influenza vaccines for healthcare providers across the U.S.
Seqirus provides a differentiated portfolio of seasonal influenza vaccines that offer protection for people of all ages who are eligible to be vaccinated in the U.S. The portfolio for the 2022/23 U.S. influenza season includes:
- FLUCELVAX® QUADRIVALENT (Influenza Vaccine), the first and only cell-based, quadrivalent influenza vaccine, which for the first full season is now available for individuals six months of age and older1.
- FLUCELVAX QUADRIVALENT is a cell-based influenza vaccine, designed to produce an exact match to WHO-selected influenza virus strains.3
- FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted), the first and only adjuvanted quadrivalent seasonal influenza vaccine for adults 65 and older, which is now preferentially recommended by the Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) over standard dose influenza vaccines2,4.
- FLUAD QUADRIVALENT is specifically created for adults 65 years and older using Seqirus’ MF59® adjuvant, designed to help strengthen, broaden and lengthen the immune response to influenza vaccination.4,5,6,7
- AFLURIA® QUADRIVALENT (Influenza Vaccine), an egg-based, quadrivalent influenza vaccine approved for use in eligible persons six months of age and older.8
“This season, Seqirus’ portfolio of influenza vaccines is poised to provide protection to more people than ever before, including vulnerable populations like young children and adults 65 years and older,” said Dave Ross, Vice President, North America Commercial Operations, Seqirus. “We look forward to continuing our work with public health partners, who rely on us season after season to deliver safe and effective flu vaccines in order to vaccinate as many people as possible to reduce the risk of flu-related illness and complications.”
According to the CDC, influenza caused up to 52,000 deaths and 710,000 hospitalizations annually between 2010-2020 in the U.S.9 The CDC continues to recommend vaccination as a critical tool to help protect against influenza by preventing disease and lessoning the severity of disease.10
“While influenza rates have been low since the beginning of the COVID-19 pandemic, relaxed COVID-19 mitigation measures coupled with the return to usual activities could increase the likelihood of a flu resurgence such as what we are seeing already in the Southern Hemisphere,” said Dr. Gregg Sylvester, Chief Health Officer, Seqirus.11,12 “With Seqirus’ rich history and exclusive focus on influenza, we know that influenza vaccination can save lives and is an important step we can take to help protect ourselves, our loved ones and our communities.”
About Seasonal Influenza
Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.13 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.13 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.13 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.14 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.10 The CDC recommends that people get vaccinated by the end of October.10
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-CRP-22-0030
###
MEDIA CONTACT
Maria Tortoreto
+1 (201) 248-5208
Maria.Tortoreto@Seqirus.com
###
FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted),
AFLURIA® QUADRIVALENT (Influenza Vaccine), and
FLUCELVAX® QUADRIVALENT (Influenza Vaccine)
IMPORTANT SAFETY INFORMATION for HCPs
INDICATIONS AND USAGE
FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and types 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.
AFLURIA® QUADRIVALENT (Influenza Vaccine) is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine. AFLURIA QUADRIVALENT is approved for use in persons 6 months of age and older.
FLUCELVAX® QUADRIVALENT (Influenza Vaccine) 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.
IMPORTANT SAFETY INFORMATION
CONTRAINDICATIONS
Do not administer FLUAD QUADRIVALENT or AFLURIA QUADRIVALENT to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. 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 (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT or 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) may occur in association with administration of injectable vaccines including FLUAD QUADRIVALENT and FLUCELVAX QUADRIVALENT. Syncope can be accompanied by transient neurological signs such as visual disturbance, paresthesia, and tonic-clonic limb movements. Ensure procedures are in place to avoid falling injury and to restore cerebral perfusion following syncope by maintaining a supine or Trendelenburg position.
The immune response to FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals.
Vaccination with FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT or FLUCELVAX QUADRIVALENT may not protect all vaccine recipients against influenza disease.
ADVERSE REACTIONS
FLUAD QUADRIVALENT:
The most common (≥ 10%) local and systemic reactions with FLUAD QUADRIVALENT in elderly subjects 65 years of age and older were injection site pain (16.3%), headache (10.8%) and fatigue (10.5%).
AFLURIA QUADRIVALENT:
AFLURIA QUADRIVALENT administered by needle and syringe:
In adults 18 through 64 years, the most commonly reported injection-site adverse reaction was pain (≥ 40%). The most common systemic adverse events were myalgia and headache (≥ 20%).
In adults 65 years of age and older, the most commonly reported injection-site adverse reaction was pain (≥ 20%). The most common systemic adverse event was myalgia (≥ 10%).
In children 5 through 8 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse event was headache (≥ 10%).
In children 9 through 17 years, the most commonly reported injection-site adverse reactions were pain (≥ 50%), redness and swelling (≥ 10%). The most common systemic adverse events were headache, myalgia, and malaise and fatigue (≥ 10%).
In children 6 months through 35 months of age, the most commonly reported injection-site reactions were pain and redness (≥ 20%). The most common systemic adverse events were irritability (≥ 30%), diarrhea and loss of appetite (≥ 20%).
In children 36 through 59 months of age, the most commonly reported injection site reactions were pain (≥ 30%) and redness (≥ 20%). The most commonly reported systemic adverse events were malaise and fatigue, and diarrhea (≥ 10%).
The safety experience with AFLURIA (trivalent formulation) is relevant to AFLURIA QUADRIVALENT because both vaccines are manufactured using the same process and have overlapping compositions:
In adults 18 through 64 years of age, the most commonly reported injection-site adverse reactions with AFLURIA (trivalent formulation) when administered by the PharmaJet Stratis Needle-Free Injection System were tenderness (≥ 80%), swelling, pain, redness (≥ 60%), itching (≥ 20%) and bruising (≥ 10%). The most common systemic adverse events were myalgia, malaise (≥ 30%), and headache (≥ 20%).
FLUCELVAX QUADRIVALENT:
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 FLUAD QUADRIVALENT, AFLURIA QUADRIVALENT and FLUCELVAX QUADRIVALENT.
FLUAD® QUADRIVALENT, AFLURIA® QUADRIVALENT and FLUCELVAX® QUADRIVALENT are registered trademarks of Seqirus UK Limited or its affiliates.
PharmaJet® and STRATIS® are registered trademarks of PharmaJet.
###
REFERENCES
1 FLUCELVAX® QUADRIVALENT (Influenza Vaccine) [package insert]. Holly Springs, NC: Seqirus Inc, 2021.
2 National Center for Immunization & Respiratory Diseases. Advisory Committee on Immunization Practices. Summary and Proposed Recommendations for 2022-23 Influenza Season. Accessed July 2022.
3 Rajaram, 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 July 2022.
4 FLUAD® QUADRIVALENT (Influenza Vaccine, Adjuvanted) [package insert]. Holly Springs, NC: Seqirus Inc, 2019.
5 O’Hagan DT, Ott GS, Nest GV, Rappuoli R, Giudice GD. (2013). The history of MF59® adjuvant: a phoenix that arose from the ashes. Expert Rev Vaccines: 2013;12(1): 13-3.
6 Frey SE, Aplasca-De Los Reyes MR, Reynales H, et al. (2014). Comparison of the safety and immunogenicity of an MF59®-adjuvanted with a non-adjuvanted seasonal influenza vaccine in elderly subjects. Vaccine. 2014;32:5027-5034.
7 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.
8 AFLURIA® QUADRIVALENT [package insert]. (2020). Parkville, AU: Seqirus Inc.
9 Centers for Disease Control and Prevention (CDC). Burden of Flu. Retrieved from: https://www.cdc.gov/flu/about/burden/index.html. Accessed July 2022.
10 Centers for Disease Control and Prevention (CDC). Who Needs a Flu Vaccine and When. Retrieved from: https://www.cdc.gov/flu/prevent/vaccinations.htm. Accessed July 2022.
11 Chiu, Nan-Chang, et al. Impact of Wearing Masks, Hand Hygiene, and Social Distancing on Influenza, Enterovirus, and All-Cause Pneumonia During the Coronavirus Pandemic: Retrospective National Epidemiological Surveillance Study. Retrieved from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7471891/. Accessed July 2022.
12 Australian Government Department of Health. Australian Influenza Surveillance Report. Retrieved from: https://www1.health.gov.au/internet/main/publishing.nsf/Content/cda-surveil-ozflu-flucurr.htm/$File/flu-06-2022.pdf. Accessed July 2022.
13 Centers for Disease Control and Prevention (CDC). Key Facts about Influenza. Retrieved from https://www.cdc.gov/flu/about/keyfacts.htm. Accessed July 2022.
14 Centers for Disease Control and Prevention (CDC). 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 July 2022.