Inactivated quadrivalent influenza vaccine (Seqirus GmbH)

According to CDC estimates, there were between 35 million and 65 million U.S. cases of the flu between October 2023 and June 2024. The dog days of summer might be in full swing, but for flu vaccine makers, its a busy time prepping for this fall's influenza season. CSL Seqirus said it kicked off influenza vaccine shipments on July 9, when it began to ship out its three options, according to a press release. The company’s portfolio includes unique offerings such as Flucelvax, the “first and only” cell-based influenza vaccine and Fluad, which is recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) for people 65 and older. CSL Seqirus also makes the egg-based vaccine Afluria for people six months of age and older. "As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes,” the drugmaker’s chief health officer, Gregg Sylvester, M.D., said in a statement. Last flu season in the U.S. saw significant decreases in vaccination rates and a spike in influenza-related hospitalizations and deaths, CSL Seqirus said, citing preliminary CDC estimates. Sanofi, for its part, said it began its initial vaccine shipments on July 10, with more planned through October. Sanofi’s 2024/2025 flu vaccine portfolio includes its Flublok—a quadrivalent shot that's made using insect cells—as well as standard and high-dose versions of its Fluzone.  GSK said it started shipping its doses on July 11 following a licensing and lot-release approval from the FDA, according to a release. The company said it “worked quickly” to get doses produced and shipped after vaccine strain recommendations were made in February.   GSK markets Flulaval and Fluarix and expects to distribute more than 36 million doses in the U.S. this flu season. It takes about two weeks after vaccination for antibodies to develop to combat flu, so vaccination is recommended ahead of the season, according to CSL Seqirus. That would ideally be in September or October for those who need only one dose, the CDC says. The CDC advises all eligible people who are six months and older receive an annual vaccine, especially those at an increased risk of severe complications, including older adults, pregnant people and children under five years old.

CSL Seqirus is the only manufacturer to offer a differentiated influenza vaccine for all eligible people aged six months and older in the United States. Centers for Disease Control and Prevention (CDC) trend findings indicate a significant decline in influenza vaccination rates, which poses a serious risk to public health infrastructure and underscores the importance of receiving an annual influenza vaccination.1,2 According to the CDC, it is recommended that all eligible people aged six months and older receive their annual influenza vaccine, especially people at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.2,3 SUMMIT, N.J., July 9, 2024 /PRNewswire/ -- CSL Seqirus, a business of CSL (ASX: CSL), today announced that it has commenced shipping its differentiated portfolio of influenza vaccines. This year, the company's influenza vaccines are being produced as trivalent influenza vaccine (TIV) formulations, in compliance with the U.S. Food and Drug Administration's (FDA) directive to remove the B/Yamagata strain.4 "We are proud to support healthcare providers in their efforts to vaccinate their patients and communities to help turn around concerning declines in seasonal influenza vaccination rates," said Stefan Merlo, Vice President of Commercial Operations, North America, CSL Seqirus. "We are a committed partner in public health and are doing our part to educate, inform, and meet the evolving needs of the public, ensure customers are prepared for the upcoming flu season, and help reverse this downward trend to restore vaccination rates." This season, the 2024/25 influenza vaccine portfolio for CSL Seqirus, the only manufacturer to offer a differentiated influenza vaccine option approved for use in people aged six months and older, includes: FLUCELVAX® (Influenza Vaccine), the first and only cell-based influenza vaccine indicated for use in people six months and older.5 FLUAD® (Influenza Vaccine, Adjuvanted), the first and only adjuvanted seasonal influenza vaccine for adults 65 and older, which is preferentially recommended by the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) over standard-dose influenza vaccines.6,7 FLUAD contains an MF59® adjuvant that is designed to strengthen, broaden, and lengthen the immune response when added to an influenza vaccine.6,8,9 AFLURIA® (Influenza Vaccine), an egg-based, influenza vaccine approved for use in eligible people six months of age and older.10 The impact of declining vaccination rates poses a serious risk to public health infrastructure, with preliminary estimates from the CDC reporting an increase in influenza-related hospitalizations and deaths last season, in comparison to seasons prior, as well as an overburdened healthcare system.11,12 Across all age cohorts, vaccination rates experienced double-digit percentage declines over the past three flu seasons according to internal calculations based on influenza tracking data.13 This includes a notable 22% drop among children aged 6 months to 18 years and a 14% decrease in adults over 65, a group that typically maintains stable immunization rates.13 Additionally, the public health burden of influenza outpaces other respiratory illness.11,14,15 During the 2023/24 flu season, influenza accounted for nearly half of hospitalizations attributed to infectious diseases including influenza, COVID and respiratory syncytial virus (RSV) combined and over half of total deaths.11,14,15 This data underscores the importance of the CDC's recommendation that all eligible people aged six months and older receive an annual influenza vaccination as an essential measure to help prevent influenza and its complications.2 This is especially important for those at an increased risk of severe influenza-related complications, such as older adults, pregnant people, and children under five years old.3 "Influenza continues to pose a significant threat, as evidenced by recent flu seasons," said Dr. Gregg Sylvester, Chief Health Officer, CSL Seqirus. "As we begin distributing influenza vaccines to healthcare providers throughout the U.S., it is imperative that we work to maintain high vaccination rates this season to help reduce the burden of influenza-related illnesses and the risk of severe outcomes." For additional information on our influenza vaccines for the upcoming flu season as well as resources about vaccination campaigns and CDC guidance, visit flu360.com. About Seasonal Influenza Influenza is a common, contagious seasonal respiratory disease that may cause severe illness and life-threatening complications in some people.16 Influenza can lead to clinical symptoms varying from mild to moderate respiratory illness to severe complications, hospitalization and in some cases, death.16 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.16 Preliminary estimates from the Centers for Disease Control and Prevention (CDC) report that during the 2023/24 influenza season, there were an estimated 390,000-810,000 influenza-related hospitalizations in the U.S.11 The CDC recommends annual vaccination for people aged six months and older, who do not have any contraindications.2 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.2 The CDC recommends that for most people who need only 1 dose of flu vaccine, vaccination should ideally happen in September or October.2 About CSL Seqirus CSL Seqirus is part of CSL (ASX: CSL). As a global leader in the protection of public health and one of the largest influenza vaccine providers in the world, CSL Seqirus is committed to preventing infectious diseases, like influenza and COVID-19, and is 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, CSL Seqirus offers a broad portfolio of innovative, differentiated vaccines in more than 20 countries around the world. For more information about CSL Seqirus, visit . About CSL CSL (ASX: CSL; USOTC: CSLLY) is a global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies. Today, CSL – including our three businesses: CSL Behring, CSL Seqirus and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 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 about CSL, visit . Intended Audience This press release is issued from CSL Seqirus 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 CSL Seqirus products may vary from country to country. Please consult your local regulatory authority on the approval status of CSL 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-24-0016 MEDIA CONTACT Tiffany Cody +1 (908) 370-1863 [email protected] FLUAD ® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine) IMPORTANT SAFETY INFORMATION What are FLUAD® (Influenza Vaccine, Adjuvanted), FLUCELVAX® (Influenza Vaccine), and AFLURIA® (Influenza Vaccine)? FLUAD is a vaccine that helps protect people aged 65 years and older from the flu. FLUCELVAX and AFLURIA are vaccines that helps protect people aged 6 months and older from the flu. Vaccination with any of these may not protect all people who receive the vaccine. Who should not receive FLUAD, FLUCELVAX, or AFLURIA? You should not receive FLUAD nor AFLURIA if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or to a previous influenza vaccine. You should not receive FLUCELVAX if you have a history of severe allergic reactions (e.g., anaphylaxis) to any component of the vaccine. Before receiving FLUAD, FLUCELVAX, or AFLURIA, 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 vaccine. The decision to give any flu vaccine 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, FLUCELVAX, and AFLURIA? pain, tenderness, redness, itching, bruising, and/or swelling where the vaccine was given headache extreme tiredness muscle aches feeling unwell (malaise) Additional side effects seen in children include: raised hardened area where the vaccine was given changes in eating habits/loss of appetite sleepiness irritability diarrhea These are not all the possible side effects of FLUAD, FLUCELVAX, and AFLURIA. You can ask your healthcare provider for more information and for advice about any side effects that concern you. What do I do if I have side effects? Report any severe or unusual side effects to your healthcare provider . To report SUSPECTED ADVERSE REACTIONS, contact CSL Seqirus at 1-855-358-8966 or VAERS at 1-800-822-7967 or . Before receiving any of these vaccines, please see the full US Prescribing Information for FLUAD, FLUCELVAX, or AFLURIA. You can ask your healthcare provider or pharmacist for information about FLUAD, FLUCELVAX, or AFLURIA that is written for healthcare professionals. REFERENCES 1 Centers for Disease Control and Prevention (CDC). Flu Vaccination Coverage Update. Retrieved from: . Accessed June 2024. 2 CDC. Who Needs a Flu Vaccine and When. Retrieved from: . Accessed June 2024. 3 CDC. People at Higher Risk of Flu Complications. . Accessed June 2024. 4 Food and Drug Administration (FDA). Center for Biologics Evaluation and Research. 184th Vaccines and Related Biological Products Advisory Committee. March 2024. Retrieved from: . Accessed June 2024. 5 FLUCLEVAX. Package Insert. CSL Seqirus Inc. 6 FLUAD. Package Insert. CSL Seqirus Inc. 7 Grohskopf LA, Blanton LH, Ferdinands JM, et al. Prevention and Control of Seasonal Influenza with Vaccines: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023–24 Influenza Season. MMWR Recomm Rep 2023;72(No. RR-2):1–25. DOI: . 8 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. 9 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. 10 AFLURIA. Package Insert. CSL Seqirus Inc. 11 CDC. 2023-2024 Preliminary In-Season Burden Estimate. Retrieved from: . Accessed June 2024. 12 CDC. Disease Burden of Flu. Retrieved from: . Accessed June 2024. 13 IQVIA PharMetrics Plus Administrative Claims Database. 14 CDC. RSV Surveillance & Research. Retrieved from: . Accessed June 2024. 15 CDC. COVID Data Tracker. . Accessed June 2024. 16 CDC. Key Facts about Influenza. Retrieved from . Accessed June 2024. SOURCE CSL Seqirus