Influenza virus vaccine, quadrivalent(GlaxoSmithKline Plc)

GSK supports seasonal flu immunization in the US by shipping FLULAVAL (Influenza Vaccine) and FLUARIX (Influenza Vaccine) in advance of flu season PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced it has started shipping doses of its trivalent seasonal influenza vaccines to US healthcare providers and pharmacies in preparation for the 2025-26 flu season. This immediately follows a licensing and lot-release approval from the US Food and Drug Administration (FDA). Both FLULAVAL and FLUARIX will be available in a 0.5mL, single-dose, pre-filled syringe and are indicated for people six months and older. According to the US Centers for Disease Control and Prevention (CDC), annual influenza vaccination is the first and most important action recommended to reduce the risk of flu and its potentially serious outcomes. Ideally, vaccination should occur by the end of October, but people can continue to get vaccinated as long as the flu poses a threat.1 CDC recommends an annual flu vaccination for anyone aged six months or older who does not have contraindications.1,2 CDC estimates that from October 1, 2024, through May 17, 2025, there were 47 – 82 million flu illnesses, 610,000 – 1.3 million flu hospitalizations and 27,000 – 130,000 flu deaths.3 The 2024-25 flu season was the first season since 2017-18 that the CDC classified as high severity, and preliminary CDC estimates indicate that it was the worst flu season (based on flu illnesses, hospitalizations and deaths) the US has seen in the last 15 years.4,5 For egg-based influenza vaccines for the 2025-26 flu season in the Northern Hemisphere, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended including an A/Victoria/4897/2022 (H1N1)pdm09-like virus, an A/Croatia/10136RV/2023 (H3N2)-like virus and a B/Austria/1359417/2021 (B/Victoria lineage)-like virus.6 About Influenza The flu is a contagious respiratory illness caused by influenza viruses that infect the nose, throat and sometimes the lungs. It can cause mild-to-severe illness and at times can lead to death.7 Anyone, including healthy people, can get the flu, however, it can be more serious for children younger than five, adults 65 years and older, people with a body mass index (BMI) of 40 kg/m2 or higher, pregnant women and people with pre-existing chronic health conditions, such as asthma, diabetes and heart disease.7 For more information about the flu, visit https://www.cdc.gov/flu/about. Indication for FLUARIX and FLULAVAL FLUARIX and FLULAVAL are vaccines indicated for active immunization for the prevention of disease caused by influenza A subtype viruses and type B virus contained in the vaccines. FLUARIX and FLULAVAL are approved for use in persons aged 6 months and older. Important Safety Information for FLUARIX and FLULAVAL Do not administer FLUARIX or FLULAVAL to anyone with a history of severe allergic reactions (eg, anaphylaxis) to any component of the vaccine, including egg protein, or following a previous dose of any influenza vaccine. If Guillain-Barré syndrome has occurred within 6 weeks of receipt of a prior influenza vaccine, the decision to give FLUARIX or FLULAVAL should be based on careful consideration of the potential benefits and risks. Syncope (fainting) can occur in association with administration of injectable vaccines, including FLUARIX and FLULAVAL. Procedures should be in place to avoid injury from fainting. Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUARIX and FLULAVAL. If FLUARIX or FLULAVAL is administered to immunosuppressed persons, including individuals receiving immunosuppressive therapy, the immune response may be lower than in immunocompetent persons. The most common solicited local adverse reactions with FLUARIX in adults were pain and redness, and the most common systemic adverse reactions were muscle aches, fatigue, and headache. In children aged 5 through 17 years, the most common solicited local adverse reactions were pain, redness, and swelling, and the most common systemic adverse reactions were muscle aches, fatigue, and headache. In children aged 3 through 4 years, the most common solicited local adverse reactions were pain, redness, and swelling, and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. In children aged 6 through 35 months who received FLUARIX QUADRIVALENT, the most common solicited local adverse reactions were pain and redness, and the most common systemic adverse reactions were irritability, loss of appetite, and drowsiness. The most common solicited local adverse reactions with FLULAVAL in adults were pain, redness, and swelling, and the most common solicited systemic adverse reactions were fatigue, headache, and muscle aches/arthralgia. In children aged 3 through 17 years, the most common solicited local adverse reaction was pain. In children aged 3 through 4 years, the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. In children aged 5 through 17 years, the most common solicited systemic adverse reactions were muscle aches, headache, and fatigue. In children aged 6 through 35 months who received FLULAVAL QUADRIVALENT, the most common solicited local adverse reaction was pain, and the most common solicited systemic adverse reactions were irritability, drowsiness, and loss of appetite. Vaccination with FLUARIX or FLULAVAL may not result in protection of all vaccine recipients. Please see full Prescribing Information for FLUARIX and for FLULAVAL. About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2024. Registered in England & Wales: No. 3888792 Registered Office: 79 New Oxford Street London WC1A 1DG References 1. Centers for Disease Control and Prevention. Preventing Seasonal Flu. Available at: https://www.cdc.gov/flu/prevention. Accessed June 30, 2025. 2. Centers for Disease Control and Prevention. Who Needs a Flu Vaccine. Available at: https://www.cdc.gov/flu/vaccines/vaccinations.html. Accessed June 30, 2025. 3. Centers for Disease Control and Prevention. Preliminary Estimated Flu Disease Burden 2024-2025 Flu Season. Available at: https://www.cdc.gov/flu-burden/php/data-vis/2024-2025.html. Accessed June 30, 2025. 4. Centers for Disease Control and Prevention. Past Flu Season Severity Assessments. Available at: https://www.cdc.gov/flu/php/surveillance/past-seasons.html. Accessed June 30, 2025. 5. Centers for Disease Control and Prevention. Severity, Disease Burden, and Prevented Burden for the 2024-2025 Influenza Season. Available at: https://www.cdc.gov/acip/downloads/slides-2025-06-25-26/03-dugan-influenza-508.pdf. Accessed June 30, 2025. 6. U.S. Food and Drug Administration. Influenza Vaccine Composition for the 2025-2026 U.S. Influenza Season. Available at: https://www.fda.gov/vaccines-blood-biologics/influenza-vaccine-composition-2025-2026-us-influenza-season. Accessed June 30, 2025. 7. Centers for Disease Control and Prevention. About Influenza. Available at: https://www.cdc.gov/flu/about. Accessed June 30, 2025.

Co-administration of OVX836 with seasonal inactivated influenza vaccine (Fluarix® Tetra) was well-tolerated and demonstrated a favorable safety profileRobust complementary immune responses were induced, with no major interference observed Lyon, France – July 10, 2025 – Osivax, a biopharmaceutical company developing vaccines to provide broad-spectrum protection against highly mutating infectious viruses, today announced the publication of positive results from its Phase 2a, OVX836-004, study in the journal Vaccines. The study evaluated the safety and immunogenicity of co-administering OVX836, Osivax’ broad-spectrum influenza vaccine candidate, with the hemagglutinin antigen (HA)-based inactivated influenza vaccine Fluarix® Tetra. The full article “Safety and Immunogenicity of OVX836, a Nucleoprotein-Based Universal Influenza Vaccine, Co-Administered with Fluarix® Tetra, a Seasonal Hemagglutinin-Based Vaccine” is now available online. In the OVX836-004 study (NCT05284799), 180 healthy adults aged 18 to 55 years were randomized to each receive two concomitant intramuscular injections of Fluarix® Tetra and placebo, Fluarix® Tetra and OVX836 (480 µg), or OVX836 and placebo, both administered into the deltoid muscle of the non-dominant arm. Key findings include: Favorable safety and tolerability profile of OVX836 when administered alone or in combination with Fluarix® Tetra; no severe or unsolicited adverse events were reported Comparable local and systemic reactions across all treatment groups Strong HA-specific antibody responses were observed in all groups immunized with Fluarix® Tetra, whether co-administered with OVX836 or as a stand-alone, with similar HAI titers across all four influenza strains Robust NP-specific immune responses, both humoral and cell-mediated, were measured in all groups receiving OVX836, whether co-administered with Fluarix® Tetra or as a stand-alone “The favorable safety profile and strong immune response observed in this study provide encouraging evidence that OVX836 can be co-administered with a standard seasonal influenza vaccine,” commented Dr. Nicola Groth, MD, CMO of Osivax. “These findings support the potential of OVX836 to lead to higher efficacy due to synergistic effects of the immune responses when combined with standard seasonal flu vaccine and to further reinforce the versatility of our vaccine candidate, marking an important milestone in our efforts to broaden protection against influenza in years of strain mismatches.” “The results underscore OVX836’s strong potential as a valuable component of combination approaches with seasonal vaccines,” added Alexandre Le Vert, CEO and Co-Founder of Osivax. “By inducing strong and complementary immune responses, our approach positions us to meaningfully advance influenza prevention on a broader scale. The data collected will support the continued development of OVX836 as we focus on a single-injection formulation that streamlines vaccination delivery and maximizes public health impact.” About OVX836 OVX836 is a first-in-class influenza A vaccine candidate that targets the nucleoprotein (NP), a highly conserved internal antigen. Unlike surface antigens, the NP is much less likely to mutate, providing a broader and more universal immune response. Osivax’ oligoDOMTM technology enables the design and production of a recombinant version of the NP, which self-assembles into a nanoparticle, thus triggering powerful T- and B-cell immune responses. OVX836 has been tested in 7 clinical trials with 1,400 participants so far, and has shown promising safety, immunogenicity, and efficacy read-outs. About OVX836-004OVX836-004 is a randomized, double-blind, reference-controlled, single-center Phase 2a clinical trial run in Australia (NCT05284799), to assess the co-administration of NP-based flu vaccine OVX836 at 480μg with a conventional seasonal, HA-based quadrivalent inactivated influenza virus vaccine (QIV), the current standard of care in the flu vaccine market. The clinical study is evaluating the safety and level of immune response generated by each vaccine individually and when co-administered to confirm the absence of immune interference. About Osivax Osivax is a clinical-stage biopharmaceutical company leveraging its novel, self-assembling nanoparticle platform technology, oligoDOMTM, to develop transformative, first-in-class pan-respiratory virus vaccines generating superior T-cell responses in addition to strong and sustained B-cell responses. The company is establishing proof of concept with its broad-spectrum influenza vaccine candidate, OVX836, which is currently in Phase 2 clinical trials with over 1,400 volunteers tested and encouraging efficacy proof of concept data. Osivax’ ambition is to develop a pan-respiratory virus vaccine to prevent all strains of influenza and all variants of Covid-19 in one single shot. The company will expand into other infectious disease indications through combinations and collaborations worldwide. For further information: www.osivax.com ContactAlexandre LE VERT, CEOcontact@osivax.com+33 (0)9 70 30 13 80 For Media InquiriesTrophic CommunicationsDesmond James or Anja Heuerosivax@trophic.eu +49 (0) 151 678 59086 or +49 (0) 151 106 199 05