Arexvy (respiratory syncytial virus vaccine, adjuvanted) / GSK - LARVOL DELTA

Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three respiratory syncytial virus seasons (AReSVi-006): a multicentre, randomised, observer-blinded, placebo-controlled, phase 3 trial. (PubMed, Lancet Respir Med) - P3 | "A single RSVPreF3 OA dose was efficacious against RSV-LRTD over three RSV seasons in people aged 60 years or older, despite a decrease in efficacy over time. Further research is needed to establish the optimal revaccination strategy. These results support the favourable benefit-risk profile of RSVPreF3 OA to help protect against RSV-LRTD for at least three RSV seasons."

Journal • P3 data • Cardiovascular • Heart Failure • Pulmonary Embolism • Respiratory Diseases • Respiratory Syncytial Virus Infections

Arexvy recommended for adults aged 50-59 at increased risk for severe respiratory syncytial virus (RSV) disease by US Advisory Committee on Immunization Practices (GSK Press Release) - "GSK plc...is pleased that the Advisory Committee on Immunization Practices (ACIP) voted in favour of recommending the use of RSV vaccines including GSK’s Arexvy (Respiratory Syncytial Virus Vaccine, Adjuvanted) in adults aged 50-59 who are at increased risk for severe RSV disease. This includes people with conditions like COPD, asthma, diabetes, heart disease and those in residential care. This expands on ACIP’s previous vote in June 2024 to recommend RSV vaccines for adults aged 60-74 who are at increased risk and all adults aged 75 and older....In making its recommendation, the ACIP considered positive results from a phase III trial [NCT05590403]..."

DSMB • Respiratory Syncytial Virus Infections

Design of a peptide-based vaccine against human respiratory syncytial virus using a reverse vaccinology approach: evaluation of immunogenicity, antigenicity, allergenicity, and toxicity. (PubMed, Front Immunol) - "Attempts to develop an hRSV vaccine have faced safety and efficacy challenges, with only three FDA-approved vaccines (Moderna's Mresvia, Pfizer's Abrysvo, and GSK's Arexvy) available...We then characterized its kinetic properties, evaluated its structural integrity, and analyzed its interactions with Toll-like receptors (TLRs) using molecular docking, modeling, and refinement with AlphaFold3 and ClusPro...This study presents a promising peptide-based vaccine candidate against hRSV that can effectively engage the immune system, showing strong immunogenicity and antigenicity. Future in vitro and in vivo studies are essential to evaluate the ability of the multi-epitope vaccine candidate to stimulate both humoral and cell-mediated immune responses and to assess its efficacy and safety profile."

Journal • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • IFNG • IL2 • TLR1 • TLR4

Development and evaluation of ELISA serological immunoassays for influenza and respiratory syncytial viruses. (PubMed, Diagn Microbiol Infect Dis) - "These ELISA assays are scalable tools for seroepidemiological and maternal transfer studies. Future work will include correlation with neutralizing antibodies and paired maternal-infant analyses."

Journal • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

New developments in the prevention and management of RSV in 2025 (PubMed, Rev Med Suisse) - "Prevention has advanced with the introduction of vaccines such as Arexvy and Abrysvo, as well as nirsevimab for infants. These innovations are expected to significantly reduce the burden of RSV in the coming years."

Journal • Infectious Disease • Pediatrics • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Immunogenicity of RSV Vaccination in Thoracic-Organ Transplantation (ISHLT 2025) - "This study evaluated the immunogenicity of two RSV vaccines, Arexvy and Abrysvo, in this population.Methods This was a prospective, single-center study among transplant recipients and healthy controls eligible for the RSV vaccine...Univariate analyses found age and mycophenolate mofetil negatively associated with increased Ab titers (p<0.05), while vaccine, organ type and time from transplant were not...Most thoracic transplant recipients mounted a robust response to the RSV vaccine that was durable over a 3-month period. Presuming that the humoral and cellular responses measured relate to protection, its duration may inform the need for additional vaccine doses in this population."

Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation • CD4 • CD8

A Study on the Immune Response and Safety of Vaccine Against Respiratory Syncytial Virus (RSV) Given to Adults 18 to 49 Years of Age at Increased Risk for Respiratory Syncytial Virus Disease, Compared to Older Adults 60 Years of Age and Above (clinicaltrials.gov) - P3 | N=1459 | Completed | Sponsor: GlaxoSmithKline | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

HUMORAL AND CELLULAR IMMUNE RESPONSE TO ADJUVANTED RESPIRATORY SYNCYTIAL VIRUS VACCINE RSVPREF3 IN ADULTS AFTER ALLOGENEIC HEMATOPOIETIC CELL TRANSPLANTATION (EBMT 2025) - "Vaccination with Arexvy is well tolerated in patients following allogeneic HCT. However, preliminary findings indicate that a single dose may elicit an insufficient immune response in many patients. Final results will help guide future vaccination strategies for this particularly vulnerable patient population."

Clinical • Fatigue • Graft versus Host Disease • Immunology • Musculoskeletal Pain • Pain • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplantation

RSV Prefusion F3 Vaccine in Lung Transplant Recipients elicits CD4+ T-cell response in all Vaccinees. (PubMed, Am J Transplant) - "The immunogenicity of the novel RSV Prefusion F3 (RSVPreF3-AS01, Arexvy, GlaxoSmithKline) vaccine in immunocompromised patients remains largely unknown...These results suggest that some patients may derive clinical benefit from the vaccine through cellular immunity, even without an antibody response. Furthermore, the vaccine was well tolerated in this vulnerable population, with no major safety concerns observed."

Journal • Respiratory Diseases • Respiratory Syncytial Virus Infections • Transplant Rejection • Transplantation • CD4

Efficacy, safety, and immunogenicity of the AS01E-adjuvanted respiratory syncytial virus prefusion F protein vaccine (RSVPreF3 OA) in older adults over three RSV seasons: a randomized trial (ESCMID Global 2025) - "Organised by The Lancet group"

Clinical • Late-breaking abstract • Respiratory Diseases • Respiratory Syncytial Virus Infections

Development, Current Status, and Remaining Challenges for Respiratory Syncytial Virus Vaccines. (PubMed, Vaccines (Basel)) - "Two protein subunit vaccines (GSK's Arexvy and Pfizer's Abrysvo) and one mRNA RSV vaccine (Moderna's mRESVIA) are now available...Furthermore, ongoing vaccine surveillance and further evaluation, particularly among immunocompromised patients, frail elderly subjects, and young infants that were under- or not represented in pivotal clinical trials, are necessary. As in the success story of combined pediatric vaccines, combination vaccines, conferring protection against several respiratory illnesses in one dose, could help improve vaccine acceptance and coverage rates in older adults."

Journal • Review • Geriatric Disorders • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Safety and Immunogenicity Study of Revaccination With SCB-1019T in Healthy Adults (clinicaltrials.gov) - P1 | N=160 | Not yet recruiting | Sponsor: Clover Biopharmaceuticals USA, LLC

New P1 trial • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

In brief: New warning for the RSV vaccines Arexvy and Abrysvo. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Hematological Malignancies • Leukemia • Oncology • Respiratory Syncytial Virus Infections

2024 Adoption Rates of RSV Preventative Measures in Infants, Pregnant Mothers, and the Elderly. (AAAAI-WAO 2025) - "Percentages of eligible infants receiving Nirsevimab, of pregnant mothers receiving Abrysvo and of elderly patients receiving Arexvy, MResvia and Abrysvo were extracted...Cases of RSV in patients who received prevention were low. Overall low rates of vaccination indicate a crucial need to increase awareness of RSV prevention among healthcare workers."

Clinical • Late-breaking abstract • Respiratory Diseases • Respiratory Syncytial Virus Infections

A Study of RSV-HMPV Bivalent Vaccine VXB-241 in Older Adults (clinicaltrials.gov) - P1 | N=144 | Active, not recruiting | Sponsor: Vicebio Australia Proprietary Limited | Recruiting ➔ Active, not recruiting

Enrollment closed • Respiratory Diseases • Respiratory Syncytial Virus Infections

Characteristics of the First Italian Older Adults Vaccinated with an Adjuvanted Respiratory Syncytial Virus (RSV) Vaccine. (PubMed, Medicina (Kaunas)) - "More positive attitudes towards RSV vaccination were observed (p < 0.01) among subjects who received more COVID-19 vaccine doses, whose reasons for the current RSV vaccination were the willingness to be protected or to be in good health and the feeling of being at risk for RSV. The first Italian users of the novel RSVPreF3 OA vaccine were represented by high-risk individuals with a comparatively high prevalence of co-morbidities, high uptake of the seasonal respiratory vaccines and high trust in immunization."

Journal • Cardiovascular • Diabetes • Infectious Disease • Influenza • Metabolic Disorders • Novel Coronavirus Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

World's 1st RSV vaccine, GSK's Arexvy, lands in Korea (Korea Biomedical Review) - "On Tuesday, the Ministry of Food and Drug Safety (MFDS) approved the use of Arexvy for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older....The Korean approval of Arexvy was based on the results of the ongoing phase 3 clinical RSV OA=ADJ-006 study conducted in 17 countries in the Northern and Southern Hemispheres....The study is ongoing, and the MFDS approved Arexvy based on efficacy data through the second season....In the second season, the efficacy of Arexvy for RSV-related LRTD was 56.1 percent."

Korea approval • Respiratory Syncytial Virus Infections

RSV Vaccination in Immunocompromised Patients. (clinicaltrials.gov) - P2 | N=200 | Recruiting | Sponsor: Medical University of Vienna | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Health Technology Assessment del vaccino ricombinante adiuvato contro il virus respiratorio sinciziale (Arexvy®). (PubMed, J Prev Med Hyg) - No abstract available

Journal

...TV drug ad spenders’ list with single largest monthly total this year (Fierce Pharma) - "In seventh place and up three spots is Eli Lilly and Boehringer Ingelheim’s diabetes drug Jardiance, while GSK’s RSV vaccine Arexvy is down in eighth position, a fall of two spots despite the British pharma spending more than $2 million more on the vaccine’s ads last month...The final two are Novo Nordisk’s injectable GLP-1 diabetes drug Ozempic, keeping its ninth place two months in a row, while Bristol Myers Squibb’s heart drug Camzyos brings up the rear in tenth, down two spots from September....There was no top 10 listing for Pfizer’s COVID-19 med Paxlovid in October."

Commercial • Cardiomyopathy • Immunology • Infectious Disease • Metabolic Disorders • Obesity • Obstructive Hypertrophic Cardiomyopathy • Respiratory Diseases • Type 2 Diabetes Mellitus

Potential public health impact of vaccination against respiratory syncytial virus using the adjuvanted RSVPreF3 in older adults in Hong Kong (APSR 2024) - "Adjuvanted RSVPreF3 OA vaccination substantially reduced RSV burden in HK OA ≥60 YOA, demonstrating the potential public health benefits of RSV vaccination programs in this population."

Clinical • Infectious Disease • Influenza • Respiratory Diseases • Respiratory Syncytial Virus Infections

Expanded age indication for GSK's AREXVY, the first respiratory syncytial virus (RSV) vaccine approved in Canada for adults aged 50-59 at increased risk (Canada Newswire) - "GSK's AREXVY (respiratory syncytial virus vaccine - recombinant, AS01E adjuvanted) has been approved in Canada for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 50-59 years of age who are at increased risk for RSV disease. In Canada, the vaccine was previously approved for use in adults aged 60 and older and is strongly recommended by the National Advisory Committee on Immunization (NACI) for all adults 75 years and older and those aged 60 and above in nursing homes and other chronic care facilities. NACI also recommends that adults aged 60-74 years may consider RSV vaccination in consultation with a health care provider."

Canada approval • Infectious Disease • Respiratory Syncytial Virus Infections

Estimation of the Public Health and Economic Impact of RSVPreF3 OA on Older Adults in Germany (ISPOR-EU 2024) - "RSVPreF3 OA vaccine is one of the only available prevention strategies for RSV infections and can lead to a significant reduction of cases and burden on the healthcare system. Funding: GSK (GSK study identifier: VEO-000578)."

Clinical • HEOR • Geriatric Disorders • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of RSVPreF3 OA Vaccine for Adults 60 Years or Older in Austria (ISPOR-EU 2024) - "Comparing the ICER to the WHO's willingness-to-pay threshold of €49,500 per QALY (one Austrian GDP per capita), vaccinating adults 75+ with RSV PreF3 OA and adults 60-74 with underlying medical conditions is cost-effective and can reduce the RSV burden in Austria. Funding: GSK (VEO-000930)."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections

Cost-Effectiveness Analysis of RSVPreF3 OA Vaccine in Sweden for Adults Aged ≥ 60 Years (ISPOR-EU 2024) - "The RSV strategy is therefore cost-effective at a WTP of 500,00 SEK/QALY in both population studies, compared to no vaccination and can reduce the burden of RSV in Sweden. Funding: GSK (GSK study identifier: VEO-000935)."

Clinical • Cost effectiveness • HEOR • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections