A Phase II, Randomized, Partially Blinded Study to Assess the Safety, Tolerability and Immunogenicity of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Infants

The purpose of this study is to assess the safety, tolerability and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenACWY-7b) vaccine intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups, in healthy infants 2 months of age (MoA) at enrolment.

Start Date29 Nov 2021

Sponsor / Collaborator

GSK Plc

NCT05087056

/ Active, not recruitingPhase 2

A Phase IIb, Randomized, Observer-Blind Study to Describe the Safety, Tolerability, and Immunogenicity of MenABCWY Administered on Different Dosing Schedules in Healthy Adolescents

The purpose of this study is to assess the safety, tolerability, and immunogenicity of the combined meningococcal groups A, B, C, W and Y (MenABCWY) vaccine (GSK3536819A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups.

Start Date18 Nov 2021

Sponsor / Collaborator

GSK Plc

NCT04886154

/ CompletedPhase 1/2

A Phase I/II, Randomised, Controlled Study to Assess the Safety, Effectiveness and Immune Response of Meningococcal Combined ABCWY Vaccine When Administered to Healthy Adults (Phase I) and to Healthy Adolescents and Adults (Phase II)

The purpose of this study was to assess the safety, effectiveness, and immune response of the meningococcal combined ABCWY vaccine (GSK4023393A) intended to protect against invasive meningococcal disease (IMD) caused by all 5 meningococcal serogroups. The first time-in-human (FTIH), Phase I part of this study was conducted in healthy adults in a dose-escalating fashion with 2 formulations of the investigational MenABCWY-2Gen vaccine and served as a safety lead-in to the Phase II study. The Phase II part of the study was conducted in 2 parts: The 'formulation and schedule-finding' part followed in healthy adolescents and young adults and was designed to select the vaccine formulation and the schedule to be tested in Phase III. The 'blood sourcing' part was conducted in healthy adults in order to collect sufficient serum samples for the development of assays to be used in the MenABCWY-2Gen vaccine clinical development program.

Start Date14 Jun 2021

Sponsor / Collaborator

GSK Plc

100 Clinical Results associated with MenABCWY vaccine (GSK)

100 Translational Medicine associated with MenABCWY vaccine (GSK)

100 Patents (Medical) associated with MenABCWY vaccine (GSK)

Literatures (Medical) associated with MenABCWY vaccine (GSK)

01 Feb 2026·NURSE PRACTITIONER

The Drug Update

Article

Author: Theroux, Jenna D. ; Marino, Adriane B. ; Drake, Evan S. ; Hofler, Kendra Gemmill ; Long, Trent

ABSTRACT:

In the first half of 2025, the US FDA approved several new drugs that have relevance for those practicing in primary care. This article highlights the following new medications and vaccinations: suzetrigine (Journavx); gepotidacin (Blujepa); meningococcal groups A, B, C, W, and Y vaccine (Penmenvy); clesrovimab-cfor (Enflonsia); and acoltremon (Tryptyr). Additionally, this article highlights the recent approval of moderately to severely active Crohn's disease as a new indication for guselkumab (Tremfya).

31 Dec 2025·Expert Review of Vaccines

Immunogenicity and safety of meningococcal vaccines, MenACWY-CRM and 4CMenB, in groups at increased risk for meningococcal disease

Review

Author: Shravani Bobde ; Catherine A. Cosgrove ; Woo-Yun Sohn ; Chiranjiwi Bhusal

INTRODUCTION:

Individuals with immunocompromising conditions (e.g. asplenia, complement deficiency, HIV infection) or with high exposure to Neisseria meningitidis (e.g. laboratory workers, those in outbreak settings) have an increased risk of meningococcal disease. Immunization with meningococcal serogroups ACWY (MenACWY) and serogroup B (MenB) vaccines is recommended for high-risk groups in many countries, although definitions of high-risk vary. There are not yet clinical data for the pentavalent meningococcal serogroups ABCWY (MenABCWY) vaccines in high-risk populations.

AREAS COVERED:

This review examines studies conducted in high-risk groups with the component vaccines of GSK's MenABCWY vaccine, the 4-component MenB vaccine (4CMenB) and quadrivalent MenACWY CRM₁₉₇-glycoconjugate vaccine (MenACWY-CRM). These component vaccines have been licensed for more than 10 years and are recommended in groups categorized as high risk.

EXPERT OPINION:

The component vaccines of GSK's MenABCWY vaccine, 4CMenB and MenACWY-CRM, have demonstrated immunogenicity and safety in high-risk groups, including with concomitant or sequential vaccine administration. As expected, immunogenicity was reduced in patients with complement deficiencies, particularly those receiving eculizumab. Further data are required on meningococcal vaccination in high-risk groups for the future refinement of national and regional recommendations and to support proactive approaches to improve vaccine uptake in high-risk groups.

01 May 2025·LANCET INFECTIOUS DISEASES

Breadth of immune response, immunogenicity, reactogenicity, and safety for a pentavalent meningococcal ABCWY vaccine in healthy adolescents and young adults: results from a phase 3, randomised, controlled observer-blinded trial

Article

Author: Langley, Joanne ; Carter, Robert ; Simon, William ; Jeanfreau, Robert ; Ackerman, Ronald ; Pelayo, Enrique ; Ukkonen, Benita ; Willemsen, Arnold ; Freeman, George ; Trapani, Mauro ; Staben, Jonathan ; Vale, Noah ; Chakerian, Maia ; Rämet, Mika ; Lattanzi, Maria ; de Looze, Ferdinandus ; Dionne, Marc ; Cetin, Benhur Sirvan ; Zemanek, Josef ; Paavola, Pauliina ; Vachon, Marie-Louise ; Athan, Eugene ; Dzongowski, Peter ; Surber, Joseph ; Cetin, Benhur ; Beran, Jiří ; Osowa, Alexander ; Farjo, Rand ; Dinleyici, Ener Cagri ; Silas, Peter ; Ayesu, Kwabena ; Byars, William ; Spaziererova, Martina ; Koski, Susanna ; Tipton, Mary ; Dalebout, Marije ; Meisalu, Sandra ; Lechevin, Isabelle ; Adamovska, Renata ; Bhusal, Chiranjiwi ; Ince, Tolga ; Rouhbakhsh, Rambod ; Raulier, Stefanie ; Tapiero, Bruce ; Laajalahti, Outi ; Finn, Daniel ; Grubb, Paul ; Bernard, David ; Gottfredson, Ryan ; Pavlasek, Miroslav ; Morelle, Danielle ; Kokko, Satu ; Jones, Jake ; Kiiroja, Kaia ; Richmond, Peter ; Toneatto, Daniela ; Dražan, Daniel ; Patel, Minesh ; Bloch, Mark ; Rok, Walter ; Seppä, Ilkka ; Sanchez, Yamirka ; Schear, Martin ; Gupta, Anil ; Tiong, Florence ; Sadarangani, Manish ; Mehta, Hemalini ; Scott, John ; Richmond, Peter C ; Nolan, Terry ; Kellner, James ; Wauters, Dominique ; Ulukol, Betul ; Langley, Joanne M

BACKGROUND:

A multicomponent meningococcal serogroups ABCWY vaccine (MenABCWY) could provide broad protection against disease-causing meningococcal strains and simplify the immunisation schedule. The aim of this trial was to confirm the effect of the licensed meningococcal serogroup B (MenB) vaccine, 4CMenB, against diverse MenB strains, and to assess the breadth of immune response against a panel of 110 MenB strains for MenABCWY containing the antigenic components of 4CMenB and licensed serogroups ACWY vaccine, MenACWY-CRM, the non-inferiority of the immune response with MenABCWY versus 4CMenB and MenACWY-CRM, safety, and MenABCWY lot-to-lot consistency.

METHODS:

We conducted a phase 3 randomised, controlled, observer-blinded trial of healthy adolescents and young adults (age 10-25 years) across 114 centres in Australia, Canada, Czechia, Estonia, Finland, Türkiye, and the USA. Exclusion criteria included previous vaccination with a MenB vaccine or (within the last 4 years) MenACWY vaccine. Participants were randomly allocated (5:5:3:3:3:1 ratio) via a central randomisation system using a minimisation procedure to receive 4CMenB at months 0, 2, and 6 (referred to as 4CMenB 0-2-6 hereafter); or 4CMenB at months 0 and 6 (referred to as 4CMenB 0-6 hereafter); or MenABCWY (three groups, each receiving one production lot of the MenACWY-CRM component) at months 0 and 6; or MenACWY-CRM at month 0. Demonstration in the per-protocol set of the consistency of three MenACWY-CRM component lots of the MenABCWY vaccine was a primary objective (demonstrated with two-sided 95% CIs for the ratio of human serum bactericidal antibody [hSBA] geometric mean titres against each serogroup within predefined criteria [0·5-2·0]). The primary endpoints (breadth of immune response) for the MenB component of MenABCWY and 4CMenB were measured using the endogenous complement hSBA (enc-hSBA) assay against a panel of 110 diverse MenB invasive disease strains. For each serum sample, 35 strains from the 110 MenB strain panel were randomly selected for testing. The 4CMenB breadth of immune response data have been published separately. For MenABCWY, breadth of immune response was assessed in two analyses: a test-based analysis of the percentage of samples (tests) without bactericidal serum activity against MenB strains 1 month after two MenABCWY doses versus the percentage after one MenACWY-CRM dose in the per-protocol set, and a responder-based analysis of the percentage of participants (responders) whose sera killed 70% or more strains at 1 month after two MenABCWY doses in the full analysis set. A lower limit of two-sided 95% CI above 65% would demonstrate breadth of immune response. Other primary outcomes included non-inferiority (5% margin) of two MenABCWY doses versus two 4CMenB doses by enc-hSBA assay in the per-protocol set, non-inferiority (10% margin) of two MenABCWY doses versus one MenACWY-CRM dose in MenACWY vaccine-naive participants by traditional hSBA assay in the per-protocol set, and safety in all vaccinated participants. This trial is registered with ClinicalTrials.gov, NCT04502693, and is complete.

FINDINGS:

Between Aug 14, 2020, and Sept 3, 2021, 3651 participants were enrolled and randomly allocated (900 in the 4CMenB 0-2-6 group and 908 in the 4CMenB 0-6 group, 1666 in the three MenABCWY groups combined, and 177 in the MenACWY-CRM group). All primary objectives for MenABCWY were met. Consistency of immune responses against the three production lots of the MenACWY component of MenABCWY was demonstrated since two-sided 95% CIs for the ratios of hSBA geometric mean titres against serogroups A, C, W, and Y for each pair of lots were within the predefined equivalence criteria. The lot data were pooled for the remainder of MenABCWY endpoints. By enc-hSBA assay, breadth of immune response against the MenB strain panel was 77·9% (95% CI 76·6 to 79·2) in the test-based analysis and 84·1% (81·4 to 86·5; 687 of 817 participants) in the responder-based analysis. Non-inferiority of MenABCWY to 4CMenB was demonstrated by enc-hSBA assay: the difference in percentage of samples with bactericidal serum activity between the MenABCWY group (82·5% [95% CI 82·1 to 83·0]; 21 222 of 25 715) and 4CMenB 0-2 group (83·1% [82·7 to 83·6]; 22 921 of 27 569) was -0·61% (-1·25 to 0·03). Non-inferiority of two-dose MenABCWY to one-dose MenACWY-CRM was demonstrated by traditional hSBA assay, with differences between the MenABCWY group and MenACWY group in percentages of participants with a four-fold rise in hSBA titres of 11·3% (5·9 to 19·0) for serogroup A, 47·2% (38·1 to 56·3) for serogroup C, 35·3% (26·9 to 44·5) for serogroup W, and 27·0% (19·4 to 35·8) for serogroup Y. MenABCWY reactogenicity was mostly of mild or moderate severity and transient, with similar frequencies of adverse events in the MenABCWY and 4CMenB groups and no safety concerns were identified.

INTERPRETATION:

This study demonstrates breadth of immune response against a panel of 110 MenB strains for the MenB component of the investigational MenABCWY vaccine, when administered as a 0-6 months schedule to the target population of adolescents and young adults, with predefined criteria for success met for both breadth of immune response endpoints and for non-inferiority versus 4CMenB. This investigational vaccine could provide broad meningococcal serogroup coverage in a simplified immunisation schedule, thus aiding the public health attempt in preventing invasive meningococcal disease due to five Neisseria meningitidis serogroups in adolescents and young adults.

FUNDING:

GSK.

News (Medical) associated with MenABCWY vaccine (GSK)

29 Oct 2025

·www.fiercebiotech.com

GSK abandons hopes for CD226 cancer therapies, dropping remaining phase 2 assets

GSK dropped a couple of infectious disease assets from its phase 2 pipeline this morning.\n GSK once dreamed of harnessing the CD226 axis to create a new generation of blockbuster cancer drugs. But that dream appeared to die this morning as the pharma closed the last programs related to this modality.The CD226 molecule is expressed on the surface of T and NK cells, binding to the CD155 and CD112 molecules found on tumor cells to stimulate an immune response. Three immune checkpoints—namely CD96, PVRIG and TIGIT—are known to interfere with this process.Back in 2022, GSK branded the CD226 axis a “particularly promising new area for next-generation immuno-oncology therapies.” As a result, the company launched a series of programs over the years to produce checkpoint inhibitors aimed at these three targets with hopes of generating billions in peak net sales.However, these ambitions hit a major roadblock earlier this year when the pharma finally dropped its iTeos Therapeutics-partnered anti-TIGIT antibody belrestotug, resulting in a 471 million pound sterling ($629 million) impairment charge.Then, this morning’s third-quarter earnings results brought news that other CD226-related programs have also been abandoned.One of these is nelistotug, also known as GSK6097608, an iTeos- and 23andMe-partnered anti-CD96 antibody GSK had been evaluating in a phase 2 study of 360 patients with recurrent/metastatic PD-L1 positive squamous cell carcinoma of the head and neck. The study, which kicked off in 2023, tested nelistotug in combination with both GSK’s own immunotherapy Jemperli and its recently discontinued iTeos-partenered anti-TIGIT drug belrestotug.GSK had also been running a phase 1 study to evaluate similar combinations as well as nelistotug as a monotherapy for patients with advanced solid tumors.The other nail in GSK’s CD226 coffin is the pharma’s decision to halt work on its anti-PVRIG antibody GSK4381562. The drug, which GSK licensed from Surface Oncology, had previously been listed in phase 2 development, with GSK also running a phase 1 study of the asset in 141 patients with advanced solid tumors as a monotherapy and in combination with other cancer agents.When asked by Fierce Biotech on a call with journalists this morning whether GSK has given up on its CD226 dream, outgoing CEO Emma Walmsley said it is “perfectly normal that we switch off some things.”“The really important thing is we do it before it becomes expensive, and then we refocus all of our energy on the things that have high potential and that can be really big,” she told Fierce.The pharma industry “requires risk appetite in terms of the deployment of R&D capital, and most things don\'t actually work,” Walmsley pointed out.Fierce recently sat down with GSK executives to map out the pharma’s antibody-drug conjugate ambitions, and Walmsley reaffirmed that this portfolio is “one of the key things that you\'ll hear a lot more about over the next couple of years.” Away from oncology, GSK also dropped several infectious disease assets from its phase 2 pipeline during the quarter.They included a second-generation meningitis vaccination for serogroups A, B, C, W and Y. GSK had been assessing the vaccine, dubbed GSK4023393, in a phase 2 study of infants.That decision comes eight months after GSK secured FDA approval for another MenABCWY vaccine, which is marketed as Penmenvy. Unlike the infant-focused GSK4023393, Penmenvy is currently indicated for 10- to 25-year-olds.The company also ended work on a phase 2-stage recombinant subunit vaccine for cytomegalovirus infection, as well as finally pulling the plug on a development of the TG2 inhibitor GSK3915393 for pulmonary fibrosis after already ending work in celiac disease.In GSK’s phase 1 pipeline, the company removed a DNMT1 inhibitor called GSK4172239 the pharma had been assessing for sickle cell disease.

Phase 2VaccinePhase 1ImmunotherapyClinical Result

13 Oct 2025

·www.businesswire.com

Pfizer to Highlight Advancements in Respiratory Health and Infectious Disease Research at IDWeek 2025

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE: PFE, “Pfizer”) will present data across its infectious disease portfolio at the upcoming IDWeek 2025 congress, held in Atlanta from October 19-22, 2025. Data in 46 abstracts from company- and collaborator-led studies will showcase significant advancements in preventing and treating infectious diseases. “IDWeek 2025 offers a critical opportunity to highlight our cutting-edge scientific progress and collaborate with global health experts in our ongoing battle against infectious diseases,” said Annaliesa Anderson, Ph.D., Senior Vice President and Chief Vaccines Officer, Pfizer. “At Pfizer, we continue to prioritize innovation and rigorous data generation through clinical studies and real-world analysis supporting the vaccines and therapeutics for our infectious disease pipeline.” Presentations will include research from Pfizer’s diverse infectious disease portfolio, including COVID-19, respiratory syncytial virus (RSV), pneumococcal disease, Lyme disease, meningococcal disease, and other serious bacterial and viral infections. Details for the oral and poster presentations are below: Title/Abstract Number Presenting Name/Type Date/Time (ET) Location ORAL & LATE-BREAKING PRESENTATIONS Attitudes about COVID and Community Engagement with Patients (ACCEPt): Global Survey Reveals the Ongoing Impact of Long COVID-19 on Medically Vulnerable Populations, Five Years On R Paredes Oct 22 4:15 – 4:30PM B211-B212 Effectiveness of the JN.1-adapted BNT162b2 COVID-19 Vaccine in High-Risk Groups against Hospitalization in Europe: A Test-Negative Case-Control using the id.DRIVE Platform H Volkman Oct 21 1:45 – 3:00PM B401-B402 Real-world Abrysvo Vaccine Effectiveness (VE) against Respiratory Syncytial Virus (RSV)-related Lower Respiratory Tract Disease (LRTD) Hospitalizations and Emergency Department Admissions over Two RSV Seasons—Kaiser Permanente of Southern California (KPSC), October 2023–April 2025 S Tartof Oct 20 3:15 – 4:30PM B401-B402 Immunosuppression and RSV Prefusion F Protein Vaccine Effectiveness in Older Adults: A Prespecified sub analysis from the DAN-RSV Trial A Jensen Oct 20 3:15 – 4:30PM B401-B402 POSTER PRESENTATIONS COVID-19 COVID-19 vaccine uptake in children aged 1 - 4 years from state vaccine registry data through March 2024 T Ahi Oct 22 12:15 PM Poster Hall B4-5 Public Health and Economic Impact of Increased Uptake of an Additional Dose of Pfizer-BioNTech KP.2-Adapted COVID-19 Vaccine, 2024-2025 Formula, Among US Adults ≥ 65 Years of Age A Yehoshua 12:15 PM Poster Hall B4-5 Physician Perceptions and Decision-Making Factors in Prescribing COVID-19 Antivirals: Qualitative Research Findings M Fernandez 12:15 PM Poster Hall B4-5 Ibuzatrelvir Potently Reduced Viral RNA Levels Despite the High Rate of Anti-S Seropositivity: a Post Hoc Analysis of Serology in the Phase 2b Study in Adults Without Risk Factors for Severe COVID-19 JH Kim 12:15 PM Poster Hall B4-5 Inpatient Burden of Respiratory Syncytial Virus, COVID-19, or Influenza in the United States Among Children < 5 Years of Age K Andersen 12:15 PM Poster Hall B4-5 Severity of Omicron COVID-19 variants: a global systematic literature review D Malhotra 12:15 PM Poster Hall B4-5 COVID-19 Case Attack Rate Differences by Vaccination Status and Vaccine Effectiveness among US Nursing Home Residents, October 5, 2024 to January 5, 2025 F Khan 12:15 PM Poster Hall B4-5 Invasive Group B Streptococcus (GBS) Invasive Group B Streptococcus among hospitalized pregnant and postpartum women, 2016-2024: a Unites States database study S Willis 12:15 PM Poster Hall B4-5 Long-Term Healthcare Utilization and Expenditures for Infants with Invasive Bacterial Infections During Birth Hospitalizations K Schley 12:15 PM Poster Hall B4-5 Lyme Disease Risk Perception and Communication about Lyme Disease Prevention by Healthcare providers: A Mixed-Methods Study N Patel 12:15 PM Poster Hall B4-5 Gestational Lyme disease incidence and pregnancy-related outcomes among women in the United States, 2015-2024 S Willis 12:15 PM Poster Hall B4-5 Healthcare Costs Associated With Lyme Disease Among Medicare Fee-for-Service Beneficiaries in the United States: A Retrospective Claims-Based Study H Yu 12:15 PM Poster Hall B4-5 Meningococcal Disease Need for Broad Protection Against Invasive Meningococcal Disease Among US College Students J Presa 12:15 PM Poster Hall B4-5 Characterization of Factor H Binding Protein Expression for Neisseria meningitidis Serogroup B Isolates, 2015–2022 K Weiss 12:15 PM Poster Hall B4-5 Clinical Development of MenABCWY (PenbrayaTM), a Broadly Protective Pentavalent Meningococcal Vaccine L Zoloras 12:15 PM Poster Hall B4-5 Utility of the Pentavalent MenABCWY Meningococcal Vaccine (PenbrayaTM) Within Alternative US Meningococcal Vaccination Schedules J Presa 12:15 PM Poster Hall B4-5 Ten-year retrospective review of medical records at five hospitals in the United States highlights the potential for under-detection of invasive meningococcal disease F Angulo 12:15 PM Poster Hall B4-5 Awareness, Attitudes and Perceptions of Meningococcal Vaccines among Caregivers of Adolescents in the United States J Presa 12:15 PM Poster Hall B4-5 Pneumococcal Disease Re-evaluating economic & health impact of PCV20 in adults using real-world effectiveness data J Vietri 12:15 PM Poster Hall B4-5 Invasive pneumococcal pneumonia: is bacteremia the appropriate indication of severity? P Peyrani 12:15 PM Poster Hall B4-5 Variability in Case-Ascertainment Methodology and Rates of Adult Invasive Pneumococcal Disease using a US Healthcare Claims Database A Miles 12:15 PM Poster Hall B4-5 Temporal Trends in Rates of Hospitalized Pneumonia among US Adults and Residual Disparities by Race and Socioeconomic Status A Miles 12:15 PM Poster Hall B4-5 Demographic and Clinical Characteristics, by Pneumococcal Serotype, of Adults Hospitalized with Community Acquired Pneumonia in the US L Grant 12:15 PM Poster Hall B4-5 Differences in invasive pneumococcal disease clinical presentations and serotype distribution among children with and without underlying risk factors K Hulten 12:15 PM Poster Hall B4-5 Nasopharyngeal Colonization in South Texas Children Less Than 6 Years of Age With or Without Lower Respiratory Tract Infections K Hulten 12:15 PM Poster Hall B4-5 Real-world effectiveness of 20-valent pneumococcal conjugate vaccine among adults 65-74, 75-84, and ≥85 years of age in the United States A Miles 12:15 PM Poster Hall B4-5 Uptake and Series Completion with Pneumococcal Conjugate Vaccine by Social Determinants of Health among Children in the United States A Miles 12:15 PM Poster Hall B4-5 Influenza Symptom Burden During the First Week of Acute Influenza Infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study during the 2024/25 Season T Hu 12:15 PM Poster Hall B4-5 The Burden of Influenza on Health-Related Quality of Life and Work Productivity During the First Week of infection Among US Adults: An Interim Analysis of a Nationwide Prospective Study T Hu 12:15 PM Poster Hall B4-5 The Socioeconomic Value of Adult Respiratory Vaccination in the United States: A Benefit-Cost Analysis T Hu 12:15 PM Poster Hall B4-5 Respiratory Syncytial Virus (RSV) How do recent population-level RSVpreF vaccine impact results from the United Kingdom relate to previously reported vaccine effectiveness results? N Aliabadi 12:15 PM Poster Hall B4-5 Bivalent RSV Prefusion F-Based Subunit Vaccine Recipients with Chronic Kidney Disease Achieved High Neutralizing Titers One Month After Vaccination F Rahman 12:15 PM Poster Hall B4-5 Immunogenicity and Safety of Bivalent Respiratory Syncytial Virus (RSVpreF) Vaccine In Non-Pregnant HIV Infected Older Adults T Mikati 12:15 PM Poster Hall B4-5 Estimating Risk of Guillain-Barré Syndrome in US Medicare-Enrolled Older Adults Following Medically Attended Respiratory Syncytial Virus Disease: A Self-Controlled Case Series Analysis C Liang 12:15 PM Poster Hall B4-5 Time to Testing, Diagnosis, and Hospitalization Among Pediatric and Adult Patients with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Time-Series Model Estimation of RSV-Attributable Respiratory Hospitalizations and Mortality in Adults in Finland C Liang 12:15 PM Poster Hall B4-5 Burden of Hospitalizations Due to Respiratory Syncytial Virus (RSV) in Adults ≥50 Years of Age and Those with Congestive Heart Failure or Chronic Obstructive Pulmonary Disease Exacerbations A Tippett 12:15 PM Poster Hall B4-5 What if Adult RSV Vaccine Uptake in the US was High Like in Scotland? Missed Opportunities to Reduce Public Health and Economic Burden of RSV R Sato 12:15 PM Poster Hall B4-5 Strategies to promote adult vaccination against respiratory pathogens: a narrative literature review E Williams 12:15 PM Poster Hall B4-5 Attributes of Point-of-Care Nucleic Acid Amplification Tests for Respiratory Syncytial Virus (RSV): Results of a Systematic Literature Review K Date 12:15 PM Poster Hall B4-5 RSV Signs and Symptoms at Time of Hospitalization among Pediatric and Adult Population with RSV in Two Seasons: A Real-World Data Analysis using Electronic Health Records in US W Tang 12:15 PM Poster Hall B4-5 Tick-Borne Encephalitis (TBE) Tick-borne encephalitis (TBE) in international travelers and TBE vaccine recommendations for travelers to Europe F Angulo 12:15 PM Poster Hall B4-5 Prescribing Information for Pfizer Medicines Please see full Prescribing Information for ABRYSVO® (Respiratory Syncytial Virus Vaccine) or visit https://abrysvoadult.pfizerpro.com. Please see full Prescribing Information for COMIRNATY® (COVID-19 Vaccine, mRNA) or visit https://comirnatyhcp.com. Please see full Prescribing Information including BOXED WARNING for PAXLOVIDTM (Nirmatrelvir and Ritonavir) or visit https://paxlovid.pfizerpro.com. Please see full Prescribing Information for PREVNAR 20® (Pneumococcal 20-valent Conjugate Vaccine) or visit https://prevnar20.pfizerpro.com. Please see full Prescribing Information for PREVNAR 13® (Pneumococcal 13-valent Conjugate Vaccine). Please see full Prescribing Information for PENBRAYA® (Meningococcal Groups A, B, C, W, and Y Vaccine) or visit https://penbraya.pfizerpro.com. Please see full Prescribing Information for TRUMENBA® (Meningococcal Group B Vaccine) or visit https://trumenba.pfizerpro.com. Please see full Prescribing Information for TICOVAC™. About Pfizer: Breakthroughs That Change Patients’ Lives At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products, including innovative medicines and vaccines. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For 175 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.Pfizer.com. In addition, to learn more, please visit us on www.Pfizer.com and follow us on X at @Pfizer and @Pfizer News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of October 13, 2025. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about Pfizer’s infectious disease pipeline, in-line products and product candidates, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risk and uncertainties include, among other things, uncertainties regarding the commercial success of Pfizer’s infectious disease products and product candidates; the uncertainties inherent in research and development, including the ability to meet anticipated clinical endpoints, commencement and/or completion dates for our clinical trials, regulatory submission dates, regulatory approval dates and/or launch dates, as well as the possibility of unfavorable new clinical data and further analyses of existing clinical data; risks associated with interim and preliminary data; the risk that clinical trial data are subject to differing interpretations and assessments by regulatory authorities; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when any drug applications, biologics license applications and/or emergency use authorization applications may be filed in any jurisdictions for any potential indication for Pfizer’s product candidates; whether and when any such applications that may be pending or filed for any of Pfizer’s product candidates may be approved by regulatory authorities, which will depend on myriad factors, including making a determination as to whether the product's benefits outweigh its known risks and determination of the product's efficacy and, if approved, whether any such product candidates will be commercially successful; decisions by regulatory authorities impacting labeling, manufacturing processes, safety and/or other matters that could affect the availability or commercial potential of Pfizer’s products or product candidates, including development of products or therapies by other companies; manufacturing capabilities or capacity; risks and uncertainties related to changes to vaccine or other healthcare policy in the U.S.; uncertainties regarding the ability to obtain or maintain recommendations from vaccine advisory or technical committees and other public health authorities and uncertainties regarding the commercial impact of any such recommendations, including uncertainties related to the potential impact of narrowing recommended patient populations; challenges related to public vaccine confidence or awareness; risks and uncertainties related to issued or future executive orders or other new, or changes in, laws or regulations; uncertainties regarding the impact of COVID-19 on Pfizer’s business, operations and financial results; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.

VaccineClinical ResultPhase 2

17 Apr 2025

·pmlive.com

GSK’s five-in-one meningococcal vaccine recommended by CDC advisory committee

GSK’s five-in-one meningococcal vaccine has been recommended by the US Centers for Disease Control and Prevention’s (CDC) immunisation panel as part of the adolescent meningococcal vaccination schedule. Penmenvy combines the antigenic components of GSK’s approved Bexsero and Menveo meningococcal vaccines to target five common invasive meningococcal disease (IMD)-causing serotypes (A, B, C, W and Y). The Advisory Committee on Immunization Practices (ACIP) has recommended that individuals aged over ten years be given a single dose of Penmenvy as an alternative to the separate administration of MenACWY and MenB vaccinations when both vaccines would be given in the same visit, typically at age 16. It is hoped that this will simplify meningococcal vaccine delivery and lead to higher uptake. The CDC will now review ACIP’s recommendation as it makes a final decision on Penmenvy. IMD is an uncommon but serious illness caused by the bacterium Neisseria meningitidis. It is a major cause of meningitis and septicaemia, and can result in long-term consequences such as neurological damage, amputations and hearing loss. Babies, young children and those who are in their late teens and early adulthood are among those at the highest risk. GSK’s chief scientific officer, Tony Wood, said: “We welcome this positive recommendation that can help strengthen disease prevention efforts in the US. “Pentavalent vaccines can reduce the number of injections required to help protect against invasive meningococcal disease – especially disease caused by serogroup B. Their use could improve immunisation rates among adolescents and young adults in the US, who are at an age with increased risk.” The recommendation comes just two months after the US Food and Drug Administration (FDA) approved Penmenvy for use in individuals aged from ten to 25 years. The regulator’s decision was supported by positive results from two late-stage trials, which evaluated Penmenvy’s safety, tolerability and immune response in over 4,800 people in this age population. Judy Klein, president and founder of Unity Consortium, a non-profit organisation focused on adolescent health and immunisation in the US, welcomed the FDA’s decision: “The consequences of IMD can be devastating for those who contract it, for their families and friends… Pentavalent menABCWY vaccines could help address the disease by providing protection against the five vaccine-preventable serogroups in one vaccine and making it easier for adolescents to get the coverage they need.”

VaccineDrug ApprovalmRNAClinical Study

100 Deals associated with MenABCWY vaccine (GSK)

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Meningococcal Infections	United States	GlaxoSmithKline Biologicals (Shanghai) Ltd.	14 Feb 2025
Meningococcal Infections	United States	GlaxoSmithKline Biologicals SA	14 Feb 2025

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis, Meningococcal	Phase 3	United States	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	Argentina	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	Australia	GSK Plc	25 Jan 2021
Meningitis, Meningococcal	Phase 3	Canada	GSK Plc	25 Jan 2021

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05082285 (CTgov)	Phase 2	Meningococcal Infections	726	MenACWY-7B low dose vaccine (MenACWY-7B Low Dose Group)	pmehrrpsqd = lnhjbcbgit phvvbrbhud (zliyaiylml, nllmgommrv - bymyjtmosf) View more	-	26 Jun 2026
				MenACWY-7B high dose vaccine (MenACWY-7B High Dose Group)	pmehrrpsqd = ykurotuagn phvvbrbhud (zliyaiylml, osbvmyvrvy - iwbzxgbaxt) View more
NCT04707391 (FDA_CBER) Manual	Phase 3	Meningococcal Infections	-	PENMENVY	xqypwgoeov(tawkgigjwb) = zqsvruscwd fpxyptlrmo (drjksvncyr, 91.6 - 98.3) View more	Positive	14 Feb 2025
				MENVEO	xqypwgoeov(tawkgigjwb) = gsuqkitrtx fpxyptlrmo (drjksvncyr, 93.0 - 96.9) View more
NCT04502693 (FDA_CBER) Manual	Phase 3	Meningococcal Infections	-	PENMENVY	wfohfpjoox(wbtenvztnh) = yrylvsqkez yiksybwgqk (esegjwxexa, 69.7 - 76.5) View more	Positive	14 Feb 2025
				BEXSERO	wfohfpjoox(wbtenvztnh) = ebykxpneyw yiksybwgqk (esegjwxexa, 74.8 - 81.2) View more
NCT04502693 (FDA_CBER) Manual	Phase 3	Meningococcal Infections	-	PENMENVY	jatgmwlihc(qjyuklsaeh) = bidxqtgosy lwkztfimwd (jsrgogdzac, 95.7 - 97.8) View more	Positive	14 Feb 2025
				MENVEO	jatgmwlihc(qjyuklsaeh) = toiuchlneu lwkztfimwd (jsrgogdzac, 77.6 - 91.5) View more
NCT04707391 (CTgov)	Phase 3	Meningitis, Meningococcal	1,250	Placebo+MenABCWY vaccine (ABCWY Group)	yeyxspwncz = nxakvaxgrz hdjpxfwlli (xxbqtxgyyl, tuaopynudu - ecmxmxrugk) View more	-	03 Jul 2024
				MenB vaccine+MenACWY vaccine (ACWY Group)	yeyxspwncz = pglzozpuph hdjpxfwlli (xxbqtxgyyl, jbkcohvwda - jxbgdhgudj) View more
NCT04502693 (CTgov)	Phase 3	Meningococcal Infections	3,657	rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY)+Meningococcal Groups A, C, W and Y Conjugate Vaccine ( (MenB_0_2_6 Group)	vcrckyhiev = edgmnduxtt kizdrmsvto (bjlwdjihyd, lyzhqqtrag - lsetebugej) View more	-	05 Mar 2024
				Placebo+rMenB+OMV NZ vaccine+Y Conjugate Vaccine (MenACWY)+Meningococcal Groups A, C, W and Y Conjugate Vaccine ( (MenB_0_6 Group)	vcrckyhiev = femkoyunyb kizdrmsvto (bjlwdjihyd, gynljcxrgt - yqifsemtyo) View more
NCT02451514 (CTgov)	Phase 2	Meningococcal Infections	129	MenABCWY+OMV vaccine (MenABCWY+OMV Group)	vskerexcyw = zmwgvxuhll ctxtclywid (gjlyodccbc, sxnoonncld - ijkzqucosj) View more	-	09 Jul 2020
				MenABCWY+OMV vaccine (MenACWY Group)	vskerexcyw = lrvnsefexl ctxtclywid (gjlyodccbc, nqvndtmysb - qpkaxavmwh) View more
NCT03587207 (CTgov)	Phase 2	Meningitis, Meningococcal	520	MenABCWY vaccine (MenABCWY Group)	icubqsiupz(flgiteeeje) = gidtwadrci qjmwxhrlyb (vyeqfiedsf, asfiskeovj - fqqdocchwy) View more	-	02 Jan 2020
				rMenB+OMV NZ (Bexsero) vaccine+MenACWY (Menveo) vaccine (rMenBOMV+ACWY_S Group)	icubqsiupz(flgiteeeje) = nuqxhkxuzt qjmwxhrlyb (vyeqfiedsf, sqmsoqctbw - moiypvvmgv) View more
NCT02946385 (CTgov)	Phase 2	Meningococcal Infections	604	MenABCWY (ABCWY_0_2)	kgxetperps = jwocapanyb bpjynngnbj (jszczzacof, tfucnbyvao - ulxuvymiha) View more	-	20 Aug 2019
				MenABCWY (ABCWY_0_2_6)	kgxetperps = rsfapvqloa bpjynngnbj (jszczzacof, vmnkdmdylh - yhednwrpeg) View more
NCT02140762 (Pubmed \| Vaccine)	Phase 2	Invasive Fungal Infections	301	MenABCWY vaccine (MenABCWY)	gqatabnyju(fydkbrwvnd) = wvdqtgivbc uuusxgybce (qgszvqvauh, 65 - 69)	-	23 Aug 2018

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