The goal of this clinical trial is to determine the immunogenicity of certain vaccines in protecting against meningitis B (MenB) in young adults who have previously received a different MenB vaccine.
The main questions it aims to answer are:
* How many participants are protected against four key types of MenB bacteria before and after getting the new vaccine?
* How strong is the immune response after vaccination, and how many people show a noticeable boost in immune response?

Start Date01 Oct 2025

Sponsor / Collaborator

Emory University

[+1]

NCT05873751

/ CompletedNot Applicable

Effect of Trumenba on Gonococcal Infections in Adolescents and Young Adults in the United States: A Retrospective Cohort Study

Brief Summary:
The main purpose of the study is to learn about how well Trumenba vaccine shot works against gonorrhea infection.
This study looks at data records from a database in the United States.
This study includes patient's data from the database who:
* Are 15-30 years old.
* Have received at least one dose of Trumenba and a MenACWY vaccine or who have received only MenACWY vaccine.
This data has already been collected in the past and is being studied between April and June of 2023.

Start Date24 Apr 2023

Sponsor / Collaborator

Pfizer Inc.

NCT04893811

/ CompletedPhase 4

A PHASE 4, OPEN-LABEL, SINGLE-ARM TRIAL TO DESCRIBE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF TRUMENBA(REGISTERED) WHEN ADMINISTERED TO IMMUNOCOMPROMISED PARTICIPANTS ≥10 YEARS OF AGE

The aim of this study is to evaluate the safety, tolerability, and immunogenicity of 2 doses of Trumenba® (on a 0- and 6-month schedule) in immunocompromised participants by functionally assessing antibody production in asplenic and complement-deficient individuals ≥10 years of age.

Start Date18 Aug 2021

Sponsor / Collaborator

Pfizer Inc.

100 Clinical Results associated with Meningococcal group B vaccine(Pfizer Inc.)

100 Translational Medicine associated with Meningococcal group B vaccine(Pfizer Inc.)

100 Patents (Medical) associated with Meningococcal group B vaccine(Pfizer Inc.)

Literatures (Medical) associated with Meningococcal group B vaccine(Pfizer Inc.)

01 May 2025·VACCINE

Article

Author: Bogaerts, Bert ; Goeders, Nathalie ; Mattheus, Wesley ; Roosens, Nancy H C ; Vanneste, Kevin

Invasive meningococcal disease (IMD) caused by Neisseria meningitidis can result in life-threatening meningitis and septicaemia. There are twelve serogroups of N. meningitidis, but most cases of IMD are caused by serogroups A, B, C, W, X and Y. In Europe, serogroup B (MenB) accounts for 51 % of documented cases as recently reported by the European Centre for Disease Prevention and Control (ECDC). As a major cause of IMD, genomic surveillance of circulating MenB strains and assessment of the potential impact of vaccination programs could help inform public health policy. In this study, a collection of 493 strains was analysed, collected in Belgium by the National Reference Centre between 2016 and 2022. Slide agglutination was used for serogroup determination and whole genome sequencing (WGS) was used to further characterize these strains. The observed serogroups were: MenB (n = 281), MenY (n = 95), MenW (n = 83), MenC (n = 30), non-groupable isolates (n = 2), MenE (n = 1) and MenX (n = 1). A higher prevalence of MenY and MenW was observed in older adults. MenB isolates were grouped into 110 sequence types (STs), 89 of which belonged to 16 clonal complexes (CCs). Coverage of the MenB-FHbp vaccine (Trumenba, bivalent rLP2086; Pfizer Inc., New York, NY, USA ipv Philadelphia) was predicted using the Meningococcal Deduced Vaccine Antigen Reactivity (MenDeVAR) index. Of the 281 MenB strains collected between 2016 and 2022, 89.1 % (lower limit - upper limit: 78.6-100.0 %) were predicted by MenDeVAR to be covered by the vaccine. This study highlights the benefits of a pathogen surveillance program and the need for experimental characterization of continuously evolving antigenic variants.

02 Jan 2023·Human vaccines & immunotherapeutics

Review

Author: Presa, Jessica ; Burman, Cynthia ; Cane, Alejandro ; Tort, Maria J. ; Bocchini, Joseph A.

Invasive meningococcal disease (IMD) is rare but associated with high morbidity and mortality. In the United States, the most vulnerable age groups are infants and adolescents/young adults, and the most common type of IMD is caused by serogroup B (MenB). MenB is preventable among adolescents and young adults with the use of two licensed vaccines, MenB-FHbp (Trumenba®, bivalent rLP2086; Pfizer Inc, Collegeville, PA) and MenB-4C (Bexsero®; GSK Vaccines, Srl, Italy). Because the effectiveness of MenB vaccination is dependent on broad vaccine coverage across circulating disease-causing strains, we reviewed the available clinical and real-world evidence regarding breadth of coverage of the two licensed vaccines in adolescents and young adults in the United States. Both vaccines protect against various MenB strains. More controlled data regarding breadth of coverage across MenB strains are available for MenB-FHbp compared with MenB-4C, whereas more observational data regarding US outbreak strain susceptibility are available for MenB-4C.

01 Aug 2022·Monatsschrift Kinderheilkunde : Organ der Deutschen Gesellschaft fur Kinderheilkunde

Impfprophylaxe rekurrierender invasiver Erkrankungen mit Meningokokken

Review

Author: Müller, Andreas

Invasive meningococcal diseases are rare but lead to a high morbidity and mortality in the patients. The risk of becoming infected again with a different or the same serotype is significantly increased after an infection has gone through and in the case of certain previous illnesses such as complement defects.The Committee for Infectious Diseases and Vaccinations of the German Academy for Pediatrics and Adolescent Health proposes the following approach for prevention of recurrent invasive meningococcal infections:Children and adolescents without a complete meningococcal vaccination status should be vaccinated with 4CMenB (Bexero®, Trumenba®) and/or vaccinated against serogroups A, C, W and Y (Menveo®, Nimenrix®, MenQuadfi®) immediately after healing of an invasive meningococcal disease according to the specification of the information for healthcare professionals. Prior isolated screening for complement deficiencies is not necessary for the vaccination decision in these patients.

News (Medical) associated with Meningococcal group B vaccine(Pfizer Inc.)

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

16 Jun 2025

·www.prnewswire.com

Solu Therapeutics Appoints Enda Moran, PhD, MBA as Chief Operating Officer

BOSTON, June 16, 2025 /PRNewswire/ -- Solu Therapeutics, a biotechnology company pioneering novel therapies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas, today announced the appointment of Enda Moran, PhD, MBA as Chief Operating Officer (COO). "As we advance our Phase 1 clinical trial of STX-0712 in patients with resistant/refractory chronic myelomonocytic leukemia (CMML) and other hematologic malignancies, Enda brings outstanding experience in large-scale biomanufacturing and company operations to our leadership team," said Philip J. Vickers, President and CEO of Solu Therapeutics. "His expertise in scaling biologic therapeutics and guiding early-stage programs through development will be instrumental as we grow and work to deliver transformative therapies for patients living with cancer, immunological diseases and other serious illnesses." As COO, Dr. Moran will lead core operational functions at Solu including chemistry manufacturing and controls (CMC), quality, program management, IT, and facilities management. He will also play a key role in building the infrastructure needed to support Solu's CyTAC™ (Cytotoxicity Targeting Chimera) and TicTAC™ (Therapeutic Index Control Targeting Chimera) platforms as the company progresses toward multiple clinical and regulatory milestones. "I am very excited to join the Solu Therapeutics team at this pivotal moment as the company moves into a new phase of growth," said Dr. Moran. "The CyTAC and TicTAC platforms are rooted in strong science and have the potential to change the landscape for patients who are desperately in need of new treatment options. I look forward to applying my experience to maximize the potential of these platforms and bring a new generation of innovative therapies to the patients who need them most." Dr. Moran has over three decades of experience leading biomanufacturing and technical development across pharma and biotech. He previously held senior scientific roles at GSK and Wyeth before joining Pfizer as Senior Director of Biomanufacturing, where he led global teams supporting the development and production of successful commercial therapies including Enbrel®, Trumenba®, Xyntha®, and the Prevnar®13 vaccine. He later joined Northern Biologics as Vice President and Head of CMC and Manufacturing, where he was instrumental in advancing multiple development programs and enabling the strategic acquisition of assets by AstraZeneca and Boehringer Ingelheim. Most recently, he served as CEO of Matrivax, leading a successful corporate restructuring and completion of a Phase 1 clinical trial. About Solu Therapeutics Solu Therapeutics is a biotechnology company cofounded by Longwood Fund and committed to developing an innovative class of therapeutic agents that uniquely pair small molecules with monoclonal antibodies to eliminate disease-driving cells in cancer, immunology, and other therapeutic areas. By leveraging its proprietary CyTAC (Cytotoxicity Targeting Chimera) and TicTAC (Therapeutic Index Control Targeting Chimera) platforms, Solu is advancing therapies that combine the target-binding capability of small molecules with the therapeutic power of biologics. Our lead product candidate, STX-0712, is currently in Phase 1 clinical development for the treatment of advanced hematologic malignancies including CMML. For more information, visit . Media Contact Holly Stevens [email protected] CG Life SOURCE Solu Therapeutics WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 1Executive ChangeVaccine

16 Apr 2025

·www.businesswire.com

GSK’s 5-in-1 Meningococcal Vaccine PENMENVY Receives Positive Recommendation from US Advisory Committee on Immunization Practices

Vaccine recommended to help protect persons over 10 years old in the United States (US) against disease-causing serogroups of Neisseria meningitidis (A, B, C, W, and Y) Broad serogroup coverage in one vaccine reduces injections to help improve vaccination rates and help protect more US adolescents and young adults Vaccine doses will be ready for use in the US from Summer 2025 PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has voted to recommend use of PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) as part of the adolescent meningococcal vaccination schedule. Recommendations made by the ACIP are reviewed and, if adopted, are published as official CDC recommendations. ACIP voted to recommend that persons over 10 years old receive a single dose of PENMENVY as an alternative to separate administration of meningococcal serogroups A, C, W, and Y (MenACWY) and meningococcal serogroup B (MenB) vaccinations when both vaccines would be given on the same clinic visit, typically at age 16. This recommendation, if adopted, will allow for vaccination against serogroups A, B, C, W, and Y in fewer doses, could simplify meningococcal vaccination delivery and could improve immunization rates, helping protect more US adolescents against these five disease-causing serogroups for which the US CDC has previously issued recommendations.1 GSK’s MenABCWY vaccine combines the antigenic components of the Company’s two well-established meningococcal vaccines—BEXSERO (Meningococcal Group B Vaccine) and MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine). On February 14, 2025, the US Food and Drug Administration (FDA) approved GSK’s MenABCWY vaccine for use in individuals aged 10 through 25 years.2 Tony Wood, Chief Scientific Officer at GSK, 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 immunization rates among adolescents and young adults in the US, who are at an age with increased risk.” Although MenB is the leading cause of invasive meningococcal disease (IMD) among this population, less than 13% of 17-year-olds received the recommended two-dose vaccination series; around 32% received at least one dose according to 2023 CDC survey data.3,4 Three of every four MenB doses currently administered in the US are manufactured by GSK,5 positioning the company well to lead in the US market as MenB-containing vaccination schedules must be completed with the same manufacturer’s MenB vaccine.6 About IMD IMD is an uncommon but serious illness that can lead to death for up to one in ten of those who contract it in as little as 24 hours from onset, despite treatment.7 IMD is easily misdiagnosed, with early symptoms often mistaken for the flu.7,8 Approximately one in five survivors may experience long-term consequences such as brain damage, amputations, hearing loss, and nervous system problems.8 Although anyone can get IMD, adolescents and young adults between the ages of 16 and 23 years are one of the groups at highest risk due to common behaviors that help transmit the bacteria that cause IMD, such as living in close quarters like college dormitories, kissing and sharing drinks, utensils, or smoking devices.9,10 About PENMENVY (Meningococcal Groups A, B, C, W, and Y Vaccine) GSK’s MenABCWY vaccine is an injectable suspension for intramuscular use. The vaccine is supplied as one vial of lyophilized MenACWY Component (powder) which is reconstituted at the time of use with the accompanying prefilled syringe of MenB Component (liquid). In the US, PENMENVY is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroups A, B, C, W, and Y in individuals aged 10 through 25 years. The FDA-approved dosing is to administer two doses six months apart. The US Prescribing Information is available here.11 Important Safety Information for PENMENVY in the US The following is based on the US Prescribing Information for PENMENVY. Please consult the full Prescribing Information for additional safety information. Do not administer PENMENVY to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of PENMENVY, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine Syncope (fainting) has occurred in association with administration of PENMENVY PENMENVY may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains Immunocompromised persons, including those receiving immunosuppressive therapy, may have reduced immune responses to PENMENVY Persons with certain complement deficiencies and persons receiving treatment that inhibits terminal complement activation are at increased risk for invasive disease caused by N. meningitidis, including disease caused by serogroups A, B, C, W, and Y, even if they develop antibodies following vaccination with PENMENVY Guillain-Barré syndrome (GBS) has been reported in temporal relationship following administration of a U.S.-licensed meningococcal quadrivalent polysaccharide conjugate vaccine. The decision by the healthcare professional to administer PENMENVY to persons with a history of GBS should take into account the expected benefits and potential risks The most commonly reported solicited adverse reactions in individuals aged 10 through 25 years after Dose 1 and Dose 2: pain at the injection site, fatigue, headache, myalgia, nausea, erythema, and swelling. The most commonly reported solicited adverse reactions in MenACWY conjugate vaccine-experienced individuals aged 15 through 25 years after Dose 1 and Dose 2: pain at the injection site, headache, fatigue, myalgia, and nausea About BEXSERO (Meningococcal Group B Vaccine) GSK’s MenB vaccine has received regulatory approval in over 55 countries, including the US, and is used in 18 national immunization programs worldwide for the prevention of IMD caused by Neisseria meningitidis serogroup B. More than 110 million doses have been distributed worldwide since 2015.12 Clinical data supported its effectiveness in helping to protect adolescents and young adults against diverse disease-causing strains of MenB, with a well-characterized safety profile. In the US, BEXSERO is indicated for active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B in individuals aged 10 through 25 years. The US Prescribing Information is available here.13 Important Safety Information for BEXSERO in the US The following is based on the US Prescribing Information for BEXSERO. Please consult the full Prescribing Information for additional safety information. Do not administer BEXSERO to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of BEXSERO or after a previous dose of BEXSERO The tip cap of the prefilled syringe may or may not be made with natural rubber latex. Natural rubber latex may cause allergic reactions Syncope (fainting) can occur in association with administration of BEXSERO BEXSERO may not protect all vaccine recipients and may not provide protection against all meningococcal serogroup B strains Some individuals with altered immunocompetence may have reduced immune responses to BEXSERO Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by N. meningitidis serogroup B even after being vaccinated with BEXSERO The most commonly reported solicited adverse reactions: pain at the injection site, fatigue, headache, nausea, erythema, myalgia, and swelling About MENVEO (Meningococcal [Groups A, C, Y, and W-135] Oligosaccharide Diphtheria CRM197 Conjugate Vaccine) GSK’s MenACWY vaccine has received regulatory approval in over 60 countries, including the US, with more than 80 million doses distributed worldwide since 2010.14 It offers evidence of immunogenicity with a well-characterized safety profile. In the US, MENVEO is indicated for active immunization to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, Y, and W-135 in individuals 2 months through 55 years of age. MENVEO does not prevent N. meningitidis serogroup B infections. The US Prescribing Information is available here.15 Important Safety Information for MENVEO in the US The following is based on the US Prescribing Information for MENVEO. Please consult the full Prescribing Information for additional safety information. Do not administer MENVEO to individuals with a severe allergic reaction (e.g., anaphylaxis) to a previous dose of MENVEO, to any component of this vaccine, or to any other diphtheria toxoid-containing vaccine Syncope (fainting) has occurred in association with administration of MENVEO Some individuals with altered immunocompetence, including some individuals receiving immunosuppressant therapy, may have reduced immune responses to MENVEO Individuals with certain complement deficiencies and individuals receiving treatment that inhibits terminal complement activation (for example, eculizumab) are at increased risk for invasive disease caused by Neisseria meningitidis serogroups A, C, Y, and W, even after being vaccinated with MENVEO Guillain-Barré syndrome has been reported in temporal relationship following administration of another US-licensed meningococcal quadrivalent polysaccharide conjugate vaccine Apnea following intramuscular vaccination has been observed in some infants born prematurely Common solicited adverse reactions: at 2 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, vomiting, and diarrhea; at 7 months through 23 months of age - tenderness and erythema at injection site, irritability, sleepiness, persistent crying, change in eating habits, and diarrhea; at 2 through 10 years of age - injection site pain, erythema, irritability, induration, sleepiness, malaise, and headache. Among adolescents and adults aged 11 through 55 years were pain at the injection site, headache, myalgia, malaise, and nausea - similar rates were observed following a booster dose In two clinical studies, there were no notable differences in frequency and severity of solicited adverse reactions in individuals who received MENVEO 1-vial presentation compared to individuals who received the 2-vial presentation Vaccination with MENVEO may not result in protection in all vaccine recipients 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 in the “Risk Factors” section 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: Centers for Disease Control and Prevention. About Meningococcal Vaccines . Available at: https://www.cdc.gov/vaccines/vpd/mening/hcp/about-vaccine.html . Accessed April 2025. GSK. Penmenvy, GSK’s 5-in-1 meningococcal vaccine, approved by US FDA to help protect against MenABCWY. Available at: https://www.gsk.com/en-gb/media/press-releases/penmenvy-gsk-s-5-in-1-meningococcal-vaccine-approved-by-us-fda-to-help-protect-against-menabcwy/ . Accessed April 2025. Cheng WY, et al . Determinants of Meningococcal ACWY vaccination in adolescents in the US: completion and compliance with the CDC recommendations . Hum Vaccin Immunother . 2020;16(1):176-188. Centers for Disease Control and Prevention. National Vaccination Coverage Among Adolescents Aged 13–17 Years — National Immunization Survey-Teen, United States, 2023 . Available at: https://www.cdc.gov/mmwr/volumes/73/wr/mm7333a1.htm#:~:text=Among%20adolescents%20aged%2013%E2%80%9317%20years%20included%20in%20the%202023,view%2Fcdc%2F159388 . Accessed April 2025. GSK Data on File Calculation of GSK share in US MenB market January – December 2024 . REF-269547. Based on information licensed from IQVIA: IQVIA, DDD, Meningococcal B market all channels, period January – December 2024, reflecting estimates of real-world activity. All rights reserved. Centers for Disease Control and Prevention. Meningococcal Vaccine Recommendations. Available at: https://www.cdc.gov/meningococcal/hcp/vaccine-recommendations/index.html . Accessed April 2025. Thompson MJ, et al. Clinical recognition of meningococcal disease in children and adolescents. Lancet. 2006;367(9508):397-403. Marshall GS, et al. Understanding the Sequelae of Invasive Meningococcal Disease in the United States. Infect Dis Ther. 2024;13(11):2213-2220. European Centers for Disease Control and Prevention. Outbreak of invasive meningococcal disease in the EU associated with a mass gathering event, the 23rd World Scout Jamboree, in Japan . 21 August 2015. Available at: https://www.ecdc.europa.eu/sites/default/files/media/en/publications/Publications/Meningococcal-disease-scouts-EU-August-2015.pdf . Accessed April 2025. Centers for Disease Control and Prevention. Risk Factors for Meningococcal Disease. Available at: https://www.cdc.gov/meningococcal/risk-factors/index.html . Accessed April 2025. GSK. US Prescribing Information for Penmenvy . Available at: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Penmenvy/pdf/PENMENVY.PDF . Accessed April 2025. GSK Data on File. Number of Bexsero doses shipped from 2015 to November 2023 REF-219766 GSK. US Prescribing Information for Bexsero . Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Bexsero/pdf/BEXSERO.PDF . Accessed April 2025. GSK Data on File. Menveo Doses Shipped from 2010 to end of 2022 REF-195452. GSK. Prescribing Information for Menveo . Available at: gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Menveo/pdf/MENVEO.PDF . Accessed April 2025.

VaccineDrug ApprovalClinical ResultImmunotherapyClinical Study

100 Deals associated with Meningococcal group B vaccine(Pfizer Inc.)

External Link

KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Meningitis, Meningococcal	Australia	Pfizer Australia Pty Ltd.	14 Sep 2017
Invasive meningococcal disease	European Union	Pfizer Europe MA EEIG	24 May 2017
Invasive meningococcal disease	Iceland	Pfizer Europe MA EEIG	24 May 2017
Invasive meningococcal disease	Liechtenstein	Pfizer Europe MA EEIG	24 May 2017
Invasive meningococcal disease	Norway	Pfizer Europe MA EEIG	24 May 2017
Meningococcal Infections	United States	Wyeth Pharmaceuticals LLC	29 Oct 2014

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Meningitis	Phase 2	Australia	Pfizer Inc.	01 Nov 2006

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02531698 (CTgov)	Phase 2	Meningococcal Infections	400	rLP2086 (Group 1 Bivalent rLP2086 (>=24 Months to <4 Years))	weiqfyymmi = goamxnpmkt sehqcejuyw (oamkdunupx, gtqeyeqavl - vclsrfhdyx) View more	-	27 Mar 2018
				rLP2086 (Group 1 Bivalent rLP2086 (>=4 Years to <10 Years))	weiqfyymmi = nqcyxsgqlv sehqcejuyw (oamkdunupx, kflhseslww - zqwjnhwszc) View more
NCT01461980 (CTgov)	Phase 2	Meningococcal Infections	2,648	pertussis (Tdap) vaccine+Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine (MCV4+Tdap+rLP2086)	yvwsyfcaxs(kziodefyul) = pnhssnwolv icsxopkxxf (ghlymjkxyl, kuzabcwxix - lwpbrgxbut) View more	-	25 May 2015
				Tdap+MCV4 (MCV4+Tdap+Saline)	yvwsyfcaxs(kziodefyul) = mixtsnawub icsxopkxxf (ghlymjkxyl, erayxrrhwn - wsqclkvxsr) View more
NCT01352793 (CTgov)	Phase 3	Meningitis, Meningococcal	5,715	Neisseria meningitidis serogroup B (MnB) bivalent recombinant lipoprotein 2086 (rLP2086) vaccine (Group 1: rLP2086)	dpmtbqhirb = vzstgmcldx qkyennobci (ksfixjetlh, ygeqbplhhd - ynpxgoswvx) View more	-	11 Mar 2015
				HAV (Group 2: HAV/Saline/HAV)	dpmtbqhirb = vfphbuoshy qkyennobci (ksfixjetlh, ackgawsuyo - sjwavzhhpn) View more
NCT01768117 (B1971042, CTgov)	Phase 2	Meningitis, Meningococcal	13	rLP2086	hwwryaaglo = ryibpekgvt tckricvyvl (tyohtklcfz, aqrlldlkiw - usybqvpzzv) View more	-	09 Mar 2015
NCT01323270 (CTgov)	Phase 2	Meningitis, Meningococcal	753	Repevax (Group 1: rLP2086 + Repevax)	ewzdmublch = gqrqcibclg nsazvpfiwz (anxebqbmpg, haeohxmthl - qlkporhxuu) View more	-	26 Nov 2014
				Saline+Repevax (Group 2: Saline+Repevax)	ewzdmublch = wbiwnjanen nsazvpfiwz (anxebqbmpg, tnoycestyc - xtnsgkrbxp) View more
NCT00798304 (CTgov)	Phase 2	Meningitis, Meningococcal	46	InfanrixHexa+Rotarix+Prevenar+Meningitec (Control)	iobivqfeim = dxhhdjipat amqgglftkz (kopkliuucs, umhvmsqmmk - owzpwjpyku) View more	-	26 Nov 2014
				Recombinant lipoprotein 2086 (rLP2086) (rLP2086 20 mcg)	iobivqfeim = mlqzgtxwoi amqgglftkz (kopkliuucs, srfxvickif - wkjlpvagok) View more
NCT01461993 (CTgov)	Phase 2	Meningococcal Infections	2,499	Gardasil (Group 1: rLP2086 + Gardasil)	sbgsxwuzfm(txiskzkpqy) = rzcvoelmom zsoraaoumx (roynwzqosh, fhrhrtrkxk - gxrxqvevbu) View more	-	26 Nov 2014
				Saline+Gardasil (Group 3: Saline + Gardasil)	sbgsxwuzfm(txiskzkpqy) = kkrfhjzxjh zsoraaoumx (roynwzqosh, servhrrmaf - eorybsvbnb) View more
NCT00798304 (Pubmed \| Vaccine)	Phase 1/2	-	46	rLP2086 vaccine at 20-μg dose	rmznsnchpv(qcxxzupwpg) = dtaoqkuyzx iqglemawjb (rbajgtzgmt )	-	08 Sep 2014
				rLP2086 vaccine at 60-μg dose	rmznsnchpv(qcxxzupwpg) = kgjvwisgdq iqglemawjb (rbajgtzgmt )

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