Meningococcal group A, C, W 135 and Y conjugate vaccine(GlaxoSmithKline Plc)

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.

2025年4月8日，智飞生物一连发布了三个III期临床管线的公告，宣布旗下三大疫苗管线取得关键进展：四价流脑结合疫苗获得Ⅲ期临床试验总结报告、双价痢疾结合疫苗即将在孟加拉国启动III期临床试验、治疗用卡介苗进入III期临床阶段。这三项进展覆盖传染病预防与癌症治疗领域，标志着智飞生物在创新疫苗研发上迈入密集收获期。1、矩阵完善：四价流脑疫苗冲刺上市智飞生物全资子公司智飞绿竹研发的ACYW135群脑膜炎球菌多糖结合疫苗获得了Ⅲ期临床试验总结报告：该疫苗具有良好的免疫原性及安全性，全面达到临床试验预设目标，在免疫原性方面非劣效于对照疫苗，且基本符合《脑膜炎球菌疫苗临床试验技术指导原则》对免疫原性与安全性评价的设计要求。据悉，目前国内有1款四价流脑结合疫苗上市，为康希诺生物自主研发的ACYW135群流脑多糖结合疫苗曼海欣Menhycia，其是我国首款，全球第4款获批上市的四价流脑结合疫苗。在此之前国外三款上市的四价流脑结合疫苗分别为赛诺菲巴斯德的Menactra/MenQudafi、GSK的Menveo以及辉瑞的Nimenrix。从产品商业化布局来看，若智飞生物的该款四价流脑疫苗成功获批上市销售，将与公司已上市的A群C群脑膜炎球菌多糖疫苗（盟纳克®）、ACYW135群脑膜炎球菌多糖疫苗（盟威克®）、A群C群脑膜炎球菌多糖结合疫苗（盟纳康®）形成协同效应，进一步夯实公司脑膜炎疫苗矩阵，强化公司自主产品的市场地位，提升公司竞争力。2、全球首创：双价痢疾疫苗剑指空白市场智飞绿竹研发的福氏宋内氏痢疾双价结合疫苗是全球首款进入III期临床的同类产品，拟在孟加拉国开展的Ⅲ期临床试验，将采用随机、盲法、安慰剂对照评价该疫苗针对6月龄至5周岁婴幼儿的有效性、免疫原性和安全性。目前公司已经完成于孟加拉国开展Ⅲ期临床试验的准备工作，即将启动受试者入组。根据世界卫生组织公报报告，细菌性痢疾全球每年发病人数达到1.647亿，其中1.632亿在发展中国家，且69%的病例发生在5岁以下儿童。引起细菌性痢疾的志贺菌主要包括4种菌群：痢疾志贺菌、福氏志贺菌、鲍氏志贺菌和宋内氏志贺菌，全球以福氏、宋内氏志贺菌感染为主，占总发病数的90%以上。而智飞绿竹研发的该款疫苗主要就是针对福氏、宋内氏志贺菌2种菌群。值得注意的是，该疫苗的国内Ⅲ期临床试验已于2021年12月开展，孟加拉国III期试验将补充国内数据，为国际化布局铺路。3、瞄准蓝海：治疗用卡介苗攻坚膀胱癌智飞生物全资子公司智飞龙科马自主研发的治疗用卡介苗的Ⅲ期临床试验在湖南省完成首例受试者给药。该临床试验采用多中心、随机、盲法对照设计，以评价该产品用于预防18周岁及以上人群非肌层浸润性膀胱癌术后复发的有效性和安全性。该疫苗系用卡介菌经培养收集菌体，制备高浓度卡介菌悬液，加入适宜稳定剂冻干制成的免疫治疗剂，用于治疗膀胱原位癌以及预防处于Ta或T1期的膀胱乳头状瘤经尿道切除术后的复发。据悉，截至目前，仅有1款治疗用卡介苗在国内获批上市，为成都生物的必赛吉。另外，今年1月，可恩生物宣布其治疗用卡介苗（BCG）Ⅲ期临床研究已顺利完成全部受试者的入组。研究采用多中心、随机、双盲、阳性对照设计，旨在评估治疗用卡介苗预防中、高危非肌层浸润性膀胱癌术后复发的有效性和安全性，在广东省、北京市、上海市、天津市、四川省等共计30个研究中心招募412名受试者。并预计将在2026年Q1获得Ⅲ期临床主要终点数据。参考资料：[1]智飞生物公告.[2]如何评价国产四价流脑结合疫苗？. 接种答疑. 2024-01-18.[3]里程碑进展|治疗用卡介苗Ⅲ期临床研究完成入组. 可恩生物. 2025-01-17.[4]中国自主研发卡介苗助力膀胱癌治疗. 拜尔健. 2018-02-25.识别微信二维码，可添加药时空小编请注明：姓名+研究方向！