Pneumococcal polysaccharide vaccine 23-valent(Merck Sharp & Dohme)

根据GSK刚刚发布不久的第三季度财报，GSK已终止24价肺炎球菌候选疫苗AFX3772针对成人的2期临床研究，将重点开发仍在临床前阶段的30价以上的肺炎疫苗，GSK预计在2025年将其推进临床。 AFX3772是GSK在2022年斥资33亿美元（21亿美元的预付款和12亿美元的潜在开发里程碑付款 ）收购Affinivax公司获得的主要项目之一。 对于放弃的原因，GSK发言人对FIERCE解释是因为竞争加剧。今年9月，Vaxcyte公司公布了其31价肺炎疫苗VAX-31在针对50岁及以上成年人中的1/2期临床研究数据，与辉瑞Prevnar 20的“头对头”比较表现亮眼。 当初GSK考虑收购Affinivax的时候，其与辉瑞就肺炎疫苗的竞争已进行到了白热化阶段，最直接的压力来自辉瑞手中的肺炎疫苗Prevnar系列。彼时，GSK手中10价肺炎疫苗Synflorix销售额在下滑，而辉瑞的Prevnar系列疫苗却顶住了疫情和政府采购的压力，销售额逆势不衰。此外，默沙东的Vaxneuvance的获批也进一步加剧了竞争的激烈程度。 GSK之所以押注Affinivax公司的AFX3772，当时重要的原因之一是在Affinivax公布的一项2期临床研究中，不论是否接种过默沙东的Pneumovax 23，AFX3772对某些血清型的免疫反应比辉瑞公司上一代Prevnar 13更高。 虽然此后辉瑞Prevnar 20 上市削弱了AFX3772在血清型覆盖方面的优势。不过，Affinivax认为自家产品的优势不仅限于此，其多抗原呈递系统MAPS要比传统的结合疫苗技术能诱导更广泛的保护性免疫反应。Affinivax的首席科学官Hal Barron博士曾在一份声明中提到，该平台在诱导B细胞和T细胞反应方面的表现吸引了GSK。 尽管这次GSK战略终止了针对AFX3772针对成人的肺炎研究，但GSK的发言人仍表示，相信Affinivax的多抗原递送系统的潜力。AFX3772针对儿童的2期临床研究还在继续进行。 编辑 | 姚嘉 yao.jia@PharmaDJ.com  总第2234期 访问研发客网站，深度报道和每日新闻抢鲜看 www.PharmaDJ.com

October 23, 2024 7:58 pm ET Age-based recommendations for adult pneumococcal vaccination lowered from 65 to 50 years of age and older National-level CDC surveillance data shows CAPVAXIVE covers the serotypes responsible for approximately 84% of invasive pneumococcal disease cases, compared to approximately 52% covered by PCV20 RAHWAY, N.J.--(BUSINESS WIRE)-- Merck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the U.S. Centers for Disease Control and Prevention’s (CDC’s) Advisory Committee on Immunization Practices (ACIP) voted to update the adult age-based pneumococcal vaccination guidelines and recommends CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine) for pneumococcal vaccination in adults 50 years of age and older. The updated ACIP guidelines recommend a single dose of CAPVAXIVE for: Adults 50 years of age and older who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown; Adults 19-49 years of age with certain underlying medical conditions or other risk factors who have not previously received a pneumococcal conjugate vaccine or whose previous vaccination history is unknown; Adults 19 years of age and older who have started their pneumococcal vaccine series with PCV13 (pneumococcal 13-valent conjugate vaccine) but have not received all recommended PPSV23 (pneumococcal 23-valent polysaccharide vaccine) doses. Shared clinical decision-making is also recommended regarding use of a supplemental dose of CAPVAXIVE for adults 65 years of age and older who have completed their vaccine series with both PCV13 and PPSV23. CAPVAXIVE is indicated for: Active immunization for the prevention of invasive disease and pneumonia caused by Streptococcus pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15B, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in adults individuals 18 years of age and older; Active immunization for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B in individuals 18 years of age and older. CAPVAXIVE should not be administered to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid; see additional Select Safety Information below. The indication for the prevention of pneumonia caused by S. pneumoniae serotypes 3, 6A, 7F, 8, 9N, 10A, 11A, 12F, 15A, 15C, 16F, 17F, 19A, 20A, 22F, 23A, 23B, 24F, 31, 33F and 35B is approved under accelerated approval based on immune responses as measured by opsonophagocytic activity (OPA). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. “The CDC’s decision to lower the age-based vaccination recommendations to begin at age 50 has the potential to be a practice-changing milestone,” said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. “This recommendation is a significant step forward in efforts to enhance equitable access and may improve vaccination rates. We’re pleased about this progress and thank the CDC for their commitment to addressing invasive pneumococcal disease and pneumococcal pneumonia in adults.” Based on national-level CDC data from 2018-2022, the serotypes covered by CAPVAXIVE are responsible for more cases of invasive pneumococcal disease (IPD) in adults compared to PCV20 (pneumococcal 20-valent conjugate vaccine). In adults 50 years of age and older, CAPVAXIVE covers the serotypes responsible for approximately 84% of IPD cases, compared to approximately 52% covered by PCV20. These values are based on CDC epidemiologic data and do not reflect the efficacy of the respective vaccines. There are currently no studies comparing the efficacy of CAPVAXIVE and PCV20. In certain at-risk adult populations in Alaska, Colorado, New Mexico, Oregon and the Navajo Nation, a higher prevalence of IPD caused by serotype 4, which is not included in CAPVAXIVE, has been reported. IPD surveillance from other geographic areas in the U.S. has not detected significant percentages of serotype 4. These provisional recommendations will be published on the CDC website following the meeting and will be official once reviewed and finalized by the director of the CDC and the Department of Health and Human Services. Select Safety Information for CAPVAXIVE Do not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (eg, anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid. Individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE. The most commonly reported (>10%) solicited adverse reactions in individuals 18 through 49 years of age who received CAPVAXIVE were: injection-site pain (73.1%), fatigue (36.0%), headache (27.5%), myalgia (16.4%), injection-site erythema (13.8%), and injection-site swelling (13.3%). The most commonly reported (>10%) solicited adverse reactions in individuals 50 years of age and older who received CAPVAXIVE were: injection-site pain (41.2%), fatigue (19.7%), and headache (11.0%). Vaccination with CAPVAXIVE may not protect all vaccine recipients. About CAPVAXIVE CAPVAXIVE is Merck’s approved 21-valent pneumococcal conjugate vaccine indicated for active immunization for the prevention of invasive disease and pneumonia in adults 18 years of age and older. CAPVAXIVE is specifically designed to help address Streptococcus pneumoniae serotypes predominantly responsible for adult invasive pneumococcal disease (IPD), including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other pneumococcal vaccines. CAPVAXIVE is administered as a single dose. About Pneumococcal Disease Pneumococcal disease is an infection caused by a bacteria called Streptococcus pneumoniae . There are about 100 different types (referred to as serotypes) of pneumococcal bacteria, which can affect adults differently than children. Pneumococcal disease can be invasive or non-invasive. Non-invasive pneumococcal illnesses include pneumonia (when pneumococcal disease is confined to the lungs), whereas invasive pneumococcal illnesses include pneumococcal bacteremia (infection in the bloodstream), bacteremic pneumococcal pneumonia (pneumonia with bacteremia) and pneumococcal meningitis (infection of the coverings of the brain and spinal cord). Pneumococcal pneumonia is a type of bacterial pneumonia, which is the most common clinical presentation of pneumococcal disease in adults. It’s estimated that over 150,000 adults are hospitalized from pneumococcal pneumonia each year in the U.S. About Merck At Merck, known as MSD outside of the United States and Canada, we are unified around our purpose: We use the power of leading-edge science to save and improve lives around the world. For more than 130 years, we have brought hope to humanity through the development of important medicines and vaccines. We aspire to be the premier research-intensive biopharmaceutical company in the world – and today, we are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. We foster a diverse and inclusive global workforce and operate responsibly every day to enable a safe, sustainable and healthy future for all people and communities. For more information, visit www.merck.com and connect with us on X (formerly Twitter) , Facebook , Instagram , YouTube and LinkedIn . Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA This news release of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; the company’s ability to accurately predict future market conditions; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; dependence on the effectiveness of the company’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended December 31, 2023 and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site ( www.sec.gov ). Please see Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_pi.pdf and Patient Information/Medication Guide for CAPVAXIVE at https://www.merck.com/product/usa/pi_circulars/c/capvaxive/capvaxive_ppi.pdf . Media Contacts: Julie Cunningham (617) 519-6264 julie.cunningham@merck.com Chrissy Trank (640) 650-0694 chrissy.trank@merck.com Investor Contacts: Peter Dannenbaum (732) 594-1579 peter.dannenbaum@merck.com Alexis Constantine (732) 594-1578 alexis.constantine@merck.com Source: Merck & Co., Inc.