Meningitis, Pneumococcal

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.

Millions of newly eligible U.S. adults aged 50 to 64 now recommended to receive vaccination against invasive pneumococcal disease (IPD) and pneumococcal pneumonia 1 NEW YORK--(BUSINESS WIRE)-- Pfizer Inc. (NYSE: PFE) announced today that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practice (ACIP) voted to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine) for all adults aged 50 and older. This recommendation is pending final approval by the director of the CDC and the Department of Health and Human Services. With respect to PREVNAR 20, ACIP recommended: Vaccination is recommended for all adults aged ≥50 years and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown. “ACIP’s vote to expand adult pneumococcal vaccination to now include all adults aged 50 and older marks an important milestone in Pfizer’s long-standing commitment to reducing the burden of this life-threatening disease,” said Luis Jodar, PhD, Senior Vice President, Vaccines and Anti-Infectives Chief Medical Affairs Officers, Pfizer. “PREVNAR 20 offers protection against the serotypes responsible for the majority of invasive pneumococcal disease cases in this age group. Expanding its use also provides an opportunity to limit the re-emergence of disease-causing strains like serotype 4, which has recently affected certain U.S. adult populations and is covered by the vaccine.” In the U.S., the 20 serotypes contained in PREVNAR 20 are estimated to cause over 2,000 deaths and more than 65,000 cases of invasive pneumococcal disease (IPD), including bacteremia and meningitis, and community-acquired pneumonia annually in adults aged 50 to 64. 2 Between 2018 and 2022, more than half of IPD cases in people aged 50 to 64 were caused by these 20 serotypes. 3 Vaccination with PREVNAR 20 helps prevent serotype 4 disease, which incidence has been rising in certain populations in the western U.S. 4 About PREVNAR 20 ® PREVNAR 20 ® is Pfizer’s next-generation pneumococcal conjugate vaccine that includes capsular polysaccharide conjugates for the 13 serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) already included in Prevnar 13 ® (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]). The vaccine also contains capsular polysaccharide conjugates for seven additional serotypes (8, 10A, 11A, 12F, 15B, 22F and 33F) that cause invasive pneumococcal disease (IPD), 5,6,7,8,9 and have been associated with high case-fatality rates, 10,11,12,13 antibiotic resistance, 14,15,16 and/or meningitis. 17,18 PREVNAR 20 helps protect against disease caused by the 20 Streptococcus pneumoniae serotypes in the vaccine. On June 8, 2021, Pfizer announced the U.S. Food and Drug Administration (FDA) approved PREVNAR 20 for the prevention of invasive pneumococcal disease and pneumococcal pneumonia in adults aged 18 years or older. On September 30, 2022, the FDA approved the addition of information in the PREVNAR 20 prescribing information regarding coadministration with an influenza vaccine, adjuvanted (Fluad Quadrivalent 19 ), in adults aged 65 years or older. INDICATIONS FOR PREVNAR 20 PREVNAR 20 ® is a vaccine indicated for: the prevention of invasive disease caused by 20 Streptococcus pneumoniae strains (1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F) in individuals 6 weeks and older. the prevention of otitis media (middle ear infection) caused by 7 of the 20 strains in individuals 6 weeks through 5 years. active immunization for the prevention of pneumonia caused by Streptococcus pneumoniae strains 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15B, 18C, 19A, 19F, 22F, 23F, and 33F in individuals 18 years of age and older. The indication of PREVNAR 20 for the prevention of pneumonia caused by S. pneumoniae serotypes 8, 10A, 11A, 12F, 15B, 22F, and 33F in individuals 18 years of age and older is approved based on immune responses. Continued approval may depend on a supportive study IMPORTANT SAFETY INFORMATION FOR PREVNAR 20 PREVNAR 20 ® should not be given to anyone who has had a severe allergic reaction to any component of PREVNAR 20 or to diphtheria–toxoid-containing vaccine. Individuals with weakened immune systems may have a lower immune response. Safety data are not available for these groups. A temporary pause in breathing after getting the vaccine has been observed in some infants who were born prematurely. For premature infants, talk to your doctor about the infant's medical status when deciding to get vaccinated with PREVNAR 20. In individuals 2, 4, 6, and 12 through 15 months of age vaccinated with a 4-dose schedule, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, decreased appetite and injection site redness, injection site swelling, and fever. In individuals 15 months through 17 years of age vaccinated with a single dose, the most common side effects reported at a rate of >10% were irritability, pain at the injection site, drowsiness, fatigue and muscle pain, decreased appetite, injection site swelling and injection site redness, headache, and fever. In individuals 18 years and older, the most common side effects reported at a rate of >10% were pain at the injection site, muscle pain, fatigue, headache, and joint pain. Also, injection site swelling was common in individuals 18 years through 59 years of age. Ask your doctor about the risks and benefits of PREVNAR 20. Only a doctor can decide if PREVNAR 20 is right for you or your child. View the full Prescribing Information. 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 23, 2024. 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 PREVNAR 20 ® (20-valent Pneumococcal Conjugate Vaccine), including its potential benefits and a vote by ACIP to expand its recommendation for the use of certain pneumococcal vaccines, including PREVNAR 20 for all adults aged 50 and older and for adults aged 19–49 years with certain underlying conditions or risk factors who have not received a PCV or whose vaccination history is unknown, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of PREVNAR 20 and uncertainties regarding the commercial impact of ACIP’s recommendation; 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; 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 biologics license applications may be filed in any other jurisdictions for PREVNAR 20 for any potential indications; whether and when any such applications that may be pending or filed 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 PREVNAR 20 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 PREVNAR 20; uncertainties regarding the ability to obtain recommendations from vaccine advisory or technical committees and other public health authorities regarding PREVNAR 20 and uncertainties regarding the commercial impact of any such recommendations; uncertainties regarding the impact of COVID-19 on our 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, 2023, 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 . ________________________________ 1 U.S. Census Bureau. Population by age. https://data.census.gov/table?q=Population%20by%20age. Accessed October 2024. 2 Perdrizet J, Chilson E, Wasserman M, et al. Current and future pneumococcal conjugate vaccine serotype-specific burden in the United States adult population. Abstract No. ISP20-287 Presented at ISPPD-12, Toronto, June 21-25, 2020. Available at: https://cslide.ctimeetingtech.com/isppd20/attendee/confcal/presentation/list?q=Perdrizet. 3 U.S. Centers for Disease Control and Prevention. Summary of Work Group Interpretations of EtR and Policy Option on PCV21 Use in Adults. https://www.cdc.gov/acip/downloads/slides-2024-06-26-28/04-Pneumococcal-Kobayashi-508.pdf. Presented June 27, 2024. Accessed October 11, 2024. 4 U.S. Centers for Disease Control and Prevention. Summary of Risk-based Pneumococcal Vaccination Recommendations. https://www.cdc.gov/pneumococcal/hcp/vaccine-recommendations/risk-indications.html. Updated October 10, 2024. Accessed October 11, 2024. 5 Baisells E, Guillot L, Nair H, et al. Serotype distribution of Streptococcus pneumoniae causing invasive disease in children in the post-PCV era: A systematic review and meta-analysis. PlosOne. 2017;12(5): e0177113. 6 Hausdorff W & Hanage W. Interim results of an ecological experiment – conjugate vaccination against the pneumococcus and serotype replacement. Hum Vaccin Immunother. 2016;12(2):358-374. 7 Cohen R, Cohen J, Chalumeau M, et al. Impact of pneumococcal conjugate vaccines for children in high- and non-high income countries. Expert Rev Vaccines. 2017;16(6):625-640. 8 Moore M, Link-Gelles R, Schaffner W, et al. Effect of use of 13-valent pneumococcal conjugate vaccine in children on invasive pneumococcal disease in children and adults in the USA: analysis of multisite, population-based surveillance. Lancet Infect Dis. 2015;15(3):301-309. 9 Metcalf B, Gertz RE, Gladstone RA, et al. Strain features and distributions in pneumococci from children with invasive disease before and after 13-valent conjugate vaccine implementation in the USA. Clin Microbiol Infect. 2016;22(1):60.e9-60.e29. 10 Oligbu G, Collins S, Sheppard CL, et al. Childhood deaths attributable to invasive pneumococcal disease in England and Wales, 2006–2014. Clin Infect Dis. 2017;65(2):308-314. 11 van Hoek, Andrews N, Waight PA, et al. Effect of serotype on focus and mortality of invasive pneumococcal disease: Coverage of different vaccines and insight into non-vaccine serotypes. PlosOne. 2012;7(7):e39150. 12 Stanek R, Norton N, Mufson M. A 32-years study of the impact of pneumococcal vaccines on invasive Streptococcus pneumoniae disease. Am J Med Sci. 2016;352(6):563-573. 13 Harboe ZB, Thomsen RW, Riis A, et al. Pneumococcal serotypes and mortality following invasive pneumococcal disease: A population-based cohort study. PlosOne. 2009;6(5):e1000081. 14 Azzari C, Cortimiglia M, Nieddu F, et al. Pneumococcal serotype distribution in adults with invasive disease and in carrier children in Italy: Should we expect herd protection of adults through infants’ vaccination? Hum Vaccin Immunother. 2016;12(2):344-350. 15 Tomczyk S, Lynfield R, Schaffner W, et al. Prevention of antibiotic-nonsusceptible invasive pneumococcal disease with the 13-valent pneumococcal conjugate vaccine. Clin Infect Dis. 2016;62(9):1119-1125. 16 Mendes RE, Hollingsworth RC, Costello A, et al. Noninvasive Streptococcus pneumoniae serotypes recovered from hospitalized adult patients in the United States in 2009 to 2012. Antimicrob Agents Chemother. 2015;59(9):5595-5601. 17 Olarte L, Barson WJ, Lin PL, et al. Impact of the 13-valent pneumococcal conjugate vaccine on pneumococcal meningitis in US children. Clin Infect Dis. 2015;61(5):767-775. 18 Thigpen MC, Whitney CG, Messonnier NE, et al. Bacterial meningitis in the United States, 1998–2007. NEJM. 2011;364(21):2016-2025. 19 Fluad Quadrivalent is not a Pfizer product Category: Vaccines Media Contact: PfizerMediaRelations@Pfizer.com +1 (212) 733-1226 Investor Contact: IR@Pfizer.com +1 (212) 733-4848 Source: Pfizer Inc.

STRIDE-8 results presented at IDWeek build on the proven clinical profile of CAPVAXIVE, marking the latest Phase 3 study evaluating CAPVAXIVE to demonstrate robust immune responses in adults CAPVAXIVE covers the serotypes responsible for approximately 84% of invasive pneumococcal disease cases in adults 50 and older RAHWAY, NJ, USA I October 16, 2024 I Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced results from STRIDE-8, a Phase 3 trial evaluating CAPVAXIVE™ (Pneumococcal 21-valent Conjugate Vaccine), at IDWeek 2024 in Los Angeles, California. The trial evaluated the immunogenicity, safety and tolerability of CAPVAXIVE compared to PCV15 (pneumococcal 15-valent conjugate vaccine) in combination with PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in vaccine-naïve adults 18-64 years of age with certain chronic conditions that put them at an increased risk of pneumococcal disease. Key findings from the STRIDE-8 trial include: “Adults with chronic medical conditions, such as kidney disease or diabetes, are particularly vulnerable to invasive pneumococcal disease, which may increase their risk of severe illness,” said Dr. Walter Orenstein, professor emeritus of medicine, epidemiology, global health and pediatrics at Emory University and member of Merck’s Scientific Advisory Committee. “These data further demonstrate that the broad serotype coverage CAPVAXIVE provides can help prevent invasive disease among vulnerable adults.” CAPVAXIVE is indicated for: 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. 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 data presented during IDWeek build on the robust clinical profile of CAPVAXIVE and illustrate the importance of improving equitable access for those at high risk for invasive pneumococcal disease,” said Dr. Macaya Douoguih, Therapeutic Area Head, Vaccines Clinical Research, Merck Research Laboratories. “Our commitment to prioritizing research and advancements that benefit populations at highest risk of invasive pneumococcal disease remains critical.” In addition to STRIDE-8, Merck also presented results from a targeted literature review of the clinical and economic burden of pneumococcal disease in U.S. adults. The findings concluded that Black adults and adults in rural areas with lower levels of education and income face higher disease burden and lower rates of pneumococcal vaccination. Data from a modeling study evaluating the health impact of the introduction of CAPVAXIVE in U.S. adults were also presented. The modeling study concluded that the use of CAPVAXIVE in adults reduced IPD incidence by 33.9% in the U.S. after 10 years, in the setting of continued pediatric PCV vaccination. This equated to approximately 14,000 fewer cases with CAPVAXIVE than PCV20 (pneumococcal 20-valent conjugate vaccine) after 10 years. CAPVAXIVE is specifically designed to help protect adults against the serotypes that cause the majority of invasive pneumococcal disease (IPD) cases. Based on CDC data from 2018-2021, the serotypes covered by CAPVAXIVE are responsible for more cases of IPD in adults compared to 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. The Phase 3 program for CAPVAXIVE spanned multiple studies, including STRIDE-3 ( NCT05425732 ), STRIDE-4 ( NCT05464420 ), STRIDE-5 ( NCT05526716 ), STRIDE-6 ( NCT05420961 ), STRIDE-7 ( NCT05393037 ), STRIDE-8 ( NCT05696080 ), STRIDE-9 ( NCT05633992 ) and STRIDE-10 ( NCT05569954 ). Summary of Findings from Select Studies Presented at IDWeek Data from STRIDE-8 (Abstract #P-45) STRIDE-8 ( NCT05696080 ) is a Phase 3, randomized, double-blind, active comparator-controlled clinical study, evaluating the immunogenicity, safety and tolerability of CAPVAXIVE in adults 18-64 years of age with increased risk for pneumococcal disease (including adults who experienced diabetes mellitus, heart disease, kidney disease, liver disease and lung disease) who had not previously received a pneumococcal vaccine (n=518). Immunogenicity of CAPVAXIVE was compared with sequential administration of PCV15 followed by PPSV23. Participants were randomized 3:1 to receive a single dose of CAPVAXIVE on Day 1 followed by placebo at Week 8, or a single dose of PCV15 on Day 1 followed by a single dose of PPSV23 at Week 8. Primary objectives included serotype-specific OPA GMTs and IgG GMCs at Day 1 and 30-days post-vaccination (Day 30 for CAPVAXIVE + placebo and Week 12 for PCV15 + PPSV23). Safety was evaluated as the proportion of participants with adverse events. Results showed that: Results from Disparities and Inequities in Pneumococcal Disease Burden Targeted Literature Review (Abstract # P-242) A targeted literature review was conducted on the clinical and economic burden of pneumococcal disease in U.S. adults, with a focus on the disparities and inequities by race, geography, urbanicity, income, education and employment. Of 4,609 identified publications (published from January 2012 – July 2024), 12 studies were evaluated. Key findings showed that disparities in burden from pneumococcal disease exist in the U.S., particularly among Black adults and those living in rural areas with lower education and income. Detailed findings included: The study concluded that more research is needed to further examine disparities and inequities in the burden of pneumococcal disease. Results from Modeling Study Quantifying the Impact of Introducing a New Adult-Focused PCV in the United States (Abstract #P-58) A modeling study evaluated CAPVAXIVE in comparison to PCV20 to quantify the health impact of both vaccines in U.S. adults. The compartmental model captured pneumococcal carriage transmission in the presence of age- and serotype-specific pneumococcal vaccines and was calibrated to the corresponding IPD data in the U.S. The model was then used to quantify the impact of both CAPVAXIVE and PCV20 on overall IPD incidence in adults of all ages, accounting for continued pediatric PCV vaccination. Analysis assumed pediatric vaccination continued at 82% coverage with an 80/20 mix of PCV20/PCV15 in infants and that 57% of adults aged 65 and older would have received a PCV in the last 10 years. Results showed that while the continued use of both CAPVAXIVE and PCV20 led to reductions in IPD incidence when compared to current disease rates, the use of CAPVAXIVE led to fewer overall cases than the use of PCV20 after 10 years, with a 33.9% reduction across all ages versus a 28.9% reduction, respectively. These results equated to approximately 14,000 fewer cases of IPD in adults with CAPVAXIVE than with PCV20. Findings also showed that despite a greater number of cases in the serotypes not included in CAPVAXIVE when compared to adult PCV20 use, indirect protection of adults from pediatric vaccination resulted in continued declines in these serotypes from present values. 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. 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 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. Merck’s Commitment to Pneumococcal Disease Protection Merck has been at the forefront of pneumococcal disease prevention through vaccination for more than four decades and remains committed to helping to protect people of all ages from this disease. Merck’s ongoing pneumococcal vaccine development program is designed to provide options that address the specific needs of different populations, including infants and children, healthy adults and at-risk sub-groups. This approach recognizes that disease burden in pediatric and adult populations is often driven by different bacterial strains, or serotypes, and aims to address unmet needs by offering vaccine options that target serotypes posing the greatest global risk to each population. To learn more about Merck’s pipeline, visit www.merck.com . 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 . SOURCE: Merck