CAPVAXIVE is the only Pneumococcal Conjugate Vaccine (PCV) specifically indicated and studied in the U.S. for use in this population<\/b><\/p>\n
CAPVAXIVE, when added to existing primary pediatric pneumococcal vaccination series, helps deliver additional protection by including serotypes not contained in approved primary pediatric PCV series<\/b><\/p>\n
RAHWAY, N.J.–(BUSINESS WIRE<\/a>)– \nCAPVAXIVE is indicated for:<\/p>\n \nCAPVAXIVE 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.<\/p>\n \nThe indication for the prevention of pneumonia caused by S. pneumoniae<\/i> 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.<\/p>\n \n\u201cChildren and adolescents with certain chronic conditions are at an increased risk for pneumococcal disease, including pneumonia, meningitis, and bloodstream infections,\u201d said Dr. Rotem Lapidot, Chief of Pediatric Infectious Diseases at Rambam Health Care Campus, investigator, STRIDE-13 trial. \u201cThis approval recognizes the potential of CAPVAXIVE to deliver additional protection by including serotypes not contained in approved primary pediatric PCV series, and represents a new approach to helping protect children and adolescents at increased risk for pneumococcal disease.\u201d<\/p>\n \nThe approval is based on data from the Phase 3 STRIDE-13 trial, which evaluated CAPVAXIVE compared to PPSV23 (pneumococcal 23-valent polysaccharide vaccine) in children and adolescents aged 2 through 17 years who completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. See \u201cSTRIDE-13 Clinical Data Supporting Approval\u201d below for additional details.<\/p>\n \n\u201cWhile CAPVAXIVE was specifically designed for adults, it may also offer additional disease protection for this specific population of children and adolescents, when given after the primary pediatric pneumococcal vaccination series,\u201d said Dr. Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. \u201cThe approval of CAPVAXIVE for children and adolescents at increased risk for pneumococcal disease demonstrates our commitment to addressing this disease in people of all ages, not only addressing an unmet need, but also reinforcing Merck\u2019s longstanding commitment to public health and infectious diseases.\u201d<\/p>\n \nThe expanded indication for CAPVAXIVE complements existing primary pediatric pneumococcal vaccination series for children and adolescents at increased risk for pneumococcal disease. According to a 2025 study of 2015-2019 CDC ABC surveillance data, including three groups, one of which consisted of children <18 years old (age range 31 to 109 months; n=219) with at least one risk condition for invasive pneumococcal disease (IPD) such as chronic heart disease, chronic lung disease, diabetes, and chronic kidney disease, CAPVAXIVE covers the serotypes responsible for ~79% of IPD cases. In this risk group, the 11 unique serotypes covered by CAPVAXIVE account for ~40% of IPD cases. These values are based on CDC epidemiologic data and do not reflect the efficacy of CAPVAXIVE. There are currently no studies evaluating the efficacy of CAPVAXIVE.<\/p>\n About CAPVAXIVE<\/b><\/p>\n \nCAPVAXIVE is Merck\u2019s 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 and for the prevention of invasive disease in children and adolescents aged 2 through 17 years who have one or more chronic medical conditions that put them at an increased risk of pneumococcal disease. CAPVAXIVE was specifically designed to help address the Streptococcus pneumoniae<\/i> serotypes predominantly responsible for IPD in adults, including eight unique serotypes, 15A, 15C, 16F, 23A, 23B, 24F, 31 and 35B compared to other approved pneumococcal vaccines. CAPVAXIVE<\/b>is administered as a single dose.<\/p>\n \nCAPVAXIVE helps provide coverage against the serotypes responsible for approximately 82% of IPD cases in adults 50 years of age and older, compared to ~54% by PCV20, based on national-level CDC data from 2019-2023. 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.<\/p>\n \nWith this approval, CAPVAXIVE is also indicated for the prevention of invasive disease in children and adolescents aged 2 through 17 years who have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease.<\/p>\n Select Safety Information for CAPVAXIVE in Children and Adolescents at Increased Risk for Pneumococcal Disease in the U.S.<\/b><\/p>\n \nDo not administer CAPVAXIVE to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to any component of CAPVAXIVE or to diphtheria toxoid.<\/p>\n \nSyncope may occur with administration of injectable vaccines.<\/p>\n \nIndividuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to CAPVAXIVE.<\/p>\n \nThe 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%).<\/p>\n \nThe 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%).<\/p>\n \nThe most commonly reported (>10%) solicited adverse reactions in individuals 2 through 17 years of age who are at increased risk for pneumococcal disease were: injection-site pain (67.7%), injection-site erythema (24.3%), fatigue (20.1%), injection-site swelling (18.8%), headache (17.1%), malaise (13.3%), and irritability (11.6%).<\/p>\n \nVaccination with CAPVAXIVE may not protect all vaccine recipients.<\/p>\n STRIDE-13 Clinical Data Supporting Approval<\/b><\/p>\n \nSTRIDE-13 (NCT06177912<\/a>) is a randomized, double-blind, active comparator-controlled Phase 3 study that evaluated individuals 2 through 17 years of age with one or more prespecified medical conditions (diabetes mellitus, chronic heart disease, chronic kidney disease, chronic liver disease, chronic lung disease) known to increase the risk of pneumococcal disease and who have previously completed a primary pneumococcal vaccination regimen at least 8 weeks prior to enrollment (n=874). Participants were randomized 3:2 to receive a single dose of CAPVAXIVE (n=527) or PPSV23 (n=347). Results from the study include:<\/p>\n About Pneumococcal Disease<\/b><\/p>\n \nPneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae<\/i>. 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).<\/p>\n About Merck<\/b><\/p>\n \nAt 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 \u2013 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<\/a> and connect with us on X (formerly Twitter)<\/a>, Facebook<\/a>, Instagram<\/a>, YouTube<\/a> and LinkedIn<\/a>.<\/p>\n Forward-Looking Statement of Merck & Co., Inc., Rahway, N.J., USA<\/b><\/p>\n \nThis news release of Merck & Co., Inc., Rahway, N.J., USA (the \u201ccompany\u201d) includes \u201cforward-looking statements\u201d 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\u2019s 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.<\/p>\n \nRisks 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\u2019s 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\u2019s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and\/or regulatory actions.<\/p>\n \nThe 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\u2019s Annual Report on Form 10-K for the year ended December 31, 2025 and the company\u2019s other filings with the Securities and Exchange Commission (SEC) available at the SEC\u2019s Internet site (www.sec.gov<\/a>).<\/p>\n Please see the Prescribing Information for CAPVAXIVE (Pneumococcal 21-valent Conjugate Vaccine) at <\/b>https:\/\/www.merck.com\/product\/usa\/pi_circulars\/c\/capvaxive\/capvaxive_pi.pdf<\/b><\/a>and the Patient Information\/Medication Guide for CAPVAXIVE at <\/b>https:\/\/www.merck.com\/product\/usa\/pi_circulars\/c\/capvaxive\/capvaxive_ppi.pdf <\/b><\/a>.<\/b><\/p>\n View source version on businesswire.com: <\/span>https:\/\/www.businesswire.com\/news\/home\/20260618416609\/en\/<\/a><\/span><\/p>\n \nMedia Contacts:<\/p>\n \nOlivia Finucane \nAlayna Shamy \nInvestor Contacts:<\/p>\n \nPeter Dannenbaum \nDamini Chokshi KEYWORDS:<\/b> United States North America New Jersey<\/p>\n INDUSTRY KEYWORDS:<\/b> Research Clinical Trials Biotechnology Other Health Health Pharmaceutical General Health Other Science Science<\/p>\n
\nMerck (NYSE: MRK), known as MSD outside of the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for CAPVAXIVE\u00ae <\/sup>(Pneumococcal 21-valent Conjugate Vaccine) to include children and adolescents aged 2 through 17 years who have completed a primary pediatric pneumococcal vaccination series and have one or more chronic medical conditions that put them at an increased risk for pneumococcal disease. With this approval, CAPVAXIVE is the only PCV specifically indicated and studiedin the U.S. for use in this patient population.<\/p>\n\n
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004 7881 262476
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olivia.finucane@msd.com<\/a><\/p>\n
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(732) 403-0397
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alayna.shamy@merck.com<\/a><\/p>\n
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(732) 594-1579
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peter.dannenbaum@merck.com<\/a><\/p>\n
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(732) 594-1577
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damini.chokshi@merck.com<\/a><\/p>\n
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