Clinical Data Supporting Approval Demonstrated Non-Inferior Immune Responses for the Serotypes Shared with PCV13 (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F)<\/b><\/p>\n
\u00a0VAXNEUVANCE Elicited Superior Immune Responses for Serotypes 3, 22F and 33F Compared to PCV13, Which Are Major Causes of Disease<\/b><\/p>\n
KENILWORTH, N.J.–(BUSINESS WIRE<\/a>)– \nThe U.S. Centers for Disease Control and Prevention\u2019s (CDC) Advisory Committee on Immunization Practices (ACIP) is expected to meet in October to discuss and make recommendations on the use of VAXNEUVANCE in adults.\n<\/p>\n \nVAXNEUVANCE was approved based on data from seven randomized, double-blind clinical studies assessing safety, tolerability, and immunogenicity in adults (see \u201cClinical Data Supporting FDA Approval\u201d below for additional details). Clinical data showed that immune responses elicited by VAXNEUVANCE were non-inferior to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for the 13 shared serotypes, as assessed by opsonophagocytic activity (OPA) Geometric Mean Titers (GMTs).\n<\/p>\n \nAdditionally, immune responses for VAXNEUVANCE were superior to PCV13 for shared serotype 3 and for the two serotypes unique to VAXNEUVANCE, 22F and 33F. In the pivotal Phase 3 PNEU-AGE (V114-019) study, superiority for VAXNEUVANCE relative to PCV13 was based on statistically significantly greater OPA GMT ratios for serotypes 22F [GMT Ratio 32.52 (95% Confidence Interval (CI) 25.87, 40.88)] and 33F [GMT Ratio 7.19 (95% CI 6.13, 8.43)], as well as for the key secondary objective assessing serotype 3 [GMT Ratio 1.62 (95% CI 1.40, 1.87)]. Randomized controlled trials assessing the clinical efficacy of VAXNEUVANCE compared to PCV13 have not been conducted.\n<\/p>\n \n\u201cSome adults, including older adults or those with certain chronic medical conditions or immunocompromising conditions, are at increased risk for pneumococcal disease and its serious, sometimes life-threatening complications,\u201d said Dr. Jose Cardona, Indago Research and Health Center, coordinating investigator for the PNEU-AGE trial. \u201cThe FDA\u2019s approval of VAXNEUVANCE is based on robust Phase 2 and 3 studies assessing immune responses in a broad range of adult populations and provides an important new option in protection from invasive pneumococcal disease.\u201d\n<\/p>\n \nPneumococcal disease is an infection caused by bacteria called Streptococcus pneumoniae,<\/i> or pneumococcus. Different strains of this bacteria are called serotypes. Invasive pneumococcal disease (IPD) occurs when the bacteria infect parts of the body that are usually free from germs. Approximately 80 percent of all adult IPD burden is among adults 50 years of age and older. Serotypes 3, 22F and 33F contribute significantly to the burden of IPD, and serotype 3 is the leading cause of IPD in adults in the U.S.\n<\/p>\n \n\u201cAt Merck, we are committed to helping protect more people from invasive pneumococcal disease. That\u2019s why we set out to develop a conjugate vaccine that includes pneumococcal serotypes that pose the greatest threat and elicits a strong immune response to each serotype covered,\u201d said Dr. Roy Baynes, senior vice president and head of global clinical development, chief medical officer, Merck Research Laboratories. \u201cThe FDA approval of VAXNEUVANCE builds on Merck\u2019s more than 40 years of experience in pneumococcal disease prevention with a new option that includes serotypes responsible for substantial disease burden in adults, like serotype 3, as well as serotypes 22F and 33F, which are associated with a high degree of invasiveness and antibiotic resistance.\u201d\n<\/p>\n About VAXNEUVANCE<\/b><\/p>\n \nVAXNEUVANCE, Merck\u2019s approved 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S. pneumoniae <\/i>serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F individually conjugated to CRM197<\/sub> carrier protein. VAXNEUVANCE is indicated for active immunization for the prevention of invasive disease caused by the S. pneumoniae<\/i> serotypes contained in the vaccine. VAXNEUVANCE previously received Breakthrough Therapy designation from the FDA for the prevention of IPD in adults 18 years of age and older. In January 2021, it received Priority Review designation.\n<\/p>\n \nMerck is involved in litigation challenging the validity of several Pfizer Inc. patents that relate to pneumococcal vaccine technology in the United States and several foreign jurisdictions.\n<\/p>\n Select Safety Information for VAXNEUVANCE<\/b><\/p>\n \nDo not administer VAXNEUVANCE to individuals with a severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid.\n<\/p>\n \nSome individuals with altered immunocompetence, including those receiving immunosuppressive therapy, may have a reduced immune response to VAXNEUVANCE.\n<\/p>\n \nThe most commonly reported solicited adverse reactions in individuals 18 through 49 years of age were: injection site pain (75.8%), fatigue (34.3%), myalgia (28.8%), headache (26.5%), injection site swelling (21.7%), injection site erythema (15.1%) and arthralgia (12.7%).\n<\/p>\n \nThe most commonly reported solicited adverse reactions in individuals 50 years of age and older were: injection site pain (66.8%), myalgia (26.9%), fatigue (21.5%), headache (18.9%), injection site swelling (15.4%), injection site erythema (10.9%) and arthralgia (7.7%).\n<\/p>\n \nVaccination with VAXNEUVANCE may not protect all vaccine recipients.\n<\/p>\n Clinical Data Supporting FDA Approval <\/b><\/p>\n \nVAXNEUVANCE was approved based on data from seven randomized, double-blind clinical studies designed to evaluate its safety, tolerability, and immunogenicity in 7,438 individuals from a variety of adult populations and clinical circumstances, 5,630 of whom received VAXNEUVANCE. These included studies of:\n<\/p>\n \nA Phase 3 descriptive study included individuals with stable underlying medical conditions (e.g., diabetes mellitus, renal disorders, chronic heart disease, chronic liver disease, chronic lung disease including asthma) and\/or behavioral risk factors (e.g., smoking, increased alcohol use) that increased their risk of developing pneumococcal disease. Participants were randomized to receive VAXNEUVANCE (n=1,135) or PCV13 (n=380), followed by PNEUMOVAX\u00ae <\/sup>23 (pneumococcal vaccine polyvalent) six months later (V114-017\/PNEU-DAY [NCT03547167]). VAXNEUVANCE elicited immune responses to all 15 serotypes as assessed by OPA GMTs at 30 days following vaccination. Additionally, following vaccination with PNEUMOVAX 23, the OPA GMTs for the 15 serotypes in VAXNEUVANCE were numerically similar among subjects who had received VAXNEUVANCE or PCV13 for the first vaccination.\n<\/p>\n \nA Phase 3 active comparator-controlled descriptive study in pneumococcal vaccine-na\u00efve adults 50 years of age or older assessed the use of VAXNEUVANCE (n=327) or PCV13 (n=325), followed by PNEUMOVAX 23 one year later (V114-016\/PNEU-PATH [NCT03480763]). Following vaccination with PNEUMOVAX 23, OPA GMTs were numerically similar between the two vaccination groups for the 15 serotypes in VAXNEUVANCE.\n<\/p>\n About Merck <\/b><\/p>\n \nFor 130 years, Merck, known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world\u2019s most challenging diseases in pursuit of our mission to save and improve lives. We demonstrate our commitment to patients and population health by increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to prevent and treat diseases that threaten people and animals \u2013 including cancer, infectious diseases such as HIV and Ebola, and emerging animal diseases \u2013 as we aspire to be the premier research-intensive biopharmaceutical company in the world. For more information, visit www.merck.com<\/a> and connect with us on Twitter<\/a>, Facebook<\/a>, Instagram<\/a>, YouTube<\/a> and LinkedIn<\/a>.\n<\/p>\n Forward-Looking Statement of Merck & Co., Inc., Kenilworth, N.J., USA<\/b><\/p>\n \nThis news release of Merck & Co., Inc., Kenilworth, 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 products that the products 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.\n<\/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 the global outbreak of novel coronavirus disease (COVID-19); 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.\n<\/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 2020 Annual Report on Form 10-K and the company\u2019s other filings with the Securities and Exchange Commission (SEC) available at the SEC\u2019s Internet site (www.sec.gov<\/a>).\n<\/p>\n Please see Prescribing Information for VAXNEUVANCE (pneumococcal 15-valent conjugate vaccine) at https:\/\/www.merck.com\/product\/usa\/pi_circulars\/v\/vaxneuvance\/vaxneuvance_pi.pdf<\/a>. <\/b><\/p>\n and Patient Information at https:\/\/www.merck.com\/product\/usa\/pi_circulars\/v\/vaxneuvance\/vaxneuvance_ppi.pdf<\/a><\/span>.<\/b><\/p>\n \nBrands mentioned are trademarks of their respective owners.\n<\/p>\n
\n(NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved VAXNEUVANCE\u2122<\/sup><\/b> (Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease caused by Streptococcus pneumoniae<\/i> serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F in adults 18 years of age and older. The approval follows the FDA\u2019s Priority Review of Merck\u2019s application. VAXNEUVANCE is contraindicated for individuals with a history of severe allergic reaction (e.g., anaphylaxis) to any component of VAXNEUVANCE or to diphtheria toxoid; see additional Select Safety Information below.\n<\/p>\n\n
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