RAHWAY, N.J.–(BUSINESS WIRE<\/a>)– \nThe CHMP opinion will now be considered by the European Commission (EC) for amending the marketing authorization in the EU, and a final decision is expected by the end of the year.\n<\/p>\n \n\u201cWe are committed to advancing protection for those at increased risk for pneumococcal disease, which includes those under the age of 2 years and children of any age who have certain underlying conditions,\u201d said Dr. Eliav Barr, senior vice president, head of global clinical development and chief medical officer, Merck Research Laboratories. \u201cWe are pleased with the CHMP\u2019s positive opinion as it brings us one step closer to our goal of helping to protect against pneumococcal strains that pose substantial risk to infants and children in Europe.\u201d\n<\/p>\n \nPneumococcal disease is an infection caused by the bacterium Streptococcus pneumoniae<\/i>, or pneumococcus. While there are more than 100 different types of S. pneumoniae<\/i>, called serotypes, a selected number of serotypes are responsible for the majority of pneumococcal infections. Invasive pneumococcal disease (IPD) can cause serious and potentially life-threatening infections such as bacteremia (infection in the bloodstream); bacteremic pneumonia (pneumonia with bacteremia); and meningitis (infection of the coverings of the brain and spinal cord).\n<\/p>\n \nThe CHMP opinion was based on data from eight randomized, double-blind clinical studies that enrolled approximately 8,400 individuals from a variety of pediatric populations and clinical circumstances; of these, approximately 5,400 received VAXNEUVANCE.\n<\/p>\n \nIn July 2021, VAXNEUVANCE received approval from the U.S. Food and Drug Administration (FDA) 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, and in June 2022, the FDA approved an expanded indication for VAXNEUVANCE to include individuals 6 weeks through 17 years of age.\n<\/p>\n About VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine)<\/b><\/p>\n \nVAXNEUVANCE, Merck\u2019s 15-valent pneumococcal conjugate vaccine, consists of purified capsular polysaccharides from S.<\/i>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.\n<\/p>\n \nVAXNEUVANCE is indicated in the EU for active immunization for the prevention of invasive pneumococcal disease and pneumonia caused by S. pneumoniae <\/i>in individuals 18 years of age and older.\n<\/p>\n \nVAXNEUVANCE is indicated in the U.S. for active immunization of individuals 6 weeks of age and older for the prevention of invasive disease caused by the S. pneumoniae <\/i>serotypes contained in the vaccine.\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 \nApnea following intramuscular vaccination has been observed in some infants born prematurely. Vaccination of premature infants should be based on the infant\u2019s medical status and the potential benefits and possible risks.\n<\/p>\n \nThe most commonly reported solicited adverse reactions in children vaccinated with a four-dose series at 2, 4, 6, and 12 through 15 months of age, provided as a range across the series, were: irritability (57.3% to 63.4%), somnolence (24.2% to 47.5%), injection-site pain (25.9% to 40.3%), fever \u226538.0\u00b0C (13.3% to 20.4%), decreased appetite (14.1% to 19.0%), injection-site induration (13.2% to 15.4%), injection-site erythema (13.7% to 21.4%) and injection-site swelling (11.3% to 13.4%).\n<\/p>\n \nThe most commonly reported solicited adverse reactions in children and adolescents 2 through 17 years of age vaccinated with a single dose were: injection-site pain (54.8%), myalgia (23.7%), injection-site swelling (20.9%), injection-site erythema (19.2%), fatigue (15.8%), headache (11.9%) and injection-site induration (6.8%).\n<\/p>\n \nThe most commonly reported solicited adverse reactions in adults 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 adults 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 Merck\u2019s Commitment to Pneumococcal Disease Protection<\/b><\/p>\n \nMerck 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\u2019s ongoing pneumococcal vaccine development program is designed to provide tailored options to address the specific needs of different populations, including infants and children, healthy adults and at-risk subgroups. 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\u2019s pneumococcal portfolio and pipeline, visit https:\/\/www.merck.com<\/a>.\n<\/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 Twitter<\/a>, Facebook<\/a>, Instagram<\/a>, YouTube<\/a> and LinkedIn<\/a>.\n<\/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.\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 Annual Report on Form 10-K for the year ended December 31, 2021 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 <\/b>https:\/\/www.merck.com\/product\/usa\/pi_circulars\/v\/vaxneuvance\/vaxneuvance_pi.pdf<\/b><\/a> and Patient Information\/Medication Guide for VAXNEUVANCE at <\/b>https:\/\/www.merck.com\/product\/usa\/pi_circulars\/v\/vaxneuvance\/vaxneuvance_ppi.pdf<\/b><\/a>.<\/b><\/p>\n
\nMerck (NYSE: MRK), known as MSD outside of the United States and Canada, announced today that the European Medicines Agency\u2019s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of VAXNEUVANCE\u2122(Pneumococcal 15-valent Conjugate Vaccine) (pronounced VAKS-noo-vans) for active immunization for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae<\/i> in infants, children and adolescents from 6 weeks to less than 18 years of age. VAXNEUVANCE is currently authorized for use in the European Union (EU) for individuals 18 years of age and older.\n<\/p>\n<\/p>\n
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