공시 • Mar 18
Merck Presents New Data Reinforcing Long-Term Efficacy of Gardasil 9 and Gardasil At Eurogin International Multidisciplinary HPV Congress 2026
Merck, known as MSD outside of the United States and Canada, announced it will present new clinical and real-world data reaffirming the long-term effectiveness of the company’s 9-valent Human Papillomavirus (HPV) vaccine, GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) and its 4-valent HPV vaccine, GARDASIL (Human Papillomavirus 4-valent Vaccine, Recombinant) against certain HPV-related cancers and diseases at the EUROGIN International Multidisciplinary HPV Congress 2026 in Vienna, Austria, from March 18-21. Data to be presented include results from studies evaluating the long-term effectiveness of HPV vaccination in women 16 to 26 years of age, showing vaccine effectiveness for at least 14 years following 3 doses of the 9-valent vaccine, and vaccine effectiveness up to 18 years after 3 doses of the quadrivalent vaccine against HPV 16/18-related high-grade cervical disease. The company will share additional data on certain HPV-related oropharyngeal cancers, and adult- and juvenile-onset Recurrent Respiratory Papillomatosis (RRP) through studies done in the U.S., Denmark, Sweden, and the United Kingdom. Details on key abstracts for Merck: Data on Long-Term Efficacy of GARDASIL 9 and GARDASIL: Long-term effectiveness of the 9-valent HPV vaccine in women aged 16-26 years at vaccination from Scandinavian countries FC01 – HPV Vaccines I (Pathirana) Wed, 3/18/26 8:30-10:00 AM CEST. Long-term effectiveness and immunogenicity of the quadrivalent HPV vaccine in young women from three Nordic countries: 18-year follow-up of the Future Il study (Kjaer) Sat, 3/21/26 8:00-9:40 AM CEST. Data on Trends in the Incidence of Adult- and Juvenile-Onset RRP: Clinical perspective of HPV diseases of the upper airway SS04 – HPV related infections and disease of the upper airway (Klussmann) Wed, 3/18/26 1:30-3:00 PM CEST. Trends in the incidence of adult- and juvenile-onset recurrent respiratory papillomatosis in the United States SS04 – HPV related infections and disease of the upper airway Wed, 3/18/26 1:30-3:00 PM CEST (Mahale). Incidence of Recurrent Respiratory Papillomatosis (RRP) in Denmark and Sweden during 2000-2023: Two nation-wide cohort studies in children and young adults SS04 – HPV related infections and disease of the upper airway Wed, 3/18/26 1:30-3:00 PM CEST (Sundström). Comparative modeling of RRP elimination strategies in the UK and Denmark SS04 – HPV related infections and disease of the upper airway (Birger) Wed, 3/18/26 1:30-3:00 PM CEST. GARDASIL, Merck’s 4-valent HPV Vaccine, is not marketed in the United States. Indication for GARDASIL and GARDASIL 9: GARDASIL 9 is a vaccine indicated in females 9 through 45 years of age. GARDASIL is a vaccine indicated in females 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by human papillomavirus (HPV) Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11. GARDASIL 9 is indicated in males 9 through 45 years of age. GARDASIL is indicated in males 9 through 26 years of age. GARDASIL 9 is indicated for the prevention of anal, oropharyngeal and other head and neck cancers caused by HPV Types 16, 18, 31, 33, 45, 52, and 58; and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, 18, 31, 33, 45, 52, and 58. GARDASIL is indicated for the prevention of anal cancer caused by HPV Types 16 and 18, and precancerous or dysplastic lesions caused by HPV Types 6, 11, 16, and 18. Both are indicated for the prevention of genital warts caused by HPV Types 6 and 11. The GARDASIL 9 oropharyngeal and head and neck cancer indication is approved under accelerated approval based on effectiveness in preventing HPV-related anogenital disease. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. GARDASIL 9 and GARDASIL do not eliminate the necessity for vaccine recipients to undergo screening for cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers as recommended by a health care provider. GARDASIL 9 and GARDASIL have not been demonstrated to provide protection against diseases caused by: HPV types not covered by the vaccine; HPV types to which a person has previously been exposed through sexual activity. Not all vulvar, vaginal, anal, oropharyngeal and other head and neck cancers are caused by HPV, and GARDASIL 9 and GARDASIL protect only against those vulvar, vaginal, anal, oropharyngeal and other head and neck cancers caused by HPV types contained in the vaccines. GARDASIL 9 and GARDASIL are not a treatment for external genital lesions; cervical, vulvar, vaginal, anal, oropharyngeal and other head and neck cancers; or cervical intraepithelial neoplasia (CIN), vulvar intraepithelial neoplasia (VIN), vaginal intraepithelial neoplasia (VaIN), or anal intraepithelial neoplasia (AIN). Vaccination with GARDASIL 9 or GARDASIL may not result in protection in all vaccine recipients. Select Safety Information: GARDASIL 9 and GARDASIL are contraindicated in individuals with hypersensitivity, including severe allergic reactions to yeast, or after a previous dose of GARDASIL 9 or GARDASIL. Because vaccinees may develop syncope, sometimes resulting in falling with injury, observation for 15 minutes after administration is recommended. Syncope, sometimes associated with tonic-clonic movements and other seizure-like activity, has been reported following HPV vaccination. When syncope is associated with tonic-clonic movements, the activity is usually transient and typically responds to restoring cerebral perfusion. Safety and effectiveness of GARDASIL 9 and GARDASIL have not been established in pregnant women. For GARDASIL 9, the most common (>10%) local and systemic adverse reactions in females were: injection-site pain, swelling, erythema, and headache. The most common (>10%) local and systemic reactions in males were injection-site pain, swelling, and erythema. For GARDASIL, the most common (>1.0%) adverse reactions were headache, fever, nausea, dizziness; and injection-site pain, swelling, erythema, pruritus, and bruising.
