Rowe, N.J., March 13, 2024 - Merck Sharp & Dohme (Merck is the corporate trading name of Merck & Co. of Rowe, N.J., U.S.A.) announced at the European Organization for the Study of Genital Infections and Neoplasms (EUROGIN) Congress 2024 plans to initiate a novel multivalent human papillomavirus (HPV) vaccine clinical trial designed to provide broader protection against HPV types. At the same time, Merck Sharp & Dohme also plans to conduct additional clinical trials to evaluate the protective efficacy and safety of Gardasil®9 [nine-valent human papillomavirus vaccine (brewer's yeast)] single-dose regimen1 compared to the already approved three-dose regimen.

Within China, Gardasil®9 is indicated for the prevention of cervical cancer caused by HPV types 16, 18, 31, 33, 45, 52, and 58; cervical intraepithelial neoplasia (CIN grades 1/2/3) and adenocarcinoma in situ (AIS) of the uterine cervix caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 in women between the ages of 9 and 45 years; and Persistent infections caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58.Gardasil®9 is available in a three-dose vaccination program for ages 9 to 45 years (0, June, and December), and a new two-dose vaccination program for ages 9 to 14 years (0, 6 to 12 months) was approved in January of this year. The two-dose vaccination program provides more economical and convenient health protection for more women in the appropriate age group, and will work together with the original three-dose vaccination program to help women in the appropriate age group to stay away from cervical cancer and cervical lesions associated with HPV infection.

Multivalent HPV Vaccine Development

Merck Sharp & Dohme plans to initiate the first human trial (Phase I) in the fourth quarter of 2024. Vaccine-related researchers will build on Gardasil® and Gardasil®9 in order to develop a new multivalent human papillomavirus (HPV) vaccine that offers broader protection against HPV types. The additional development pipeline utilizes the Company's proprietary virus-like particle (VLP) technology to integrate additional VLPs to expand HPV type coverage. The broader HPV types include several types known to have high impact in African and Asian populations, as well as in individuals of African and Asian descent.

Evaluating the Potential Protective Efficacy and Durability of Gardasil®9 Single-Dose Vaccination Programs

In response to industry calls for more clinical data on alternative vaccination regimens for Gardasil®9. Merck Sharp & Dohme plans to conduct two clinical trials aimed at assessing the short- and long-term protective efficacy and immunogenicity of Gardasil®9 single-dose vaccination versus the currently approved 3-dose vaccination regimen, and to clarify whether Gardasil®9 single-dose vaccination can provide comparable long-term protective efficacy to the approved vaccination regimen while meeting regulatory requirements. The related clinical trial is expected to begin enrolling clinical trial subjects in the fourth quarter of 2024.

HPV Vaccine Supply

In response to the increasing global demand for Gardasil® and Gardasil®9 vaccinations and to support a broader and equitable vaccine supply, Merck Sharp & Dohme has invested significantly in vaccine manufacturing. Beginning in 2019, Merck Sharp & Dohme is committed to expanding capacity by increasing production at existing plants as well as constructing new facilities. Vaccine supply almost doubles under the new initiative between 2017 and 2020 and subsequently doubles again between 2020 and 2024. Merck Sharp & Dohme expects to supply sufficient quantities of HPV vaccine to meet expected demand in 2025, while continuing to work on expanding vaccine supply capacity in the future.

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