Through the GARDASIL Access Program, Merck pledges to donate at least three million doses of GARDASIL to organizations and institutions in eligible lowest-income countries. The program will accommodate proposals from applicants to design and implement smaller scale HPV vaccination projects, rather than nationwide programs. Endorsement by the Ministry of Health will be a critical prerequisite for each application. The operational experiences and lessons learned by participants in the GARDASIL Access Program will be widely disseminated in an effort to contribute to the public knowledge base on HPV vaccine access and child/adolescent immunization models in lowest income countries.
To implement this commitment: Merck will partner with a non-profit organization which will manage the GARDASIL Access Program with strategic guidance provided by an independent Advisory Board comprised of international public health experts. The Advisory Board will provide strategic direction, review and recommend applications for approval and offer technical suggestions to optimize the effectiveness and quality of the program. The non-profit organization will administer the program, convene the Advisory Board regularly to review incoming applications, approve applications based on Advisory Board recommendations and coordinate delivery of donated vaccine to recipients.
Organizations and institutions in eligible lowest income countries will be eligible to apply.
- Establish partnership with a non-profit organization to manage this donation program
- Establish an independent Advisory Board comprised of international public health experts
- Develop eligibility criteria and RFP process in consultation with the Advisory Board
- Develop and issue first RFP inviting eligible applicants to propose HPV vaccination projects
In the United States, GARDASIL is a vaccine indicated for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, and vaginal cancers; precancerous or dysplastic lesions; and genital warts caused by HPV Types 6, 11, 16 and 18. Indications for use may be different depending on the country. (Please visit www.gardasilaccessprogram.org/section/150 for product specific information.)
In developed countries such as the United States, most women have access to routine Pap screening programs that allow for the identification and treatment of cervical cancer in its early stages of disease, thereby keeping cervical cancer rates low. By contrast, relatively few women in lowest-income countries--where approximately 80% of worldwide cervical cancer cases occur--have access to cervical cancer screening programs. HPV vaccination, as part of a comprehensive cervical cancer control program, can reduce the incidence of cervical cancer in lowest income countries. However, there are many barriers to vaccination that must be overcome.
Historically, there has been a 15 to 20-year lag between the introduction of new vaccines in developed and developing countries. Such delays have resulted from a number of factors including funding constraints, gaps in disease awareness and competing national health priorities. Additional challenges arise when lowest income countries consider introducing new vaccines, such as HPV vaccines, for older children and adolescent populations.
The GARDASIL Access Program offers a platform for participating organizations and institutions to find support in the areas of program design and implementation. The Program has an independent Advisory Board comprised of international public health experts which provides advice and technical suggestions to optimize the efficacy and quality of the GARDASIL Access Program and reviews program applications. The GARDASIL Access Program aims to foster lasting partnerships within the HPV community in an effort to increase access to HPV vaccination and identify best practices for child and adolescent vaccination models in the least developed countries. Key stakeholders who are integral in this collaboration include Ministries of Health and Education, the GAVI Alliance, UICC, PATH, Family Care International, WHO, PAHO, UNICEF, and UNFPA, civil society and academia, among others. For detailed information on the GARDASIL Access Program, please visit www.gardasilaccessprogram.org