Merck has a long-standing commitment to help improve access to GARDASIL^® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] in developing countries, where more than 85 percent of the world's cervical cancer cases occur.

In September 2012, the Republic of Uganda through the Ministry of Health (MoH), supported by Merck, announced the launch of a national vaccination program with GARDASIL. Cervical cancer is the most frequent cancer diagnosed among women in Uganda, and incidence rates of the disease in the country are about three times the global average. An estimated 3,500 women in Uganda are diagnosed with cervical cancer each year. Through this agreement with Merck, the vaccination program will be implemented with 460,000 doses of GARDASIL donated to 12 districts in Uganda, enough to vaccinate approximately 140,000 eligible girls 9 to 13 years of age over a two year period. The program represents the first phase of Uganda's national roll out plan for human papillomavirus (HPV) vaccination.

In September 2011, Merck announced its plans to contribute $3 million over three years to Pink Ribbon-Red Ribbon™, to address both cervical and breast cancer in sub-Saharan African nations. Pink Ribbon-Red Ribbon is a historic initiative that brings together public and private sector partners including Susan G. Komen for the Cure, the George W. Bush Institute, the President's Emergency Plan for AIDS Relief (PEPFAR), UNAIDS, the U.S. government and other corporate organizations. Through this three-year commitment, Merck will work with Susan G. Komen for the Cure to support the initiative to raise awareness about the burden of breast and cervical cancer, mobilize additional partners and work towards increased access to cervical cancer screening, treatment for women and HPV vaccination of appropriate girls in sub-Saharan Africa.

In 2009, Merck and QIAGEN N.V., a Netherlands holding company and the leading global provider of sample and assay technologies, began to collaborate on a new program to increase access to human papillomavirus (HPV) vaccination and HPV DNA testing in some of the most resource-poor areas of the world. This initiative marked the first time a vaccine manufacturer and a molecular diagnostics company have collaborated to address the burden of cervical cancer in one comprehensive approach. As part of the collaboration, Merck intends to provide, for free up to 5 million doses of GARDASIL, and QIAGEN intends to add to its existing 1 million tests donation program by providing HPV DNA tests to screen an additional 500,000 women. In April 2011, the Government of Rwanda, along with Merck and QIAGEN, announced that Rwanda would be the first recipient of this collaborative effort and the first GAVI-eligible country to implement a comprehensive program that incorporates HPV vaccination and HPV DNA testing. Additionally, and as part of the collaboration between Merck and QIAGEN, an agreement has been signed with Tanzania to provide doses of GARDASIL at no cost to Tanzania to support a phased launch for their HPV vaccination program.

Merck also partnered with the Government of Bhutan and the Australian Cervical Cancer Foundation (ACCF) to initiate a six-year program aimed at reducing incidence of cervical cancer in the country. Through this partnership, announced in May 2010, Bhutan became the first developing nation in the world to implement a national cervical cancer vaccination program. Led by Her Majesty the Royal Grandmother Ashi Kesang Choeden Wangchuck and the Bhutan Ministry of Health, the first year of the program provided an opportunity for appropriate girls and young women between the ages of 12 and 18 to be vaccinated with GARDASIL, and achieved an approximately 90 percent vaccination rate for all three doses, according to the Bhutan Ministry of Health. In subsequent years, the program continues to provide an opportunity for appropriate 12-year- old girls to be vaccinated with GARDASIL. The Bhutan HPV vaccine program is serving as a model for other developing countries that aspire to implement national cervical cancer vaccination programs.

Additionally, Merck partnered with the international nonprofit organization PATH to provide GARDASIL for the conduct of HPV vaccine demonstration projects in Peru, Vietnam and India. GARDASIL was provided to vaccinate approximately 30,000 appropriate girls participating in HPV Vaccines: Evidence for Impact demonstration projects. The overall initiative was designed to strengthen the capacity of developing countries to prevent cervical cancer by generating and providing necessary evidence for public sector introductions of HPV vaccines, informing global advocacy efforts, and providing analyses to help accelerate access to HPV vaccines. The projects suggest that high coverage with HPV vaccine can be achieved through various delivery strategies in the countries studied.¹

Through the charitable GARDASIL Access Program, Merck pledged to donate at least 3 million doses of GARDASIL for use in smaller-scale HPV vaccination projects in eligible lowest-income countries around the world. The program enabled organizations and institutions to gain operational experience designing and implementing HPV vaccination projects, with the goal of supporting the development of successful child and adolescent immunization models. The program accommodates proposals from applicants to design and implement smaller-scale HPV vaccination projects rather than nationwide programs. The operational experiences and lessons learned by participants in the program will be disseminated in an effort to contribute to the public knowledge base on HPV vaccine access and child/adolescent immunization models. After consultation with various stakeholders, it was decided that, as of August 2012, the GARDASIL Access program will no longer award doses to new projects. However, Merck's full donation commitment of at least three million doses of GARDASIL will be honored and options for how remaining doses of GARDASIL could be used are currently being explored. Importantly, commitments to already-awarded project will continue to be honored. Also, experiences and lessons learned from past and current Program participants will continue to be disseminated to the public health community by Axios Healthcare Development, a US non-profit organization, which manages the GARDASIL Access Program. Learn more about the GARDASIL Access Program and this development.

¹ LaMontagne et al, Bull World Health Org 2011.

• Merck is committed to:
  • Engaging in innovative Research and Development (R&D) to provide vaccines that address vital global health needs
  • Reducing the gap between vaccine availability in developed countries and their introduction in the developing world through timely registration and introduction of our vaccines
  • Developing creative partnerships that address the full range of factors affecting access to our vaccines in resource-constrained settings including those to increase manufacturing capacity, address implementation challenges and build healthcare capacity and infrastructure.