Vaccines
Access to Health
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We aim to increase population vaccine coverage and achieve the broadest possible access to our vaccines within a sustainable framework.

Vaccines are one of the most valuable health innovations in modern times, according to the World Health Organization (WHO), the U.S. Centers for Disease Control and Prevention (CDC), and other leading health authorities.1,2,3,4,5 Our company’s framework is one that allows ongoing research, development and distribution of innovative vaccines that address important unmet health needs. Consistent with our overarching Access to Health Statement of Guiding Principles, we have a comprehensive strategy.

Our Commitments

  • Support ongoing surveillance and assessments to understand infectious-disease trends and their impact on people
  • Engage in innovative research and development (R&D) to provide vaccines that address vital global health needs
  • Strive to maintain the highest standards of safety and product quality in all stages of vaccine development and manufacturing
  • Invest in manufacturing improvements to help assure reliable product supply and lower production costs
  • Use tiered (or differential) pricing—systematically pricing vaccines at differing levels appropriate to the value they create under economic conditions where they are used—to facilitate broad access
  • Work with governments and nongovernmental organizations (NGOs) to build sustainable and effective vaccine delivery programs that reliably reach people
1 WHO, UNICEF, World Bank. State of the world’s vaccines and immunization, 3rd ed. Geneva, World Health Organization, 2009. http://whqlibdoc.who.int/publications/2009/9789241563864_eng.pdf?ua=1. Accessed September 23, 2014.
2 Centers for Disease Control and Prevention. Ten Great Public Health Achievements—United States, 2001–2010. Morb Mortal Wkly Rep. 2011;60(19):619–623.
3 Ibid.; 60(24):814–818.
4 Centers for Disease Control and Prevention. Achievements in Public Health, 1900–1999 Impact of Vaccines Universally Recommended for Children – United States, 1990–1998. Morb Mortal Wkly Rep. 1999;48(12):243–248.
5 World Medical Association. Statement on the Prioritisation of Immunisation. World Medical Association 63 General Assembly, 2012; Bangkok, Thailand. http://www.wma.net/en/30publications/10policies/v4/. Accessed September 23, 2014.
R&D

Our company conducts innovative research and development to provide vaccines that address vital unmet and emerging global health needs.

For more than 100 years, our scientists have been discovering vaccines that have been impacting lives. We remain one of the few companies dedicated to the complex business of researching and producing vaccines to address the public health burden of disease for people around the world.

We support the Sustainable Development Goal “Ensure healthy lives and promote well-being for all at all ages,” through our efforts to address two main causes of death from preventable or treatable disease in children under five years of age in the developing world—diarrheal and pneumococcal diseases1—as well as measles, mumps and rubella. In addition, our company is working with a number of collaborators, including global and national health organizations, to develop vaccines that target additional diseases of global significance, such as Ebola.

We are also working to develop a vaccine to prevent dengue. Each year, it is estimated that there are 390 million people infected with dengue viruses throughout the tropics and subtropics, resulting in up to 100 million cases of dengue fever, with at least 500,000 of those cases being classified as severe.2 Furthermore, it is currently estimated that there are 3.97 billion people living in more than 140 countries where dengue transmission occurs, and there is no registered vaccine or specific therapy to protect these people at risk. In 2014 we in-licensed the NIH live attenuated vaccine candidate and we are working to start clinical trials as quickly as possible.

There are 100 million cases of dengue fever annually.

We seek to establish new business models and partnerships for research and development. A case in point is the MSD-Wellcome Trust Hilleman Laboratories, headquartered in India. Hilleman Laboratories, founded in 2009, is the first-of-its-kind nonprofit research and development joint venture, with a mission to develop affordable vaccines for global health. Its expertise in medical research is targeted toward creating new vaccines in areas of unmet need as well as adapting existing vaccines for more effective delivery in low-income countries.

Since 2011, Hilleman Laboratories has been focused on a project to develop a heat-stable rotavirus vaccine including the development of a novel delivery device. Advancing closer to its vision of bridging the immunization gap in developing nations, Hilleman Laboratories initiated a Phase I/II clinical trial of its oral vaccine against rotavirus infection. After successful completion of the preclinical stage and securing necessary regulatory approvals, Hilleman Laboratories initiated enrollment of a clinical study to establish proof of concept for its heat-stable vaccine candidate in 2016.

Hilleman Laboratories also secured regulatory approval to conduct a Phase I/II clinical study of its oral cholera vaccine candidate in 2016.

In response to WHO’s global call for increased Cholera vaccine supply, Hilleman Laboratories worked closely with academic institutions in Sweden as well as clinical and manufacturing organizations in Bangladesh, to bridge the gap between academia and biotech for the advancement of affordable lifesaving vaccines.

Hilleman Laboratories continues to engage the external global health community through various forums, including ongoing dialog with its Strategic Advisory Group, which is composed of leading health experts who provide the laboratories with input on customer needs, strategic direction and disease-area needs.

1 UNICEF: Progress for Children Report, 2011
2 www.denguevaccines.org
Manufacturing & Supply

We invest in manufacturing improvements to help assure reliable product supply and lower production costs.

We continue to make investments in manufacturing capacity as part of our long-term strategy to reach more people around the world with our vaccines. As evidence of our progress toward supplying more of the globe, in 2015 nearly 60 percent of the vaccine doses provided went to ex-U.S. countries as compared to approximately 30 percent in 2010.

These investments demonstrate the company’s continued commitment to providing high-quality vaccines to meet increasing global demand for these products. In addition, we continue to explore potential partnerships with low-cost manufacturers to bring down the cost of vaccines.

In 2015, nearly 60 percent of the vaccine doses provided went to ex-U.S. countries, as compared to approximately 30 percent in 2010.

We have a long history of progress in this area. Our hepatitis B license of technology to manufacturers in China dates back to the 1990s, and has resulted in over 100 million doses of recombinant hepatitis B vaccine being produced by our collaborators each year to address the public health burden of hepatitis B in China.

In 2014, together with the Instituto Butantan, a Brazilian biomedical research center and vaccine producer, we signed an agreement outlining the terms of a productive development partnership (PDP) for the technology transfer of our company’s quadrivalent human papillomavirus (HPV) vaccine. This agreement culminates several years of work and follows the inclusion of GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] in Brazil’s National Immunization Program. Through this important transfer of vaccine technology, the government of Brazil will be able to fully support its long-term national vaccination efforts against HPV-related diseases.

Pricing

Our company works with governments, international health and development organizations, donor groups, nongovernmental organizations (NGOs), and others to support countries’ population health aims and help improve sustainable access to our vaccines.

We use tiered pricing for vaccines as an equitable way to achieve twin objectives: to expand access to people who need vaccination, and also to ensure sufficient return on investment over time to support the complex and costly research and development and other activities necessary to create new vaccines.

We consider a variety of factors in arriving at a price in a given country, including public health need, health and economic value of the vaccine, the country’s ability to support vaccine delivery and achieve population health coverage, its level of economic development, its fiscal capacity for investments in health and actual health spending, its mechanism and policies for procuring vaccines, and others.

In the developing world, our company’s commitment to helping protect global health by improving the affordability, availability and accessibility of vaccines is fundamental to our business and overall mission. We offer ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent) and GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] at an access price that is significantly less than the price of these vaccines in developed markets. The access price is exclusive to the public sectors of the countries eligible for support from Gavi, the Vaccine Alliance (Gavi).

In 2015, we extended our current Gavi prices for ROTATEQ and GARDASIL through 2025 to Gavi-graduated countries with a per-capita GNI not exceeding US$3,200. This action greatly assists in meeting the needs of the developing world by facilitating access to these innovative vaccines in the poorest countries, while making sure they remain affordable and sustainable in the long term. We believe that our pricing approach contributes to wider access to our vaccines, while taking into account our need to continue investing in vaccine research, development and production.

For additional information regarding pricing, see Public Policy Statement: Access to Our Vaccines.

Stakeholder Engagement

Our partnership with Gavi and other alliance partners is helping to ensure that infants and girls in the poorest countries have access to rotavirus and HPV vaccines.

Through active engagement with Gavi, we have helped to foster an environment that led to mobilization of funding and partner technical support for the introduction of new vaccines in the world’s poorest countries. Focusing on the anticipated need for our Human Papillomavirus (HPV) and rotavirus vaccines, GARDASIL and ROTATEQ, our company collaborated with Gavi and other members of the alliance, including UNICEF, to understand estimated country demand for the vaccines over time, and to determine the lowest possible access prices that could be sustainably offered to Gavi and UNICEF for the vaccine volumes to be delivered to these poorest countries.

To date, 17 countries approved by Gavi for HPV have selected GARDASIL, and 6 Gavi countries are using ROTATEQ. This has resulted in more than 15 million doses of GARDASIL and ROTATEQ being shipped to Gavi-eligible countries throughout 2015.

Ebola

Our collaboration with partners on an Ebola vaccine is working in an unprecedented way to quickly respond to a global health crisis in West Africa.

The Ebola epidemic that was first reported in 2014 is the largest in history, and has taken a devastating toll on affected countries in West Africa. Although this outbreak has been largely contained, sporadic cases of disease continue to be reported and eliminating the outbreak at its source in West Africa is a critical international health priority.

To respond to the Ebola crisis that started in 2014, we joined with the international health community in efforts to eliminate the Ebola outbreak and put necessary steps in place to help prevent another.

As part of our longstanding commitment to developing medicines and vaccines to address infectious diseases, our company licensed a vaccine candidate to prevent Ebola Zaire virus from NewLink Genetics Corporation in late 2014. The candidate was originally developed by the Public Health Agency of Canada.

We are collaborating with a number of governmental and nongovernmental organizations to advance this vaccine candidate to licensure as quickly as possible.

Development of our company’s investigational Ebola vaccine candidate has been supported through extraordinary collaborative efforts from leading global and national health organizations, including the World Health Organization, the U.S. Centers for Disease Control and Prevention (CDC), the National Institute of Allergy and Infectious Diseases, the Walter Reed Army Institute of Research, the Canadian Immunization Research Network, and the U.S. Army Medical Research Institute of Infectious Diseases.

Major funders in bringing our investigational Ebola vaccine candidate forward include the U.S. Defense’s Defense Threat Reduction Agency (DTRA) and Joint Vaccine Acquisition Program (JVAP), the U.S. Department of Health and Human Service’s Biomedical Advanced Research Development Authority (BARDA), the National Institutes of Health (NIH) and the Wellcome Trust.

The vaccine candidate has undergone Phase I studies, and sufficient safety and immune response data were generated to support moving the vaccine forward for Phase II/III testing. Phase II/III testing was initiated with studies starting in Liberia in February 2015, in Guinea in March 2015, and in Sierra Leone in April 2015. Consequently, the vaccine candidate has been able to move quickly into three large-scale trials in affected countries in West Africa.

The preliminary results from the Guinean clinical study suggest a potential role for our company’s vaccine candidate and the study is continuing. Additional studies are also underway to help define the vaccine candidate’s safety and efficacy profile.

We are also committed to providing the vaccine to Gavi-eligible countries at the lowest possible access price if the vaccine meets regulatory standards for safety and effectiveness in clinical trials and is appropriately licensed. Furthermore, we have signed an agreement with GAVI, the Vaccine Alliance, that was announced during the Annual Meeting of the World Economic Forum in Davos, Switzerland in January. Under the Advance Purchase Commitment, Gavi has provided $5 million towards the development of our company’s rVSV∆G-ZEBOV-GP live attenuated Ebola Zaire vaccine, on the understanding that it will be submitted for licensure by the end of 2017. If approved, the vaccine candidate would become one of the world’s first licensed Ebola vaccines and Gavi would be able to begin purchasing the vaccine to create a stockpile for future Ebola Zaire virus outbreaks.

On December 23, 2015, we announced that the application for Emergency Use Assessment and Listing (EUAL) for the company’s investigational Ebola Zaire vaccine, V920 (rVSV-∆G-ZEBOV-GP, live attenuated), has been accepted for review by the World Health Organization (WHO). According to the WHO, the EUAL process is designed to expedite the availability of vaccines needed for public health emergencies such as another outbreak of Ebola. The procedure is intended to assist United Nations procurement agencies and Member States on the acceptability of using a vaccine candidate in an emergency-use setting. EUAL designation is not prequalification by WHO, but rather is a special procedure implemented when there is an outbreak of a disease with high rates of morbidity and/or mortality and a lack of treatment and/or prevention options. In such instances, WHO may recommend making a vaccine available for a limited time, while further clinical trial data are being gathered for formal regulatory agency review by a national regulatory authority.

Through all of these efforts, we hope to expedite the development of a vaccine for Ebola and, if demonstrated to be efficacious and well-tolerated, to make it available to individuals and communities at risk of Ebola Zaire virus infection around the world.

Rotavirus

We are pursuing multiple approaches to increase global access to ROTATEQ® (rotavirus vaccine, live, oral, pentavalent).

Rotavirus gastroenteritis is a leading cause of severe diarrhea in infants and young children. Africa accounts for a large proportion of the global total of rotavirus deaths with nearly a quarter of a million African children dying from the dehydrating diarrhea caused by rotavirus infection every year.2 Since 2009, the World Health Organizations’s (WHO’s) Strategic Advisory Group of Experts (SAGE) has recommended the inclusion of rotavirus vaccination in all national immunization programs, helping to ensure access to rotavirus vaccines in the world’s poorest countries.3

Since 2006, 163 million doses of ROTATEQ have been distributed worldwide.

We believe that we have an important role in contributing toward this goal. Since its launch in 2006, ROTATEQ has been registered and approved in more than 120 countries, and approximately 163 million doses have been distributed worldwide (numbers as of December 2015). Together with our partners, including country governments, Gavi, the Vaccine Alliance (Gavi) and other stakeholders, we are working to expand access to rotavirus vaccines to help address this problem. Currently, six Gavi-eligible African countries have launched national immunization programs using ROTATEQ.

A case study4 conducted by the Agence de Médecine Préventive (AMP) on the introduction of ROTATEQ in Burkina Faso concluded that the introduction was successful and the three-dose schedule integrated well into the current schedule of the National Immunization Programme. This evaluation enabled identification of challenges and provided solutions, useful information for countries planning to introduce rotavirus vaccines. We continue to evaluate and implement approaches aimed at improving product attributes to better meet the specific needs of low- and middle-income countries in the future. This includes work to develop a heat-stable rotavirus vaccine being conducted through the MSD-Wellcome Trust Hilleman Laboratories.

1 Tate, J., et al., “2008 estimate of worldwide rotavirus-associated mortality in children younger than 5 years before the introduction of universal rotavirus vaccination programmes: a systematic review and meta-analysis” Lancet, February 2012, p. 136.
2 ”Preventing Rotavirus Disease in The Gambia.” RotaFlash, August 15, 2013.
3 http://www.who.int/mediacentre/news/releases/2009/rotavirus_vaccines_20090605/en/index.html, Accessed March 6, 2013.
4 Global Immunization News (GIN) August 2014: Burkina Faso AMP.
Cervical Cancer

Our company is committed to supporting public health initiatives that increase access to vaccines where they are most needed.

In March 2014, more than 5,000 municipalities in Brazil kicked off the national campaign of human papillomavirus (HPV) vaccination using GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] to vaccinate appropriate girls in Brazil ages 9–13. In Brazil, cervical cancer is a leading cause of death in women, with more than 5,000 women dying of the disease each year.1 GARDASIL is now being supplied to the National Immunization Plan (NIP) through a partnership between our company and Instituto Butantan, a Brazilian biomedical research center and vaccine producer.

This partnership highlights our commitment to working closely with governments and scientific institutions to ensure broad and sustained access to GARDASIL. We have a long-standing commitment to helping improve access to GARDASIL in developing countries, where more than 85 percent of the world’s cervical cancer cases occur.2 We have engaged in a number of multidisciplinary partnerships that help resource-poor countries gain access to HPV vaccination.

HPV Vaccination Partnerships

In September 2012, the Republic of Uganda, through the ministry of health (MoH) and supported by our company, announced the launch of a vaccination program with GARDASIL. Through this agreement with our company, the vaccination program was implemented with just under a half million 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 represented the first phase of Uganda’s national rollout plan for HPV vaccination. As a result of phase 1, Uganda launched its full national HPV-vaccination program in 2015 with support from Gavi. the Vaccine Alliance (Gavi).

A young girl is vaccinated during the September 2012 phased launch of a national vaccination program with GARDASIL in the Republic of Uganda.

In 2015, our company concluded a six-year partnership with the Royal Government of Bhutan and the Australian Cervical Cancer Foundation (ACCF) aimed at reducing incidence of cervical cancer in Bhutan. Through this partnership, Bhutan became the first developing nation in the world to implement a national cervical cancer vaccination program.

The first year of the program provided an opportunity for appropriate girls and young women from ages 12 to 18 to be vaccinated with GARDASIL, and achieved an approximately 90 percent vaccination rate for all three doses, according to the Bhutan MoH. In subsequent years, the program continued to provide an opportunity for appropriate 12-year-old girls to be vaccinated with GARDASIL. Analysis of the program by the MoH has been instrumental in better understanding the critical success factors in successful implementation, such as a school-based delivery platform and support from the education system4. These programs in Uganda and Bhutan are serving as models for other developing countries that aspire to implementing national cervical cancer vaccination programs.

Cervical Cancer Prevention & Treatment Partnerships

Our company continues to work to create novel partnerships that take a comprehensive approach to cervical cancer prevention and treatment. For instance, in September 2011, we announced plans to contribute $3 million to Pink Ribbon Red Ribbon™(PRRR) to address both cervical and breast cancer in sub-Saharan African nations. PRRR is a historic initiative that brought 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 corporate organizations. Through this commitment, we continue to work with Susan G. Komen for the Cure to support the initiative.

Throughout 2015, activities focused on the countries of Tanzania and Zambia, including a donation of equipment to expand screen-and-treat services for cervical pre-cancer in Tanzania, programs to raise the national awareness of available cervical and breast cancer services, the improvement of treatment protocols for breast cancer, mobilization of the community in efforts against cervical cancer, and provisions of advanced surgical training to physicians in Zambia. In 2015, PRRR added activities in Ethiopia to bolster the country’s commitment to breast and cervical cancer prevention and care, which includes HPV vaccination with GARDASIL.

In 2013 and 2014, Botswana, with support from our company and from PRRR, successfully completed a two-year HPV-vaccination demonstration project to gain experience for an anticipated national HPV-vaccination rollout. The project provided the ministry of health with valuable learning that guided the rollout of the national program, which completed its first campaign in 2015. Secondary cervical cancer prevention and treatment are being supported through PRRR partners providing community awareness, increased capacity through health care worker training, and screening and treatment equipment.

Also in 2013, following our previous donation of 180,000 doses of GARDASIL through the GARDASIL Access Program, for a two-year HPV-vaccination demonstration program in three districts, we agreed to donate an additional 30,000 doses to the Zambian MoH for a third year of the program. Together with PRRR partners, we have also provided technical support for the program, which continues in 2016. Results to date indicate that in 2015–2016, 87 percent of the targeted population of girls received the first two vaccine doses. The Zambia MoH is leveraging the results of this program to make preparations for a transition to a Gavi-supported HPV-vaccination program.

Commitment to Support HPV Vaccine Introduction

Beginning in 2006, we partnered with the international nonprofit organization PATH to provide GARDASIL for the conducting of post-licensure 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 vaccines can be achieved through various delivery strategies in the countries studied.

Additionally, through the charitable GARDASIL Access Program, we donated more than 1.3 million doses of GARDASIL for use in smaller-scale HPV-vaccination projects in eligible lowest-income countries around the world. The program, which came to a conclusion in 2015, has enabled organizations and institutions in 21 countries to gain operational experience in designing and implementing HPV-vaccination projects, with the goal of supporting the development of successful child and adolescent immunization models.

As of March 2016, seven countries (Cameroon, Ghana, Kenya, Mali, Tanzania, Uganda and Uzbekistan) that participated in the GARDASIL Access Program are among the first approved by Gavi for HPV programs using GARDASIL, and five of the programs are already underway.

In addition, Lesotho, which completed two HPV-vaccination projects with the support of the GARDASIL Access Program, continues to conduct a national program with its own resources.

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1 Globocan 2012 data Accessed March 20,2014.
http://globocan.iarc.fr/old/bar_pop.asp?selection=24076&title=Brazil&sex=2&statistic=0&window=1&grid=1&color1=5&color1e=&color2=4&color2e=&orientation=1&submit=%C2%A0Execute.
2 CDC Global Health, p.1A.
3 WHO 2010 Summary Report, p. 4A.
4 Dorji, et al., “Introduction of a National HPV vaccination program into Bhutan.” Vaccine, June 2016, p. 3,726.