Vaccines are one of the most valuable public health innovations of 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 has played a defining role in the history of vaccines. For more than 100 years, our scientists have been discovering and developing vaccines to help protect children, adolescents and adults from a number of serious diseases.6
In that time, our company has been home to some of the world’s greatest vaccinologists, including the late Dr. Maurice Hilleman, a scientist and visionary who developed more than 40 vaccines for humans and animals over the course of his remarkable career.7
Dr. Maurice Hilleman, ca. 1962.
Our long history of success in discovering, developing, manufacturing and distributing vaccines is the foundation on which we will build a healthier future for people of all ages worldwide.
“I think there’s perhaps no better example of how we make our mark on long-term health than our vaccines business. The bottom line is, children are protected and communities are being changed for the better around the world because of our company.”
Kenneth C. Frazier
Chairman and CEO
Our company’s framework is one that allows the ongoing research, development and distribution of innovative vaccines that address important unmet health needs. In keeping with our overarching Access to Health Statement of Guiding Principles, we have a comprehensive strategy.
- 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 the economic conditions where they are used—to facilitate broad access
- Work with governments and nongovernmental organizations (NGOs) to build sustainable and effective vaccination programs that reliably reach people
Following the end of a successful 20-year joint venture with Sanofi Pasteur, in January 2017, our company reintegrated our broad vaccines portfolio of pediatric, adolescent and adult vaccines into 19 MSD countries across Europe. We’re proud to build on the success of the joint venture and move forward independently managing the MSD vaccines portfolio in the region. The addition of the vaccine portfolio in Europe strengthens our global position as a leader in vaccines and infectious disease prevention.
Our company invents—i.e., conducts innovative research and development—to create vaccines that address unmet and emerging global health needs.
RESEARCH AND DEVELOPMENT
We remain one of the few companies dedicated to the complex business of researching and producing vaccines to help address the public health burden of infectious diseases for people around the world.
Our company is working with a number of collaborators, including global and national health organizations, to develop vaccines that target diseases of global significance, such as pneumococcal disease, respiratory syncytial virus (RSV), cytomegalovirus (CMV), herpes zoster and Ebola.
We are also working to develop a vaccine to prevent dengue. It is estimated that each year 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.8 Nearly 4 billion people live in the more than 140 countries where dengue transmission occurs.9 At this time, there is no broadly registered and widely available vaccine or specific therapy to protect these people at risk. In 2014, we in-licensed the NIH live attenuated dengue vaccine candidate. NIH-sponsored Phase II clinical trials are currently ongoing and preparations for company-sponsored trials are in progress.
In addition to engaging in vaccine R&D, we are focused on exploring ways to improve the characteristics of our vaccines. This includes investing in improved production approaches, formulations, schedules and presentations, as well as investigating opportunities to improve supply security and expand the number of serotypes in our vaccines, and evaluating the appropriateness of our vaccines for additional populations.
MSD-Wellcome Trust Hilleman Laboratories
We are committed to increasing global vaccination coverage and supporting sustainable vaccination programs that expand access and uptake. Vaccines not only need to be made available in communities, but need to be administered to people so they are immunized—whether in a rural village, an urban clinic, or somewhere in between. Product attributes such as heat-stability, doses (single or multiple doses in a vial), vial size, and vial technology (such as temperature monitoring) can make it easier for public health systems to manage vaccination and for community health care workers to vaccinate people in unique geographies and resource-limited environments.
We are proud to be engaging with the global health community to help address such challenges through the MSD-Wellcome Trust Hilleman Laboratories, a unique and creative partnership founded in 2009 with co-funding from our company and Wellcome Trust. Headquartered in New Delhi, India, Hilleman Laboratories is an innovative research and development center focused on increasing global health impact by developing high-quality, affordable vaccines tailored for lower-income settings (including countries eligible for support from Gavi, the Vaccine Alliance).
Hilleman Laboratories is pursuing exciting and innovative vaccine development to combat two high-burden, life-threatening diseases—diarrhea and bacterial meningitis—for which vaccine use is still limited in lower-income countries, or for which vaccines do not exist. For protection against diarrhea, Hilleman Laboratories is developing an affordable, heat-stable rotavirus vaccine, an affordable cholera vaccine to help increase global supply, and vaccines against diarrheal pathogens for which vaccines are not yet available, enterotoxigenic Escherichia coli (ETEC) and Shigella.
Additionally, Hilleman Laboratories is developing an affordable, first-of-its-kind polyvalent conjugate vaccine to protect against five types of meningococcal disease (A, C, Y, W, X). Hilleman Laboratories pursues its work in strong collaboration with governmental and nongovernmental organizations spanning global public health, science, technology, and the vaccine industry, including for example, the World Health Organization, Gavi, UNICEF, vaccine manufacturers, and many others.
Inspired by the rich legacy and innovative spirit of Dr. Maurice Hilleman, Hilleman Laboratories is committed to addressing major public health needs and reducing inequity around the world. Toward that end, Hilleman Laboratories is dedicated to delivering high-quality, affordable, user-centered vaccines that can be implemented in effective, sustainable ways to help protect the health of children, families and communities in low-income settings. Learn more about Hilleman Laboratories’ exciting endeavors at: www.hillemanlabs.org.
MANUFACTURING AND SUPPLY
We continue to invest in manufacturing and end-to-end supply improvements in both capability and capacity to help assure the sustainable, reliable supply of quality and affordable vaccines to serve global needs.
We continue to make investments in manufacturing capability and capacity as part of our long-term strategy to reach more people around the world with our vaccines. To ensure a reliable supply of quality products, we have invested more than $1 billion to modernize and expand our existing facilities and build new vaccine manufacturing sites. We have manufacturing sites in West Point, Pennsylvania, U.S.; Durham, North Carolina, U.S.; Elkton, Virginia, U.S.; and Carlow, Ireland. We seek to develop the capability and capacity to serve a significant portion of the world’s population.
The total number of doses distributed of our vaccines has nearly doubled since 2010. And over the past seven years, our global reach has doubled: In 2016, approximately 60 percent of our vaccines were distributed outside the U.S., up from just 30 percent in 2010.
Importantly, we are working hard to ensure that many of these doses reach people in the low-income settings where they are needed most. More than 22 million doses of just two of our vaccines—GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant] and ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent)—have been distributed in Gavi-eligible countries through 2016. Today, 19 Gavi-eligible countries have launched immunization programs with GARDASIL, and four are using ROTATEQ. More broadly, working with Gavi, UNICEF, and other partners, we have worked to mobilize funding and technical support to enable the successful introduction of underused vaccines in the world’s poorest countries.
RELIABLE & HIGH-QUALITY SUPPLY10
Our manufacturing division has undertaken an ambitious program to reduce the cost of production by increasing efficiency, minimizing procurement spending and improving supply performance, including on-time deliveries and reduction of supply shortages.
Maintaining product quality is paramount. To provide high-quality vaccines to people who need them, we manage our supply chain through policies and procedures designed to keep the distribution system secure. Tools such as serialization—a unique identification number on each package that goes to market—add extra security to the vaccine supply chain. A serial number on an individual package enables anyone along the supply chain to scan the code and authenticate it as a genuine product. Additionally, to help offset supply uncertainties, we produce a strategic vaccine reserve to respond quickly to unanticipated market demand.
We also have initiatives in place to help ensure that our packaging reduces unnecessary waste and is environmentally friendly. For instance, evaluating opportunities to reduce packaging elements for providers that have a controlled delivery environment or removing unnecessary packaging for individual units within bulk purchasing can result in substantial efficiencies and reduced waste.
We continue to explore potential strategic partnerships with other manufacturers to bring down the cost of vaccines and promote greater access in local markets. We have a long history of progress in this area, dating back to our hepatitis B license of technology to manufacturers in China in the 1990s.
In 2014, we signed an agreement with the Instituto Butantan, a Brazilian biomedical research center and vaccine producer, outlining the terms of a productive development partnership (PDP) for the technology transfer of our company’s quadrivalent human papillomavirus (HPV) vaccine. Through this important transfer of vaccine technology, GARDASIL is now being supplied to Brazil’s National Immunization Plan (NIP) through a partnership between our company and Instituto Butantan supporting the government of Brazil in its long-term national vaccination efforts against HPV-related diseases. In addition, we are working with Instituto Butantan on the transfer of technology for the production of our hepatitis A vaccine, VAQTA (Hepatitis A Vaccine, Inactivated).
REGISTRATION & PREQUALIFICATION
We seek to ensure global access to our vaccines by obtaining and maintaining up-to-date product registrations around the globe. Additionally, we seek to obtain WHO prequalification so that our vaccines may be easily obtained and distributed to underserved areas of the world’s poorest countries.
Ten Years of Licensure
The year 2016 was an important one for our key vaccines, as we celebrated the 10-year anniversaries of initial licensure for ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent), ZOSTAVAX (Zoster Vaccine Live) and GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant] and the significant impact these vaccines have had on population health.
The following table summarizes the registration and WHO prequalification status of a select list of our vaccines.
|GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]||GARDASIL9® (Human Papillomavirus 9-valent Vaccine, Recombinant)||RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent)||M-M-RII (MEASLES, MUMPS and RUBELLA VIRUS VACCINE LIVE)||VARIVAX® (Varicella Virus Vaccine Live) \|
|Product Is WHO-Prequalified11||Yes||No||Yes||Yes||No|
|Date of Prequalification||May 20, 2009||N/A||October 7, 2008||January 6, 2009||N/A|
|Approximate Number of Countries Where Product Is Registered (as of Q1 2017)||130||50||120||70||60|
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 vaccination programs.
We use tiered pricing for vaccines as an equitable way to achieve twin objectives: to expand access to people who need vaccination, and 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 needs, the 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.
We also consider inequities in access within a country. Where regulations and infrastructure allow, reduced pricing has been offered to support government- or donor-funded coverage of lower-economic-tier segments.
Our company’s commitment to helping protect global health by improving the affordability, availability, accessibility, and use of our vaccines around the world is fundamental to our business and overall mission. We offer ROTATEQ and GARDASIL 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.
In 2015, we extended our current Gavi prices for ROTATEQ and GARDASIL through 2025 to Gavi-graduated countries with a per-capita Gross National Income (GNI) not exceeding $3,200. This action greatly assists in meeting the needs of low- and lower-middle-income countries by facilitating access to these vaccines in those countries while also 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. In the short period of time since we made our price commitment to countries transitioning out of Gavi support, five countries have taken advantage of the offer to introduce or continue existing national HPV vaccination programs.
To respond to the Ebola crisis that started in 2014, our company joined with the international health community in efforts to respond to the outbreak and put necessary steps in place to help prevent another one. In late 2014, our company licensed a promising vaccine candidate (originally engineered by the Public Health Agency of Canada) from NewLink Genetics Corporation, aimed at preventing the Ebola Zaire virus. We are collaborating with others to advance this vaccine candidate to licensure as quickly as possible.
Should our investigational vaccine receive licensing, our company has pledged to make the vaccine available to the world’s poorest countries (Gavi-eligible) at the lowest possible access price. Our company and Gavi, the Vaccine Alliance, have signed an agreement, announced at the 2016 World Economic Forum in Davos, that will help us take the vaccine through licensure and WHO prequalification.
For additional information regarding pricing, see our Public Policy Statement: Access to Our Vaccines.
Ebola and Preventing Future Epidemics
To respond to the Ebola crisis that started in 2014, we joined with the international health community in efforts to contain the Ebola outbreak and put necessary steps in place to address emerging threats in the future.
In November of that year, our company announced that we had licensed a vaccine candidate, originally engineered by the Public Health Agency of Canada, from NewLink Genetics Corporation.
Our decision was based on strong preclinical data in multiple animal models following a single dose of vaccine, and on in-house scientific expertise and know-how regarding the cell line used to manufacture the vaccine. Our rich history in vaccine clinical development and public-private partnerships, and our passion to do what we could to contain a rapidly emerging infectious disease epidemic and public health crisis, spurred a vaccine development effort that was unprecedented in terms of pace and partnerships, resulting in the availability of interim efficacy results within 10 months after the first Phase I clinical trial was started.
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), had been accepted for review by the World Health Organization (WHO).
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. In December 2016, The Lancet published final results of the 2015 Guinea Ebola study.12
In 2016, the U.S. FDA granted our Ebola vaccine candidate V920 Breakthrough Therapy Designation, and the EMA granted it PRIME (PRIority MEdicines) status.
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.
Through all of these efforts, we hope to expedite the development of a vaccine for Ebola and, if it is demonstrated to be efficacious and well-tolerated, to make it available to individuals and communities around the world at risk of Ebola Zaire virus infection.
PREVENTING FUTURE EPIDEMICS
On January 19, 2017, our company joined with world leaders and NGOs to announce the launch of the Coalition for Epidemic Preparedness Innovations (CEPI), a global coalition to create new vaccines for emerging infectious diseases.
An innovative public-private philanthropic partnership, CEPI was founded by the governments of India and Norway, the Bill & Melinda Gates Foundation, the Wellcome Trust and the World Economic Forum. Other partners include multinational pharmaceutical corporations—including MSD—and nongovernmental organizations (NGOs). CEPI is backed by the World Health Organization and Doctors Without Borders.
CEPI will support needed research and development of vaccines that could be deployed rapidly to contain outbreaks before they become global health emergencies.
Epidemics and pandemics in recent years have highlighted the extent to which infectious diseases threaten human life and health, and economic and social disruption. These outbreaks have exposed the shortcomings in the world’s capacity to prepare and respond. Ebola and Zika are the most recent examples; others include SARS, MERS, Chikungunya, Lassa and Nipah.
CEPI is potentially an evolutionary leap forward in how we collectively conduct R&D into infectious diseases that come and go, posing challenges for clinical trials, for manufacturing, and for just-in-time delivery.
Our company collaborates with organizations and local governments worldwide to help foster community access to HPV education, prevention, detection and early treatment.
By helping to raise awareness of the connection between HPV and cervical cancer, and by increasing access to cervical cancer screenings and other prevention programs, we aim to empower communities worldwide to reduce the burden of certain HPV-related cancers.
The year 2016 marked an important milestone in our ambition to help protect against cervical cancer and certain other HPV-related cancers and diseases. In 2006, the U.S. Food and Drug Administration (FDA) and several other regulatory bodies around the world approved the world’s first human papillomavirus (HPV) vaccine, GARDASIL. Ten years and over 200 million doses later, the impact of GARDASIL in real-world settings is becoming apparent following the introduction of government-funded HPV vaccination programs in 70 countries.13
In 2016, we were proud to provide support for the launch of India’s first government-funded HPV immunization program, in the state of Punjab. During the Phase I launch event, nearly 95 percent of the eligible population of girls were vaccinated with GARDASIL. This program represents important progress toward our goal of expanding global vaccine access.
In the same year, we saw the initiation of two new partnership programs featuring HPV vaccination, one in Haiti and the other in Peru. In Haiti, one of the poorest countries in the world, our company is collaborating with Zanmi Lasante in a two-year HPV vaccination program across three districts. The program is expected to vaccinate a total of 30,000 girls against HPV-related diseases. The first round of vaccinations, in mid-2016, achieved a coverage rate of over 95 percent. Health officials in Haiti plan to leverage the learnings from this program in the development of a national vaccination program.
In Peru, we are working with CerviCusco, Direct Relief, and the Peru Ministry of Health on an HPV vaccination program in Cusco. CerviCusco is a clinic for specialized medical care in the prevention and detection of cervical cancer in women from the underserved mountainous region of Cusco. As of early 2017, CerviCusco had begun vaccinating an expected total of over 32,000 persons with GARDASIL.
In addition to these two new programs, another 30,000 doses of GARDASIL were donated to the Ministry of Health in Zambia in an extension of its multiyear pilot program. Bolstered by the success of the pilot, Zambia is developing plans to expand it into a national HPV vaccination program with support from Gavi, the Vaccine Alliance.
Our Legacy of Initiatives to Increase Access to HPV Vaccine
Our company extends Gavi pricing for GARDASIL for 10 years to select Gavi-graduated countries.
We are awarded a significant portion of the UNICEF HPV vaccine tender, providing a sustained supply of GARDASIL to countries eligible to procure vaccines through Gavi.
Botswana, with support from the Pink Ribbon Red Ribbon partnership, begins a two-year HPV vaccination demonstration project to gain experience for a national HPV vaccination program.
In September 2012, the Republic of Uganda, through the Ministry of Health, with support from our company, announces the launch of a GARDASIL vaccination program. Through this agreement, the vaccination program is 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 represents the first phase of Uganda’s national rollout plan for HPV vaccination.
A young girl is vaccinated during the September 2012 phased launch of a national GARDASIL vaccination program in the Republic of Uganda.
Together with the Government of Rwanda and QIAGEN, N.V., we begin the first-ever national cervical cancer prevention program in sub-Saharan Africa. Over the three-year program, our company donates over 1.4 million doses of GARDASIL, and more than 96 percent of eligible girls receive all three doses in the first two years.
Also in 2011, our company announces plans to contribute $3 million to Pink Ribbon Red Ribbon to address both cervical and breast cancer in sub-Saharan African nations. Through this commitment, we work with Susan G. Komen for the Cure, government ministries of health and local partners to support the initiative in Zambia, Botswana, Tanzania and Peru. Learn more about PRRR here.
Initial activities include a donation of equipment to expand screen-and-treat services for cervical precancer in Tanzania, programs to raise 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 the provision of advanced surgical training to physicians in Zambia.
With support from the Australian Cervical Cancer Foundation (ACCF) and our company, Bhutan becomes the first developing nation in the world to implement a national cervical cancer vaccination program. In the first year of the six-year program, over 130,000 doses of GARDASIL donated by our company are administered, with approximately 90 percent of eligible 12–18-year-old females receiving all three doses. After the first year, ACCF provides financial support to the Royal Government of Bhutan to secure doses of GARDASIL at the access price offered by our company.
We announce a commitment to helping improve access to GARDASIL in developing countries by creating the GARDASIL Access Program (GAP) and donating the vaccine. By closeout of the program in 2015, over 1.3 million doses of GARDASIL have been donated to 31 GAP projects in 21 countries across the globe, providing helpful information about the feasibility of HPV vaccine delivery in developing-country settings.
Beginning in 2006, the first year of GARDASIL licensure, we partner with the international nonprofit organization PATH to provide GARDASIL for the conduct of post-licensure HPV-vaccine demonstration projects in Peru, Vietnam and India. GARDASIL is donated to vaccinate approximately 30,000 appropriate girls participating in the demonstration projects. The initiative was designed to strengthen the capacity of developing countries to help 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.
|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 April 2, 2017.|
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 63rd General Assembly, 2012, Bangkok, Thailand. https://www.wma.net/policies-post/wma-statement-on-the-prioritisation-of-immunisation/. Accessed April 2, 2017.
6. The College of Physicians of Philadelphia. The History of Vaccines. http://www.historyofvaccines.org/timeline#EVT_102212. Accessed March 19, 2017.
7. Obituaries – Maurice Hilleman. BMJ. 2005;330:1028. doi: https://doi.org/10.1136/bmj.330.7498.1028. Published April 28, 2005.
8. “The global distribution and burden of dengue.” Nature, 2013, Apr 25;496(7446):504–507. doi: 10.1038/nature12060. Epub 2013 Apr 7.
9. “Refining the global spatial limits of dengue virus transmission by evidence-based consensus.” PLoS Negl Trop Dis. 2012;6:e1760. doi: 10.1371/journal.pntd.0001760.
10. Some content for this section taken from Economic Outlook, Spring 2015. Premier.
12. "Efficacy and effectiveness of an rVSV-vectored vaccine in preventing Ebola virus disease: final results from the Guinea ring vaccination, open-label, cluster-randomised trial (Ebola Ça Suffit!).” Lancet, 2017;389:505–518. http://dx.doi.org/10.1016/S0140-6736(16)32621-6.
13. “Systematic Review of 58 Publications of Real-World Use of GARDASIL®,” presented at EUROGIN Congress. http://www.mrknewsroom.com/news-release/vaccine-news/systematic-review-58-publications-real-world-use-gardasil-presented-eurogi. Accessed April 3, 2017.