Vaccines

Vaccines

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

Vaccines are vital in the global fight against disease, eradicating smallpox and nearly eliminating other diseases like polio worldwide.2, 6 According to the World Health Organization, vaccines help prevent more than 30 infectious diseases and save 2 to 3 million lives globally each year.1, 7

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.8

In that time, our company has been home to some of the 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.9

 

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.

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 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 Approach

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.10 Nearly 4 billion people live in the more than 140 countries where dengue transmission occurs.11 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.

IMPROVING VACCINES

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.

For example, in 2016, our company received WHO Prequalification for GARDASIL® [Human Papillomavirus Quadrivalent (Types 6, 11, 16 and 18) Vaccine, Recombinant], in “Controlled Temperature Chain” (CTC) environment. This was granted after we conducted a thorough clinical assessment of the vaccine thermostability. The CTC allows vaccines to be kept at temperatures outside of the traditional cold chain of +2°C to +8°C for up to three days under monitored and controlled conditions. This CTC compatibility improves the programmatic suitability in areas where cold chain infrastructure is the weakest.

MSD-Wellcome Trust Hilleman Laboratories

We are committed to increasing global vaccination coverage and supporting sustainable vaccination programs that expand access and uptake. Certain product attributes can make it easier for public health systems to manage vaccination programs 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 a research and development center focused on enabling increased immunization rates through innovative vaccine science and technology that can help improve the design and affordability of vaccines for lower-income settings (including countries eligible for support from Gavi, the Vaccine Alliance).

Hilleman Laboratories’ current portfolio consists of pursuing vaccine development to combat two high-burden, life-threatening diseases—diarrhea and bacterial meningitis. For protection against diarrhea, Hilleman Laboratories is testing innovations to help improve vaccine implementation of lyophilized vaccines, pursuing development of an affordable cholera vaccine in support of global cholera prevention and control, and researching vaccines against other 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 government and non-government organizations, spanning global public health, science, technology, and the vaccine industry, including, for example, the World Health Organization, Gavi, UNICEF, vaccine manufacturers, and 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.

As part of our long-term strategy to reach more people around the world with our vaccines, 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 increased significantly since 2010. And over the past eight years, our global reach has also increased dramatically: In 2017, approximately 65 percent of our vaccines were distributed outside the U.S., up from just 28 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 31 million doses of just two of our vaccines—GARDASIL and ROTATEQ® (Rotavirus Vaccine, Live, Oral, Pentavalent)—have been distributed in Gavi-eligible countries through 2017. Today, 28 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 helped to mobilize funding and technical support to enable the successful introduction of underused vaccines in the world’s poorest countries.

RELIABLE AND HIGH-QUALITY SUPPLY12

Our manufacturing division has undertaken an ambitious program to reduce the cost of production by increasing efficiency, minimizing procurement spending and improving supply performance.

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. Learn more.

MANUFACTURING PARTNERSHIPS

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 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 AND 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.

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] GARDASIL®9 (Human Papillomavirus 9-valent Vaccine, Recombinant)13 RotaTeq® (Rotavirus Vaccine, Live, Oral, Pentavalent) M-M-R®II (Measles, Mumps & Rubella Virus Vaccine Live) VARIVAX® (Varicella Virus Vaccine Live)
Product Is WHO Prequalified14Yes Yes Yes Yes Yes
Date of PrequalificationMay 20, 2009 February 9, 2018 October 7, 2008 January 6, 2009 February 9, 2018
Approximate Number of Countries Where Product Is Registered (as of Q1 2017) 130 70 120 70 60

PRICING

Our company works with governments, international health and development organizations, donor groups, 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.

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 collaborative efforts to help develop an investigational vaccine against Ebola virus disease.

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 rich history in vaccine clinical development and public-private partnerships, and our commitment to respond to unmet health needs, positioned us well to join a vaccine development collaboration that resulted in the availability of interim Phase III efficacy results in humans 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 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 the final results of the 2015 Guinea Ebola study.15

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 planning to file regulatory applications for V920 with the European Medicines Agency (EMA) and the FDA in 2019.

If the vaccine is licensed, we are committed to making the vaccine available to Gavi-eligible countries at the lowest possible access price. In the meantime, our company maintains supply of the investigational vaccine in collaboration with the US Government, the WHO, and Gavi. This investigational vaccine can be used in emergency situations under a clinical access protocol at the request of relevant authorities and with appropriate regulatory frameworks in place─as was done in the May 8–July 24, 2018, outbreak in the Equateur Province of the Democratic Republic of the Congo (DRC) and again in the North Kivu outbreak in the DRC that began on August 1, 2018.

2018 Fortune Change the World List

Our company is proud to be ranked number two on Fortune Magazine’s 2018 “Change the World” list for our work in Ebola in partnership with the global health community and affected countries.

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 NGOs. CEPI is backed by WHO 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.

Cervical Cancer

Our company collaborates with organizations and local governments worldwide to help foster community access to HPV education, prevention, detection and early treatment.

In 2017, partnership programs to improve access to HPV vaccination continued in Haiti and 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 nearly 30,000 girls against certain HPV-related cancers and diseases. Vaccinations completed in 2016 to 2017, achieved a coverage rate of >93 percent for two doses.

To complement these efforts in Haiti, in early 2018 the St. Boniface Haiti Foundation initiated a school-based HPV vaccination program with donated doses of GARDASIL. This program is expected to vaccinate up to 5,000 girls in Haiti through 2019. And, in combination with the program being conducted by Zanmi Lasante, 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 2018, CerviCusco had nearly completed vaccinating an expected total of over 30,000 persons with GARDASIL.

In addition, Zambia, which received a donation of 30,000 doses of GARDASIL in 2016, was able to leverage the experience gained and was approved in late 2017 for a national HPV vaccination program with Gavi support.

Our Legacy of Initiatives to Increase Access to HPV Vaccine

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.

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.

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.

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.

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

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.

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.

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.

Our company extends Gavi pricing for GARDASIL for 10 years to select Gavi-graduated countries.

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. WHO. Poliomyelitis. Fact Sheet No 114. http://www.who.int/mediacentre/factsheets/fs114/en/. Accessed April 4, 2018.
7. WHO. Immunization Coverage Fact Sheet. http://www.who.int/mediacentre/factsheets/fs378/en/. Accessed April 4, 2018.
8. The College of Physicians of Philadelphia. The History of Vaccines. http://www.historyofvaccines.org/timeline#EVT_102212. Accessed March 19, 2017.
9. Obituaries—Maurice Hilleman. BMJ. 2005;330:1028. doi: https://doi.org/10.1136/bmj.330.7498.1028. Published April 28, 2005.
10. “The global distribution and burden of dengue.” Nature, 2013, Apr 25;496(7446):504–507. doi: 10.1038/nature12060. Epub 2013 Apr 7.
11. “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.
12. Some content for this section taken from Economic Outlook, Spring 2015. Premier.
13. Not currently available through UNICEF procurement; awaiting Vaccine Vial Monitor (VVM).
14. https://extranet.who.int/gavi/PQ_Web/Browse.aspx?nav=3.
15. "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.