Vaccines are one of the most valuable public health innovations of modern times, according to the WHO, the U.S. Centers for Disease Control and Prevention (CDC) and other leading health authorities.1, 2, 3, 4, 5
- Approximately 73 percent of our vaccines are now distributed outside the U.S., up from 28 percent in 2010
- Since the beginning of the latest Ebola outbreak in the Democratic Republic of the Congo (DRC), we have donated and shipped more than 250,000 doses of investigational vaccine to the World Health Organization (WHO) in support of outbreak response efforts
- As of April 2020, the vaccine has been approved in seven African countries, representing a historic moment for global public health and an unprecedented effort by a diverse set of partners from around the world
- Joined the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the George W. Bush Institute (Bush Institute) in the Go Further Partnership to end AIDS and Cervical Cancer among HIV-positive women in Africa
Vaccines are vital in the global fight against disease, eradicating smallpox and nearly eliminating other diseases like polio worldwide.2, 6 According to WHO, vaccines help prevent more than 30 infectious diseases and save two million to three 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
- 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 innovations 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, non-governmental organizations (NGOs), and a wide variety of stakeholders to build sustainable and effective vaccination programs that reliably reach people
Kenneth C. FrazierChairman and CEO
“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.”
Our company’s framework is one that allows the ongoing research, development and distribution of innovative vaccines that address important unmet health needs.
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. As we look to the future, we’re making investments in our pipeline and manufacturing capability to help protect one billion more lives by 2030.
As a company dedicated to saving and improving lives for more than 100 years, we have a special responsibility to help in the fight against COVID-19. MSD has been fully committed to developing an effective response to the COVID-19 pandemic since it was first recognized, and we know that success will require global collaboration among countries and companies and more.
In May 2020, we announced two COVID-19 vaccine development efforts—a collaboration with IAVI and plans to acquire Themis Bioscience, a company focused on vaccines and immune-modulation therapies for infectious diseases, including COVID-19. We also announced a research collaboration with Ridgeback Biotherapeutics to develop a novel oral antiviral candidate for the treatment of COVID-19.
Learn more about our response to COVID-19.
Research and development
We remain one of the few global companies dedicated to the complex business of researching and producing vaccines to help address the public health burden of infectious diseases and provide societal benefits for people around the world.
But inventing and developing vaccines is complex, time intensive and carries no guarantees. Doing so takes vast resources, investment and ingenuity. It takes active collaboration by tireless teammates who partner with governments, academic researchers, non-government organizations and others around the world.
Our company is working with several collaborators, including global and national health institutions, to develop vaccines that target diseases of global significance. These programs include respiratory syncytial virus (RSV) and cytomegalovirus (CMV).
We are also working to develop a vaccine to help prevent dengue fever. 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 four billion people live in the more than 140 countries where dengue transmission occurs.11
In 2014, we in-licensed the National Institutes of Health (NIH) live attenuated dengue vaccine candidate. NIH-sponsored Phase II clinical trials are ongoing, and Instituto Butantan is conducting a Phase III trial of their vaccine, which is based on the NIH parental strains. A Phase I company-sponsored clinical trial is also ongoing. In December 2018, the Company announced a collaboration with Instituto Butantan to support data sharing between the institutions in order to speed development of their respective dengue vaccine candidates.
In addition to engaging in new vaccine R&D, we are also innovating to improve the characteristics of our existing vaccines. This includes investing in improved production approaches, formulations, schedules and presentations. Efforts also focus on investigating opportunities to improve supply security, expanding the number of serotypes in our vaccines and evaluating the appropriateness of our vaccines for additional populations. This allows us to do more and have a greater public health impact than before.
MSD-Wellcome Trust Hilleman Laboratories
We are committed to discovering and developing new vaccines and helping expand global vaccination coverage by supporting efforts that contribute to more sustainable vaccination programs that expand access and uptake.
Inspired by the rich legacy and innovative spirit of Dr. Maurice Hilleman, we are proud to be engaging with the global health community in support of these objectives through the MSD-Wellcome Trust Hilleman Laboratories. This unique partnership was 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. The organization’s mission is to pursue innovation in vaccine science and technology that helps make access to vaccines more affordable and equitable in lower-income markets. Hilleman Laboratories specializes in early discovery and development science that if shown to have promise, finds expert partners to whom vaccine candidates can be transferred for further testing, registration and if approved, eventual manufacturing in support of supply to Gavi and others.
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, WHO, Gavi, UNICEF, vaccine manufacturers and others. Current program areas include working to innovate vaccines for cholera, shigella and meningitis that are more affordable and meet the needs of low-income country vaccination programs. Learn more about Hilleman Laboratories’ work at www.hillemanlabs.org.
Manufacturing and supply
In the last few years, countries around the world have enacted new or expanded vaccination programs. This has contributed to an unprecedented increase in global demand for vaccines.
We are committed to increasing our capacity and supply capability. We plan to invest $16 billion in capital projects over the next five years, with a significant portion dedicated to vaccines. In fact, in 2019, we supplied our highest ever quantity of vaccines globally.
We continue to invest in manufacturing and end-to-end supply improvements in both capability and capacity to help ensure a sustainable, reliable supply of quality and affordable vaccines to serve global needs.
Reliable and high-quality supply
Our manufacturing division continuously works to improve manufacturing processes and reduce operating costs 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.
We continue to explore potential strategic partnerships with other manufacturers to increase supply and promote greater access in local markets.
Registration and pre-qualification
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 pre-qualification so that our vaccines may be easily obtained and distributed to underserved areas of the world’s poorest countries. On November 12, 2019 we obtained WHO Prequalification for our Ebola virus vaccine.
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)12||ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)||M-M-R®II (Measles, Mumps & Rubella Virus Vaccine Live)||VARIVAX (Varicella Virus Vaccine Live)||ERVEBO (Ebola Zaire Vaccine, Live)|
|Product is WHO prequalified13||Yes||Yes||Yes||Yes||Yes||Yes|
|Date of prequalification||May 20, 2009||February 9, 2018||October 7, 2008||January 6, 2009||February 9, 2018||November 12, 2019|
|Approximate number of countries where product is registered (as of April, 2020)||133||83||127||75||78||38|
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 dual objectives: to expand access for people who can benefit from vaccination, and to ensure sufficient return on investment over time to support the complex and costly research, development, and manufacturing capacity necessary to create and supply new vaccines and address post licensure regulatory requirements.
We consider a variety of factors in arriving at a price in a given country, including the local burden of disease, the health 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, as well as its mechanism and policies for procuring vaccines. In addition, we work with governments to address affordability challenges and increase system efficiencies to support the sustainability of immunization programs.
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 GARDASIL at an access price that is significantly less than the value-based price in other countries. 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 GARDASIL through 2025 to Gavi-graduated countries with a per-capita gross national income (GNI) not exceeding $3,200. This action greatly assists Gavi-transitioned countries by facilitating access to these vaccines in those countries, while also making sure they remain affordable and sustainable in the long term. In the short period of time since we made our price commitment to countries transitioning out of Gavi support, six countries have taken advantage of the offer to introduce or continue existing national HPV vaccination programs.
We are working actively with Gavi, UNICEF, and WHO on an arrangement for supplying ERVEBO to help establish and build the world’s first global stockpile of Ebola virus vaccine. We also remain actively engaged with Gavi on policy efforts to improve access to vaccines in Gavi-transitioned countries. We believe that our pricing approach contributes to broader access to our vaccines while taking into account our need to continue investing in vaccine research, development and production.
Programs and initiatives
Our work to help address the Ebola virus disease
In response to the 2014 outbreak of Ebola in West Africa, we joined global health partners from across sectors in collaborative efforts to help develop an investigational vaccine against the Zaire Ebola virus disease. Today, we are closely working with global collaborators on our priorities of supporting pre-licensure preparedness and response through the availability of our investigational vaccine and planning for future, more permanent stockpiles comprised of licensed vaccine.
Since the beginning of the latest Ebola outbreak in the DRC, our company has donated and shipped more than 280,000 doses of investigational vaccine to WHO in support of outbreak response efforts. The investigational vaccine was used in accordance with locally approved clinical access protocols and WHO-guided immunization strategies. We continue to be humbled by the courage of everyone fighting to end this outbreak, particularly the Government of the DRC, the WHO and its Regional Office for Africa, community organizations, health care workers, and frontline responders, many of whom sacrificed their lives to save others.
Our company continues licensure efforts to enable more sustainable access of an Ebola virus vaccine to those who need it most. Based on data submitted for accelerated assessment in March 2019, in November 2019 the European Commission granted a conditional marketing authorization for active immunization of people 18 years of age or older to protect against Ebola Virus Disease (EVD) caused by Zaire Ebola virus. One day after receipt of the European Commission conditional marketing authorization, the WHO prequalified ERVEBO, stating that the vaccine meets the organization’s standards for quality, safety and efficacy.
On December 20, the vaccine was approved by the U.S. Food and Drug Administration (FDA) and on December 31, the vaccine was approved in the DRC. As of April 29, 2020, the vaccine has been approved in seven African countries. These approvals mark a historic moment for global public health and represent an unprecedented effort by a diverse set of partners from around the world.
In addition to our work toward development, licensure and sustainable manufacturing of a safe and efficacious Ebola virus vaccine, we have worked with partners to bolster in-country capacity in a number of African countries. These include efforts to effectively monitor adverse experiences following vaccination, building further confidence in vaccine safety information. We are also working closely with global partners to share our experience. Our company’s lessons learned could help the broader public health community be better prepared to mount effective responses against novel pathogens such as the ongoing SARS-CoV-2 pandemic. We are committed to using all available expertise to help improve the health and wellbeing of people everywhere.
Our work to address the burden of HPV related cancers and diseases
In recent years, there have been calls-to-action by WHO, the American Cancer Society (ACS) and National Cancer Institute (NCI)-designated cancer center to work toward the reduction and possible elimination of certain HPV-related cancers. While progress has been made in the fight against certain HPV-related diseases, more work is needed, as HPV-related cancers remain a significant public health burden for women and men. These are important steps toward a world where the number of women and men affected by certain HPV-related cancers is greatly reduced.
Addressing the burden of certain HPV-related cancers will require sustained commitment, coordinated research and action by multiple stakeholders. Dynamic efforts should include screening, prevention, treatment, infrastructure strengthening and surveillance and monitoring. Our company is committed to working with organizations and governments across the globe to support these goals.
As a result of the increased awareness of the burden of HPV-related cancers and diseases, HPV vaccine recommendations and goals have changed. Countries around the world have enacted new or expanded existing vaccination programs, which have created an unprecedented increase in global demand for vaccines, including our company’s vaccines. We are significantly ramping up our production capacity, utilizing contract manufacturing organizations for the first time ever and investing significantly in capital projects over the next five years, with significant funding dedicated to vaccine expansion. This investment and expansion further exemplify our company’s long-term commitment to support global public health.
Our commitment to expanding access and enabling vaccination to help protect eligible populations globally remains firm. Recognizing the disproportionate burden of disease in low- and mid-income countries, we plan to distribute a significant portion of our HPV vaccines to low- and middle-income countries, including non-Gavi countries, in 2020.
Despite the inherent complexity, long lead times and significant infrastructure required for vaccine development and manufacturing, our commitment to access for all stakeholders remains firm. Our company’s continued commitment to collaborate with stakeholders on expanding access, coupled with existing global partnerships, will enable equitable access to our HPV vaccines around the world.
Building confidence in vaccination
Vaccine hesitancy is a serious global health problem threatening the progress which has been made in combating the spread of many serious and preventable infectious diseases.
We are engaged in multi-level efforts to help rebuild confidence in vaccination and are working with a variety of partners. Our approach includes global, national and local engagement.
Globally, as we develop new vaccines, we think years ahead to anticipate and lessen hesitancy. For example, when conducting clinical trials to ensure safety and efficacy, we are considering the type of information people need to promote confidence and reduce hesitancy when these vaccines become available.
Nationally, we are working with partners to build strong and resilient immunization systems. We believe this is the key to sustaining high vaccination rates and helping communities prevent, manage and recover from hesitancy-related issues. For example, we are partnering with the WHO and Agence de Medecine Preventiave (AMP) to develop more robust vaccine safety surveillance and reporting in countries at high-risk for Ebola outbreaks. We are also supporting capacity building to anticipate and manage hesitancy issues in partnership with authorities. In India and Bolivia our company contributed to technical briefings and issues management workshops with scientists, government officials, implementing partners and key community leaders.
Locally, we are committed to supporting communities as we believe we have a role and responsibility to work alongside policy makers, health care providers, patients and our employees to enhance knowledge and capabilities about vaccines. In France we have joined a consortium of public and private sector stakeholders as part of the Immuniser Lyon initiative which aims to raise vaccination confidence in Lyon, France. Working with local and regional health agencies, health care professionals, hospitals, patients’ associations and the City of Lyon, our company encourages patients to discuss vaccination with their doctor.
Vaccinations role in mitigating antimicrobial resistance
We recognize the importance of vaccination as a complementary strategy in the fight against antimicrobial resistance (AMR).
Vaccines can play an important role in this process by:
- Preventing infections and reducing carriage and transmission of the AMR pathogen and,
- Reducing the presence of clinical symptoms, thereby reducing both appropriate and inappropriate antibiotic use
Our company is currently working to prevent such infections and thereby decrease AMR by responding to the call to develop innovative AMR-relevant vaccines and support the uptake of existing vaccines that could have an impact on AMR.
Currently, we are evaluating V114, an investigational 15-valent pneumococcal vaccine designed to protect against Streptococcus pneumoniae infection and expand coverage of two additional serotypes not covered by currently available vaccines. Universal coverage with a pneumococcal vaccine could avert up to 11.4 million days of antibiotic use per year in children younger than five years of age—a 47 percent reduction in the amount of antibiotics used to treat pneumonia caused by S. pneumoniae.
We are also working with government and non-governmental organizations to build strong vaccine ecosystems that ensure the broadest access to existing vaccines needed to combat AMR and facilitate rapid uptake when new AMR-relevant vaccines come to market.
Discovering, developing and distributing vaccines to address unmet health needs is complex and takes active collaboration within the global health community. Our company partners with governments, academic researchers and non-government organizations around the world, including:
MSD-Wellcome Trust Hilleman Laboratories
This unique partnership was founded in 2009 with co-funding from our company and Wellcome Trust, and is focused on pursuing innovation in vaccine science and technology that helps make access to vaccines more affordable and equitable in lower-income markets. Hilleman Laboratories does its work in strong collaboration with government and non-government organizations, spanning global public health, science, technology and the vaccine industry, including, for example, WHO, Gavi, UNICEF, vaccine manufacturers and others. Current program areas include working to innovate vaccines for cholera, shigella and meningitis that are more affordable and more suited to meet the needs of low-income country vaccination programs. Learn more about Hilleman Laboratories’ work at www.hillemanlabs.org.
Partnerships to increase access to our HPV vaccines
In Peru, we continue to work 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 late 2019, CerviCusco had nearly completed vaccinating an expected total of over 30,000 persons with GARDASIL.
Partnership to end AIDS and cervical cancer
In 2019, our company joined the U.S. President’s Emergency Plan for AIDS Relief (PEPFAR) and the George W. Bush Institute (Bush Institute) in the Go Further: Partnership to End AIDS and Cervical Cancer among HIV-positive women in Africa. The focus of the partnership is an accelerated strategy for prevention, screening and treatment, with the goal of significantly reducing HPV-related cervical cancer in HIV-positive women as well as nationwide cervical cancer rates in sub-Saharan Africa. As part of the partnership, our company will provide PEPFAR with HPV vaccine for use in a research study in a cohort of HIV-positive women.
Partnerships to support confidence in vaccination
MSD is supporting the WHO and local technical partners, such as the Agence de Médecine Préventive (AMP), to develop more robust vaccine safety surveillance and reporting in countries at high-risk for Ebola outbreaks. The project aims to identify gaps in collection, response and reporting of adverse events following immunization (AEFI) and to help countries monitor and respond to potential safety issues. As a result, this project seeks to improve the public’s confidence in vaccines and the health system that administers them. The project was completed in the Democratic Republic of the Congo, the Republic of the Congo, and the Central African Republic, and will be expanded to ten additional countries in the future.
In Tanzania, Senegal, Uganda and Cote d’Ivoire, the AMP-Afrique Training in Vaccine Hesitancy initiative supported by MSD seeks to build capacity of health professionals and civil society organizations to address vaccine hesitancy. Two-day training workshops on vaccine hesitancy were held in each country to help establish the causes of vaccine hesitancy and to identify actions that would help to build vaccine confidence.
In the U.S. our company was a founding member of an industry coalition led by the Biotechnology Industry Organization (BIO), with the goal of empowering state coalitions to build and support sustainable advocacy efforts to combat vaccine hesitancy. As part of this effort, we supported research to help identify key vaccination advocates and develop appropriate metrics to track program progress, including changes in the legislative environment and attitudes toward vaccination requirements. Initial program results in the U.S. (Oregon, Oklahoma, Idaho and Texas) suggest that strong state coalitions can positively influence public confidence in vaccination.
Our company partners with the Global Parliamentary Alliance on Rights, Health & Development to give political leaders the information they need to develop policies to improve access to vaccination for all. To date, the partnership, which is part of a program supported by the World Health Organization, Bill & Melinda Gates Foundation and the United Nations Population Fund, successfully educated parliamentarians through forums held in Africa, Asia and Europe with plans to expand into Latin America in the future.
- Agence de Medecine Preventiave (AMP)
- Direct Relief
- Gavi, The Vaccine Alliance
- George W. Bush Institute (Bush Institute)
- Government of the Democratic Republic of the Congo (DRC)
- MSD-Wellcome Trust Hilleman Laboratories
- Peru Ministry of Health
- U.S. President’s Emergency Plan for AIDS Relief (PEPFAR)
- World Health Organization (WHO)
Key accomplishments and milestones in 2019 include:
The total number of doses of our vaccines that have been distributed has increased significantly since 2010 and our global reach has also increased dramatically: in 2019, approximately 73 percent of our vaccines were distributed outside the U.S., up from 28 percent in 2010.
More than 56 million doses of 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 2019. This represents important progress toward ensuring that these vaccines reach people in low-income settings with a high burden of disease.
In 2019, we made significant progress in our efforts to help address Ebola virus disease. Based on data submitted for accelerated assessment in March of 2019, in November 2019 the European Commission granted a conditional marketing authorization for active immunization of people 18 years of age or older to protect against Ebola Virus Disease caused by Zaire Ebola virus. One day after receipt of European Commission conditional marketing authorization, WHO prequalified ERVEBO, stating that the vaccine meets the organization’s standards for quality, safety and efficacy.
On December 20, the vaccine was approved by the U.S. FDA and on December 31, the vaccine was approved in DRC. As of April 29, 2020, the vaccine has been approved in seven African countries. These approvals mark a historic moment for global public health and represent an unprecedented effort by a diverse set of partners from around the world.
- Fortune: 2018 Change the World Issue
- TIME: The 50 Genius Companies in 2018
- NPR: The Decade in Global Health: New Drugs, Faster Trials, Social Media to the Rescue
- The Washington Post: 19 good things that happened in 2019
- Smithsonian Magazine: The Top Ten Scientific Discoveries of the Decade
- National Geographic: These are the top 20 scientific discoveries of the decade
- Foreign Policy: 10 Important Stories You Might Have Missed in 2019
|1WHO, 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.|
2Centers for Disease Control and Prevention. Ten Great Public Health Achievements—United States, 2001–2010. Morb Mortal Wkly Rep. 2011;60(19):619–623.
4Centers 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.
5World 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.
6WHO. Poliomyelitis. Fact Sheet No 114. http://www.who.int/mediacentre/factsheets/fs114/en/. Accessed April 4, 2018.
7WHO. Immunization Coverage Fact Sheet. http://www.who.int/mediacentre/factsheets/fs378/en/. Accessed April 4, 2018.
8The College of Physicians of Philadelphia. The History of Vaccines. http://www.historyofvaccines.org/timeline#EVT_102212. Accessed March 19, 2017.
9Obituaries—Maurice Hilleman. BMJ2005;330:1028. https://doi.org/10.1136/bmj.330.7498.1028. Published April 28, 2005.
10The global distribution and burden of dengue.” Nature, 2013, Apr 25;496(7446):504–507. doi: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.
12Not currently available through UNICEF procurement; awaiting Vaccine Vial Monitor (VVM).