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 WHO, vaccines help prevent more than 30 infectious diseases and save 2–3 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
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.
“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.”
– Ken 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.
- 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 and nongovernmental organizations (NGOs) to build sustainable and effective vaccination programs that reliably reach people
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 global 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.
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 and non-government organizations around the world.
Our company is working with a number of collaborators, including global and national health institutions, to develop vaccines that target diseases of global significance, such as pneumococcal disease, respiratory syncytial virus (RSV), cytomegalovirus (CMV) and Ebola virus disease.
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 4 billion people live in the more than 140 countries where dengue transmission occurs.11 In 2014, we in-licensed the 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, 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 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 whose mission is to pursue innovation in vaccine science and technology that helps make access to vaccines more affordable and equitable in lower-income markets. It 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 more suited to meet the needs of low-income country vaccination programs. Learn more about Hilleman Laboratories’ work 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 ensure a sustainable, reliable supply of quality and affordable vaccines to serve global needs.
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. At the same time, the number of vaccine manufacturers has remained the same, and some have stopped production of certain vaccines, creating additional needs for supply.
We are committed to meeting this increased global demand for our vaccines, and we are significantly ramping up our production capacity to do so. We plan to invest $16 billion in capital projects over the next five years, with a significant portion dedicated to vaccines. In fact, we are already supplying vaccines at our highest-ever annual production rate.
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 2018, approximately 69 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 40 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 2018.
Reliable and high-quality supply
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.
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 increase supply and promote greater access in local markets. We have a long history of progress in this area, dating back to our licensing of hepatitis B technology to manufacturers in China in the 1990s.
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)12||ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent)||M-M-R®II (Measles, Mumps & Rubella Virus Vaccine Live)||VARIVAX (Varicella Virus Vaccine Live)|
|Product is WHO prequalified13||Yes||Yes||Yes||Yes||Yes|
|Date of prequalification||May 20, 2009||February 9, 2018||October 7, 2008||January 6, 2009||February 9, 2018|
|Approximate number of countries where product is registered (as of Q2 2018)||136||78||126||74||71|
In February 2018, VARIVAX® (Varicella Virus Vaccine Live) was the first varicella vaccine to receive World Health Organization (WHO) prequalification, making it eligible for procurement by the United Nations Children’s Fund (UNICEF) and other United Nations agencies for use in national vaccination programs.
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 for people who can benefit from 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 and address post-licensure regulatory requirements as well as the manufacturing capacity needed to supply them.
We consider a variety of factors in arriving at a price in a given country, including public health need and 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, 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 value-based price of these vaccines in other 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 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. 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. 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.
As mentioned in WHO’s Top 10 Health Threats 2019, vaccine hesitancy threatens to reverse progress made in tackling vaccine-preventable diseases. Vaccination is one of the most cost-effective ways of avoiding disease—it currently helps prevent 2–3 million deaths a year, and a further 1.5 million could be avoided if global coverage of vaccinations improved.
Responding to present and future epidemics
In response to the 2014 outbreak of Ebola in West Africa, we joined our global health partners from across sectors in collaborative efforts to help develop an investigational vaccine against the Zaire Ebola virus disease. Five years later, our company’s commitment to innovatively work with a diverse set of partners to provide supply of the investigational Ebola Zaire vaccine as part of international response efforts to address Ebola outbreaks remains steadfast.
Since the beginning of the latest Ebola outbreak in the Democratic Republic of the Congo (DRC), the company has donated and shipped hundreds of thousands of doses of investigational vaccine to WHO in support of current outbreak response efforts. We are deeply humbled by our collaboration with partners on the ground working to stop this outbreak amidst an ever-evolving context. To better support these ongoing response efforts in the DRC and neighboring countries, We have decided to expand emergency-use replenishment plans. Our company believes that this decision reaffirms our commitment to do the best it can to accelerate the availability of investigational Ebola vaccine supply.
In addition to working toward an increased stockpile of investigational Ebola vaccine, our company is making progress with regulatory submissions to obtain licensure to enable more sustainable access of an Ebola vaccine to those who need it most. Efforts to develop a vaccine against Ebola Zaire disease is a testament to the power of innovation and public-private partnerships, and we will continue to support this endeavor.
The Ebola virus outbreaks and other recent epidemics and pandemics have highlighted the extent to which infectious diseases threaten human life and health and lead to 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 pathogen examples; others include SARS, MERS, Chikungunya, Lassa and Nipah.
In addition to our work toward development, licensure and sustainable manufacturing of a safe and efficacious Ebola Zaire vaccine to add to the toolbox of Ebola response efforts, we are 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 keep disease outbreaks from becoming epidemics or pandemics in the future and to mount effective responses against novel pathogens. We are committed to using all its available expertise to help improve the health and well-being of people everywhere.
Over the last year, calls-to-action have been set forth by the World Health Organization (WHO), the American Cancer Society (ACS) and National Cancer Institute (NCI)-designated cancer centers to work toward the reduction and possible goal of elimination of certain HPV-related cancers. While progress has been made in the fight against certain HPV-related diseases, more work needs to be done as HPV-related cancers remain a significant public health burden in women and men. These efforts 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 and coordinated research and action across multiple stakeholders and 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, and 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 a sizable portion dedicated to vaccine expansion. This investment and expansion represents another example of 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 mid-income countries, including non-Gavi countries, in 2019.
Additionally, we continue to work in partnership with stakeholders on programs to support increased access to our vaccine. For example, 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 achieved more than 93 percent vaccination among 5,000 girls 9–13 years of age, living in hard-to-reach areas. And, in combination with the program being conducted by Zanmi Lasante, a nonprofit health care organization, 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.
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.
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 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 an exploratory research study in a cohort of HIV-positive women in Eswatini and Namibia.
|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. BMJ2005;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: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).