Merck manufactures vaccines against chickenpox and shingles, measles, mumps, rubella, Haemophilus Influenzae Tybe b (Hib), pneumococcal disease, hepatitis A and B, cervical cancer and rotavirus gastroenteritis. And our research continues. We see real opportunities for the future of vaccine discovery, development and distribution. We believe that advances in science will lead to new generations of vaccines, such as those that will combat HIV, just as vaccines eliminated small pox in the past century.

To improve the health care infrastructure needed to implement immunization programs, and to ensure that vaccines reach those who need them, especially in developing countries, we continue to develop novel business strategies and work with many partners in public/private collaborations.

Merck’s Vaccines

Merck makes 11 vaccines aimed at preventing a wide variety of diseases, particularly in children and adolescents. However, we have also begun to make vaccines for diseases that affect older people, such as shingles.

Vaccine	Disease Area
COMVAX® [Haemophilus b conjugate (meningococcal protein conjugate) and hepatitis B (recombinant) vaccine]	Heamophilus influenzae type b and hepatitis B
ZOSTAVAX® (zoster vaccine live)	Shingles
GARDASIL® [human papillomavirus quadrivalent (Types 6, 11, 16, and 18) vaccine, recombinant]	Cervical cancer, cervical lesions, vulvar lesions, vaginal lesions and genital warts caused by HPV types 6, 11, 16, 18
M-M-R® II (measles, mumps, and rubella virus vaccine live)	Measles, mumps, rubella (German measles)
PedvaxHIB® [Haemophilus b conjugate vaccine (meningococcal protein conjugate)]	Heamophilus influenzae type b
PNEUMOVAX® 23 (pneumococcal vaccine polyvalent)	Pneumococcal disease
ProQuad® (measles, mumps, rubella and varicella virus vaccine live)	Measles, mumps, rubella (German measles) and chickenpox
RECOMBIVAX HB® [hepatitis B vaccine (recombinant)]	Hepatitis B
ROTATEQ® (rotavirus vaccine, live, oral, pentavalent)	Rotavirus
VAQTA® (hepatitis A vaccine, inactivated)	Hepatitis A
VARIVAX® (varicella virus vaccine live)	Chickenpox

Merck is taking steps to expand access to two of our vaccines – GARDASIL and ROTATEQ – in the developing world.

Vaccines in the Developing World

A unique challenge in introducing new vaccines in resource-constrained settings is the need to demonstrate the feasibility of mass immunization among the targeted population and the public health benefit in terms of health and economic outcomes of immunization. This information is vital to countries' decision-making and prioritization-setting processes for scarce health resources – both financial and professional. Merck is pursuing a systematic and thoughtful approach to expanding access to ROTATEQ and GARDASIL in the developing world. (Developing World Backgrounder PDF*) Merck is carrying out a number of initiatives to demonstrate the public health impact of routine vaccination programs and to accelerate the introduction of vaccines in resource-poor countries.

In 2006, Merck introduced ROTATEQ, a vaccine against rotavirus, a disease whose effects kill nearly 600,000 children each year mainly in the developing world. As of June 2009, ROTATEQ was approved in 90 countries, 15 of which are GAVI eligible countries. Merck is sharing clinical data on ROTATEQ and rotavirus disease epidemiology — from studies conducted in 22 countries and in more than 80,000 infants and children — with health authorities, governments, nongovernmental organizations and physicians around the world.

Through a first-of-its-kind donation and partnership program launched in 2006, Merck introduced ROTATEQ in Nicaragua.  This program marked the first time there was access to a vaccine in the public sector of a developing country in the same year it was first licensed in a developed country.

Merck is continuing our research efforts in collaboration with the PATH Rotavirus Vaccine Program to study the safety and efficacy of ROTATEQ in Bangladesh, Vietnam, Ghana, Kenya and Mali. Through these studies, we hope to learn how factors such as poor nutrition and the presence of intestinal bacteria and viruses might play a role in recipient's response to the vaccine and better understand its efficacy and safety in developing world environments. Trials at all sites in Africa and Asia involve more than 7,500 infants. Trials are ongoing with results expected in late 2009.

In 2005, the World Health Organization (WHO) moved to recommend rotavirus vaccination as one of the core list of childhood immunizations. In late 2006, GAVI announced funding to make rotavirus vaccines available in the poorest countries of Latin America and Central and Eastern Europe; some countries in Latin America have begun to utilize GAVI funding for implementing rotavirus vaccination programs. In 2009, the Strategic Advisory Group of Experts (SAGE), the principal advisory group to the World Health Organization (WHO) for vaccines and immunization, recognized the importance of rotavirus vaccination and recommended the inclusion of rotavirus vaccination in all national immunization programs. Importantly, this includes countries in Asia and Africa, where these vaccines are needed the most. 

In 2006, Merck also introduced GARDASIL, a vaccine to prevent cervical, vulvar, and vaginal cancers, precancerous and dysplastic lesions; and genital warts caused by the Human Papillomavirus (HPV). Cervical cancer is the second most common cause of cancer death in women worldwide, resulting in nearly a half-million diagnoses and 250,000 deaths each year. Greater than 80 percent of these deaths are in the developing world where access to preventive screenings is often rare and a vaccine could make a measurable impact on women’s health. By the end of 2008, GARDASIL was approved in 109 countries, many under fast-track or expedited review, of which 23 re GAVI-eligible.

In 2007, Merck made a commitment to donate at least three million doses of GARDASIL over five years to support cervical cancer vaccination in lowest-income countries. The GARDASIL Access Program is made possible by a pledge from Merck and is managed by Axios Healthcare Development (AHD), a U.S. non-profit organization. For more information please click here.

Merck is also working with the Indian Council of Medical Research (ICMR) to study GARDASIL in underserved populations in India, a country that carries one fourth of the  world's cervical cancer burden. Cervical cancer is the most common form of cancer in Indian women.

Merck plans to study the immunogenicity and safety of GARDASIL in Sub-Saharan Africa. In addition, Merck is conducting studies with GARDASIL in special populations — including HIV-positive men and women — that may have relevance in the developing world. 

Merck is sharing clinical data on GARDASIL, HPV epidemiology and cervical cancer rates from studies done in 39 countries and more than 27,000 patients with health authorities, governments, nongovernmental organizations and physicians around the world. This information will help countries determine the priority that HPV disease and cervical cancer should have on their health agendas and to understand the need for improved infrastructure for prevention, screening and treatment.

In April 2009, The World Health Organization (WHO) published its official HPV Position Paper strongly supporting the introduction of HPV vaccines in all of its 193 member states. This comprehensive position paper from WHO underscores the crucial role HPV vaccination can play in helping to prevent cervical cancer and other HPV-related diseases. It marks a major advance in global health and a pivotal step forward for women everywhere.

In June 2008, the GAVI Alliance included HPV vaccines on its list of vaccines for potential future investment.

World Health Organization (WHO) Prequalification

Merck is committed to registering our vaccines worldwide — including in developing countries and all countries in which it conducts clinical trials — in an expedient and transparent fashion. Toward this end, we have set a goal to reduce the historic gap of 15-20 years between product introduction in developed and developing countries with each new vaccine we introduce. We also are developing benchmarks and metrics that can chart our progress toward accelerating access to new vaccines, particularly ROTATEQ and GARDASIL. It is important to recognize, however, that regulatory approval depends on local regulatory processes.

To increase the transparency of the Company's product registration status, we are disclosing the list of countries where ROTATEQ and GARDASIL are licensed every six months. Click below:

ROTATEQ ( PDF*)
GARDASIL ( PDF*)

WHO pre-qualification is an important step in Merck's access efforts. Merck received WHO pre-qualification for ROTATEQ in October 2008, MMR-II in December 2008 and GARDASIL in May 2009. WHO prequalification signifies  that vaccines meet the requirements of quality, safety and efficacy of UN agencies, including UNICEF and The Pan American Health Organization, and is an important step toward providing global access and ensuring that all vaccines — including Merck's — provided to developing countries are of the very highest quality.

Vaccine Pricing

In 2007, Merck's Executive Committee approved a new developing world pricing policy for Merck vaccines. Under the policy, the Company offers two of our vaccines — GARDASIL and ROTATEQ — in the developing world at prices at which we do not profit. This pricing is available to public sector markets in GAVI-eligible countries, which are among the world's least developed countries. We chose to prioritize access to these vaccines based on a comprehensive evaluation of our vaccine portfolio and on the developing world's needs, and after review of the public health priorities of international agencies such as the WHO. ROTATEQ and GARDASIL protect against diseases that contribute to the deaths of approximately 600,000 and 250,000, respectively, each year. We believe that our pricing approach will contribute to wider access to our vaccines, while taking into account Merck's need to continue to invest in vaccine research, development and production.

For more developed middle income countries, Merck will provide our vaccines at tiered prices based on countries' ability to pay.

Merck continues to seek novel ways to reduce the cost of its vaccines further in developing countries. One way is to partner with licensors to reduce or waive the royalty on vaccine doses sold in developing countries. In 2008, CSL Limited agreed to waive Merck’s royalties for sales of GARDASIL in the developing world to help expand access to GARDASIL. Merck believes that the decision of CSL to waive the royalties will result in lower prices and is an example of how industry partners can work together to develop sustainable solutions for vaccine access. We hope that other organizations that collect royalties on GARDASIL and ROTATEQ will also consider waiving royalties for doses provided to the developing world.

We are also pursuing manufacturing efficiences and exploring potential partnerships with low-cost manufacturers to bring down the cost of manufacturing our vaccines.

The content on this page was last modified on September 15, 2009.

Merck & Co., Inc., Whitehouse Station, NJ, USA, and Schering-Plough Corporation, Kenilworth, NJ, USA, are now one company. We have combined our global operations under the name Merck & Co., Inc. We are working to update our corporate responsibility Web site to reflect our new, combined, global organization.