Attacking a Potential Killer of Children

Helping to Improve Children’s Health in Nicaragua: The Merck-Nicaraguan Ministry of Health RotaTeq® Partnership.

For millions of children living in the developing world, the first few years of life can be a struggle just to survive, due in large part to the threat of a handful of diseases that have been eradicated or are easily treatable in the developed world. Such is the case with rotavirus, a severe, acute form of gastroenteritis characterized by vomiting, watery diarrhea, and fever. Infection may result in dehydration, hospitalization, and/or death. Prior to vaccine introduction, it was estimated that worldwide more than 527,000 children less than five years of age died each year from rotavirus; more than 80 percent of those deaths occurred in developing countries.

In 2006, the healthcare company Merck (outside the United States and Canada known as MSD) introduced RotaTeq® – its live oral pentavalent rotavirus vaccine – in the United States. Merck recognized, however, that this vaccine was most needed in the developing world, where the introduction of new vaccines has traditionally lagged behind developed countries by 15 to 20 years.

“We knew that the developing world could not wait 20 years for this vaccine, and recognized – thanks to new funding sources such as the GAVI Alliance – that it could realize its goal to shorten the time for vaccine introduction,” says Dr. Mark Feinberg, Chief Public Health Officer at Merck.

With this benefit in mind, Merck sought to introduce RotaTeq® soon after its US introduction in a developing country with a high rotavirus disease burden and a strong immunization program. Nicaragua, one of the poorest countries in Latin America, fit those criteria. In 2005, Nicaragua experienced one of its largest gastroenteritis outbreaks, with more than 64,000 individuals affected and more than 56 deaths. Disease occurred predominantly in children under five years of age, and 67 percent of the gastroenteritis was identified as rotavirus.

Nicaragua benefited from a good infrastructure for vaccine storage and delivery and had vaccination rates of 87–99 percent for routine childhood vaccines – equal to or better than the rates in some developed countries. Nicaragua also was one of 72 countries eligible for funding through the GAVI Alliance, which supports the purchase of new vaccines for low-income countries to help meet the UN Millennium Development Goals.

The only problem was that Nicaragua could not afford the new vaccine, which could address an urgent public health need.

After more than a year of discussions, the Merck-Nicaraguan Ministry of Health RotaTeq® Partnership was announced in September 2006. Merck pledged to donate enough rotavirus vaccine for three birth cohorts of children – or roughly 150,000 children every year for three years. Every eligible child would receive a three-dose regimen of RotaTeq® as part of Nicaragua’s routine national vaccine program.

Merck also provided funding to help Nicaragua introduce the vaccine, improve disease awareness, develop appropriate educational materials about the vaccine, and update the routine vaccination card. The company also provided technical and financial assistance to assess the impact of the vaccine on rotavirus disease. The major goal of the project was not only to successfully introduce another vaccine into Nicaragua’s standard childhood vaccination schedule, but also to demonstrate the reduction in this potentially life-threatening disease and transition the program from a Merck-supported effort to an independent and sustainable program.

Over the next three years, Merck donated more than 1.3 million doses of RotaTeq® to Nicaragua, vaccinating more than 90 percent of infants with all three doses. The key measures used to assess the impact of the vaccine were an enhanced rotavirus surveillance system to identify any cases of rotavirus and a study to estimate vaccine effectiveness. Data revealed a major reduction (58 to 73 percent) in severe rotavirus cases in Nicaragua within the first year of the vaccine being routinely administered. In December 2009, financial support for the project was transitioned to GAVI. Today – one year after the project ended – Nicaragua continues to routinely vaccinate all children against rotavirus with vaccine purchased by GAVI.

The success of the project was due to many factors and partners.

The Nicaraguan Ministry of Health was acutely aware of the significant morbidity and mortality associated with rotavirus and recognized the urgency of providing their children with rotavirus vaccine. Merck and the Ministry of Health worked closely together in training more than 200 physicians and health workers in Nicaragua about the safety and efficacy of the vaccine, the proper age of administration for each vaccine dose, and storage and handling of the vaccine. Epidemiologists from both organizations worked to develop study protocols to strengthen the country’s disease surveillance network and to assess the impact of the vaccine.

The involvement of NGOs and multilateral organizations also was critical. The Pan American Health Organization (PAHO), the US Centers for Disease Control and Prevention (CDC), PATH – an international nonprofit organization focused on health issues – and several local NGOs became strong supporters.

Importantly, all partners recognized from the beginning the importance of ensuring long-term sustainability of vaccine funding.

Nicaragua was the first GAVI-eligible country to introduce a new vaccine in the same year that it was licensed and introduced in the United States. The country has benefited from the introduction of rotavirus vaccine not only through reduction in rotavirus disease, but also by strengthening its vaccine infrastructure, its research capabilities, and identification of a sustainable vaccine financing mechanism.

According to Feinberg, “The pharmaceutical industry has a long history of product philanthropy, launching multi-year donation programs, and donating its time and resources for capacity-building purposes to those in need. While philanthropy will continue to play an important role, many in the industry are starting to recognize the value in identifying areas where the company can make a difference through its core business and by aligning with the Principles of the UN Global Compact.”

The Merck-Nicaraguan Ministry of Health RotaTeq® Partnership is such an example.