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Questions & Answers
The UNICEF/BD Partnership Calls for a "High Risk" Approach
Some In-Country Activities
Staff at UNICEF

Questions & Answers

In fact, governments of the world declared the elimination of neonatal tetanus a priority goal at the 1990 World Summit for Children. In the spring of 1998, BD and UNICEF announced the creation of the Partnership for Maternal and Child Health (the "Partnership") – a public-private partnership to advance the elimination of maternal and neonatal tetanus (MNT) worldwide. The disease, often known as the "silent killer", affects newborns delivered at home, under unsanitary conditions in remote villages. Pregnant women are also 'at-risk' if deliveries or other medical procedures are conducted amidst unhygienic conditions. Stricken infants die within 4-7 days of infection, usually within the first 3 weeks of life. Many of these deaths occur even before their birth can be officially recorded. During 1998 it was estimated that 215,000 newborns and 30,000 women died from MNT. The Partnership recognizes the need to invite additional partners to collaborate on the effort to fulfill its potential. The collective strengths of many partners will ensure millions of women around the globe will be immunized, protecting them and their children.

What is tetanus / MNT?
Tetanus is caused by a bacteria, c. tetani, and commonly found in soil, dust and animal feces. MNT is often caused by unclean birthing practices, such as using unsterile instruments and dressings when performing obstetrical procedures and cutting umbilical cords.

Tetanus is a painful disease, causing lockjaw, muscle stiffness, fever and spasms. The fatality rate is very high – ranging from 70% to 100%, depending on the access to healthcare.

What are the goals of the Partnership?
The goals of the Partnership include:

1. To eliminate* MNT world-wide by the year 2005.
2. To promote safe injection practices worldwide.

*Eliminate is defined as less than 1 case per 1000 live births in every district of every country every year.

In order to achieve the goals, the Partnership endeavors to elevate awareness of MNT as a public health problem and mobilize needed resources to address it.

Who are the partners of the initiative to date?
The Partnership fosters an environment which draws on the strengths of its many partners and supporters. These include: BD (Becton Dickinson), United Nations Children's Fund (UNICEF), the US Fund for UNICEF, the Program for Appropriate Technology in Health (PATH), the United States Agency for International Development (USAID), the United Nations Population Fund (UNFPA) and the World Health Organization (WHO). Additionally, a coalition of bi-lateral and multi-lateral organizations, Non-Governmental Organizations (NGOs) and others who support the goals of eliminating MNT and promoting safe injections play a role in this private-public partnership. Recently the Gates Foundation provided a grant to the US Fund for UNICEF in support of the MNT program.

Originally, BD committed a one million dollar cash donation as well as a three million dollar donation of product, equipment and technical assistance to the effort. As a result of this initial grant, a five year global plan for the elimination of MNT was developed. It called for a high-risk approach targeting the 27 countries that account for over 90% of the cases of MNT reported worldwide. BD has since expanded its commitment to donate auto-disable syringes and devices through an innovative agreement with UNICEF that will touch the lives of millions of women. The two BD products which will be used are the BD UniJect™ pre-filled injection device and the BD SoloShot™ auto-disable syringe.

BD is firmly committed to the UNICEF/ WHO guidelines to ensure safe immunization practices, and also will provide the expertise of BD people around the globe to assist the initiative in its efforts to reach the most inaccessible women and children in the world with this life-saving program.

What are the components of the five-year global plan?
The plan calls for the implementation of a high-risk strategy. High-risk districts are defined as areas where the reported or estimated annual incidence of neonatal tetanus exceeds one case in one thousand live births, or where less than 80% of all women of child-bearing age have received two doses of tetanus vaccine. A high risk area would also include districts where no data is available.

Essential to success of the global action plan is the local development of national plans within existing high-risk areas. Immunization against MNT and health education campaigns must address the integration of this initiative with other primary health care efforts. Additionally, plans will outline the local capacity to implement three properly-spaced rounds of tetanus toxoid immunization and a commitment to safe injection practices through appropriate technology.

Essential elements of the global plan include:

• Identification of all districts in 57 countries at risk for MNT;
• Immunization of more than 100 million women of childbearing age with three rounds of tetanus toxoid vaccine;
• Improvement of birth delivery practices through education and the provision of disposable delivery kits;
• Documentation of achievements;
• Improvement of immunization services, community surveillance and school immunization programs.

What financial challenges need to be surmounted in order to implement the global plan?
Between the years 2000 and 2005 a fundraising goal of about $100 million is set to reach the 100 million women at risk in 57 countries. Administering the three doses of tetanus toxoid vaccine that are needed to prevent MNT costs about $1.20 for each woman, including funds to teach and promote clean birthing practices. The $100 million total does not reflect the total cost of the initiative and participating governments will be major partners in providing further resources.

In addition to the development of the five-year global elimination plan, what other progress has the Partnership already made?
As of 12/99, there are 6 countries which have benefited from the Partnership. These countries have been able to implement activities that further the Partnership goals, either through direct program activities, research on safe injection practices or strengthened surveillance systems used to identify MNT cases regionally. These countries are: China, Bangladesh, Indonesia, Vietnam, India, and Ethiopia. Additionally, studies were conducted in Brazil.

Also, UNICEF, with technical assistance from PATH, selected Biofarma, the Indonesian national vaccine manufacturer, as the tetanus toxoid vaccine producer to fill donated BD UniJect™ devices with vaccines for use in this program. Biofarma will donate 9 million vaccine doses to the Partnership program. The BD UniJect™ pre-filled injection device is the company's newest auto-disable technology developed specifically to ensure safe immunization practices. The BD UniJect™ device incorporates several safety features, including a one-way valve that prevents reuse. It is revolutionizing vaccine delivery by providing increased safety and expanded use due to its simplicity and low cost. It was initially designed by PATH, a non-profit, non-governmental international health organization, with support from USAID. Filled BD UniJect™ devices will become available to the Partnership during the year 2000.

An additional BD Global Health Fund grant supports the staffing of an associate at Columbia University through a fellowship in international and public health. This officer is seconded to UNICEF to work directly on the Partnership activities and acts as liaison among and between the partners of the project.

A working group on safe disposal issues has been identified among the members of the Partnership and will soon begin preliminary meetings to identify problems and possible solutions.

The program plan calls for the institution of a program review committee to be composed of experts in the fields of MNT and safe injections. Intended to provide technical assistance and guidance to the program, this committee is currently being formed.

Also, BD is a SIGN associate sharing with other stakeholders a common interest in the safe and appropriate use of injections.

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The UNICEF/WHO/UNFPA Strategy Calls for a "High Risk" Approach to Eliminate Maternal and Neonatal Tetanus (MNT)

The strategy calls for a high-risk approach to be implemented in 57 countries. It focuses on providing 3 rounds of tetanus toxoid vaccine to all women of childbearing age and promoting clean birthing practices through health education in the areas identified as "high risk". Countries routinely immunize women and children against diseases and the MNT program intends to build upon and strengthen these existing efforts.

Also, UNICEF will particularly focus MNT elimination activities in the 27 countries where 90% of the world's cases occur using this high risk approach. MNT can be found primarily in areas where most women do not have access to routine immunizations, skilled birth attendants and antenatal care services. By targeting high risk areas, UNICEF employs a practical, cost effective and sustainable way to eliminate MNT and improve clean delivery practices.

Each nation's plan will be developed at the country level by the Ministry of Health* with input from partners in-country such as the United Nations Children's Fund (UNICEF), the World Health Organization (WHO), the United Nations Population Fund (UNFPA) and Non-Governmental Organizations (NGOs) conducting health programs.

To date the 27 highest-risk countries are:

* For countries with no plan to eliminate the disease, UNICEF will provide technical assistance to promote and develop national and district micro-plans.

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In-Country Activities

January 2000, 6 countries have implemented activities to further the goals of the Partnership through direct program activities (among them MNT vaccination campaigns and training) and strengthening surveillance systems to identify MNT cases regionally. These include: China, Bangledesh, Indonesia, Vietnam, India, and Ethiopia. Additionally, studies and research on safe injection practices were conducted in Brazil with the Pan American Health Organization (PAHO) and the World Health Organization (WHO).

In Vietnam, reusable and disposal syringes are used for routine EPI (Expanded Program on Immunization) activities at the health centers. For the first time in Vietnam's EPI history, auto-disable syringes were used when conducting MNT elimination activities in 2 districts, vaccinating over 40,000 women.

Monitoring and evaluations are critical if countries are to reach the MNT elimination goal of less than one case per 1,000 live births in every district, every year. In Bangladesh and China, effective surveillance of MNT is required in order to identify high-risk districts in those countries and to plan elimination activities in those areas. In Bangladesh, evaluation of previous MNT campaigns, targeting nearly 8 million women, were conducted by reviewing hospital-based records at sentinel sites and lot-quality assessment surveys. China is developing a monitoring and reporting system in 37 counties in 5 provinces – including training and procurement of project equipment to track MNT cases.

Brazil, in collaboration with the PAHO and WHO, has completed a study on injection safety in several states in the country. The study is being used in guiding regional policy on future immunization campaigns.

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Ethiopia, one of the poorest countries in the world, has a population of nearly 60 million and one of the highest infant mortality rates in the world: 114 deaths out of every 1,000 live births. Ethiopia first used auto-disable syringes to conduct a critical measles campaigns, an approach recommended by WHO because of that country's extremely low vaccine coverage and susceptibility to outbreaks. The Ministry of Health (MOH) plans to expand the measles campaign this year, as well as target one MNT high risk district with tetanus toxoid vaccination to childbearing age women.

Indonesia has also conducted a study, in 3 high-risk districts, incorporating both the MNT high risk approach and safe injection practices. Because school immunization programs are key to sustaining MNT elimination, the study targeted primary school children under 5 years of age.

In India, neonatal tetanus in just 4 states accounts for over 50% of deaths from that disease for the whole country. In response, the government of India has heightened efforts in these 4 states, starting in Rajasthan. The state of Rajasthan immunized 4.5 million women with TT (tetanus toxoid) vaccine. In an effort to promote safe injection practices country-wide, the immunizations were conducted using auto-disable syringes. As the Rajasthan program is evaluated, the findings will be useful in developing strategies for the other high risk states.

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Staff at United Nations Children's Fund (UNICEF)

Technical Advisor to UNICEF
Dr. François Gasse

Dr. Gasse is a French citizen born in Nice. He graduated as a Medical Doctor in 1973 from the University of Marseille, France and obtained a Masters Degree in Public Health in 1981 from Johns Hopkins University, Baltimore, Maryland. In 1982, Dr. Gasse joined the Expanded Programme of Immunization at the World Health Organization's headquarters where he was responsible for providing assistance to African countries in the planning, implementation and evaluation of immunization programs. In 1989, he spearheaded the efforts of the World Health Assembly to eliminate neonatal tetanus as endorsed by the World Summit for Children's goal.

Dr. Gasse has worked at university teaching hospitals in Afghanistan and Zambia, and spent three years in Equatorial Guinea as a medical epidemiologist. Considered one of the leading technical experts on maternal and neonatal tetanus (MNT), Dr. Gasse has worked in more than 40 developing countries.

Project Associate
Catherine Winter

In its inaugural year, the BD Global Health Fund provided funding to the Columbia University School of Public Health to support a staff associate assigned to this public health initiative. Today, that associate, Ms. Catherine Winter, continues to play a vital role with the project as permanent UNICEF staff to the initiative. A graduate of the Columbia School of Public Health, Catherine received her M.P.H. from the Center for Population and Family Health in 1997. Her fieldwork has included assignments in Guinea, Namibia and Ecuador. She has worked with a variety of international organizations including the International Rescue Committee, Save the Children, the United Nations Population Fund, World Teach and CARE.

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