Hepatitis B is a highly infectious virus that is transmitted almost 100 times more effectively than HIV/AIDS. It attacks the liver and is a major cause of liver cancer. It kills more than 500,000 people a year globally.
Indonesia-the world's fourth most populous country-is the world's first to use Uniject devices filled with hepatitis B vaccine on a nationwide scale. In parts of Indonesia, as much as 70 percent of the population have been infected with hepatitis B virus. The new program is the result of intense collaboration between the Indonesian government and the Children's Vaccine Program (CVP), part of a Seattle-based non-governmental organization, the Program for Appropriate Technology in Health (PATH).
"By providing hepatitis B in Uniject, Indonesia is making injections safer while also increasing access to the vaccine," said Mark Kane, director of PATH's Children's Vaccine Program. "We are excited to be part of an effort that stands ready to reach nearly five million newborns every year-including some four million born outside of hospitals."
In order to vaccinate all these children against hepatitis B within the first week of life, the Indonesian government, with help from CVP, is beginning a birth-dose training program this month for 60,000 community-based midwives, one for every village in the far-flung nation. The midwives will begin using Uniject with hepatitis B vaccine in core immunization services by the end of October.
Unlike occasional "National Immunization Days" that focus just on polio, the core infant immunization program vaccinates children against seven killer diseases, including polio, diphtheria, tetanus, pertussis (whooping cough), tuberculosis, measles, and hepatitis B.
In support of Indonesia's infant immunization program, The Vaccine Fund recently awarded US$16.3 million for hepatitis B vaccine, plus an additional US$9.9 million for injection safety. The Global Alliance for Vaccines and Immunization (GAVI) and its funding arm, The Vaccine Fund, seek to improve immunization programs in the developing world. CVP was a founding member of GAVI and plays an active role in the alliance.
The Uniject device was invented, developed, and patented by PATH, with funding from the United States Agency for International Development (USAID) and other donors. In 1996, PATH licensed the technology to BD (Becton, Dickinson and Company), a multinational pharmaceutical company. An Indonesian vaccine producer, Biofarma, purchases the devices from BD and fills them with hepatitis B vaccine.
Uniject devices are much easier to use and safer than standard needles and syringes. Each Uniject consists of a small plastic bubble filled with a single dose of vaccine, with a short needle attached. The vaccine is injected by squeezing the bubble. Uniject devices cannot be reused, eliminating the spread of disease through contaminated needles-a serious global problem.
In adults, hepatitis B usually causes an acute infection but is rarely fatal. However, infants infected during birth or shortly thereafter often become chronic carriers of the virus. Even though they show no symptoms as children, they can infect others, and they are at high risk of developing life-threatening liver disease. As many as one-quarter of children infected in the first year of life will eventually die as a result of hepatitis B. An estimated 350 million people around the world carry the hepatitis B virus.
Vaccination is the best method of preventing hepatitis B. In areas such as Indonesia, where mother-to-child transmission is high, it is most beneficial when given in the first week of life. Correctly administered, hepatitis B vaccine is 95 percent effective.
"Previously, only children born in hospitals were immunized at birth," said Indriyono Tantoro, Director for Epidemiological Surveillance, Immunization, and Maternal Health in the Indonesian Ministry of Health. "Uniject eliminates both the need for needle sterilization and the wastage of vaccine that comes with using multi-dose vials. It makes our immunization program safer and more cost-efficient, allowing midwives to reach previously 'unreachable' Indonesian infants."
A recent Indonesian cost study found that even though pre-filled Uniject devices are more expensive per unit to buy, they actually save US$0.05 to $0.15 per immunized child. The savings come mainly from reducing vaccine wastage. Wastage can be a serious problem when vaccines are provided in multi-dose vials (usually five- or ten-dose vials), as opposed to single-dose Uniject devices. Once multi-dose vials are opened, any vaccine left over after an immunization session is disposed of, even if only one or two children were immunized.
Indonesia first introduced the birth-dose system in a three-province pilot program supported by CVP. Results showed the percentage of infants receiving the vaccine within seven days of birth jumped from less than 5 percent to 52 percent on average in the pilot districts, and in one district reached 86 percent.
In addition to using Uniject devices, the pilot program introduced a number of other innovations. For example, it tested the ability of hepatitis B vaccine in Uniject to remain potent without refrigeration. Because hepatitis B is one of the few relatively heat-tolerant vaccines, it can be stored at room temperature for several weeks. But to be certain the vaccine was not exposed to excessive heat, each pre-filled device was labeled with a Vaccine Vial Monitor or VVM (a new technology also developed by PATH with funding from USAID). These labels change color when exposed to enough heat to destroy the vaccine. Using VVMs, midwives stored the vaccine in their homes and had them on hand when mothers went into labor. By simply checking the labels, midwives could tell if they needed to discard the vaccine.
"The success of the CVP/Indonesian pilot program was a major milestone," said Tore Godal, Executive Secretary of GAVI. "The data show that use of these new technologies, along with other reforms, can significantly increase our ability to protect newborns against this killer disease. We believe Indonesia is paving the way for similar programs throughout the developing world."
In fact, the government of Vietnam has already requested that GAVI provide hepatitis B vaccine in Uniject devices for national use by 2003. In addition, vaccine manufacturers in both China and India are beginning to fill Uniject devices with hepatitis B vaccine for their own field programs.
PATH's Children's Vaccine Program, funded by the Bill & Melinda Gates Foundation, works to assure that all children receive the full benefits of immunization without undue delay. It also supports the development and introduction of new and underused vaccines in developing countries. For more information, visit www.ChildrensVaccine.org.
PATH, The Program for Appropriate Technologies in Health is an international organization dedicated to developing, improving, and evaluating innovative solutions to public health problems. Its mission is to improve health, especially the health of women and children. It shares knowledge, skills, and technologies with governments and nongovernmental partners in low-resource settings around the world. Since 1977 PATH has managed more than 1000 projects in 120 countries, directly benefiting people, communities, and countries with limited health resources. It focuses on improving reproductive and sexual health, increasing the availability of vaccines and immunizations, preventing HIV and AIDS, improving adolescent and maternal health, and preventing gender-based violence through the advancement of human rights. For additional information, visit www.path.org.
The Vaccine Fund was established to address the need for new and underused vaccines in the world's poorest countries - those with per capita GNP below $1,000. The Fund provides resources for immunization services as well as for purchasing new and under-used vaccines against diseases such as hepatitis B, yellow fever and Haemophilus influenza type b (Hib). The Vaccine Fund mobilizes resources to serve the mission of GAVI. For more information visit www.VaccineFund.org.
The Global Alliance for Vaccines and Immunization (GAVI) is a public-private partnership focused on increasing access to vaccines among children in poor countries. Partners include national governments, UNICEF, WHO, The World Bank, the Bill & Melinda Gates Foundation, the vaccine industry, public health institutions and NGOs. For more information visit www.VaccineAlliance.org.
EDITOR'S NOTE: Photos and additional information to support this story are available at: http://childrensvaccine.org/html/rel-021001.htm