Seattle, WA, April 23, 2019 – PATH welcomes the announcement today by the World Health Organization (WHO) and the Malawi Ministry of Health that the first children have received the RTS,S/AS01 (RTS,S) malaria vaccine through routine immunization in Malawi, marking the beginning of a pilot introduction of the vaccine. Malawi is the first of the three participating countries—the others being Ghana and Kenya—to begin vaccination.
Today marks an important milestone in the history of malaria control—the first malaria vaccine introduced in Africa. Evaluation of the pilot introduction will help to inform decisions on the vaccine’s potential use on a wider scale in areas of Africa where malaria is a public health threat. PATH has worked toward this day for close to 20 years, first partnering with manufacturer, GSK, in 2001 to develop RTS,S for use in children.
“Our mission at PATH is to advance health equity through innovation and partnership,” said Steve Davis, President and CEO. “We are grateful for the wonderful partners with whom we have worked and who have contributed so much to bringing the first malaria vaccine to this point.”
The pilot introduction will take place in parts of the three participating countries where the risk of malaria is high and where coverage for other childhood vaccines is high. Children will receive the first vaccination at 5 or 6 months of age, and a final fourth dose at 2 years of age. At least 360,000 children per year across the three countries will receive the RTS,S/AS01 vaccine from the health facilities where they receive their routine childhood vaccinations. The pilot is meant to allow the partnering organizations to learn how best to deliver the required four doses of the vaccine in routine settings, assess the vaccine’s full potential role in reducing childhood deaths, and establish the vaccine’s safety profile in the context of routine use.
“This is a vaccine against a disease that has its greatest impact in Africa, where malaria still kills a young child every two minutes,” said Debbie Atherly, Global Head, Policy, Access, and Introduction for PATH Vaccines. “Few diseases are as present as malaria in the daily lives of African children and their families, and few tools are as trusted as vaccines.”
As a partner in the pilot program, PATH’s role is to lead a qualitative study on health care utilization to understand the reasons why people use or do not use the vaccine, and to assess the economics of vaccine implementation, to get a more complete sense of the cost of implementing the vaccine. PATH also provides project management and communications support to WHO and the country ministries of health.
Started in the 1980s, development of the RTS,S malaria vaccine included a Phase 3 efficacy and safety trial that involved nearly 15,500 infants and young children at 11 sites in seven African countries. This trial concluded in early 2014. Since then, the data generated on the vaccine have been reviewed by numerous health authorities. The vaccine received a positive scientific opinion from Europe's regulatory authority in July 2015; then, after a consultation process, WHO issued a position paper in January 2016, recommending pilot introduction. The data have also been reviewed by the national regulatory agencies in each of the three participating countries, which have authorized the vaccine’s use in the pilot introduction.
The vaccine is designed to help prevent Plasmodium falciparum malaria in sub-Saharan Africa and to complement other malaria control interventions, such as bednets, drugs, and insecticides, as well as appropriate case management. Despite progress made using currently available control measures, malaria remains a leading cause of death in children in sub-Saharan Africa. According to WHO, there were 219 million new malaria cases and 435,000 malaria deaths in 2017, with Africa bearing the greatest burden.
“We congratulate Malawi on pioneering the launch of the first malaria vaccine,” said Davis. “And we look forward to working with our country partners, WHO, and all those committed to evaluating the potential of this vaccine to benefit the health and well-being of children in Africa.”
PATH is a global organization that works to accelerate health equity by bringing together public institutions, businesses, social enterprises, and investors to solve the world’s most pressing health challenges. With expertise in science, health, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales solutions—including vaccines, drugs, devices, diagnostics, and innovative approaches to strengthening health systems worldwide. Learn more at www.path.org.
Media contact: Kate Davidson, PATH, media [at] path.org