RTS,S/AS01 malaria vaccine being drawn up by a healthcare worker in western Kenya.
19 Apr 2022

Seattle, April 19, 2022—PATH today welcomed a grant of close to US$ 5 million to enable expanded introduction of the RTS,S/AS01 (RTS,S) malaria vaccine through the pilot program currently underway in areas of Ghana, Kenya, and Malawi. The grant would support use of RTS,S in pilot areas that have not yet received the vaccine.

The grant to PATH was recommended by GiveWell, a US-based non-profit, for funding by Open Philanthropy, also based in the United States. The award will provide each pilot country with funds to plan for and implement the expansion of malaria vaccination through the end of 2023, the formal end of the pilot program. The grant also will allow PATH and the World Health Organization (WHO) to provide technical assistance to the countries. The vaccine doses for the expansion into the (currently) non-vaccinating pilot areas are part of GSK’s donation of up to 10 million doses for use in the pilot program.

“This new funding presents an exciting opportunity to rapidly increase the impact of the malaria vaccine by reaching more children in the pilot areas of Ghana, Kenya, and Malawi,” said John Bawa, Team Lead for Vaccine Implementation in Africa at PATH. “This early expansion of the vaccine’s use simply would not be possible without this grant.”

The availability of funds will allow the pilot countries to expand use of the vaccine in the pilot areas if they desire to do so. If the pilot countries decide to expand use of the vaccine in these areas, vaccinations could start before the end of 2022.

The pilot program, known formally as the Malaria Vaccine Implementation Programme (MVIP), was established to support the country-led introduction of RTS,S through routine immunization programs in selected areas of Ghana, Kenya, and Malawi.

Funded by Gavi, the Vaccine Alliance (Gavi), the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund), and Unitaid—and with in-kind contributions from GSK, PATH, and WHO—the program was designed to evaluate the safety, feasibility, and impact of the RTS,S malaria vaccine in routine use. Ministries of Health in the three countries lead implementation of the vaccine; WHO provides overall coordination and technical leadership for the program, in collaboration with the respective Ministries of Health and a range of in-country and international partners, including PATH.

“WHO welcomes this new funding that will ensure more children at risk can benefit from this life-saving vaccine,” said Mary Hamel, MD, WHO Team Lead for Malaria Vaccines and the WHO Lead for the MVIP. “Malaria remains a major cause of child deaths in Africa, and the malaria vaccine has shown it can substantially reduce life-threatening severe malaria and child deaths. However, the vaccine can only reach its full potential if it reaches children who need it. We greatly appreciate that GiveWell recognized this opportunity and is investing in the vaccine’s broader use.”

Based upon evidence generated through the pilots and other data, WHO recommended widespread use of the vaccine in regions of moderate to high malaria transmission in October 2021. Then, at their December 2021 meeting, the Gavi Board approved funding for a malaria vaccination program. However, Gavi funding to countries is not expected to be available until the end of 2023, given the time required for preparation of application guidelines and other processes. Countries eligible for Gavi support that decide to adopt the vaccine—including the pilot countries—will need to apply to Gavi; the first application deadline is expected in September 2022.

The opportunity to expand use of the vaccine, prior to Gavi funding becoming available, is consistent with a commitment by pilot program partners and funders to accelerate the timelines to increase access to the vaccine as rapidly as possible.

As can be the case with new vaccines, supply availability will be a factor in the rollout of the malaria vaccine. In anticipation of severely limited RTS,S supply in the first four to six years, WHO is coordinating the development of a Framework to guide global decisions about malaria vaccine allocation and to help inform national decisions about vaccine prioritization while supply is limited. The Framework is being developed based on the best available scientific evidence, shared values, input by expert advisers, and broad consultation with affected stakeholders.

“GiveWell’s evaluation of this opportunity showed it could be a cost-effective way to further reduce the burden of malaria in the pilot countries, as rapidly as possible,” said Scott Gordon, Project Director for the pilot program at PATH. “We hope that others who appreciate the potential impact of the malaria vaccine across Africa also step forward to help accelerate access to this life-saving tool.”

#          #          #

Background on the RTS,S/AS01 malaria vaccine

RTS,S/AS01 is the first WHO-recommended malaria vaccine, and the first vaccine to recieve a positive scientific opinion from a stringent regulatory authority (the European Medicines Agency). It was approved for use in pilot areas by the regulatory authorities of Ghana, Kenya, and Malawi. The pilot introduction of the vaccine began in 2019 and is ongoing through 2023. RTS,S was developed by GSK over more than 35 years and in partnership with PATH since 2001, with catalytic funding provided by the Bill & Melinda Gates Foundation to PATH for late-stage development of RTS,S between 2001 and 2015. PATH continues efforts to accelerate the development of next-generation vaccines and biologics, working with a wide range of academic, business, and governmental organizations, and continues to support research on the optimal use of RTS,S.

For more information on the Malaria Vaccine Implementation Programme, see here; additional information on RTS,S is available here, and a story about the vaccine’s use in Malawi is here.

About PATH

PATH is a global nonprofit dedicated to ending health inequity. With more than 40 years of experience forging multisector partnerships, and with expertise in science, economics, technology, advocacy, and dozens of other specialties, PATH develops and scales up innovative solutions to the world’s most pressing public health challenges. Learn more at www.path.org.  Learn more about PATH’s malaria vaccine efforts at www.malariavaccine.org.