4 Aug 2021

Media contact: Lindsay Bosslet | PATH | media [at] path.org

Seattle, WA — PATH congratulates Gavi, the Vaccine Alliance, GSK, and MedAccess for joining forces to help ensure an ongoing supply of the first malaria vaccine, GSK’s RTS,S/AS01E. This is another important step toward ensuring access to the vaccine for every child that could benefit from it.

PATH has collaborated in the development of the RTS,S/AS01E malaria vaccine since 2001, first with GSK to advance the vaccine through Phase 2 and Phase 3 trials in Africa, and, since 2017, with GSK and the World Health Organization (WHO) to support pilot implementation of the vaccine in areas of Ghana, Kenya, and Malawi. At the same time, PATH continues efforts to accelerate development of next-generation vaccines and biologics, working with a wide range of academic, business, and governmental organizations.

“It is very encouraging to see leaders in the global health community step up to help ensure access to the RTS,S vaccine,” says Carla Botting, Director of Malaria Market Access and Strategy at PATH. “GSK took a bold step when they agreed to donate millions of doses of vaccine for use in the Malaria Vaccine Implementation Program (MVIP). That donation is helping to make it possible to generate data for a potential WHO recommendation for wider use of the vaccine. Now, Gavi and MedAccess are helping to share the risk so that GSK can continue manufacturing the RTS,S antigen, which will help enable early access to the vaccine and the ability to vaccinate millions more children.”

More than two million doses have been administered since vaccinations in the large-scale pilot program began in April 2019. WHO advisory bodies are expected to review the evidence generated by the pilots thus far, as well as other research findings, in October 2021. If WHO recommends wider use of the vaccine, the Gavi Board is expected to consider financing of a broader rollout of the vaccine across Africa. If the Gavi Board approves funding, GSK will credit the Gavi-funded costs toward procurement of finished doses of the vaccine.

“The experience with development of vaccines against COVID-19 has shown the value of taking early risks in manufacturing concurrent with research and development, to ensure timely access when countries were ready to implement a vaccination program,” says Botting. “This financing mechanism for GSK’s malaria vaccine is a more modest, but very important, application of this approach to malaria.”

Botting adds, “The need for new tools to fight malaria is imperative. I will never forget one visit to Ghana in particular. The border control officer at the airport asked me the reason for my visit and I told him it was because of my work on malaria vaccines. He said one word: ‘Hurry.’

“With today’s announcement by Gavi, GSK, and MedAccess, we take another important step toward the day when a malaria vaccine is benefiting many more children in countries of sub-Saharan Africa where the burden of malaria is the greatest.”

About the RTS,S/AS01 malaria vaccine

The RTS,S/AS01E malaria vaccine, developed by GSK for more than 30 years, and in partnership with PATH since 2001, is currently being piloted in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme. The ministries of health are leading the implementation of the vaccine, which is being given to young children through the three countries’ routine immunization programs, with WHO providing technical and scientific leadership, playing a coordinating role, and working in collaboration with GSK, PATH, and a range of other partners.

RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received a positive review by regulatory authorities (positive scientific opinion from the European Medicines Agency and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP). The first dose of the vaccine has reached more than 740,000 children since the pilots were initiated by ministries of health in the three participating countries in 2019. 

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.