6 Sep 2022

The vaccine’s prequalification is a key step in protecting children and reducing the burden of malaria.

Seattle, WA—RTS,S/AS01 (also known as Mosquirix), manufactured by GSK, is the first malaria vaccine to achieve prequalification by the World Health Organization (WHO), bringing it closer to reaching millions more children at risk of malaria. The vaccine, which WHO has recommended for use among children living in areas of moderate to high P. falciparum malaria transmission, has already been given to more than 1 million children through pilot implementation, which began in 2019 in areas of Ghana, Kenya, and Malawi.

“Prequalification of the first malaria vaccine is a major advancement for child health,” said Ashley Birkett, PhD, Global Head for Malaria Vaccines & Biologics at PATH. “Prequalification further demonstrates WHO’s confidence in the safety, effectiveness, and quality of the vaccine for African countries who are considering adding it to their immunization programs. A vaccine has been a missing piece of the malaria toolkit for a long time and could save tens of thousands of young lives every year, on top of existing malaria interventions.”

WHO prequalification is a critical step toward expanding access to the vaccine. This designation allows UNICEF to purchase RTS,S and Gavi, the Vaccine Alliance is ready to provide financial assistance to eligible countries to introduce the vaccine. Gavi recently opened a US$155.7 million funding window to support the introduction of malaria vaccines between 2022 and 2025. Gavi-eligible countries can apply for support when a funding window opens toward the end of the year and closes in January 2023. Meanwhile, the three pilot countries have begun their plans to expand use of RTS,S in pilot areas that have not yet received the vaccine and will be able to submit applications to Gavi as soon as September of this year, to avoid any interruption in vaccinations.

“Over the next several months, we expect to see the expansion of vaccine use in the pilot areas of Ghana, Kenya, and Malawi—thanks to a recent grant from Open Philanthropy to PATH,” said Dr. Birkett. “This expansion will make the vaccine available to children in pilot areas not previously eligible to receive the vaccine, and it will be a first step in expanding access to the vaccine in Africa—keeping in mind that supply will be limited during the initial years of rollout, as is often the case with new vaccines.”

PATH has been involved in the development and introduction of RTS,S over the course of more than 20 years. PATH and GSK entered into a public-private collaboration in 2001 to take RTS,S through Phase 2 and Phase 3 clinical testing, with catalytic funding provided to PATH by the Bill & Melinda Gates Foundation. PATH is also a partner in the pilot implementation of the vaccine, supporting the ministries of health in Ghana, Kenya, and Malawi, working alongside WHO and other partners.

“RTS,S represents a scientific and public health breakthrough and is a pioneer vaccine in many ways,” said Dr. Birkett. “We hope this is the first of many malaria vaccines that will eventually reach this milestone.”

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.