Seattle, WA, October 2, 2023—PATH welcomed the announcement today that the World Health Organization (WHO) will include a second malaria vaccine, R21/Matrix-M, in its recommendation for malaria vaccines. The addition of R21 comes just two years after a first vaccine, RTS,S/AS01E, was recommended by WHO for use in children from five months of age. Today’s announcement also expands the use of pre-erythrocytic malaria vaccines (R21 and RTS,S) to all areas where malaria caused by the Plasmodium falciparum parasite is endemic, although countries are advised to prioritize areas of moderate to high transmission.
“Malaria still kills a child in Africa nearly every minute,” said Nanthalile Mugala, MD, MMed, PATH’s Chief of the Africa Region. “The availability of a second malaria vaccine for children in the region should increase access to this valuable addition to the malaria toolbox. Malaria vaccines, used alongside other proven interventions, can help bring this deadly disease under control and take us another step closer to a world free from malaria.”
A key next step for the R21 vaccine is WHO prequalification, the process by which WHO attests to the vaccine’s safety, effectiveness, and quality. Prequalification allows UNICEF to purchase the vaccine and Gavi, the Vaccine Alliance to provide financial assistance to eligible countries for vaccine introduction. WHO’s review of R21 for prequalification is already underway.
“We congratulate the teams at the Jenner Institute and Serum Institute of India, together with partners in Burkina Faso, Kenya, Mali, and Tanzania, for achieving this milestone,” said Ashley Birkett, PhD, Global Head of Malaria Vaccines and Biologics at PATH. “Scientists had the first evidence that a malaria vaccine was possible back in the 1970s, but it took nearly 50 years for a first vaccine to be become available for use. Today, the global health community is on the verge of having a second one.”
The RTS,S malaria vaccine was recommended by WHO in 2021 and prequalified in 2022. Thanks to a pilot program led by ministries of health and coordinated by WHO, RTS,S has been in routine use in areas of Ghana, Kenya, and Malawi since 2019. More than 5.4 million doses have been administered to more than 1.8 million children across the three countries. More than two dozen countries have expressed interest in implementing malaria vaccines and demand is projected to reach 40 to 60 million doses by 2026. Gavi has already approved vaccine introduction support for 17 countries, including the three pilot countries. However, the initial supply of RTS,S is not sufficient to meet the projected demand for the vaccine.
John Bawa, Director, Malaria Vaccine Implementation at PATH, said, “Given the strong and urgent demand for malaria vaccines in Africa, the availability of a second malaria vaccine for children would help accelerate the pace of vaccine introduction. We look forward to working with countries as they move from decision-making to vaccine implementation.”
Mr. Bawa continued, “In addition to the potential for saving more lives because of greater supply, having an additional vaccine on the market should help to reduce prices, especially over the longer term. Thanks to Gavi’s role in ensuring access to lifesaving vaccines, the price of malaria vaccines will not be an obstacle for most African countries.”
As with other vaccines, most African countries will pay US$0.20 (20 cents) per dose for the R21 and RTS,S malaria vaccines, because of Gavi’s support for vaccine use in low-income countries.
“The burden of malaria is intolerable, and it will take improved and new tools to defeat this deadly and devastating disease once and for all,” said Dr. Birkett. “Thankfully, WHO recommendations routinely recognize the importance of continued research to optimize the use of new vaccines. Indeed, it’s critical to maintain the flow of funding for research—both to strengthen the impact of existing malaria vaccines and to develop new vaccine approaches.”
“PATH is proud to have helped bring a first malaria vaccine through development into use for children at risk,” said Dr. Mugala. “We also welcome the availability of a second vaccine and hope that learnings from the RTS,S experience will continue to inform the development pathway for R21 and its future implementation.”
Background on the R21/Matrix-M malaria vaccine
The R21 malaria vaccine was designed and developed at the University of Oxford and is manufactured by Serum Institute of India Pvt Ltd (SIIPL). Clinical testing of the vaccine began in 2015. Clinical trials have been conducted or are ongoing in six African countries, Thailand, and the United Kingdom. SIIPL has provided vaccine doses for the Phase 3 licensure trials. The vaccine has now been recommended for use by WHO and awaits a decision on prequalification. R21 has been granted an export license by India and approved by the regulatory authorities of Burkina Faso, Ghana, and Nigeria.
Background on the RTS,S/AS01E malaria vaccine
RTS,S was developed by GSK over more than 35 years and in partnership with PATH since 2001. Clinical testing began in 1987 and trials have been conducted or are ongoing in ten African countries, Thailand, and the United States. GSK sponsored the Phase 3 licensure trials and provided vaccine doses. RTS,S was awarded a positive scientific opinion by the European Medicines Agency (a stringent regulatory authority) in 2015. Since 2019, the vaccine has been provided through routine immunization services in areas of Ghana, Kenya, and Malawi. In 2021, WHO recommended RTS,S for wider use, and it was prequalified by WHO in 2022. RTS,S has been approved for use by the regulatory authorities of Ghana, Kenya, and Malawi.
PATH is a global nonprofit dedicated to achieving health equity. 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 health challenges. Learn more at www.path.org. Learn more about PATH’s malaria vaccine efforts at www.malariavaccine.org.
Media contact: Carol Meja | PATH | media [at] path.org