First Malaria Vaccine Prequalified by WHO

The World Health Organization (WHO) has prequalified the first malaria vaccine, RTS,S/AS01 (also known as Mosquirix), manufactured by GSK, bringing it closer to reaching millions more children at risk of malaria. The vaccine, which is recommended for use among children living in areas of moderate to high P. falciparum malaria transmission, has already been given to more than one million children through pilot implementation that 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 and 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 the vaccine, and Gavi, the Vaccine Alliance is ready to provide financial assistance to eligible countries to introduce the vaccine. Gavi recently opened a $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 2022 and closes in January 2023.