The World Health Organisation (WHO) has added the R21/Matrix-M malaria vaccine to its list of prequalified vaccines, marking a significant milestone in the global effort to combat malaria.
The vaccine, recommended for the prevention of malaria in children, received WHO pre-qualification in October 2023, following the guidance of the WHO Strategic Advisory Group of Experts (SAGE) on Immunisation and the Malaria Policy Advisory Group.
The pre-qualification status means increased access to the vaccine, as it becomes a prerequisite for vaccine procurement by UNICEF and secures funding support for deployment by Gavi, the Vaccine Alliance.
The R21 vaccine, developed by Oxford University and manufactured by the Serum Institute of India, is the second malaria vaccine to achieve WHO pre-qualification, with the first being the RTS,S/AS01 vaccine in July 2022.
Clinical trials have demonstrated the safety and effectiveness of both prequalified vaccines in preventing malaria in children.
When deployed alongside other recommended malaria control interventions, these vaccines are expected to have a significant public health impact.
Malaria poses a substantial burden on children in the African Region, where nearly half a million children succumb to the disease annually.
Globally, in 2022, an estimated 249 million malaria cases and 608,000 malaria deaths occurred across 85 countries.
The pre-qualification of the R21/Matrix-M malaria vaccine is set to address the high demand for malaria vaccines, particularly in African countries, where malaria is a significant public health risk.
The availability of two WHO-recommended and prequalified malaria vaccines is anticipated to enhance the supply and meet the growing demand for vaccine doses.
Dr. Rogério Gaspar, Director of the Department of Regulation and Pre-qualification at WHO emphasised that achieving WHO vaccine pre-qualification ensures the safety and efficacy of vaccines within targeted health systems, contributing to global immunisation programs’ success.
Dr. Kate O’Brien, Director of WHO’s Department of Immunisation, Vaccines, and Biologicals, hailed the pre-qualification of R21/Matrix-M as a significant step toward a malaria-free future, expressing commitment to eliminating the disease’s threat.
The pre-qualification process involves WHO applying international standards to evaluate vaccine safety, effectiveness, and adherence to manufacturing standards.
Regular re-evaluation, site inspection, and targeted testing ensure the continued safety and efficacy of prequalified vaccines, meeting the specific needs of national immunisation programs.
