A significant milestone in the fight against malaria has been achieved as the World Health Organization (WHO) granted regulatory approval to the R21/Matrix-M malaria vaccine, developed by the Serum Institute of India.
This marks a crucial step forward in combating the mosquito-borne disease that disproportionately affects children in the African region.
The vaccine, a collaborative effort between the University of Oxford and the Serum Institute of India, met WHO standards for quality, safety, and efficacy.
In a press statement, the WHO declared the inclusion of R21/Matrix-M malaria on its list of prequalified vaccines, having recommended its use for preventing malaria in children on October 2, 2023.
To qualify for the WHO List of Prequalified Vaccines, a vaccine undergoes a rigorous evaluation process, including the examination of relevant data, sample testing, WHO inspections of manufacturing sites, and assessment of suitability for the target population. The approval enhances access to the vaccine, making it eligible for procurement by UNICEF and deployment funding support by Gavi, the Vaccine Alliance.
Rogerio Gaspar, Director of the Department of Regulation and Prequalification at WHO, emphasised the importance of WHO vaccine prequalification, ensuring the safety and effectiveness of vaccines in global immunisation programs. He stated, “WHO evaluates multiple products for prequalification each year, and core to this work is ensuring greater access to safe, effective, and quality health products.”
The R21/Matrix-M malaria vaccine has demonstrated high efficacy, reducing malaria cases by an impressive 75% over a year. Compared to its predecessor, this vaccine represents a significant improvement, with the best-performing vaccine prior to this achieving a 50% success rate over a year. Notably, the Serum Institute has the capacity to produce hundreds of millions of doses annually, making the vaccine more accessible.
A key factor in the widespread use of this vaccine is its affordability, priced at approximately $5 per dose in high volumes. This stands as a positive development in the global effort to make malaria prevention more accessible and cost-effective.
This approval marks the second WHO-approved malaria vaccine, following the RTS,S/AS01 vaccine's approval in July 2022. Both vaccines have demonstrated safety and effectiveness in clinical trials, promising a substantial public health impact when implemented alongside other recommended malaria control measures.
Malaria remains a significant global health challenge, with nearly half a million children in the African region succumbing to the disease annually. In 2022, the WHO reported an estimated 249 million malaria cases worldwide, resulting in 608,000 malaria-related deaths across 85 countries. The approval of the R21/Matrix-M vaccine provides renewed hope in the ongoing fight against this deadly disease.