The World Health Organization (WHO) has said it has added a new malaria vaccine to its list of prequalified vaccines, marking a "significant milestone” in the prevention of the mosquito-borne disease.

R21/Matrix-M, developed by the University of Oxford and the Serum Institute of India, is now the second malaria vaccine to be prequalified by the organisation following its prequalification of the RTS,S/AS01 vaccine in July 2022.

Malaria places a particularly high burden on the African Region, where nearly half a million children die from the disease every year.

Despite high demand, WHO outlined that the available supply of RTS,S has been limited and expects the addition of R21 to result in sufficient vaccine supply for children living in areas where malaria is a significant public health risk.

Dr Kate O’Brien, director of WHO's department of immunisation, vaccines and biologicals, said the decision marked “a huge stride in global health”.

“This is another step toward ensuring a healthier, more resilient future for those who have lived for too long in fear of what malaria could do to their children,” she said.

R21, which uses an adjuvant developed by Novavax to boost immune response, was recommended by WHO in October last year for the prevention of malaria in children following advice from the organisation’s Strategic Advisory Group of Experts on Immunization and the Malaria Policy Advisory Group.

The decision was supported by pre-clinical and clinical trial data demonstrating good safety and high efficacy in four countries at sites with both seasonal and perennial malaria transmission.

The new prequalification status for R21 means United Nations agencies can procure the vaccine for eligible countries, enabling global rollout of the vaccine.

Dr Rogério Gaspar, director of the department of regulation and prequalification at WHO explained: "Achieving WHO vaccine prequalification ensures that vaccines used in global immunisation programmes are safe and effective within their conditions of use in the targeted health systems.

“WHO evaluates multiple products for prequalification each year and core to this work is ensuring greater access to safe, effective and quality health products".

https://www.pmlive.com/pharma_news/world_health_organization_adds_second_malaria_vaccine_to_prequalification_list_1505509