Malaria, which claims the lives of nearly half a million children annually in the African region alone, faces a promising adversary as the World Health Organization (WHO) bestows prequalification status upon the R21/Matrix-M malaria vaccine. It is a groundbreaking development in the quest for effective malaria prevention. The vaccine, developed by Oxford University and manufactured by the Serum Institute of India, has been added to WHO’s prestigious list of prequalified vaccines (1).

This decision, made in October 2023, follows the recommendation by the WHO Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Group. The R21 vaccine’s prequalification is a significant stride forward in the ongoing efforts to prevent malaria, especially in children.

What is Malaria?

Malaria, a mosquito-borne disease, imposes a substantial burden on children in the African region, where nearly half a million children succumb to the disease annually. In 2022 alone, the world witnessed an estimated 249 million malaria cases, resulting in 608,000 malaria-related deaths across 85 countries.

Vaccine for Malaria Prevention in Children

The R21/Matrix-M vaccine now joins the ranks of the RTS,S/AS01 vaccine, becoming the second malaria vaccine to achieve prequalification from the WHO. The RTS,S/AS01 vaccine received this status in July 2022. WHO’s prequalification holds tremendous significance, as it opens up avenues for wider access to vaccines, positioning them as key tools in the prevention of malaria in children. It serves as a prerequisite for vaccine procurement by organizations like UNICEF and secures funding support for deployment through Gavi, the Vaccine Alliance.

Both the R21 and RTS,S/AS01 vaccines have demonstrated safety and efficacy through rigorous clinical trials, instilling confidence in their ability to prevent malaria in children. The pre-qualification process by WHO involves a comprehensive evaluation of vaccines based on international standards to ascertain their safety, effectiveness, and adherence to manufacturing benchmarks. This process ensures that vaccines used in global immunization programs meet the necessary criteria within the targeted health systems.

Malaria Vaccine Receives WHO Prequalification

Rogério Gaspar, the director of WHO’s Department of Regulation and Prequalification, emphasizes the significance of achieving WHO vaccine prequalification. He states that this achievement ensures vaccines are safe and effective within the conditions of their use in the targeted health systems. WHO’s commitment to evaluating multiple products for prequalification each year underscores its dedication to providing greater access to safe, effective, and quality health products worldwide.

As part of the prequalification process, WHO continually monitors the safety and efficacy of prequalified vaccines. This involves regular re-evaluation, site inspections, and targeted testing to maintain the high standards expected of these vaccines. The process also takes into account the specific needs of national immunization programs, considering factors such as potency, thermostability, presentation, labeling, and shipping conditions.

Embracing a Malaria-Free World with R21/Matrix-M Vaccine

The R21/Matrix-M vaccine’s prequalification marks a substantial step forward in the fight against malaria, offering hope for enhanced protection, especially for vulnerable populations like children in malaria-endemic regions. This achievement aligns with WHO’s broader mission to combat infectious diseases globally and underscores the importance of international collaboration in addressing public health challenges. The momentum gained through this prequalification sets the stage for increased accessibility and deployment of malaria vaccines, bringing us closer to the goal of a malaria-free world.

References:

1. WHO recommends groundbreaking malaria vaccine for children at risk
   
   https://www.who.int/news/item/06-10-2021-who-recommends-groundbreaking-malaria-vaccine-for-children-at-risk

Source-Medindia