In a major advancement for global health, the World Health Organization (WHO) has added the R21/Matrix-M malaria vaccine to its list of pre-qualified vaccines.
Significant development
WHO recommend Strategic Advisory Group of Experts (SAGE) on Immunization and the Malaria Policy Advisory Group, aims to prevent malaria in children.
The pre-qualification status allows for wider access to vaccines, making it a crucial prerequisite for vaccine procurement through UNICEF.
The R21 vaccine, developed through Oxford University developed The R21 vaccine where serum Institute manufactured is the second malaria vaccine to receive WHO pre-qualification.
The first one, the RTS,S/AS01 vaccine, gained pre-qualification status in July 2022.
Both vaccines have demonstrated safety and effectiveness in clinical trials, making them promising tools for preventing malaria in children.
However,when combined with other recommended malaria control interventions,
these vaccines are anticipated to have a significant public health impact.
Malaria, a mosquito-borne disease, disproportionately affects children in the African Region,
where nearly half a million young lives the disease claim annually.
Globally, in 2022,
There were an estimated 249 million malaria cases and 608,000 malaria-related deaths across 85 countries.
However,the pre-qualification of the R21/Matrix-M vaccine is expected to address the high demand for malaria vaccines, which has outstripped the limited supply thus far.
With two WHO-recommended and pre-qualified malaria vaccines now available,
Further,the supply is projected to meet the needs of African countries.
This however provide sufficient vaccine doses to protect all children in malaria-endemic areas.
Dr. Rogério Gaspar, Director of the Department of Regulation and Pre-qualification at WHO, emphasized the importance of achieving WHO vaccine pre-qualification.
Meanwhile,this ensures that vaccines used in global immunization programs are safe and effective within the targeted health systems.
WHO evaluates multiple products for pre-qualification each year,
with the primary goal of ensuring greater access to safe, effective, and quality health products.
Dr. Kate O’Brien, Director of WHO’s Department of Immunization,
Vaccines and Biologicals, hailed the pre-qualification of the R21/Matrix-M vaccine as a significant milestone in global health.
Therefore,this achievement highlights the relentless commitment to eradicate malaria-
a formidable disease that causes immense suffering and mortality among children.
The pre-qualification of this second malaria vaccine is a step closer to a healthier and more resilient future,
shielding children from the threat of malaria.
WHO and its partners are united in the pursuit of a malaria-free world.
WHO employed a pre-qualification process that involves comprehensive evaluations-
based on international standards to determine the safety,
effectiveness, and adherence to manufacturing standards of vaccines.
Additionally, WHO ensures the continued safety and efficacy of pre-qualified vaccines through regular re-evaluations, site inspections, and targeted testing.
Thus,Pre-qualification caters to the specific needs of national immunization programs, taking into account vaccine characteristics.
This is such as potency, thermostability, presentation, labeling, and shipping conditions.
The addition of the R21/Matrix-M malaria vaccine to the list of WHO pre-qualified vaccines is a significant step forward in the fight against malaria.
Consequently,this milestone brings hope to millions of children in malaria-endemic areas-
paving the way for a future free from the burden of this deadly disease.
Morever,with increased access to safe and effective vaccines, coupled with other malaria control strategies,
we are moving closer to achieving the long-awaited goal of a malaria-free world.
