2023-12-21 23:51:56
“Obtaining vaccine prequalification by theOMS ensures that vaccines used in global immunization programs are safe and effective under their conditions of use in targeted health systems,” said Dr. Rogério Gaspar, Director of the Regulatory and Prequalification Department of theOMS.
This prequalification means “broader access to vaccines as a key tool to prevent malaria in children” and is “a prerequisite for the purchase of vaccines by theUNICEF and financial support for the deployment by Gavi, the Vaccine Alliance.
The World Health Organization had recommended its use for the prevention of malaria in children, on the advice of the WHO Strategic Advisory Group of Experts (SAGE) on Immunization and the Advisory Group on Immunization Policy. of malaria last October.
Two safe vaccines
The R21 vaccine is the second malaria vaccine prequalified by the WHO, after the RTS,S/AS01 vaccine which obtained prequalification status in July 2022.
Clinical trials have shown that both vaccines are safe and effective in preventing malaria in children. When implemented at scale, alongside other recommended malaria interventions, they are expected to have a significant impact on public health. Malaria, a mosquito-borne disease, takes a particularly heavy toll on children in the African region, where nearly half a million children die from the disease each year.
Globally, in 2022, there will be an estimated 249 million cases of malaria and 608,000 deaths from this disease in 85 countries.
The prequalification of the world’s second malaria vaccine, developed by the University of Oxford and manufactured by the Serum Institute of India, is expected to expand access to malaria prevention through vaccination.
Demand for malaria vaccines is high, but supply has so far been limited. The availability of two anti-malaria vaccines recommended and prequalified by the WHO should make it possible to increase the supply to meet the strong demand from African countries and to obtain a sufficient number of vaccine doses for all children living in areas where Malaria constitutes a significant risk to public health.
Ensuring safe health products
As part of the prequalification process, WHO applies international standards to comprehensively evaluate and determine whether vaccines are safe, effective and manufactured according to international standards. WHO also ensures the continued safety and effectiveness of prequalified vaccines, including through regular re-evaluation, site inspection and targeted trials. Prequalification addresses the specific needs of national immunization programs regarding vaccine characteristics such as potency, thermostability, presentation, labeling and shipping conditions.
“WHO evaluates many products each year for prequalification and the essence of this work is to ensure better access to safe, effective and quality health products,” argued Dr Gaspar.
An unfailing commitment
The Director of the WHO Department of Immunization, Vaccines and Biologicals, Dr. Kate O’Brien, welcomed the “major step forward for global health” represented by the prequalification of R21/Matrix-M, “the second malaria vaccine recommended for children in areas where malaria is endemic.”
According to Dr O’Brien, it underlines WHO’s “unwavering commitment” to eradicating malaria, which remains a formidable enemy causing suffering and death among children.
“This is one step closer to a healthier, more resilient future for those who have lived too long in fear of what malaria could do to their children.” Together with our partners, we are united in the pursuit of a malaria-free future, where every life is protected from the threat of this disease,” concluded Dr. O’Brien.
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