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A malaria vaccine manufactured by the biotechnology company Serum Institute of India has passed the next round of regulatory approval by the World Health Organization (WHO) on December 21, 2023. The R21/Matrix-M malaria vaccine developed by the University of Oxford and the Indian company meets the WHO standards for vaccine quality, safety and efficacy.
A press statement by WHO announced that R21/Matrix-M malaria was added to the WHO's list of prequalified vaccines. The vaccine was recommended for use for the prevention of malaria in children by the global health agency on October 2, 2023.
If a vaccine has undergone thorough evaluation of relevant data, testing of samples and WHO inspection of relevant manufacturing sites — and the outcome is positive — it is included in the WHO List of Prequalified Vaccines.The WHO also tests the vaccine’s suitability for the target population, usability with appropriate concomitant products and compliance with operational specifications for packaging and presentation.
The prequalification means larger access to vaccines as a key tool to prevent malaria in children, with it being a prerequisite for vaccine procurement by United Nations Child Rights body UNICEF and funding support for deployment by Gavi, the Vaccine Alliance, the WHO said.
Rogerio Gaspar, Director of the Department of Regulation and Prequalification, WHO, said:
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.
The vaccine is highly effective and can reduce malaria cases by 75 per cent over a year. Prior to this, the best vaccine had a 50 per cent success rate over a year and a lower success rate over three years reported non-profit media outlet The Conversation. Further, Serum Institute can produce hundreds of millions of doses of this vaccine each year, it added.
The vaccine will also be cheaper, priced at around $5 per dose at high volumes, the report further said.
The R21 vaccine is the second malaria shot approved by WHO, following the RTS,S/AS01 one, which was approved in July 2022. In clinical trials, both vaccines have been shown to be safe and effective in preventing malaria in children, the WHO said.
The vaccines are expected to have a large public health impact when widely implemented alongside other recommended malaria control interventions.
Malaria, a mosquito-borne disease, has a disproportionately high impact on children in the African region, where nearly half a million children die each year. In 2022, an estimated 249 million malaria cases were witnessed globally, with 608,000 malaria deaths across 85 countries, according to the global health body.