Transforming the Battle Against Malaria: Serum Institute’s WHO-Approved Vaccine

India’s Serum Institute of India (SII), the world’s largest vaccine manufacturer, is making significant contributions to global vaccine availability, particularly during the COVID-19 pandemic. With its Pune-based operations, the SII has been supplying affordable and WHO-accredited vaccines to over 170 countries. And now, in the ongoing battle against malaria, the Serum Institute of India has taken a major step forward.

On Monday, the World Health Organization (WHO) recommended the use of the R21/Matrix-M™ malaria vaccine, developed by the University of Oxford and the Serum Institute of India. This latest vaccine is the second of its kind to be developed and promises to be a game-changer in the fight against the mosquito-borne disease, which is responsible for the deaths of mostly children.

The WHO’s recommendation comes after extensive evaluation, ensuring that the vaccine meets all necessary safety, quality, and effectiveness standards. The R21/Matrix-M™ vaccine was developed by the Jenner Institute at Oxford University, in collaboration with the Serum Institute of India and received support from the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank.

This recommendation also sets the stage for the vaccine to undergo prequalification review by the WHO, which would grant approval and enable GAVI, a global vaccine alliance, and UNICEF to purchase the vaccine from manufacturers. The approval from the WHO is a significant milestone in the fight against malaria, a disease that has long threatened the lives of billions of people worldwide, disproportionately affecting the most vulnerable populations.

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Adar Poonawalla, CEO of the Serum Institute of India, expressed his excitement at the WHO’s recommendation and approval of the R21/Matrix-M™ vaccine. He emphasized the importance of collaborative efforts between the public and private sectors, scientists, and researchers in combatting life-threatening diseases like malaria.

The R21/Matrix-M™ malaria vaccine, which will be available by mid-2024, is priced between $2 (Rs 166) and $4 (Rs 333) per dose, with four doses needed per person. This price is roughly half that of the first malaria vaccine, RTS,S. The new vaccine, branded as Mosquirix, has already been approved for use in Burkina Faso, Ghana, and Nigeria.

Both RTS,S and R21/Matrix-M™ vaccines have similar efficacy rates of around 75% when administered under the same conditions. However, the key difference lies in the R21 vaccine’s production capacity. The Serum Institute of India has established the capability to produce 100 million doses annually, with plans to double that over the next two years. In contrast, only 18 million doses of RTS,S have been produced so far.

With over 95% of malaria cases reported in Africa, the availability of a second malaria vaccine is crucial. The demand for the RTS,S vaccine currently exceeds its supply, making the development of the R21/Matrix-M™ vaccine a vital complement to malaria prevention efforts. The ease of deployment, cost-efficiency, and affordability of the R21 vaccine make it potentially life-saving, with the potential to save hundreds of thousands of lives every year.

Malaria remains a significant public health concern, with 247 million cases reported worldwide in 2021, resulting in 619,000 deaths, primarily among children under five years of age. Africa bears the brunt of the disease, accounting for over 95% of malaria cases globally.

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The approval of the R21/Matrix-M™ vaccine represents a significant step forward in the global fight against malaria, offering hope for a future free from this deadly disease. And with the support of organizations like the Serum Institute of India, scientists, researchers, and the public and private sectors working together, the goal of eradicating malaria becomes closer to reality.

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