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R21/Matrix-M™ Oxford-developed malaria vaccine, manufactured by SIIPL and scaled up with Novavax’s adjuvant, licensed in Ghana by FDA.

This breakthrough marks a major milestone in the fight against malaria, as Ghana becomes the first country to grant national licensure for the R21/Matrix-M™ vaccine.

A Crucial Step in Malaria Eradication

The R21/Matrix-M™ malaria vaccine has been granted full approval by the country’s Food and Drugs Authority (FDA Ghana) for use in children aged 5 to 36 months, the most vulnerable age group at high risk of death from malaria. With this regulatory clearance, the vaccine is expected to play a pivotal role in combating malaria and improving the health outcomes of Ghanaian and African children.

Unprecedented Efficacy and Safety

The R21/Matrix-M™ vaccine has demonstrated exceptional efficacy and safety in Phase II trials, showcasing its potential to be a game-changer in malaria prevention. Notably, the vaccine has shown high efficacy even among children who received a booster dose one year after the primary three-dose regime. These promising results highlight the effectiveness of the vaccine and its potential to meet the World Health Organization’s Malaria Vaccine Technology Roadmap goal of at least 75% efficacy.

Decades of Research and Collaboration

The development of the R21/Matrix-M™ malaria vaccine is the culmination of 30 years of malaria vaccine research at the University of Oxford. The vaccine has undergone rigorous clinical trials in the UK, Thailand, and several African countries, including Burkina Faso, Kenya, Mali, and Tanzania. The ongoing Phase III trial, which has enrolled 4,800 children, aims to gather further data on the vaccine’s efficacy and safety.

The collaboration between Oxford University and Serum Institute of India has been instrumental in the successful large-scale manufacturing and rapid development of the vaccine. Serum Institute of India, the manufacturing and commercialization license holder for the vaccine, has showcased its commitment to combatting malaria by providing vaccines and sponsoring Phase III licensure clinical trials.

Matrix-M™ Adjuvant Enhancing Vaccine Potency

The R21/Matrix-M™ malaria vaccine incorporates Novavax’s Matrix-M™ adjuvant, a saponin-based component that enhances the immune system response. The adjuvant promotes antigen-presenting cell entry and enhances antigen presentation in local lymph nodes at the injection site. Novavax’s Matrix-M™ adjuvant has also been successfully used in their COVID-19 vaccine and shows promise in other development-stage vaccines.

A Low-Cost, High-Impact Solution

One of the key advantages of the R21/Matrix-M™ malaria vaccine is its low-dose formulation, allowing for mass-scale production at a modest cost. This scalability enables the supply of hundreds of millions of doses to African countries burdened by malaria. The Serum Institute of India has already set up manufacturing capacities capable of producing over 200 million doses annually, positioning them to contribute significantly to malaria eradication efforts.

A Collaborative Approach for Global Health

The licensure of the R21/Matrix-M™ Malaria Vaccine in Ghana represents a significant milestone in the global fight against malaria. It underscores the importance of collaboration between research institutions, vaccine manufacturers, regulatory authorities, and governments in addressing public health challenges. By working together, we can ensure equitable access to life-saving vaccines and make substantial progress in reducing malaria-related deaths worldwide.

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