Every year 600,000 people die of malaria in Africa, according to the World Health Organization (WHO). Children under five years of age make up at least 80% of those deaths. Although the number of malaria-related deaths has fallen from 3,222 in 2017 to 1,316 in 2020 in Côte d'Ivoire, the mosquito-borne disease kills four people a day, mostly small children, and "remains the leading cause of medical consultations", according to the Ministry of Health.
R21/Matrix-M™ was co-developed by the University of Oxford and Serum Institute of India, leveraging Novavax’s Matrix-M™ adjuvant technology. In December 2023, the WHO granted R21/Matrix-M™ prequalification status, following a rigorous regulatory process and clinical assessment. Trials also demonstrated that the vaccine was well tolerated, with a good safety profile, with injection site pain and fever as the most frequent adverse events.
In anticipation of the roll-out, the Serum Institute of India has manufactured 25 million doses of the vaccine and is committed to scaling up to 100 million doses annually. In keeping with its aim of delivering vaccines at scale and low cost, SII is offering the vaccine at less than $4 per dose. SII’s production capability means this highly effective and affordable, low-dose malaria vaccine can be manufactured at speed and scale, critical to stemming the spread of disease, as well as protecting the vaccinated.
Adar Poonawalla, CEO of Serum Institute of India, says: 'Reducing the malaria burden is finally within sight. Today’s start of the R21/Matrix-M™ vaccine roll-out marks a monumental milestone after years of incredible work with our partners at Oxford and Novavax. At Serum, we believe that it is every person’s right to have access to affordable and essential disease prevention. That’s why we have committed to producing 100 million doses of R21, which will protect millions of lives and alleviate the burden of this deadly disease for future generations. We are thrilled to collaborate with our global partners and excited to continue playing a leading role in eliminating a disease that has been so challenging to beat.'
Today’s vaccination signifies the culmination of years of dedicated research and manufacturing efforts by the University of Oxford and the Serum Institute of India (SII) and is the start of a pivotal phase that could see many lives saved.
Professor Adrian Hill, Director of the Jenner Institute, says: 'The roll-out of the R21/Matrix-M™ malaria vaccine marks the start of a new era in malaria control interventions with the high efficacy vaccine now accessible at a modest price and very large scale to many countries in greatest need. We hope that very soon this vaccine can be provided to all countries in Africa who wish to use it.'
A total of 656,600 doses have been received, which will initially vaccinate 250,000 children aged between 0 and 23 months across 16 regions of Côte d'Ivoire. The R21/Matrix-M vaccine has also been authorised by Ghana, Nigeria, Burkina Faso and the Central African Republic.
R21 is the second malaria vaccine available in Sub-Saharan Africa following RTS,S. WHO expert reviews of data of the two available malaria vaccines, RTS,S and R21 shows that both vaccines are expected to have high public health impact. Wide implementation of the malaria vaccines, in conjunction with existing prevention methods like the use of bed nets, is expected to save tens of thousands of young lives each year.
Gavi, WHO, UNICEF, the Global Fund and others are working with countries on their plans for vaccine roll out as part of holistic malaria control and prevention plans. In total, 15 African countries are expected to introduce malaria vaccines with Gavi support in 2024, and countries plan to reach around 6.6 million children with the malaria vaccine in 2024 and 2025. Gavi and partners are working with more than 30 African countries that have expressed interest in introducing the malaria vaccine.
Dr. Sania Nishtar, Chief Executive Officer of Gavi, the Vaccine Alliance said: 'Africa has borne the brunt of malaria for far too long, and Côte d'Ivoire has suffered more than most. With two safe and effective vaccines now available alongside other interventions, we have an opportunity to finally turn the tide against this killer disease.'
John Jacobs, President and Chief Executive Officer, Novavax, says: 'The introduction of the R21/Matrix-M™ malaria vaccine in Côte d'Ivoire marks a breakthrough in the fight to protect vulnerable children against a leading cause of death across the region, while reinforcing our mission to create innovative vaccines that improve public health. Novavax is proud of the contribution of our Matrix-M™ adjuvant in this vaccine and in making this moment possible, and value our continued collaboration with University of Oxford and Serum Institute of India, as well as the lifesaving work of WHO, Gavi and UNICEF.'
The extraordinary journey behind the vaccine has been captured in a new documentary, following the development, trials and manufacturing of R21/Matrix-M™ over several years. Due to be broadcast by the BBC on 22 July (8pm BBC Two) following its premiere on PBS/NOVA The Battle to Beat Malaria tells the inside story of this historic breakthrough, revealing the decades of scientific research, as well as providing an intimate look at the scientists, medics, pharmaceutical engineers, and trial participants battling this deadly disease.