In October 2023 the University of Oxford announced that the WHO has recommended its malaria vaccine for the prevention of malaria in children. R21/Matrix-M has been endorsed by the WHO Director-General and encouraged by the WHO Strategic Advisory Group of Experts on Immunisation (SAGE) and the Malaria Policy Advisory Group (MPAG). The vaccine was developed by the University and the Serum Institute of India, using Novavax’s adjuvant.
Licensed to the Serum Institute of India, the vaccine uses Novavax’s Matrix-M adjuvant, a saponin-based adjuvant. The Serum Institute has established production capacity for 100 million doses per annum, and this is expected to double over the next two years.
“This scale of production is critical because vaccinating those at high risk of malaria will be important in stemming the spread of disease, as well as protecting the vaccinated.”
Pre-clinical and clinical trial data show good safety and high efficacy in four countries, which informed a “rigorous, detailed scientific review” by WHO. This concluded with the recommendation of the vaccine, the world’s second WHO-recommended vaccine for the prevention of malaria in children.
The vaccine was developed by The Jenner Institute and Serum Institute of India, with support from the European and Developing Countries Clinical Trials Partnership, the Wellcome Trust, and the European Investment Bank. It has already been licensed for use in Ghana, Nigeria, and Burkina Faso. Professor Sir Adrian Hill, Director of the Jenner Institute, emphasised that “multiple clinical studies” have demonstrated the vaccine’s safety and effectiveness.
“The vaccine is easily deployable, cost effective and affordable, ready for distribution in areas where it is needed most, with the potential to save hundreds of thousands of lives a year.”
Dr Mehreen Datoo, Academic Clinical Fellow in Infectious Diseases & Microbiology described Oxford’s programme as “one of the most active malaria vaccine programmes in the world”, thanks to a “network of global collaborators”.
“Today’s achievement would not be possible without the efforts of our international partners, their incredible field teams, and of course, the participants and their caregivers.”
Dr Datoo reflected that, although this is a “significant milestone”, there is “still more to do”.
“We are already working on new vaccine candidates to target other malaria parasites and clinical trials focused on the eradication of malaria.”
Dr Lisa Stockdale, Senior Immunologist, celebrated the news as a “testament to the work of our dedicated team”. However, “further work is critical” in the fight against the disease. Dr Stockdale hopes to establish “not just that the vaccine works”, but to “understand more about how it works, and apply that knowledge to future vaccines”.
A major milestone
Serum Institute of India’s CEO Adar Poonawalla stated that “malaria has threatened the lives of billions of people” for “far too long”, and “disproportionately” affects the “most vulnerable”. Thus, the WHO recommendation “marks a huge milestone on our journey to combat this life-threatening disease”. He commented that this achievement shows what can be achieved when “public and private sector, scientists and researchers, all work together towards a shared goal”.
“As we continue to work together to create a healthier, more equitable world for everyone, I am incredibly proud of the part that the Serum Institute of India has played.”
President and CEO of Novavax, John C. Jacobs, is glad that the designation “highlights the meaningful contribution” that the vaccine will have in “accelerating and expanding access”.
“Novavax celebrates the importance of this milestone and is proud of the role our saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine.”
Demand and supply
WHO notes an “unprecedented” demand for malaria vaccines, with Director-General Dr Tedros Adhanom Ghebreyesus weighing in.
“As a malaria researcher, I used to dream of the day we would have a safe and effective vaccine against malaria. Now we have two.”
He suggested that demand “far exceeds supply”, so having a second vaccine is a “vital additional tool” to protect “more children” and “bring us closer to our vision of a malaria-free future”. Dr Matshidiso Moeti, WHO Regional Director for Africa, agreed.
“This second vaccine holds real potential to close the huge demand-and-supply gap. Delivered to scale and rolled out widely, the two vaccines can help bolster malaria prevention and control efforts.”