R21/Matrix-M vaccine gets WHO green light for global rollout

The R21/Matrix-M™ malaria vaccine is one step closer to mass rollout, after officially receiving WHO prequalification status, making it eligible for procurement by United Nations agencies.

• R21/Matrix-M™ the highly effective malaria vaccine developed by The University of Oxford and the Serum Institute of India, leveraging Novavax's adjuvant technology, has been awarded prequalification status by the World Health Organization - meaning it is one step closer to being deployed in populations most at risk.

• This important regulatory milestone acts as a mandatory prerequisite for UNICEF to procure and GAVI to purchase the highly effective vaccine.

• The announcement follows an earlier recommendation issued in October by the Strategic Advisory Group of Experts (SAGE) to approve the vaccine based on its robust efficacy and safety profile.

• The vaccine is easily deployable and can be manufactured at mass scale and affordable cost, with the Serum Institute of India already establishing production capacity for 100 million doses per annum, which will be doubled over the next two years.

Today 21^st December 2023 the R21/Matrix-M^TM malaria vaccine developed by the University of Oxford and the Serum Institute of India, leveraging Novavax's adjuvant technology, has been awarded prequalification status by the World Health Organization (WHO). This milestone represents a key step in making the vaccine accessible to those who need it the most. It follows the conclusion of a rigorous regulatory process and clinical assessment, supporting the vaccine's efficacy and safety.

The prequalification moment comes shortly after the vaccine has been recommended for use by the WHO's independent advisory body, the Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG) in October 2023 for preventing malaria in children. The decision was based on pre-clinical and clinical trial data which showed good safety and high efficacy in four countries, at sites with both seasonal and perennial malaria transmission.

Professor Sir Adrian Hill, Director of The Jenner Institute, & Lakshmi Mittal and family Professor of Vaccinology, University of Oxford said: "Over 600,000 deaths mainly amongst children are caused by malaria each year.  The disease presents a uniquely difficult scientific challenge: the complex composition of malaria parasites with shape-shifting pathogen that has learned how to evade our immune system, has made the development of an effective vaccine a formidable task. R21/Matrix-M™ represents the culmination of 30 years of collaborative research and development by the University of Oxford Jenner Institute and, since 2017 in partnership with the Serum Institute of India."

The R21/Matrix-M™ vaccine is licensed to the Serum Institute of India, the world's largest vaccine manufacturer as well as a long-term partner of Oxford University. SII's production capability 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.

Adar Poonawalla, CEO of the Serum Institute of India, said: "Today's approval marks a triumph for science, collaboration, and our shared vision for a malaria-free world. This achievement inspires us to dream bigger, work harder, and strive towards a future where we can offer better solutions for the millions burdened by this disease. Together with Oxford, we envision a world where every individual, regardless of their circumstances, has access to the protection they deserve.

"This milestone is not just a validation of our efforts but a promise to those who have long awaited this news. The Serum Institute of India remains unwavering in its commitment to making this vaccine a global success, ensuring it reaches every corner where it may be needed. This is why we stand ready to produce up 100 million doses for the first year, which will be scaled up to 200 million doses (per annum) over the next two years."

In clinical trials, the vaccine has reached the primary one-year endpoint in a pivotal large-scale Phase III clinical trial - funded mainly by the Serum Institute of India, with Oxford University as the regulatory sponsor - including 4,800 children across Burkina Faso, Kenya, Mali and Tanzania. The Phase III trial results are now accepted for publication. Results showed the vaccine was well tolerated with a good safety profile. The efficacy of the vaccine over 12 months in 5-36-month-old children was 75% (95% CI 71-79; p<0.001) at sites with high seasonal malaria transmission and 68% (61-74; p<0.001) at the sites with more perennial transmission using standard age-based administration, with higher efficacy in 5-17-month-olds.

John C. Jacobs, President, and Chief Executive Officer, Novavax said: "WHO prequalification for R21/Matrix-M™ demonstrates how strategic partnerships can come together to successfully protect global public health. Novavax celebrates this moment and is proud of the impact our Matrix-M adjuvant may have with this pediatric malaria vaccine in regions that need it most."

The vaccine was developed by the Jenner Institute at Oxford University and Serum Institute of India with support from the European and Developing Countries Clinical Trials Partnership ('EDCTP'), the Wellcome Trust, and the European Investment Bank ('EIB'). To date, the R21/Matrix-M^TM malaria vaccine has been licensed for use in Ghana, Nigeria and Burkina Faso.

In combination with public health measures such as the use of insecticide-treated bed nets, this vaccine can help save and improve the lives of millions of children and their families and the extraordinary journey behind it has recently been documented by Wingspan Productions in association with HHMI Tangled Bank Studios. Expected to be broadcasted on the BBC in 2024, "The Battle to Beat Malaria" tells the inside story of this historic breakthrough, detailing the culmination of a decade's worth of scientific research as well as providing an intimate look at the scientists, medics, pharmaceutical engineers, and trial participants battling this deadly disease.