Serum - Protection from birth onwards
Phase 3 Trial data results of The R21/Matrix-M™ vaccine developed by Oxford University and Serum Institute of India Pvt Ltd, leveraging Novavax’s Matrix-M™ adjuvant has confirmed high efficacy and supported regulatory approvals and licensure in several African countries. The R21/Matrix-M™ vaccine was designed in 2011 as a potential improvement on the RTS, S/AS01 malaria vaccine designed in the 1980s. A phase II trial in Burkina Faso, reporting in 2021, was the first to show that R21/Matrix-M™ could reach the WHO-specified target of 75% efficacy in African children. Recent WHO endorsement will lead to the initial rollout of R21/Matrix-M™ in the coming months. The new results are published in The Lancet today.
The trial investigators immunised over 4800 young children in a trial in Burkina Faso, Kenya, Mali and Tanzania and found on average 78% vaccine efficacy over the first year of follow-up across all sites in the 5-17-month-old age group, the age range group which is studied for most malaria vaccines. Efficacy over this period was broadly similar across sites and in different transmission settings. Safety data from the trial have been reassuring with no serious adverse events linked to immunisation. No other vaccine has reported over 55% efficacy in the same age group. A booster dose at a year maintained good efficacy over the following 6-12 months. The vaccine also reduced infection rates in children measured at 12 and 18 months after vaccination suggesting a potentially beneficial effect in reducing malaria transmission.
R21/Matrix-M™ vaccine was well tolerated, with injection site pain and fever as the most frequent adverse events. Number of adverse events of special interest and serious adverse events did not significantly differ between the vaccine groups. There were no treatment-related deaths.
Malaria is the largest cause of death in young African children with over 600,000 deaths globally each year. Two vaccines have recently achieved and completed World Health Organization (WHO) prequalification and initial deployments are starting early this year.
Professor Adrian Hill, chief investigator of the R21/Matrix-M™ phase 3 trial said "The continued high efficacy of this new vaccine in field trials is very encouraging, and consistent with the high efficacy and excellent durability observed in a smaller four-year phase IIb trial. These data support an important role for the unique high-density nanoparticle display, of the conserved repeat region of the malaria parasite circumsporozoite protein, a feature in the design of the R21 vaccine, in providing such high vaccine efficacy and, thereby, an important new tool for malaria control".
Significantly increased immune responses to the R21/Matrix-M™ vaccine and slightly higher vaccine efficacy were observed in 5-17-month-olds compared to 18-36-month-olds malaria vaccines, supporting planned vaccine deployment initially from 5 months of age in young African children.
The vaccine is licensed to the Serum Institute of India (SII), the world’s largest vaccine manufacturer and a long-term partner of the University of Oxford. This is critical because vaccinating those at high risk of malaria will be important in stemming the spread of the disease, as well as protecting the vaccinated. Matrix-M™ adjuvant is manufactured by Novavax AB and provided to Serum Institute of India for formulation into the final vaccine drug product.
Adar Poonawalla, CEO, Serum Institute of India, said: "The Lancet study on R21/Matrix-M™ Phase 3 trials mark a significant advancement in our battle against this global threat. Our collaboration with the University of Oxford has been instrumental in developing the R21/Matrix-M™ malaria vaccine. We are dedicated to making this vaccine available, especially in Africa, where malaria poses a substantial threat to millions of lives, bringing us closer to a malaria-free world".
Professor Alassane Dicko, Principal Investigator in Mali of the R21/Matrix-M™ vaccine, said: "It has been very exciting to generate high efficacy data with the new R21/Matrix-M™ vaccine so quickly. I predict that this vaccine should be very impactful in preventing malaria deaths in African children".
John C Jacobs, CEO of Novavax commented "Approximately 1,300 children die from malaria every day, a staggering statistic for a preventable disease. The R21/Matrix-M™ Phase 3 efficacy data published in The Lancet reinforce the potential of R21/Matrix-M™ vaccine to protect children against this disease. We are proud of the role of Novavax's patented saponin-based Matrix-M™ adjuvant, which has been demonstrated to enhance the immune response, in the outcome of this clinical trial and are eager to see the realized impact of the vaccine when it is rolled out globally".
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Notes to editors:
About the University of Oxford
Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the eighth year running, and number 3 in the QS World Rankings 2024. At the heart of this success are the twin pillars of our ground-breaking research and innovation and our distinctive educational offer.
Oxford is world-famous for research and teaching excellence and is home to some of the most talented people from across the globe. Our work helps the lives of millions, solving real-world problems through a huge network of partnerships and collaborations. The breadth and interdisciplinary nature of our research alongside our personalised approach to teaching sparks imaginative and inventive insights and solutions.
Through its research commercialisation arm, Oxford University Innovation, Oxford is the highest university patent filer in the UK and is ranked first in the UK for university spinouts, having created more than 300 new companies since 1988. Over a third of these companies have been created in the last five years. The university is a catalyst for prosperity in Oxfordshire and the United Kingdom, contributing £15.7 billion to the UK economy in 2018/19, and supports more than 28,000 full-time jobs.
About The Jenner Institute
The Jenner Institute, which is where the Oxford-AstraZeneca-Serum Institute Covid-19 vaccine was designed and first made, is based within the Nuffield Department of Medicine, University of Oxford, and operates out of the Old Road Campus Research Building, in Headington, Oxford. The Jenner Institute also supports senior vaccine scientists, known as Jenner Investigators, within many other departments across the University of Oxford, as well as externally with The Pirbright Institute in Surrey, UK. The Jenner Institute brings together investigators who are designing and developing numerous vaccines to generate an exceptional breadth of scientific know-how and critical mass, whilst still allowing the individual investigators to remain independent and accountable to their funders and stakeholders.
The Jenner Institute is supported by the Jenner Vaccine Foundation, a UK registered charity and is advised by the Jenner Institute Scientific Advisory Board.
About the Serum Institute of India Pvt Ltd (SIIPL)
Serum Institute of India Pvt. Ltd, is a global leader in vaccine manufacturing, dedicated to providing affordable vaccines worldwide. Present across 170+ countries, including the US, UK, and Europe, SII holds the distinction of being the world's largest vaccine manufacturer. SII's multifunctional production and one-of-the-largest facility in Manjri, Pune, with an annual capacity of 4 billion doses, has saved over 30 million lives over the years.
Founded in 1966, SII's primary mission is to produce life-saving immunobiological drugs, with a particular emphasis on affordability and accessibility. Guided by a strong commitment to improving global health, the company has played a pivotal role in reducing the prices of essential vaccines, such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps, and Rubella. Notably, they are the manufacturers of 'Pneumosil,' the world's most affordable PCV, and 'Cervavac' the first indigenous qHPV vaccine in India. Moreover, SII has been at the forefront of the global fight against COVID-19, delivering over 2 billion doses of the COVID-19 vaccine worldwide.
To further expand its global presence and ensure widespread vaccine availability, SII has established Serum Life Sciences Ltd, a subsidiary in the UK. Through relentless pursuit of innovation, SII continues to champion the cause of affordable vaccines, making a positive impact on the lives of millions worldwide. www.seruminstitute.com
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to protect against serious infectious diseases. Novavax, a global company based in Gaithersburg, Md., U.S., offers a differentiated vaccine platform that combines a recombinant protein approach, innovative nanoparticle technology and Novavax's patented Matrix-M™ adjuvant to enhance the immune response. Focused on the world's most urgent health challenges, Novavax is currently evaluating vaccines for COVID, influenza, and COVID and influenza combined. Please visit novavax.com and LinkedIn for more information.