(IN BRIEF) The University of Oxford’s R21/Matrix-M™ malaria vaccine, developed in collaboration with the Serum Institute of India and leveraging Novavax’s adjuvant technology, has received a recommendation for use by the World Health Organization (WHO). After rigorous scientific review by the WHO’s independent advisory bodies, the vaccine has been found to meet safety, quality, and effectiveness standards. The R21/Matrix-M™ vaccine is the world’s second-ever WHO recommended vaccine for preventing malaria in children. It has already been licensed for use in Ghana, Nigeria, and Burkina Faso. Clinical trials have shown good safety and high efficacy, with the potential to save hundreds of thousands of lives annually. The Serum Institute of India has established production capacity for 100 million doses per year, with plans to double it over the next two years, making it a critical tool in combating malaria, which claims over half a million lives each year. Additional regulatory approvals are expected soon, with vaccine roll-out as early as next year.
(PRESS RELEASE) OXFORD, 3-Oct-2023 — /EuropaWire/ —
The highly effective vaccine developed by the University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant is critical to reducing over half a million malaria-related deaths annually
- R21/Matrix-M™ malaria vaccine has been recommended for use by the World Health Organization’s Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG)
- Developed by The University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant technology, R21/Matrix-M™ malaria vaccine demonstrates high efficacy with a reassuring safety profile
- The R21/Matrix-M malaria vaccine is an easily deployable vaccine that can be manufactured at mass scale and modest cost, enabling as many as hundreds of millions of doses to be supplied to countries which are suffering a significant malaria burden
- The Serum Institute of India has already established production capacity for 100 million doses per annum, which will be doubled over the next two years
- The World Health Organization’s recommendation today is required for UNICEF to procure and GAVI to purchase the vaccine, paving the way for vaccination of children in populations most at risk
- R21/Matrix-M™ malaria vaccine marks the culmination of 30 years of malaria vaccine research at the University of Oxford’s Jenner Institute
Recommendations from WHO
The R21/Matrix-MTM malaria vaccine developed by the University of Oxford and the Serum Institute of India, leveraging Novavax’s adjuvant technology, has been recommended for use by the World Health Organization (WHO) after meeting required safety, quality and effectiveness standards. [LINK to WHO release]
Following a rigorous, detailed scientific review by the WHO’s independent advisory body, the Strategic Advisory Group of Experts (SAGE) and the Malaria Policy Advisory Group (MPAG), the R21/Matrix-MTM malaria vaccine has been recommended for use. The recommendation 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, making it the world’s second-ever WHO recommended vaccine for preventing malaria in children.
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-MTM 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.
The vaccine has recently 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 under peer review before publication.
The vaccine was well tolerated with a good safety profile. The efficacy of the vaccine over 12 months 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.
There was some waning of efficacy over the first year of follow-up at both seasonal and perennial transmission sites, but a booster dose restored efficacy at the seasonal sites with a vaccine efficacy over 18 months of 74% (70-77; p<0.001).
Significantly higher vaccine-induced antibody titres were observed in the 5–17-month age group compared with 18–36-month-olds (p<0.0001). The younger age group, in whom this vaccine is most likely to be widely deployed, showed the highest 12-month vaccine efficacy at both seasonal, 79% (73-84, p<0.001), and standard sites, 75% (65-83, p<0.001).
In a previous Phase IIb clinical trial conducted in Burkina Faso, Oxford researchers and their partners reported 2 year efficacy and showed that that a booster dose of R21/Matrix-M maintained high efficacy against malaria and continued to meet the World Health Organization’s Malaria Vaccine Technology Roadmap goal of a vaccine with at least 75% efficacy. This followed earlier results from the same trial reporting 1 year efficacy of 77%.
The Phase III results improve understanding of how vaccine efficacy varies with age and across regions in relation to transmission intensity and seasonality. Further studies are also exploring optimal dosing schedules and tracking long-term immune response.
Professor Sir Adrian Hill, Director of The Jenner Institute, & Lakshmi Mittal and family Professor of Vaccinology, University of Oxford said: ‘The R21/Matrix-M™ malaria vaccine has been shown to be safe and highly effective across multiple clinical studies and is now approved as WHO policy for widespread use. 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 at The Jenner Institute, University of Oxford said: ‘The University of Oxford has one of the most active malaria vaccine programmes in the world, with 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. This is a significant milestone in the fight against malaria but there is still more to do – we are already working on new vaccine candidates to target other malaria parasites and clinical trials focussed on eradication of malaria.’
Dr Lisa Stockdale, Senior Immunologist, The Jenner Institute, University of Oxford said: ‘Today’s news is testament to the work of our dedicated team and means we have another tool with which to fight this disease that kills over half a million people every year. However, further work is critical to establish not just that the vaccine works, but to understand more about how it works, and apply that knowledge to future vaccines.’
Adar Poonawalla, CEO of the Serum Institute of India, said: “For far too long, malaria has threatened the lives of billions of people across the globe, disproportionately affecting the most vulnerable amongst us. This is why the WHO recommendation and approval of the R21/Matrix-M™️ vaccine marks a huge milestone on our journey to combat this life-threatening disease, showing what exactly can be achieved when the 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 in developing the R21 malaria vaccine. We look forward to scaling up the vaccine production to ensure that it is accessible to those who need it the most.”
John C. Jacobs, President and Chief Executive Officer, Novavax said: ‘This WHO designation highlights the meaningful contribution that R21/Matrix-M is likely to have in accelerating and expanding access to a safe, efficacious and potentially life-saving vaccine to control malaria – a disease that disproportionately impacts children. Novavax celebrates the importance of this milestone and is proud of the role of our saponin-based Matrix-M adjuvant plays in the R21/Matrix-M malaria vaccine, which has now met the rigorous standards required for WHO recommendation.’
Cost and Manufacturing Capacity
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. Notably, the Serum Institute has already established production capacity for 100 million doses per annum, which will be doubled 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.
The Matrix-M component is a proprietary saponin-based adjuvant from Novavax, which is licensed to the Serum Institute (with royalties) for use in endemic countries, while Novavax retains commercial rights in non-endemic countries. The Serum Institute reports expected production capacity of over 180M doses per year from licensure. The Serum Institute of India are collaborating with DEK Vaccines, Accra, Ghana aiming to develop capacity to undertake fill-finish manufacturing in Ghana.
Vaccine Roll-Out
With the approval and recommendations by the WHO, additional regulatory approvals are expected to follow shortly and R21/Matrix-M vaccine doses could be ready to begin wider roll-out as early as next year.
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 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 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.
About the WHO
The World Health Organization (WHO) plays a singular role in leading the global health ecosystem, producing technical guidelines and tools to prevent and treat disease, and acting as a country-level convener with an unparalleled level of trust. The crises of the 21st century, including COVID-19, have made clear both the inequity of access to effective and affordable healthcare and the indispensable role of WHO. Yet WHO lacks sufficient resources to fulfil its mandate. And, beyond funding, its vision cannot be achieved by the public sector alone. The WHO Foundation was created as an independent Swiss foundation affiliated with but independent of WHO to marshal new resources from philanthropists, foundations, businesses, and individuals to support its mission: promote health, keep the world safe, and serve the vulnerable.
Media Contact:
news.office@admin.ox.ac.uk
+44 (0)1865 280528
Dr. Adriaan Louis Taljaard
Manager Strategic Communications (Vaccines)
Adriaan.taljaard@admin.ox.ac.uk
Source: University of Oxford
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- Origami and citoQualis Team up for Startups
- Digi Communications NV announces Investors Call for the Q3 Financial Results presentation
- Digi Communications N.V. announces the extraordinary general meeting’s resolution from 4 November 2021, approving the appointment of KPMG N.V. as the Company’s statutory auditor for the 2021 financial year
- Digi Communications N.V. announces The solution reached by the Bucharest Court of Appeal regarding the investigation conducted by the Romanian National Anticorruption Directorate with respect to RCS & RDS S.A., Integrasoft S.R.L. and certain of their directors
- Digi Communications N.V. Announces the results of the auction organised by the Portuguese Authority for Telecommunications
- Haizol expands its capabilities to include component assembly and product development
- EIC, the World’s Largest Multinational Innovation Program, to Invest €13.4M in Wi-Charge, a Game Changing Wireless Power Company
- European Weightlifting Federation on its way for Electoral Congress
- “Without women, We are unable to solve the world’s greatest challenges” — She Loves Tech 12 Hot Finalists ready to get their chance at the Local Pitch in South Europe!
- Significant improvement in increasing Time In Range and reducing hypoglycemia among people equipped with Diabeloop DBLG1
- Digi Communications N.V. Announces the Convocation of the Company’s Extraordinary General Meeting of Shareholders on 4 November 2021 in order to appoint KPMG N.V. as the Company’s new statutory auditor for the financial year 2021
- Unit of Measure enters partnership with Stibo Systems
- Haizol, metal manufacturing giant, launch a brand new website which is both user friendly and interactive
- Groundbreaking Immersive Experience from Samsung and Artist Michael Murphy Reveals a New Perspective for Visual Entertainment Through the Stunningly Slim Neo QLED TV
- Collaboration between Airbus and Neural Concept
- Archpriest Nikolay Balashov on Patriarch Bartholomew’s speeches in Kiev
- ABB's Peter Voser joins Xynteo's Europe Delivers partnership as it new Chairman
- Digi Communications NV announces that a new stock option programme was approved
- Leverage the benefits of digital manufacturing with Haizol
- Digi Communications NV announces the release of the H1 2021 Financial Results
- Digi Communications NV announces Investors Call on the Financial Results for H1 2021
- Rockegitarist-Sensasjon Rocky Kramer Har Fått Hovedrollen I Mutt Productions Filmen Rockin’ In Time
- Dispatch.d Offers Unique US Market Entry Services for European Impact Brands
- CSA Research’s New Localization Intelligence Analyzer, powered by LocHub, Helps Organizations Improve their Website’s Effectiveness for Global Customers
- Customer Data Platform Industry Accelerated During Pandemic: CDP Institute Report
- Digi Communications N.V. announces that two of its subsidiaries entered into two facility agreements
- Introducing Cap Expand Partners, Helping Business Leaders Break International Barriers
- Hong Kong’s Innovation and Technology Venture Fund Becomes Strategic Financial Investor of Ignatica
- Cure for prostate cancer on the horizon
- Fanpictor signs multi-year partnership with Royal Belgian Football Association
- Fanpictor unterzeichnet mehrjährige Partnerschaft mit dem Königlich Belgischen Fussballverband
- Fanpictor signe un partenariat pluriannuel avec la Royal Belgian Football Association
- Fanpictor firma una colaboración de varios años con la Real Federación Belga de Fútbol
- Fanpictor firma una partnership pluriennale con la Royal Belgian Football Association
- Fanpictor tekent meerjarige partnership met Koninklijke Belgische Voetbalbond
- Launch of the New Akenza Platform
- De zelflerende algoritme DBLG1®: eenvoudig te gebruiken voor een optimale en gepersonaliseerde behandeling van diabetes type 1
- Launch of the Anna Lindh Foundation Virtual Marathon for Dialogue!
- Digi Communications N.V. announces the exercise of stock options by the Executive Director of the Company pursuant to the decision of the Company’s general meeting of shareholders dated 30 April 2020 and in accordance with the stock option plan approved at the level of the Company in 2017
- New research unlocks long tail growth opportunity for the tech industry
- Digi Communications NV announces the availability of the instructions on the 2020 share dividend payment
- Digi Communications NV announces that conditional stock options were granted to several Directors of the Company based on the approval of the general meeting of shareholders from 18 May 2021
- Digi Communications N.V. Announces the Company’s General Shareholders Meeting resolutions adopted on 18 May 2021 approving, amongst others, the 2020 Annual Accounts
- Digi Communications N.V. (“Digi”) announces the Q1 2021 Financial results
- Digi Communications NV announces Investors Call for the Q1 2021 Financial Results
- Digi Communications N.V. announces an Amendment to the 2021 Financial Calendar
- Fastpayhotels Hits an Industry Milestone by Connecting 500 Hotels Per Day Through DerbySoft Technology
- 4 ways to build a more flexible supply chain
- Join the world's leading virtual CBD event for FREE
- DEEPENING STRATEGIC RELATIONSHIP BETWEEN UBC AND PIONEERING DECENTRALISED PLATFORM, MANYONE
- Mono Solutions recognizes Norwegian small business agency with best website 2021 award
- Mono Solutions and Xrysos Odigos unlock new opportunities for small businesses
- Behind the scenes of a 10,000-people online conference: creating a live-event atmosphere and leveraging cybersecurity software
- Largest Supply Chain for Face masks, FFP2, FFP3 and cloth masks
- TRANSMAR AND TRANSMETRICS SIGN DEAL FOR STATE-OF-THE-ART LOGISTICS COLLABORATION
- Amendment of Digi Communications N.V. Financial Calendar for 2021
- 4iG and Digi Communications NV’s Romanian subsidiary have entered into a term sheet with regards to a potential acquisition by 4iG of DIGI Group’s Hungarian operations
- “Building Healthy Relationships and Enhancing Gender Equality”: Young women from Cyprus, Egypt, Lebanon and Jordan come together
- Bring Ventures investit dans Crossborderit (CBIT), DDP et une solution de commerce électronique
- Bring Ventures investiert in Crossborderit (CBIT), eine DDP (geliefert verzollt) und E-Commerce Lösung
- Bring Ventures invests in Crossborderit (CBIT), DDP and ecommerce solution
- Lionspeed GP with Patrick Kolb and Lorenzo Rocco joins forces with CarCollection Motorsport in 2021
- Eurekos, ein klassenbester LMS-Anbieter, hat seine Position im renommierten Fosway 9-Grid™ für Lernsysteme verbessert
- Eurekos, en førsteklasses LMS-udbyder, har forstærket sin position på den prestigefyldte Fosway 9-Grid™ for læringssystemer
- Eurekos, ein erstklassiger LMS-Anbieter, hat seine Position auf dem renommierten Fosway 9-Grid™ für Lernsysteme weiter ausgebaut
- Digi Communications N.V. announces Share transaction made by an executive director of the Company with class B shares
- Digi Communications N.V.: Announces an Amendment to the Financial Calendar for 2021
- Ideanomics Invests $13M in Italian EV Motorcycle Company, Energica
- DigiSky and Asman Technology Announce Global Reseller Agreement
- Neowintech - O Marketplace Da Sua Próxima Solução Financeira
- Neowintech - Il Marketplace per la tua prossima soluzione finanziaria
- PIONEERING DECENTRALISED SECURE MESSAGING PLATFORM MANYONE ANNOUNCES STRATEGIC RELATIONSHIP WITH UNIVERSITY COLLEGE LONDON CENTRE BLOCKCHAIN TECHNOLOGY
- Digi Communications NV announces the release of the 2020 Preliminary Financial Results
- Fraunhofer IGD develops automated robotic arm to scan cultural objects in 3D, now cooperating with Phase One
- Adapt Fast or Disappear – Choosing the Right Supplier
- Digi Communications NV announces Investors Call for the 2020 Preliminary Financial Results
- A URSAPHARM Arzneimittel e a CEBINA anunciam uma parceria com vista a reaproveitar o anti-histamínico azelastina para combater a COVID-19
- URSAPHARM Arzneimittel et CEBINA annoncent un partenariat pour reconvertir l'antihistaminique azélastine afin de lutter contre la COVID-19
- URSAPHARM Arzneimittel y CEBINA anuncian una colaboración para readaptar el antihistamínico azelastine para combatir la COVID-19
- URSAPHARM Arzneimittel and CEBINA announce partnership to repurpose the antihistamine azelastine to combat COVID-19
- ANIL UZUN Will Launch Bass Guitar Lessons Series on Youtube
- Henrik Stampe Appointed CEO for Mono Solutions
- Anna Mossberg leder Nordens största privata AI-lab i Sverige: "Utan AI riskerar svenska företag att förlora sin konkurrensfördel."
- What COVID-19 has taught us about manufacturing & the importance of a digital online marketplace
- Digi Communications N.V. announces: the Supreme Court of Hungary dismissed the Company’s appeal related to the 5G Tender procedure
- Customer Data Platform Industry to Reach $1.5 Billion in 2021: CDP Institute Report
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GreenMantra Technologies Announces Exclusive Distribution Relationship with HARKE GROUP