VPM contributes to the successful licensure of the novel malaria vaccine R21/Matrix-M^TM for first use in Ghana

Hannover, Germany – Vakzine Projekt Management GmbH (VPM) is delighted to announce the successful licensing of the novel R21/Matrix-M^TM Malaria Vaccine by the Ghana Food and Drugs Authority (FDA) for use in children as young as 5 months old up to 36 months old, in Ghana. This approval is an exciting milestone and was achieved by the joint global efforts of VPM, Serum Institute of India (SII), Oxford University, and DEK Vaccines Ltd (DEK). This synergistic collaboration facilitated the accelerated licensure process in Ghana and is a step forward on the path to ensuring vaccine equity in Africa.

Malaria is one of the leading causes of pediatric morbidity and mortality in sub-Saharan Africa. Children under 5 account for approximately 80% of all malaria-related deaths. R21/Matrix-M^TM has emerged as the most effective vaccine against malaria ever produced and shall contribute to alleviating the burden of 600,000 deaths per year. R21/Matrix-M^TM was initially developed by the lab research team of Adrian Hill, also Chief investigator of the R21/Matrix-M^TM program, and Director of the University of Oxford’s Jenner Institute. SII then licensed and scaled up manufacturing of R21/Matrix-M^TM for commercial use. Based on available clinical data, the efficacy of the vaccine is greater than 75%, which is far above the efficacy of the only other currently approved malaria vaccine. Notably, the manufacturing capacity of 200 million doses/year by SII will increase the current supply capacities by >20-fold globally.

Adar Poonawalla, CEO, Serum Institute of India, shared, “Malaria is a life-threatening disease that disproportionately affects the most vulnerable populations in our society and remains a leading cause of death in childhood. Developing a vaccine to greatly impact this huge disease burden has been extraordinarily difficult. At the Serum Institute of India, we are committed to our vision of Health for All and ensuring equitable access to vaccines for people around the world. The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana and Nigeria is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives.”

VPM was key in connecting the global partners for the approval of R21/Matrix-M^TM in Ghana. DEK is a Ghanaian consortium that aims to produce its own vaccines in Ghana to secure local vaccine availability in Ghana, and eventually all of Africa. SII is the world’s largest vaccine manufacturer by doses produced and is the manufacturing and commercialization license holder for R21/Matrix-M^TM. By leveraging its expertise and excellent network, VPM helped DEK and SII foster a mutually beneficial partnership that led to global success.

The marketing authorization of R21/Matrix-M^TM was achieved at an incredibly high pace thanks to the efficient orchestration by VPM and the regulatory expertise of DEK and SII. Other African national regulators authorities are following the positive opinion of the FDA Ghana and granted marketing authorization in their countries, and more African countries are expected to follow.

This achievement also coincides with another crucial milestone: the ground-breaking ceremony of the unveiling of DEK's new vaccine manufacturing facility in Accra, Ghana. This exciting endeavor represents a major step forward for independent vaccine production and equity in Africa.

VPM is proud to have contributed to this major success. “This partnership is a proof of our ambition towards supporting the development of safe and effective vaccines to ensure healthy living for all,” said by Dr. Leander Grode, Managing Director of VPM. “Our expertise in vaccine development, and our collaboration with global institutions and vaccine developers and manufacturers, further validates our role as a leading consultancy in the pharmaceutical industry."

VPM remains committed to advancing innovative research and development and working collaboratively with global partners to transform ground-breaking ideas into life-saving medication.

About Vakzine Projekt Management

Vakzine Projekt Management GmbH (VPM) is a German consultancy and service provider established in 2002. Within the last two decades, VPM has successfully managed the development of promising biopharmaceutical candidates, ranging from small molecules, recombinant proteins up to gene-modified live vaccines and ATMPs. VPM clients are small, medium, and large biopharmaceutical enterprises, as well as private funding organizations, and research groups. VPM brought their products from preclinical stage through clinical phases I-II-III up to approval.

Since 2012 VPM has its consulting and service business. Based on its in-depth experience and a strong network of reliable partners, VPM offers tailor-made hands-on services. The consulting and service offers refer to the entire product development phases as VPM has successfully progressed its own products along the development value chain. Read more about VPM on: https://www.vpm-consult.com/en/

About Serum Institute of India

Driven by the philanthropic philosophy of striving to make vaccines affordable around the world, Serum Institute of India Pvt (SII), Ltd. is the world’s largest vaccine manufacturer by number of doses produced and sold globally (more than 2.5 billion doses), supplying the world’s least expensive and WHO-accredited vaccines to as many as 170 countries. It was founded in 1966 with the aim of manufacturing lifesaving immunobiological drugs including vaccines worldwide. With a strong commitment towards global health, the institute’s objective has been proliferated by bringing down the prices of newer vaccines such as Diphtheria, Tetanus, Pertussis, HIB, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. SII is credited with bringing world-class technology to India, through its state-of-the-art equipped multifunctional production facility in Manjri, Pune along with spearheading the race of vaccine development against the COVID-19 pandemic. Serum Life Sciences Ltd is a subsidiary company of Serum Institute of India, with a global sales office in London to market vaccines manufactured by Serum Institute of India.

About the University of Oxford

Oxford University has been placed number 1 in the Times Higher Education World University Rankings for the seventh year running, and number 2 in the QS World Rankings 2022. At the heart of its success are the twin-pillars of their ground-breaking research and innovation and their distinctive educational offer.

Through its research commercialization 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 200 new companies since 1988. Over a third of these companies have been created in the past three 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 DEK Vaccines Ltd.

DEK Vaccines Ltd. (DEK) is an offshoot of Kinapharma Ltd.  DEK is an upcoming multiple vaccines manufacturing factory by the way of Fill & Finish being constructed in Accra, Ghana. DEK implements the Government of Ghana’s vision to achieve health security through production of vaccines for Africa in Ghana.

Contact

VPM
Dr. Leander Grode, CEO
Tel: +49 511 16 99 08 19
info@vakzine-manager.de