Distribution of R21/Matrix-MTM across the African region is expected to begin in coming weeks
Serum Institute of India, Novavax and University of Oxford mark achievement during event with Hon. Eric Garcetti, U.S. Ambassador to India, in Pune, India
GAITHERSBURG, Md., May 20, 2024 – Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M adjuvant today celebrated the first shipment of R21/Matrix-M malaria vaccine by its partner, Serum Institute of India (SII). R21/Matrix-M is the second malaria vaccine to be authorized for use in children in malaria-endemic regions and is expected to help close the gap between demand and available doses. Distribution to African countries with a high incidence of malaria is expected to begin over the coming weeks.
"The R21/Matrix-M vaccine is a vital new tool to help stop the devastating health and economic impact of malaria on nearly half of the world's population, including the tragic loss of 1,300 children every single day," said John C. Jacobs, President and Chief Executive Officer, Novavax. "Now more than ever, collaborations are imperative to address unmet needs in preventable infectious disease. Novavax is proud of our partnership with the University of Oxford and Serum Institute of India, and the role of Matrix-M adjuvant in this vaccine, and grateful for the support of Gavi and UNICEF in its rollout."
The shipment was announced during a ceremony held at SII's headquarters in Pune, India, and attended by the Hon. Eric Garcetti, U.S. Ambassador to India; Mr. Adar Poonawalla, CEO, SII; Dr. Mehreen Datoo, Associate Fellow, Clinical Lecturer in Infectious Diseases, Nuffield Department of Medicine University of Oxford; Silvia Taylor, EVP, Chief Corporate Affairs & Advocacy Officer, Novavax and other dignitaries.
Dr. Umesh Shaligram, Executive Director, R&D, Serum Institute of India said, "The commencement of the R21/Matrix-M Malaria Vaccine distribution to Africa represents a groundbreaking advancement in our mission to combat health inequalities worldwide. At the Serum Institute of India, we are incredibly proud to collaborate with our esteemed partners, Novavax and the University of Oxford, as well as Gavi, UNICEF, and the WHO, to make this life-saving vaccine accessible and affordable to those who need it most. Malaria has long been a formidable adversary, claiming countless lives and disproportionately affecting the most vulnerable populations in Africa. By delivering this vaccine to the frontlines, we are not only protecting individuals but also empowering communities and paving the way for a brighter, malaria-free future."
Created by the Jenner Institute of Oxford University and developed by Serum Institute of India, the R21/Matrix-M vaccine contains two key ingredients: the malaria-specific R21 antigen, and Novavax's saponin-based Matrix-M adjuvant to enhance the immune system response, increasing the magnitude and durability of the antibody response. Phase 3 clinical trial results demonstrating safety and efficacy against clinical malaria in children were published in February 2024 in The Lancet.
Professor Adrian Hill, Director of the Jenner Institute at Oxford University, said, "The start of the distribution at large scale of this high efficacy, very cost-effective vaccine should mark a turning point in the battle against malaria."
About Novavax
Novavax, Inc. (Nasdaq: NVAX) promotes improved health by discovering, developing and commercializing innovative vaccines to help 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. The Company's portfolio includes its COVID-19 vaccine, and its pipeline includes COVID-19-Influenza Combination and stand-alone influenza vaccine candidates. In addition, Novavax's adjuvant is included in the University of Oxford and Serum Institute of India's R21/Matrix-M malaria vaccine. Please visit novavax.com and LinkedIn for more information.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, its mission, its partnership with Serum and the impact of the R21/Matrix-M malaria vaccine on the incidence of malaria are forward-looking statements. Novavax cautions that these forward-looking statements are subject to numerous risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, Novavax's ability to successfully supply Matrix-M to its partner; SII's ability to successfully manufacture, distribute, or market the R21/Matrix-M vaccine, challenges satisfying various safety, efficacy, and product characterization requirements, including those related to process qualification, assay validation and stability testing, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, and constraints on Novavax and its partner's ability to pursue planned regulatory pathways in multiple jurisdictions simultaneously, leading to staggered regulatory filings and potential regulatory actions; challenges or delays in conducting clinical trials; challenges or delays in obtaining regulatory authorization; manufacturing, distribution or export delays or challenges; challenges in obtaining adoption and market acceptance of the R21/Matrix-M vaccine; and those other risk factors identified in the "Risk Factors" and "Management's Discussion and Analysis of Financial Condition and Results of Operations" sections of Novavax's Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q, as filed with the Securities and Exchange Commission (SEC). Novavax cautions investors not to place considerable reliance on forward-looking statements contained in this press release. Novavax encourages you to read its filings with the SEC, available at www.sec.gov and www.novavax.com, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this document, and we undertake no obligation to update or revise any of the statements. Novavax's business is subject to substantial risks and uncertainties, including those referenced above. Investors, potential investors, and others should give careful consideration to these risks and uncertainties.
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