Novavax to Supply Updated COVID-19 Vaccine to Private Healthcare Providers in the United Kingdom
For Global Investor Audience Only
Novavax’s Nuvaxovid XBB.1.5 dispersion for injection, COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) is now available to pharmacies across the United Kingdom (U.K.) for private healthcare providers to offer an updated protein-based non-mRNA option as part of the 2024 vaccination season.
Today is an important milestone for our organization. It demonstrates our commitment to deliver an updated protein-based COVID-19 vaccine as we evolve into an endemic market. It also underscores our place as a long-term partner to public health. We believe a diverse vaccine portfolio and broader access can play vital roles in protecting communities in the U.K. and elsewhere.
Our participation in the U.K. private market follows receipt of a Wholesale Dealers License from the U.K. Medicines and Healthcare products Regulatory Agency as well as the U.K. Health Security Agency’s latest Green Book update in February 2024 to include our updated COVID-19 vaccine for active immunization to prevent COVID-19 in individuals aged 12 and older.
A key component of Novavax's COVID-19 vaccine is our Matrix-M™ adjuvant which enhances the antigen-specific immune system response, making it broader and more durable. The adjuvant is also used in the R21/Matrix-M™ malaria vaccine, developed by University of Oxford and the Serum Institute of India, as well as development-stage vaccines, including our COVID-19-Influenza Combination vaccine candidate and influenza vaccine candidate.
In 2023, Novavax signed a three-year agreement with the Bill & Melinda Gates Medical Research Institute to provide Matrix-M for use in preclinical vaccine research, helping to develop biomedical interventions that address global health concerns for those in the greatest need.
Forward-Looking Statements
Statements herein relating to the future of Novavax, its operating plans and prospects, including the availability of its updated XBB version of its Novavax COVID-19 (recombinant, adjuvanted) (NVX-CoV2601) and the timing of delivery and distribution of its vaccine in the United Kingdom 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, challenges satisfying, alone or together with partners, various safety, efficacy, and product characterization requirements, including those related to process qualification and assay validation, necessary to satisfy applicable regulatory authorities; difficulty obtaining scarce raw materials and supplies; resource constraints, including human capital and manufacturing capacity, on the ability of Novavax to pursue planned regulatory pathways; challenges or delays in obtaining regulatory authorization for its product candidates, including its updated XBB version of its COVID-19 vaccine in time for the 2024-2025vaccination season or for future COVID-19 variant strain changes; challenges or delays in clinical trials; manufacturing, distribution or export delays or challenges; Novavax's exclusive dependence on Serum Institute of India Pvt. Ltd. for co-formulation and filling and the impact of any delays or disruptions in their operations on the delivery of customer orders; challenges meeting contractual requirements under agreements with multiple commercial, governmental, and other entities; 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). We caution investors not to place considerable reliance on forward-looking statements contained in this press release. You are encouraged to read our 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. Our 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.