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Novavax Prepared to Deliver Protein-based Monovalent XBB COVID Vaccine Consistent with FDA VRBPAC Recommendation for the Fall
Novavax has developed a protein-based monovalent XBB.1.5 COVID vaccine candidate and is manufacturing at commercial scale with the intent to be in market
About this update from Novavax, Inc.
[{"type":"text","content":"Novavax has developed a protein-based monovalent XBB.1.5 COVID vaccine candidate and is manufacturing at commercial scale with the intent to be in market during the fall vaccination campaignNovavax shared data demonstrating that its XBB.1.5 COVID vaccine candidate induces functional immune responses to XBB subvariants including XBB.1.5, XBB.1.16 and XBB.2.3If authorized, Novavax's protein-based vaccine candidate would be the only non-mRNA XBB.1.5 vaccine available in the U.S.Novavax intends to supply vaccine globally, consistent with FDA, WHO and EMA recommendationsGAITHERSBURG, Md., June 15, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its novel Matrix-M™ adjuvant, participated in today's U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee's (VRBPAC) meeting, which resulted in a unanimous vote recommending updating the current COVID vaccine composition to a monovalent XBB-lineage.\n\"Novavax expects to be ready for the commercial delivery of a protein-based monovalent XBB COVID vaccine this fall in line with today's VRBPAC recommendation,\" said John C. Jacobs, President and Chief Executive Officer, Novavax. \"In partnership with regulators and public health authorities, Novavax has been developing and manufacturing this vaccine candidate, and now that we are nearing harmonization on guidance from the FDA, the World Health Organization and European Medicines Agency, we believe we are in a better position to offer an alternative vaccine choice for individuals worldwide.\"\nNovavax presented data at the VRBPAC meeting that supports the recommendation to vaccinate this fall with a monovalent XBB strain. Novavax data showed that its XBB.1.5 COVID vaccine candidate induced functional immune responses for XBB.1.5, XBB.1.16 and XBB.2.3 variants, indicating a broad response that could potentially be applicable for forward-drift variants.\nNovavax will seek updated FDA labeling for its XBB COVID vaccine candidate with the goal of it being available and accessible on par with other COVID vaccines.\nAuthorized Use of the Novavax COVID-19 Vaccine, Adjuvanted in the U.S.The Novavax COVID-19 Vaccine, Adjuvanted vaccine has not been approved or licensed by the U.S. FDA, but has been authorized for emergency use by FDA, under an Emergen...