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Novavax's Updated COVID-19 Vaccine Now Approved in the EU
Novavax's updated COVID-19 vaccine is the only updated protein-based non-mRNA COVID-19 vaccine available in the European Union for individuals aged 12 and
About this update from Novavax, Inc.
[{"type":"text","content":"Novavax's updated COVID-19 vaccine is the only updated protein-based non-mRNA COVID-19 vaccine available in the European Union for individuals aged 12 and olderNovavax is working closely with EU member states to bring its updated COVID-19 vaccine to those that have requested doses through the advance purchase agreementGAITHERSBURG, Md., Oct. 31, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced the European Commission has granted approval for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 12 and older. This decision follows positive opinion for approval from the Committee for Medicinal Products for Human Use of the European Medicines Agency.\n\"Today's approval of the only updated protein-based non-mRNA COVID-19 vaccine in the EU is an important milestone as the need for vaccination continues,\" said John C. Jacobs, President and Chief Executive Officer, Novavax. \"Novavax is working closely with national authorities to have our updated vaccine delivered and available in Europe in the coming weeks.\"\nNovavax is working closely with EU member states that have requested doses through the advance purchase agreement to confirm timing of dose delivery on a country-by-country basis.\nApproval was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses against XBB.1.5, XBB.1.16 and XBB.2.3 variants. Additional non-clinical data demonstrated that Novavax's vaccine induced neutralizing antibody responses to newly emerging subvariants BA.2.86, EG.5.1 FL.1.5.1 and XBB.1.16.6 as well as CD4+ polyfunctional cellular (T-cell) responses against EG.5.1 and XBB.1.16.6. These data indicate Novavax's vaccine can stimulate both arms of the immune system and may induce a broad response against circulating variants.1,2\nIn clinical trials, the most common adverse reactions associated with Novavax's prototype COVID-19 vaccine (NVX-CoV2373) included headache, nausea or vomiting, muscle pain, joint pain, injection site tenderness, injection site pain, fatigue and malaise.\nNovavax's vaccine is authorized for use in the U.S. and is currently under review in other marke...