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Novavax's Updated COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan

Novavax's updated vaccine will be available at vaccination centers across TaiwanGAITHERSBURG, Md., Dec. 18, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX),

articleNovavax, Inc.December 18, 20233/company/novavax-inc/news/novavaxs-updated-covid-19-vaccine-receives-emergency-use-authorization-in-taiwan-2023
Novavax's Updated COVID-19 Vaccine Receives Emergency Use Authorization in Taiwan

About this update from Novavax, Inc.

[{"type":"text","content":"Novavax's updated vaccine will be available at vaccination centers across TaiwanGAITHERSBURG, Md., Dec. 18, 2023 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a global company advancing protein-based vaccines with its Matrix-M™ adjuvant, today announced that the Taiwan Food and Drug Administration has granted emergency use authorization for Nuvaxovid™ XBB.1.5 dispersion for injection COVID-19 Vaccine (recombinant, adjuvanted) (NVX-CoV2601) for active immunization to prevent COVID-19 in individuals aged 12 and older.\nDoses of Novavax's updated vaccine will be delivered to Taiwan under an existing advanced purchase agreement and will be widely available at vaccination centers across Taiwan. More information is available from the Taiwan Centers for Disease Control.\n\"We are working closely with Taiwan's authorities to ensure doses of our updated protein-based non-mRNA COVID-19 vaccine are made available at vaccination centers across Taiwan as soon as possible,\" said John C. Jacobs, President and Chief Executive Officer, Novavax. \"As we head into the holiday season with more time spent together and indoors, COVID-19 infection rates are likely to rise and our best line of defense is vaccination.\"\nAuthorization was based on non-clinical data showing that Novavax's updated COVID-19 vaccine induced functional immune responses for 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 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 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 updated COVID-19 vaccine is also authorized in the U.S., the European Union, Canada and by the World Health Organization, and is under review in other markets.\nTrade Name in the U.S. The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA).\nNOVAVAX COVID-19 VACCINE AUTHORIZE...

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