Novavax seeks Taiwan FDA emergency use nod for COVID-19 vaccine

Published On 2022-05-14 04:30 GMT   |   Update On 2024-02-16 06:02 GMT
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United States: Novavax has announced the submission of a request for emergency use authorization to Taiwan's Food and Drug Administration for its COVID-19 vaccine, NVX-CoV2373, for active immunization against SARS-CoV-2 in individuals aged 18 and over.

NVX-CoV2373 was created using Novavax' recombinant nanoparticle technology to generate antigen derived from the coronavirus spike (S) protein and is formulated with Novavax' patented saponin-based Matrix-M adjuvant to enhance the immune response and stimulate high levels of neutralizing antibodies. NVX-CoV2373 contains purified protein antigen and can neither replicate, nor can it cause COVID-19.
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The submission includes data from two pivotal Phase 3 clinical trials: PREVENT-19, which enrolled approximately 30,000 participants aged 18 years and older in the U.S. and Mexico and was published in the New England Journal of Medicine (NEJM); and a UK-based trial with almost 15,000 adult participants, also published in NEJM. In both trials, the vaccine demonstrated efficacy with a reassuring safety profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.

Read also: Novavax seeks UK nod for Nuvaxovid use in adolescents aged 12 through 17 years

"Novavax will continue to collect and analyze real-world data, including the monitoring of safety and the evaluation of variants, as the vaccine is distributed," the company stated.

NVX-CoV2373 has received conditional authorization for use in individuals older than 18 years from multiple regulatory agencies worldwide with additional filings currently under review.

Read also: Novavax 2022 COVID vaccine deliveries off to slow start, shares drop



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