Novavax COVID vaccine gets emergency use nod in Taiwan for adults
NVX-CoV2373 is a protein-based vaccine engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes COVID-19 disease.;
Gaithersburg: Novavax, Inc. has announced that the Taiwan Food and Drug Administration has granted emergency use authorization (EUA) for Nuvaxovid (NVX-CoV2373) COVID-19 vaccine in individuals aged 18 years and over.
Novavax and Taiwan have executed a supply agreement and the doses for Taiwan would represent the first shipment of Nuvaxovid to a country participating under the COVAX Facility. COVAX was established to allocate and distribute vaccines equitably to participating countries and economies.
"The authorization in Taiwan is a testament to our continued global efforts to ensure access to diversified vaccine options," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As we continue to see surges of COVID-19, we believe that additional vaccine options will bolster the global vaccination rate and help reduce the impact of COVID-19."
The EUA was based on the totality of preclinical, manufacturing and clinical trial data submitted for review. This includes 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 and tolerability profile.
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