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.
Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.
“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.
The Coalition for Epidemic Preparedness Innovations has provided critical support to Novavax, including the commitment of approximately $400 million to advance early clinical development and manufacturing scale-up around the globe.
Nuvaxovid has received authorization for use in individuals aged 18 and over from more than 40 countries in addition to Emergency Use Listing from the World Health Organization.
The Novavax COVID-19 vaccine (NVX-CoV2373) has not yet been authorized for use in the U.S. and the trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration.
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. The vaccine 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.