Novavax COVID vaccine gets interim authorization in Singapore
Gaithersburg: Novavax, Inc has recently announced that the Singapore Health Sciences Authority (HSA) has issued interim authorization for Nuvaxovid COVID-19 Vaccine (recombinant, adjuvanted) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 18 years of age and older. The vaccine, also known as NVX-CoV2373, is the first protein-based vaccine to be authorized for use in Singapore.
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. 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.
"We thank the HSA for its partnership, and we are proud that Singapore is now part of the growing list of regions to have authorized the Novavax vaccine and will have a protein-based option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "This authorization demonstrates our commitment to deliver our COVID-19 vaccine, built on a well-understood vaccine platform, worldwide to help combat the evolving pandemic."
The clinical trial data submitted to HSA for review 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 trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, NVX-CoV2373 demonstrated efficacy and a reassuring safety and tolerability profile. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups.
Initial doses of Nuvaxovid are expected to arrive in Singapore by the end of March. The brand name Nuvaxovid has not yet been authorized for use in the U.S. by the FDA.
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