15 February 2022 | Tuesday | News
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Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today 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.
"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. The most common adverse reactions observed during clinical studies (frequency category of very common ≥1/10) were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. 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.
Initial doses of Nuvaxovid are expected to arrive in Singapore by the end of March. For more information on Nuvaxovid, including the Summary of Product Characteristics, Prescribing Information and Important Safety Information, or to request additional information please visit the following websites:
The brand name Nuvaxovid™ has not yet been authorized for use in the U.S. by the FDA.
Important Safety Information
For additional information, please visit www.NovavaxCovidVaccine.com for the full Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, or to request additional information.