Anonymous
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PRESS RELEASE PR Newswire
Apr. 13, 2022, 06:00 AM
Nuvaxovid™ is the first protein-based COVID-19 vaccine authorized for use in Switzerland
GAITHERSBURG, Md., April 13, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization (CMA) 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 Switzerland.
"We are proud that Switzerland is part of the growing list of countries to authorize Nuvaxovid and that people in Switzerland will have a protein-based COVID-19 vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As we continue to fight COVID-19, we think it is incredibly important that people have a choice in vaccine options. Nuvaxovid offers something different from the current portfolio of vaccines by using a more tried and tested technology platform, while still providing a strong efficacy and safety profile."
The Swissmedic decision 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 trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, the vaccine 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.
Novavax previously announced an agreement with the government of Switzerland for up to six million doses of Novavax' COVID-19 vaccine. For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, 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...
Apr. 13, 2022, 06:00 AM
Nuvaxovid™ is the first protein-based COVID-19 vaccine authorized for use in Switzerland
GAITHERSBURG, Md., April 13, 2022 /PRNewswire/ -- Novavax, Inc. (Nasdaq: NVAX), a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced that Swissmedic, the Swiss Agency for Therapeutic Products, has granted Novavax conditional marketing authorization (CMA) 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 Switzerland.
"We are proud that Switzerland is part of the growing list of countries to authorize Nuvaxovid and that people in Switzerland will have a protein-based COVID-19 vaccine option," said Stanley C. Erck, President and Chief Executive Officer, Novavax. "As we continue to fight COVID-19, we think it is incredibly important that people have a choice in vaccine options. Nuvaxovid offers something different from the current portfolio of vaccines by using a more tried and tested technology platform, while still providing a strong efficacy and safety profile."
The Swissmedic decision 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 trial with almost 15,000 adult participants in the U.K. which was also published in NEJM. In both trials, the vaccine 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.
Novavax previously announced an agreement with the government of Switzerland for up to six million doses of Novavax' COVID-19 vaccine. For more information on Nuvaxovid, including the Summary of Product Characteristics with Package Leaflet, Prescribing Information and Important Safety Information, adverse event reporting instructions, 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...
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