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Novavax Seeks FDA Emergency Authorization For COVID-19 Vaccine


Novavax announced Monday it has formally submitted a request to the U.S Food and Drug Administration (FDA) to grant emergency use authorization (EUA) for its two-dose vaccine, NVX-CoV2373, for people 18 years and older. If granted, NVX-CoV2373 would become the fourth COVID-19 vaccine to be made available in the United States. Currently available COVID-19 vaccines are the mRNA-based vaccines—one from Pfizer-BioNTech and the other from Moderna—as well as the non-replicating viral vector vaccine from Johnson & Johnson. Novavax’s protein-based vaccine was engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the disease COVID-19, also referred to as the CCP (Chinese Communist Party) virus. The vaccine is intended to be administered in two doses 21 days apart. NVX-CoV2373 showed a “reassuring safety profile” in results from two large Phase 3 clinical trials, with an overall efficacy of about 90 percent, the company announced in a release.  » Read full article

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