Novavax announced it has submitted the final round of data on its COVID-19 vaccine to the U.S. Food and Drug Administration (FDA) in anticipation of submitting a request to the agency for emergency use authorization (EUA) in a month. The final data is related to the vaccine’s manufacturing processes, and its submission is the final prerequisite for the EUA application. The two-dose vaccine by Novavax, NVX-CoV2373, was engineered from the genetic sequence of the first strain of SARS-CoV-2, the virus that causes the disease COVID-19. It is protein-based, which sets it apart from currently available vaccines in the United States: the mRNA-based vaccines from Pfizer and Moderna, and the non-replicating viral vector vaccine from Johnson & Johnson. “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 …
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