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Novavax Vaccine to be Evaluated in U.S. Phase-3 Trial

12/29/2020

Novovax is now recruiting candidates for a Phase-3 trial of their NVX-CoV2373 vaccine in the U.S.  According to NIAID Director, Dr. Anthony S. Fauci "the launch of this study, the fifth investigational COVID-19 vaccine candidate to be tested in a Phase-3 trial in the United States, demonstrates our resolve to end the pandemic through development of multiple safe and effective vaccines". 

 

In preliminary trials, NVX-CoV2373 stimulated antibody that blocked SARS-CoV-2 spike protein from binding to cell-surface receptors.  A Phase-1 clinical trial demonstrated development of acceptable antibody levels without adverse reactions.  The vaccine is undergoing a Phase-2b trial in South Africa and 15,000 volunteers have been enrolled for a Phase-3 trial in the United Kingdom.

 

The trial will be under the oversight of the independent Data and Safety Monitoring Board in consultation with the NIH Accelerating COVID-19 Therapeutic Interventions and Vaccines  (ACTIV) initiative.

 

 The Novovax NVX-CoV2373 product deploys a custom-made spike protein mimicking the natural spike protein in the novel coronavirus. The vaccine incorporates a matrix-adjuvant responsible for an enhanced immune response. Novovax vaccine will be administered in two doses as with the mRNA vaccines currently administered under FDA Emergency Use Approval.