Novavax unveiled the successful results of the phase-1 clinical trial on a Covid-19 vaccine candidate, NVX-CoV2373, Wednesday. The company said its vaccine candidate showed immunogenicity safely on day 35.The outcome is expected to give an advantage to SK Bioscience, which earlier clinched a deal with the U.S. biotech firm to manufacture the experimental vaccine and supply it globally.
The New England Journal of Medicine (NEJM) on Wednesday published the article, titled, “Phase 1–2 Trial of a SARS-CoV-2 Recombinant Spike Protein Nanoparticle Vaccine.”NVX-CoV2373 is a nanoparticle vaccine candidate made by expressing the COVID-19 spike protein in insect cells with recombinant technology. Administering an inactivated vaccine to the human body can induce neutralizing antibodies.
Sanofi, GSK Start COVID-19 Vaccine Trial, Eye H1 2021 Approval
Sanofi and GlaxoSmithKline have moved their adjuvanted protein-based COVID-19 vaccine into the clinic, setting them on a path they expect to lead to a filing for approval in the first half of next year. The phase 1/2 trial will enroll 440 people across 11 U.S. clinical trial sites. If all goes to plan, Sanofi and GSK will have safety, tolerability and immunogenicity data from the study in December and move into phase 3 later that month. The partners expect to have the data to support a filing for approval of their two-dose adjuvanted vaccine regimen in the first half of 2021.
Sanofi and GSK are moving into the clinic on the strength of preclinical data they say suggests their vaccine has an acceptable tolerability profile and triggers the production of neutralizing antibodies at levels comparable to those seen in convalescent patients. While companies such as AstraZeneca and Moderna have rapidly advanced COVID-19 vaccines based on relatively new, unproven technologies, Sanofi and GSK have chosen a more established platform. That has put Sanofi and GSK well behind the front-runners—they are entering the clinic as rivals race to finish phase 3 trials—but could make them a force to be reckoned with once they get to market.