Novavax said Tuesday that it has so far recruited over 5500 participants in a Phase III trial of its COVID-19 vaccine candidate NVX‑CoV2373 in the UK, and that the original estimated study size of 10,000 volunteers has been expanded to 15,000, with full enrolment likely to be completed by the end of November. The company also expects a pivotal trial of the vaccine to begin in the US and Mexico by the end of next month as well, saying it has made "significant progress" with the large-scale manufacturing process, which has delayed the study start by roughly a month versus the original timing estimates.
In regards to the UK trial, which will include participants between the ages of 18 and 84 years, with and without comorbidities, Novavax said interim data are expected as soon as early first quarter of 2021, depending on the overall COVID-19 attack rate. Gregory Glenn, president of R&D at Novavax, explained that "recognising the recent, large increase in the number of COVID-19 cases in the UK, as well as the rapid progress in participant enrolment for our trial…we adjusted our plans and increased enrollment." The company added that the findings are expected to serve as the basis for global licensure.
For the US trial, Novavax said it has been developing large-scale manufacturing processes at multiple locations around the world, and plans to use production from its contract manufacturing site in Morrisville, North Carolina, for the clinical trial.
Phase I study data published in the NEJM last month showed that NVX-CoV2373 was generally well-tolerated in healthy adults 18 to 59 years of age, and also elicited "robust antibody responses numerically superior to that seen in human convalescent sera." On Tuesday, Novavax said it plans to present results from its ongoing Phase I/II trial, including new mid-stage reactogenicity data, during the US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) meeting on October 30.
In August, Novavax said it would supply 60 million doses of its coronavirus vaccine to the UK, while it is also preparing to deliver 100 million doses to the US, possibly as early as year-end, as part of a $1.6-billion contract there. The company has also signed supply agreements with Canada and Japan.
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