Novavax on Monday stated that a delayed Phase III trail of its experimental coronavirus vaccine NVX-CoV2373 will get under way in the US and Mexico "in the coming weeks." The company explained in late October that the study start had been pushed back by about a month as it worked to scale up the manufacturing process, although it said at the time that it had made "significant progress" on that front.
According to Novavax, more than 100 sites have been selected for the trial, with some alternate locations in place as well, should they be needed. The company stated it will use vaccine material produced at commercial scale for this study, adding it has been working with the FDA to get a North Carolina plant from manufacturing partner Fujifilm Diosynth Biotechnologies ready for this purpose.
NVX‑CoV2373 is a stable prefusion protein antigen derived from the SARS-CoV-2 spike protein and contains Novavax's proprietary Matrix‑M adjuvant. The company has said it is preparing to deliver 100 million doses of NVX-CoV2373 to the US, possibly as early as year-end, as part of a $1.6-billion contract with the federal government. It has also signed supply agreements with the UK, Canada, Australia and Japan.
Cantor Fitzgerald analyst Charles Duncan suggested the US trial delay was not meaningful, and that it may also give Novavax an opportunity to provide more information into the "second-generation" vaccine. NVX‑CoV2373 currently lags behind other companies' vaccines, including mRNA-based candidates by Pfizer and Moderna, both of which have applied for FDA emergency-use authorisation. An FDA advisory panel is set to meet on December 10 to discuss Pfizer's vaccine, which is being co-developed with BioNTech, while Moderna said another panel meeting would likely be held on December 17 to consider its inoculation.
Meanwhile, Novavax said an ongoing Phase III trial of NVX‑CoV2373 in the UK, which it recently expanded to 15,000 participants from an original size of 10,000, is now fully enrolled and that it continues to expect an interim readout as soon as early first quarter 2021. The data will likely form the basis for regulatory submissions in the UK, EU and other countries. According to the company, more than 25% of the UK study participants are over the age of 65, while a "large proportion" of volunteers have underlying co-morbid medical conditions.
In addition, a Phase IIb trial of NVX‑CoV2373 in South Africa is also now fully enrolled with 4422 volunteers, including 245 medically stable, HIV-positive participants. Efficacy results may be available as soon as the first quarter 2021 as well, but as with the UK trial, the availability of data depends on the COVID-19 infection rate in the region.
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