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Fujifilm Diosynth Biotechnologies’ North Carolina site will be used to manufacture Novavax’ NVX‑CoV2373 vaccine candidate for a Phase III clinical trial.
Biotech-vaccine company Novavax and contract development and manufacturing organization (CDMO) Fujifilm Diosynth Biotechnologies (FDB) announced an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax’ COVID-19 vaccine candidate, in a July 23, 2020 press release. FDB’s site in Morrisville, NC has begun production of the first batch of NVX-CoV2373.
The outsourcing agreement falls under Novavax’ $1.6 billion award by the United States government as part of Operation Warp Speed; the funding is being used by Novavax to complete late-stage clinical development, including a Phase III clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVXâCoV2373 beginning as early as late 2020. The vaccine candidate consists of a stable, prefusion protein made using Novavax’ proprietary nanoparticle technology and includes Novavax’ proprietary MatrixâM adjuvant. The batches produced at the FDB site in North Carolina will be used in a future Phase III clinical trial of up to 30,000 subjects, which is expected to begin in the fall of 2020 and which will determine the safety and efficacy of NVX-CoV2373.
“We are delighted to bring our leading technical expertise in baculovirus systems and our proven manufacturing excellence to support Novavax’ response to this global crisis,” said Martin Meeson, CEO of Fujifilm Diosynth Biotechnologies, in the press release
Novavax’ Phase I/II clinical trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age began in Australia in May. Phase I data will be released during the first week of August, and the Phase II trial is expected to begin shortly thereafter; thePhase I/II clinical trial is being supported by the Coalition for Epidemic Preparedness Innovations (CEPI).