Novavax, FUJIFILM Initiate Large Scale Mfg. of COVID-19 Vax Candidate
By Contract Pharma Staff | 07.24.20
FUJIFILM to manufacture bulk drug substance for NVX-CoV2373 from its site in Morrisville, NC for Phase III trial.
Novavax, Inc. and FUJIFILM Diosynth Biotechnologies (FDB), a contract development and manufacturing organization for biologics, viral vaccines and gene therapies, entered an agreement to manufacture bulk drug substance for NVX-CoV2373, Novavax' COVID-19 vaccine candidate. FDB's site in Morrisville, NC has begun production of the first batch of NVX-CoV2373.
This agreement falls under Novavax' recent $1.6 billion award by the federal government as part of the Operation Warp Speed (OWS) that aims to deliver millions of doses of a vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early as late 2020.
NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' Matrix–M adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future Phase 3 trial of up to 30,000 subjects, which is expected to begin in the fall of 2020.
Novavax expects preliminary immunogenicity and safety results from a Phase 1/2 trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).
This agreement falls under Novavax' recent $1.6 billion award by the federal government as part of the Operation Warp Speed (OWS) that aims to deliver millions of doses of a vaccine for COVID-19 to the U.S. population. The OWS funding is being used by Novavax to complete late-stage clinical development, including a Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX–CoV2373 beginning as early as late 2020.
NVX-CoV2373 consists of a stable, prefusion protein made using Novavax' nanoparticle technology and includes Novavax' Matrix–M adjuvant. The batches produced at the FDB site in North Carolina will be utilized in a future Phase 3 trial of up to 30,000 subjects, which is expected to begin in the fall of 2020.
Novavax expects preliminary immunogenicity and safety results from a Phase 1/2 trial of NVX-CoV2373 in 130 healthy participants 18 to 59 years of age during the first week of August. The Phase 2 portion to assess immunity, safety, and COVID-19 disease reduction is expected to begin shortly thereafter. The Phase 1/2 clinical trial is being supported by an up-to $388 million funding arrangement with the Coalition for Epidemic Preparedness Innovations (CEPI).
