The federal government has reserved a high-tech bio-manufacturing facility here for mass production of a COVID-19 vaccine as part of a program discussed Monday by President Donald Trump.
The new federal task order is reserving production capacity at one of the College Station facilities to mass manufacture vaccines through the end of 2021.
The order, which supports Operation Warp Speed, is between the federal government and the Texas A&M University System’s Center for Innovation in Advanced Development and Manufacturing (CIADM). The CIADM was developed in response to the H1N1 influenza pandemic.
As a subcontractor to the Texas A&M System, FUJIFILM Diosynth Biotechnologies, Texas, (FDB), owns and operates three facilities built through the CIADM program. They can be tapped for emergency use by the federal government.
FDB is slated to use the reserved capacity at one of the FDB facilities for the COVID-19 vaccine candidate of Novavax, Inc., NVX-CoV2373.
Valued at about $265 million, the task order also will accelerate a planned expansion at the FDB facility by helping fund new equipment for use in the current pandemic and in future emergencies.
“The Texas A&M System is ready to save lives and help protect the country,” said John Sharp, Chancellor of The Texas A&M University System. “This whole project is a triple win. It’s a win for the Texas A&M System. It’s a win for FDB. It’s a win for the nation.”
View a video on the Texas A&M System’s role in the project: <https://vimeo. com/442035087>.
Operation Warp Speed aims to begin delivering millions of doses of COVID-19 vaccines by the end of the year if the U.S. Food and Drug Administration determines candidates are safe and effective.
Novavax is being funded by the government to complete late-stage clinical development, including a pivotal Phase 3 clinical trial; establish large-scale manufacturing; and deliver 100 million doses of NVX‑CoV2373, Novavax’s COVID-19 vaccine candidate.
The FDB plant in North Carolina, where President Trump visited Monday, is already producing the Novavax vaccine candidate for its clinical trials. FDB is slated to transfer the manufacturing process to College Station in late 2020 and start bulk production in early 2021.
FDB’s facilities and workforce in Texas can accommodate multiple vaccine technologies and help expedite the government’s large-scale manufacturing efforts. The manufacturing preparation is being done in parallel with ongoing clinical trials and the FDA’s safety and effectiveness approval process.
FDB calls the facility reserved for Novavax vaccine production its “Flexible BioManufacturing Facility.”
“FUJIFILM Diosynth Biotechnologies is committed to be a partner for life and deliver these much-needed COVID-19 vaccine doses,” said Dr. Gerry Farrell, Chief Operating Officer of FDB in Texas. “We are ready to move swiftly to deliver on multiple vaccine candidates as directed by the U.S. government.”
The Texas A&M System’s CIADM was one of three centers developed in the U.S. in response to the H1N1 influenza pandemic by the Biomedical Advanced Research and Development Agency (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services.
The task order is an amendment to the CIADM contract between the System and BARDA.
“This validates why the CIADM program was established,” said Dr. W. Jay Treat, Texas A&M's Chief Manufacturing Officer for the CIADM. “We have state-of-the-art facilities ready to make millions of doses of vaccines to meet the critical needs of our citizens.”