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U.S. chooses Texas A&M bio-manufacturing center for production of COVID-19 vaccine candidates

Part of Operation Warp Speed
Posted at 3:10 PM, Jul 27, 2020
and last updated 2020-07-27 16:12:26-04

COLLEGE STATION, TX — The federal government has reserved a high-tech bio-manufacturing center at Texas A&M University 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 the Texas A&M University System Center for Innovation in Advanced Development and Manufacturing (CIADM) through the end of 2021.

FUJIFILM Diosynth Biotechnologies, Texas, (FDB) owns and operates the CIADM’s three facilities as a Texas A&M System subcontractor. FDB is slated to use one of the facilities to mass manufacture 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 facility by helping fund new equipment for use in the current pandemic and future emergencies, according to Texas A&M.

“The CIADM 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 A&M System. It’s a win for FDB. It’s a win for the nation.”

The order supports Operation Warp Speed, which 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 has been awarded $1.6 billion by the federal 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’ 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 for bulk production starting in early 2021.

FDB’s facilities and work force 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 CIADM at Texas A&M was one of three 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 doses of vaccines to meet the critical needs of our citizens.”