By Lara Korte
Texas A&M University could take a leading role in producing a COVID-19 vaccine next year if an effort from Novavax Inc. makes it through clinical trials.
The federal government will spend $265 million to reserve a manufacturing center at Texas A&M University System to mass produce a COVID-19 vaccine candidate when clinical trials are complete and approval is granted from the U.S. Food and Drug Administration, system officials said Monday.
The spending is part of a larger federal program to fast-track vaccines by the end of the year, known as Operation Warp Speed. The federal government is helping fund several efforts, including one from Moderna Inc. which is set to begin a new 30,000-subject trial, Reuters reported Monday. According to the U.S. Department of Health and Human Service, federal officials are working to narrow the field of promising vaccine candidates, and have begun working with companies such as Johnson & Johnson and AstraZeneca in testing and manufacturing vaccines.
The government is reserving the bio-manufacturing center in College Station through the end of 2021 to produce the vaccine candidate from Novavax Inc., which earlier this month received $1.6 billion to complete late-stage clinical development of the vaccine, NVX-CoV2373.
The new federal order will reserve production capacity at the Texas A&M University System Center for Innovation in Advance Development and Manufacturing, near the main Texas A&M University campus in College Station.
FUJIFILM Diosynth Biotechnologies, Texas, owns and operates the center’s three facilities as a Texas A&M University System subcontractor. The company is slated to use one of its three facilities to mass-manufacture the vaccine. The $265 million will mostly go toward expanding the facility and funding new equipment. A spokesman said Texas A&M University System will receive a small management portion of the monies, about $12 million.
Fujifilm is already manufacturing the Novavax vaccine candidate for clinical trials at its plant in North Carolina, but is slated to transfer the manufacturing process to College Station for bulk production starting in early 2021.
John Sharp, Chancellor of the Texas A&M University System, said the facility at Texas A&M is uniquely suited to mass production of the vaccine because it has multiple “clean rooms.”
In the process of manufacturing a vaccine, if a clean room gets infected, the entire operation must shut down before the facilities are cleaned and ready to resume production. But at the Texas A&M facility, multiple clean rooms are kept in trailer-like units inside one space, and if one room becomes infected, the others can continue producing while the other is cleaned, avoiding any disruption in the manufacturing process.
“So we have the ability to manufacture in a much faster clip than other places,” Sharp said. “We’ve always known that this day was coming and we’ve been prepared for it.”
The manufacturing center at Texas A&M was one of three developed in the U.S in response to the 2009 H1N1 flu pandemic.
“This validates why the CIADM program was established,” said Dr. W. Jay Treat, Texas A&M’s Chief Manufacturing Officer for the Center for Innovation in Advance Development and Manufacturing. “We have state-of-the-art facilities ready to make millions doses of vaccines to meet the critical needs of our citizens.”