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A biotech production facility in College Station could begin manufacturing hundreds of millions of doses of a COVID-19 vaccine as early as next year.
As part of a $265 million contract with the federal government, the Texas A&M University System Center for Innovation in Advanced Development and Manufacturing — which is owned and operated by Fujifilm Diosynth Biotechnologies — has been tapped to mass-manufacture a vaccine candidate that is still undergoing testing. That vaccine, which is being developed by the little-known Maryland company Novavax, is one of six candidates the federal government has put billions of dollars behind as part of its Operation Warp Speed, which is pursuing an aggressive timeline for mass-distributing a coronavirus vaccine.
President Donald Trump, appearing Monday afternoon at a North Carolina Fujifilm facility where the vaccine candidate is being developed for clinical trials, praised the progress of the Novavax vaccine and of other therapeutics.
“We will have it delivered in record time,” he said.
If clinical trials for the Novavax vaccine prove successful, the bulk production will be moved to the College Station facility — “which is quite the place,” the president said Monday — starting next year. The federal dollars will pay for equipment to significantly expand the facility’s production capacity. As many as 80 new hires are also expected.
W. Jay Treat, Texas A&M’s chief manufacturing officer for the Center for Innovation in Advanced Development and Manufacturing, said although the federal contract does not specify a certain number of doses that his facility must produce, he is optimistic that the figure could be in the hundreds of millions. And if Novavax doesn't prove successful in clinical trials, he expects the facility could pivot to begin producing a different vaccine.
If all goes well, Treat said, "I think we might have the capacity here to provide enough [doses] for the U.S. There may even be excess capacity."
Novavax, which has never brought a vaccine to market, received the federal government’s largest-yet vaccine contract of $1.6 billion earlier this month. A total of about $4 billion has been invested in companies pursuing vaccines.
According to the World Health Organization, Novavax’s vaccine is still in relatively early stages compared with competitors’. Researchers began testing the vaccine in 130 humans in May and expect to report preliminary results by the end of this month. By contrast, Moderna has already found promising results from its early phase trials and launched a trial this week that will enroll 30,000 human participants across the country.
Researchers across the globe are pursuing 166 COVID-19 vaccine candidates, but only about two dozen vaccines are currently being tested in humans, according to the World Health Organization. The U.S. Food and Drug Administration approves less than 10% of drugs that undergo clinical trials for public use.
And developing a vaccine against any new infectious disease is a challenging, time-consuming project. Researchers have outlined an optimistic 12- to 18-month timeline on developing a vaccine against the new coronavirus; that would mark the fastest vaccine development in history.
Officials with the A&M System, as well as Fujifilm, praised the federal government’s decision to entrust production to the Texas facility, which was founded with such a project in mind.
John Sharp, chancellor of the Texas A&M University System, called the project “a triple win”: for the A&M System, for Fujifilm and for the nation.
The A&M System facility was founded in 2012 as one of the U.S. government’s three national biosecurity centers, intended to develop and produce drugs that would fight pandemics and bioterrorist threats. The U.S. government decided to make an investment in domestic production facilities in the wake of the 2009 H1N1 influenza, not wanting to be reliant on other countries for vaccines in times of crisis.
Fujifilm, a photography, medical equipment and biotech corporation, now owns and operates the facility, but the federal contract runs through the A&M System as part of its long-standing partnership with the federal government on such projects.
The facility has done some work for the government, on drugs for Zika and other diseases, but the coronavirus vaccine will be its first large-scale government contract, Treat said.
Disclosure: The Texas A&M University System has been a financial supporter of The Texas Tribune, a nonprofit, nonpartisan news organization that is funded in part by donations from members, foundations and corporate sponsors. Financial supporters play no role in the Tribune's journalism. Find a complete list of them here.