Novavax Coronavirus Vaccine to Be Done at Texas Facility if Successful

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A biotech production facility at College Station could begin manufacturing hundreds of millions of doses of a COVID-19 vaccine starting next year.

As part of a $ 265 million contract with the federal government, the Center for Innovation in Development and Advanced Manufacturing at Texas A&M University, owned and operated by Fujifilm Diosynth Biotechnologies, has been leveraged to mass-produce a vaccine candidate testing is still in progress. That vaccine, which is being developed by the little-known Maryland company Novavax, is one of six candidates that the federal government has delayed billions of dollars as part of its Operation Warp Speed, which is pursuing an aggressive schedule for mass distribution. of a coronavirus. vaccine.

President Donald Trump, who appeared Monday afternoon at a Fujifilm facility in North Carolina where the candidate vaccine is being developed for clinical trials, praised the progress of the Novavax vaccine and other therapies.

“We will have it delivered in record time,” he said.

If clinical trials for the Novavax vaccine are successful, bulk production will move to the College Station facility, “which is the place,” the president said Monday, starting next year. Federal dollars will pay for the equipment to significantly expand the facility’s production capacity. Up to 80 new hires are also expected.

W. Jay Treat, Texas A&M director of manufacturing for the Center for Innovation in Advanced Development and Manufacturing, said that although the federal contract does not specify a certain number of doses that your plant must produce, he is optimistic that the figure could be in the hundreds of millions. And if Novavax is unsuccessful in clinical trials, it hopes the facility can pivot to start producing a different vaccine.

If all goes well, Treat said, “I think we could have the capacity here to provide enough [doses] for the United States there may even be overcapacity. “

Novavax, which never released a vaccine to the market, received the federal government’s largest $ 1.6 billion vaccine contract earlier this month. A total of approximately $ 4 billion has been invested in companies seeking vaccines.

According to the World Health Organization, the Novavax vaccine is still in relatively early stages compared to the competition. The researchers began testing the vaccine on 130 humans in May and expect to report preliminary results by the end of this month. By contrast, Moderna has already found promising results in its early-phase trials and launched a trial this week that will recruit 30,000 human participants across the country.

Researchers around the world are looking for 166 candidates for the COVID-19 vaccine, but only about two dozen vaccines are being tested in humans, according to the World Health Organization. The US 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 project that takes a long time. Researchers have outlined an optimistic 12-18 month schedule to develop a vaccine against the new coronavirus; That would mark the fastest vaccine development in history.

A&M System officials, as well as Fujifilm, praised the federal government’s decision to entrust production to the Texas facility, which was founded with the project in mind.

John Sharp, chancellor of the Texas A&M University System, called the project “a triple victory”: for the A&M System, for Fujifilm, and for the nation.

The A&M System facility was founded in 2012 as one of the three national biosafety centers of the US government, intended to develop and produce drugs to combat pandemics and bioterror threats. The United States government decided to make an investment in domestic production facilities following the 2009 H1N1 flu, not wanting to rely on vaccines from other countries in times of crisis.

Fujifilm, a photography, medical equipment and biotech corporation, now owns and operates the facility, but the federal contract is executed 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.

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