About 30 years ago, Michael Whitt, Ph.D., developed what now is a series of surrogate viruses to check the effectiveness of vaccines without having the dangerous ones in the lab.

For months now, labs around the world have been buying Whitt’s work to test the efficacy of their COVID vaccines. Pfizer-BioNTech is using it. So is Moderna and dozens of other pharmaceutical firms.

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What Whitt developed allows pharmaceutical companies and labs to test for immune response without using live, dangerous viruses, including SARS-CoV-2, the novel coronavirus.

“That is what our system is able to provide,” says Whitt, associate dean of the Office of Medical Education in the University of Tennessee Health Science Center College of Medicine, from his lab at 858 Madison. “It’s a way to test: Do people who are vaccinated make neutralizing antibodies?”

In the lab, the pseudo virus acts like a reporter cell, a molecule that is easy to detect.

“You take the virus, put a little color on it — red or cherry tomato,” said Dr. Scott Strome, executive dean of the College of Medicine at the University of Tennessee. “Every time that RNA virus enters in a cell, it turns that cell red.

“To see if a patient has developed immunity, you take their blood, add their antibody to the assay and add the pseudo-type virus to see if antibodies are capable of preventing the cells from turning red,” Strome said.

Pseudo viruses can be naturally produced during an infection or created in the lab. They contain fragments of host-cell DNA, but none of the nucleic acid components of the infectious virus that is their kin.

The Whitt surrogate primarily infects horses, cows and pigs, but does not cause serious disease in humans.

“We have one that fluoresces green or red under UV light,” Whitt said. “We also have a version that expresses with the protein that makes fireflies light up at night.

“You add the reagent to the infected cells and it gives off light you can measure. Another expressed in secreted enzymes.”

The products, which Whitt ships in a variety of forms to labs all over the world, are live virus packed in dry ice to protect its ability to infect. He has 20 products on the market; the most expensive cost more than $1,000.

“I feel like our lab is making a contribution.”

Michael Whitt
UTHSC

The packages are labeled “to let FedEx know this is not food or something consumable. It needs to be handled carefully.”

Whitt, who has dry ice shipping training for Category B biologicals, packs them up in the evenings. A courier picks them up the next morning. One day in late January, three Stryofoam boxes were waiting, two headed to Europe and one to a U.S. lab.

“I feel like our lab is making a contribution,” Whitt said. “They could have probably used another system, but ours is pretty user-friendly, and it works really well.”

Research using live SARS-CoV-2 (the novel coronavirus) is limited to biocontainment labs. UTHSC has one of about a dozen of the labs in the nation.

Surrogates, or pseudo viruses, mean that companies or smaller labs can work on vaccines, Strome says.

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“Small labs provide an amazing amount of innovation all around the country and world,” he said. “Pharma companies used to do a lot of their own research and development. Many have ceded their R&D to biotech firms to see who is able to develop a meaningful drug, and then they pay more money for it.

“It’s kind of cool that the pseudo-type virus being used by all the big companies for vaccine development came from UT.”

Scott Strome
Executive dean, UT College of Medicine

“It’s kind of cool that the pseudo-type virus being used by all the big companies for vaccine development came from UT,” Strome said.

Viruses fascinate Whitt, who made his initial discovery years ago at the Yale School of Medicine. In the late 1980s as a post-doc in New Haven, Connecticut, he was intent on understanding how they assemble.

“If you can understand those rules, then you can develop drugs or other small molecules that can inhibit the process,” says Whitt, who took a job as assistant professor in 1991 in the Department of Microbiology, Immunology and Biochemistry at UTHSC and worked his way up to department chairman.

Several customers, including Moderna, are now working on booster shots to cover their vaccine against the variant strains of COVID that have emerged around the world.

Every time a surrogate package is sold, a percentage of the profit funnels back to the University of Tennessee Research Foundation (UTRF), which holds the patent. The School of Medicine gets a portion, so does the Department of Microbiology, Immunology and Biochemistry. Whitt, as the inventor, gets some of the money too.

He doesn’t remember the funding formula or talk about the figures.

UTRF, a 501(c) (3), is not required to disclose them, says Richard Magrid, foundation vice president.

“The bulk of advanced science and technology gets published and moves the world forward,” Magrid said.

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But every once in a while, research isn’t just scientifically interesting, but has potential to be a commercial product, a service or the nucleus of a startup, he said.

By 2012, demand for Whitt’s surrogates was large enough that UT began selling them through Kerafast, a rare reagent distributor based in Boston.

“They’re in the business of distributing these types of research tools worldwide,” Magrid said. “Just in the pandemic, 150-plus researchers in 30 countries have bought these reagents. It’s really making an impact on COVID research, which is fantastic.”

Kerafast has noticed the uptick too.

In a company blog of the 10 reagents in its catalog that helped most advance research in 2020, Whitt’s work is No. 1.

While business for Whitt’s products is always steady, according to Kerafast spokeswoman Lisa Merollla, it increased nearly 10 times between 2019 and 2020.

“The entire Kerafast team has been very excited to play a small role in facilitating research that has led to COVID-19 treatments and are happy to have had the opportunity to collaborate with Dr. Whitt to enable global dissemination of his important reagents,” she said in an email.