This Army veteran is a key player in a worldwide coronavirus vaccine clinical trial
By JAMES T. MULDER | syracuse.com | Published: November 13, 2020
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SYRACUSE, N.Y. (Tribune News Service) — Stephen Thomas was in the U.S. Army training to be a cancer doctor in 1998 when a trip to Thailand changed the trajectory of his career.
Thomas was sent to Thailand for a month to work with doctors and researchers developing vaccines for dengue fever and other potentially deadly viruses.
At an Army research lab in Bangkok, he met some of the vaccine world’s leading scientists. He visited an Army field site where clinical trials involving thousands of children led to the development of vaccines for hepatitis A and Japanese encephalitis. Thomas was so impressed that within three days he decided to specialize in infectious disease and vaccine development.
“It was a seminal moment in my life,” says Thomas, chief of infectious disease at Upstate Medical University.
Twenty-two years later, another big moment is approaching for Thomas in Syracuse.
He was recently tapped to be the lead principal investigator worldwide for a clinical trial of a coronavirus vaccine being developed by drugmakers Pfizer and BioNTech.
Those companies stunned the world last week when they announced early results show the experimental vaccine is more than 90% effective, much better than expected. The vaccine is now considered a frontrunner in the race to stop the disease that has killed more than one million people worldwide.
The companies are expected to submit an application later this month to the FDA seeking emergency use authorization to begin distributing the vaccine. If evidence strongly suggests patients would benefit from the vaccine, the FDA can provide that authorization before it has all the evidence to prove the drug’s effectiveness and safety.
Thomas will be a key to that.
Before the companies submit that application, they will have Thomas review data compiled from about 150 sites worldwide where the experimental vaccine is being given to volunteers.
Upstate is one of those sites. It has enrolled 300 adult volunteers and expects to soon include children in the trial. Thomas is the principal investigator of the trial at Upstate.
In a trial this big with so many sites, sponsoring drugmakers typically ask a principal investigator at one of the sites to serve as the lead investigator. Dr. Kathleen Neuzil of the University of Maryland, one of the world’s leading vaccine experts, recommended Pfizer pick Thomas for the job.
His role as the lead investigator is to give Pfizer and BioNTech an outside, objective opinion on the accuracy and quality of the information and the study’s conclusions.
“I’m sort of lying in wait for the call to do the job they’ve asked me to do,” he says.
Thomas, who has received a lot of news attention for being appointed lead investigator, downplays the importance of his role. “I’m very pleased to have been asked to do it, but it’s a routine thing,” he says.
But Dr. Timothy Endy, an Upstate doctor who is Thomas’s long-time friend and mentor, says the appointment is a “big deal.”
Thomas said while the high rate of the vaccine’s effectiveness is promising, there are still a lot of unanswered questions about the vaccine. They include:
- How long will immunity last in people who are vaccinated?
- How safe is the vaccine on a long-term basis?
- Does it prevent all cases of coronavirus, or just severe cases?
- How can the vaccine be kept at required ultracold temperatures during shipping?
In addition to being chief of infectious disease, Thomas directs Upstate’s Institute for Global Health & Translational Science. That research institute is involved in 20 clinical trials or research projects involving vaccines and other drugs, five times more than it was four years ago.
Because of the rapid growth the institute outgrew its space in Upstate’s Institute for Human Performance Building at 505 Irving Ave. It recently expanded into space in the physician’s office building at Upstate’s Community Hospital campus on Onondaga Hill.
Thomas also oversees Upstate’s response to the coronavirus pandemic.
Thomas said he’s proud of the more than 20 people working on the Pfizer-BioNTech vaccine trial at Upstate. He said they have been working feverishly since May recruiting volunteers, coordinating research, drawing blood and taking nasal swabs. Although Upstate capped initial enrollment at 300 adult volunteers, it received phone calls and emails from nearly 2,000 people who wanted to participate.
“The outpouring of interest was tremendous,” he said.
He said Pfizer officials regularly communicate with Upstate and the other sites participating in the trial. Hundreds of people are on the calls.
“I love vaccine development so much because it’s a team-oriented sport,” he said.
Thomas, 50, lives in Skaneateles. He and his wife, Erica, have two children, ages 13 and 5.
He has been one of the most visible faces in the local fight to limit the spread of the coronavirus. In the early days of the outbreak, he appeared at the daily briefing of County Executive Ryan McMahon.
Thomas grew up in the Albany area. He went to Brown University on an ROTC scholarship where he earned a bachelor’s degree in biomedical ethics. He received a medical degree from Albany Medical College which he attended on an Army health professions scholarship. That scholarship required him to serve at least eight years in the Army after graduation. He completed his internship and residency at the Walter Reed Army Medical Center in Maryland.
Before joining Upstate in 2016, Thomas spent 20 years in the Army, working at the Walter Reed Army Institute of Research. He supervised teams doing research on Zika, a mosquito-borne virus that causes birth defects. He advised senior Department of Defense officials during the 2014 West Africa Ebola outbreak and worked on the development of a dengue fever vaccine. He spent six years of his early career living and working in Thailand.
“It’s been a fantastic career,” Thomas says. “It’s brought me all over the world and allowed me to meet incredible people.”
Thomas started looking for jobs in the pharmaceutical industry in 2016 when he was ready to retire from the Army.
He was recruited to Upstate by Endy, a former Army doctor who trained and mentored Thomas at Walter Reed. Endy is Upstate’s chair of microbiology and immunology, and former chief of infectious disease.
Thomas came to Upstate so he could work again with Endy as well as Mark Polhemus and Kristopher Paolino, former Army doctors he had worked with at Walter Reed. They also were recruited by Endy.
Endy and Thomas met in Thailand. Endy was working in an Army research lab in Bangkok in 1998 when he got a call from his boss at Walter Reed.
“I’ve got a hotshot medical resident here who wants to do hemoc (hematology-oncology), but he should do infectious disease,” Endy’s boss said. “I want to send him over for a month to work with you.”
Thomas was the hotshot. His flight arrived in Bangkok at midnight. Endy went to the airport to pick him up. He said the scene outside the airport, which he described as a “mosh pit,” was chaotic, with people trying to grab arriving tourists' bags.
Endy, who had not met Thomas, stood outside the airport holding a sign with Thomas’s name on it. “He came out of the airport looking perplexed, then relieved when he saw the sign,” Endy recalls.
Endy took him to the Army lab in Bangkok and the field site in northern Thailand. “What attracted Stephen was the excitement of the work, the quality of the work, being overseas and doing something important,” Endy says.
The two hit it off and have worked closely ever since.
Endy said he’s proud of Thomas’s appointment as lead investigator in the coronavirus vaccine trial.
“Pfizer is leaning on him to give them his clinical research perspective,” Endy said. “It’s an incredible role.”
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