Mark Jansen, M.D., was given a shot in his left arm on August 14.
The injection was either a potential coronavirus vaccine or a placebo – a harmless starch or sugar solution.
Jansen is Arkansas Blue Cross and Blue Shield’s chief medical officer and a veteran primary care physician. But he’s also a son who lost his mother to COVID-19, he’s invested in seeing the outcome.
Regardless of the results, Jansen hopes his contribution to this clinical trial will help scientists counter the virus, which has cost our society, and his own family, so dearly.
Dr. Jansen lost his mother to COVID-19 earlier this year. Now he is one of 30,000 American adults participating in a double-blind, placebo-controlled coronavirus vaccine study. Moderna, Inc., a Massachusetts biotechnology company, along with the National Institutes of Health, are conducting the trial.
How does a clinical trial work?
This type of study is the “gold standard” of clinical trials. The people getting the shots or the clinicians giving the shots know who gets a placebo and who gets the real treatment. Only the data analysts interpreting the results at the study’s end can tell who was in which group.
“The weird part is, if I get the placebo, yes, they’re hoping that I get COVID-19,” Jansen said.
That way, Moderna can compare rates of infection among people who received the vaccine and those who got the placebo.
“If the ones who get the actual vaccine stay well, it demonstrates the effectiveness of the vaccine,” he added.
Across the country, Moderna has roughly 89 clinical research sites involved in this third phase of its vaccine trial. The study recruits people who are at least age 18 years old and have never tested positive for coronavirus. Participants get periodic blood tests and are closely monitored throughout the trial.
When will we have a vaccine?
Moderna expects trials to last two years. So could the country possibly have a safe vaccine early next year?
“If the researchers see really good results, they can stop the trial early,” Jansen said. “That’s called ‘un-blinding’ the study.”
If that happens, Moderna would offer everyone who received the placebo the real vaccine.
Moderna is the front-runner among dozens of established and “startup” drug developers currently working on coronavirus treatments. Other drug companies in the race, which the United States government calls “Operation Warp Speed,” include AstraZeneca, GlaxoSmithKline, Johnson & Johnson and Pfizer.
Clinical trial phases 1, 2, 3
Vaccine clinical trials like Moderna’s have three primary phases, each designed to answer different questions about a potential treatment.
Phase 1 investigates the safety of a treatment in humans.
During Phase 2, researchers examine whether a treatment works.
Finally, in Phase 3, there is a comparison between a new treatment and standard treatments to see if it works better or has fewer side effects.
The federal government launched “Operation Warp Speed” as a public-private partnership with drugmakers to produce and deliver 300 million doses of COVID-19 vaccines to Americans by January 2021. On August 11, Moderna signed an agreement with the White House to produce 100 million doses of its anticipated COVID-19 vaccine.
COVID-19 hits close to home
Frances Bovick Jansen was the 11th person in Arkansas to die from COVID-19 complications. She was 94 years old. Her life was exciting and full, her son said. She sang in Hollywood and even landed a big band recording contract.
But she said goodbye to the glamorous life when she met and married Gerald Thomas Jansen, M.D., her husband of 58 years. Together, they had three sons, two daughters and many grandchildren and great-grandchildren.
On April 1, Mrs. Jansen, who had some dementia, died at Briarwood Nursing & Rehab in Little Rock.
“You don’t get over your mother’s death, but I’m dealing with it,” Jansen said. “Now that I have this chance to be a part of the solution to help eliminate the virus that ended her life … it’s personal.”
As a son and a physician, Jansen is excited to be part of medical research in a pandemic.
“Once you’re a doctor you’re always a doctor, and if you went into medicine for the right reason, you realize how remarkable this is,” Jansen said.