Longtime Evanston resident Dr. Richard Hubbard has been a participant in a Moderna COVID-19 clinical vaccine trial since August.
Dr. Hubbard had a long career as a research physician, overseeing the development of new drugs, obtaining regulatory approvals in the U.S. and Europe, and designing, supervising and reporting on clinical trials for those drugs.
Last summer Dr. Hubbard read about the Moderna trial underway at the University of Illinois. As a 69-year-old African American with underlying health conditions, he knew he was likely to be chosen to participate. He knew that drug trials often have difficulty recruiting African American participants, and that they also want a certain percentage of participants over 65 years old.
According to the U.I.C. Health website, the University of Illinois at Chicago was the only site in Chicago selected to launch the Moderna phase-3 trial, which is being administered by the National Institute of Allergy and Infectious Diseases.
Moderna received $2.5 billion in federal assistance under “Operation Warp Speed.”
The Moderna phase-3 trial has 30,000 participants, with about 1,000 locally at the U.I.C. site. In the trial, 50% of the participants received the vaccine, and 50% received a placebo.
On the UIC website Dr. Richard Novak, the lead investigator of the clinical trial, stated, “UIC has a history of engaging diverse communities in our research programs, and I believe our ability to reach the communities that have been hardest hit by the pandemic is one of the reasons that we were selected for this clinical trial.”
The trial is intended to test the efficacy of the vaccine, “to see if the vaccine will prevent people from getting coronavirus or if it will prevent people from experiencing severe illness if they do get the disease,” said Dr. Novak. Thus, for example, if a vaccine is reported to have an efficacy rate of 90%, that does not mean that 90% of participants did not contract the virus. It means that 90% either did not contract it or that if they did, their illness was not severe.
Volunteers were screened to make sure that 40% of the participants were 65 years and older. “We want to test this vaccine in people who are most at risk of experiencing complications and death due to the virus,” Dr. Novak said.
In August Dr. Hubbard called the local “investigator” at the University of Illinois Medical Center and was sent a questionnaire electronically. He was then interviewed by phone. Once he was accepted into the trial he went to UIC and was given a coronavirus test and a physical exam, had blood work done and received his first shot.
One month later he received the second, or booster shot. He had blood work done then as well.
For a week after each visit to UIC, Dr. Hubbard kept an e- diary, an electronic record of any symptoms or reactions to the shot, such as headache, low fever or pain where the shot was given. The researchers called him about every two weeks with questions. Dr. Hubbard said he had no reactions to the shots and that it is very unlikely others will have reactions to the shots. But this will not be known for certain until the trial results are released to the Food and Drug Administration.
The only precaution that he and other trial participants were given was to follow what local governmental agencies are advising.
There is no effort to control for cautious or incautious behavior by the participants. Dr. Hubbard says the number of participants in the trials is large enough that there will be participants in both categories.
The trial will last two years, or until the FDA approves the drug. Dr. Hubbard will not find out whether he received the vaccine or a placebo until he requests the information after the trial is complete. If he was given the placebo, he will get vaccinated. The researchers will continue to follow up with him by phone every few months until the trial is over.
It is common to give trial participants a stipend to cover their costs, and Dr. Hubbard received $150 per visit as compensation for participating in the trial.
Dr. Hubbard expects that the general public will begin receiving a vaccine in the second quarter of 2021.
When asked if he believes that vaccines will put an end to this pandemic, he said he expects the coronavirus will become instead “endemic,” meaning that it will not totally disappear and will be to some extent a part of everyone’s lives.
The standard current flu vaccine is only about 60% effective, largely because the flu mutates and a single vaccine cannot cover all varieties. Vaccines against the novel coronavirus being currently developed may have much higher efficacy rates, according to recent preliminary reports from manufacturers.
Dr. Hubbard emphasized the upcoming challenge of educating the public about the safety of the vaccines and the importance of getting people vaccinated. This is crucial in order to get widespread protection.
In order for people to trust that vaccines are safe and effective, Dr. Hubbard said it is important that they understand how carefully these trials are conducted.
Clinical trials are the most time consuming part of developing a new vaccine. He said he has no reservations about the safety of the Moderna or Pfizer vaccines, or about the FDA process for reviewing the safety and efficacy of the vaccines.
Dr. Hubbard has been active in the Evanston community, having served on the boards of Y.O.U. (Youth and Opportunity United) and the Evanston History Center. He currently sits on the Northwestern University Institutional Biomedical Review Board.