Clinical trial volunteers have helped make the fast-track to the introduction of vaccines to combat COVID-19 a reality. (Photo Credit: Lubo Ivanko via Adobe Stock)

After only nine months there are already multiple potentially-viable vaccines available around the world to inoculate people against the novel coronavirus. Some have been fast tracked by the Food and Drug Administration for usage in the United States, with 100,000,000 doses being shipped to all the states across the nation. The logistics of distribution are complex, and various jurisdictions are still trying to formulate parameters for deciding who gets the shots first. But in the midst of all this, there are people expressing concern about the speed with which the medicine was invented, and who are saying they won’t take it even once it is available.

This raises the question: How do people who have already been through the trials feel when they hear that people still want to wait until others have taken it? Have these volunteers not already been through that process on behalf of the wider public? To understand better how the vaccines were tested, this author reached out to two local residents who participated in the trials.

One volunteer, Paola Corcoran, is a CIS-female upper-level executive for a large financial services company. The other who replied, Daniel Sams, is a CIS-male small business owner who is very active in the LGBTQ community. Even with their relatively divergent backgrounds, their experiences were largely similar, and this will hopefully address concerns people may have about race, class and gender in terms of how the vaccine trials worked.

Jack Kirven: How did you come to participate in the vaccine trials? How did you hear about them?

Daniel Sams: I responded to an advertisement for participants on Facebook, about five months ago. A recruiter from Wake Research contacted me in September 2020.

Paola Corcoran: I read an article in The New York Times that discussed how candidates were being recruited for the vaccine trials. The article contained a link to the “COVID-19 Prevention Network.” I went to the aforementioned link and took a survey under the website’s “CoVPN Volunteer Screening Registry.” After a month and a half, I got a call from a company (Javara Research) that was carrying out the study for Moderna, and they explained the process and what the study entailed, at which point I agreed to participate.

JK: There are multiple companies developing vaccines — which one did you do?

DS: Johnson & Johnson Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate in the U.S.

PC: Moderna — mRNA-1273 vaccine.

JK: When did you do the session? Was there only one? If there were follow ups, how often did they happen, and what were they for?

DS: At 1 p.m. on Monday, Oct 5, 2020, I had my first meeting at Wake Research in Raleigh, N.C. They conducted my intake screening, which included a test for COVID-19, review and signing of consent forms, weight, height, body mass calculations, blood drawing, and finally, my one and only injection.

After the injection, I was monitored for 30 minutes for reactions. The process took four hours. I have had two follow ups, both included signing updated consent forms and my blood samples being drawn. Twice weekly I sign into my StudyHub app, and reply to questions concerning any COVID-19 symptoms. Thank goodness, I have not had symptoms.

PC: The study requires in-person medical office visits, five-minute telephone check-ups and entering data via a phone application. Study requires the completion of a total of seven scheduled in-person visits, and about 24 safety telephone calls over approximately 25 months. The first two visits were four weeks apart (mid-September 2020 and mid-October) for first shot and second shot. The in-person visits after the first two visits are months apart.

JK: Once you had the injections, did you notice any responses in your body? If yes, what were they?

DS: I had no response to the injection site, nor did I feel any side effects. I strongly believe I received the placebo.

PC: For me there were no side effects noted.

JK: Have you ever learned whether you got the vaccine or a placebo? If they don’t tell you, how do you know whether you should get more injections?

DS: That’s a very good question. The Johnson & Johnson Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate is a single shot, unlike the other candidates.

My motivation for participating was in hopes of getting vaccinated as soon as possible. I work at Legends Nightclub Complex in Raleigh, N.C. As owner of the BOXER AND BRIEF gear store within the club, I’m in constant contact with people, and wanted to set an example by joining this study.

Five days after the injection, I had a COVID-19 antibody test through LabCorp. The results were negative for COVID-19 antibodies. I learned afterward that five days does not allow enough time for antibodies to build. I had a second COVID-19 antibody test over a month later. Those results were negative for COVID-19 antibodies. I strongly believe I received the placebo.

PC: No, not yet. We were informed that once the Moderna vaccine is available for general use, participants can ask to be unblinded to figure out if they want to be vaccinated (if they received the placebo), or take no action (if they received the Moderna mRNA-1273 vaccine).

JK: Have you had any further contact since the vaccine has been approved?

DS: The Johnson & Johnson Phase 3 ENSEMBLE Trial of its Janssen COVID-19 Vaccine Candidate is still ongoing, and has not been approved.

PC: No, not yet. I do know that Moderna filed an application for Emergency Use Authorization (EUA) on Nov. 30, 2020, and the FDA will meet with vaccine experts on Dec. 17, 2020 to discuss the study results and related info. Similar to the Pfizer vaccine (EUA was approved Dec. 12, 2020), I’d expect the FDA to grant the EUA to Moderna as well, since both vaccines use similar formulation.

JK: Do you have any particular reaction to hearing that there are people who won’t take the vaccine until others have had it?

DS: I completely understand the fear people have, as the vaccines have been politically gaslighted. However, I have faith in the development process of the vaccines, the companies behind them, the steady leadership of Gov. Cooper and Dr. Mandy K. Cohen, M.D., M.PH. My wish is for us to get past those fears, set the example for others and get vaccinated as soon as the state of North Carolina makes it available to us.

PC: I understand some people may be apprehensive about the unknown (side effects of vaccine, efficacy of vaccine, etc.), but unless volunteers participate in the vaccine trial, I don’t see a path forward. How can we expect a path forward and expect life to get back to normal without a vaccine?

JK: Would you volunteer for something like this again?

DS: Yes, absolutely.

PC: I would if it was as critical or urgent, as it has been with COVID-19 pandemic.

JK: Do you have anything else you would like to share that hasn’t already been mentioned?

DS: Wear a cloth mask over your nose and mouth. Wait six feet apart. Avoid close contact. Wash your hands or use hand sanitizer.

PC: I am glad I participated in the vaccine trial, even if when unblinded I learn I received the placebo. The process was necessary for the vaccine companies to fast-track a process that can take years. There is such an urgency right now, and the world is trying to figure out a path forward and how society can get back to some sense of normalcy after enduring nine months of atypical life — lockdowns, travel restrictions, rising unemployment, severe impact to the economy, etc.

Jack Kirven completed the MFA in Dance at UCLA, and earned certification as a personal trainer through NASM. His wellness philosophy is founded upon integrated lifestyles as opposed to isolated workouts. Visit him at jackkirven.com and INTEGRE8Twellness.com.

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