My experience in the Moderna COVID-19 vaccine trial

Dr. Dave On Call

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In Episode 17 of Dr. Dave On Call, I discuss my experience in the Moderna COVID-19 vaccine trial.

This episode has been a culmination of about 2 months of my observations while participating as a research subject in the Moderna mRNA-1273 COVID-19 vaccine trial. The trail is named the COVE Study, it's an acronym for Coronavirus Efficacy and Safety Study, and the name implies protection from COVID-19, as a "cove" can be thought of a sheltered inlet.

The goal of the COVID-19 vaccine study is to understand if the mRNA-1273 study vaccine can prevent COVID-19 (efficacy) and if the study vaccine is safe. In general, the purpose of vaccines are prepare our immune system to fight infection and prevent illness. Following an effective vaccine, our immune system will produce antibodies (special proteins) that will recognize and other pathogens and make them harmless to our bodies.

About 30,000 people in the Unites States will take part in this study at about 80-100 research sites. The particular research site that I am enrolled in is at The University of Illinois Health System, Division of Infectious Diseases coordinating by Project WISH. The Principal Investigator is Dr. Richard Novak, Chair of Infectious Diseases at the University of Illinois Health system. He has dedicated his entire professional career at research treatments for emerging infectious diseases. I would really encourage you to listen to Episode 14 of Dr. Dave On Call, where we discuss the Moderna mRNA-1273 vaccine trial in greater depth with Dr. Novak.

I participated in this trial for a variety of reasons. First, I felt that I would be an ideal candidate to study the effectiveness of a COVID-19 vaccine. I am a minority, health worker with 2 children who are currently receiving in-person learning, therefore I am potentially exposed to COVID-19 more frequently. I believe that my contribution of scientific data would help answer key questions about this vaccine on a larger public health scale. As an Allergy-Immunology specialist, I have a unique understanding of vaccines and this trial would be an educational experience for myself. Further, I had a tremendous example in my mother, who participated in many experimental trials while she was being treated for acute leukemia, knowing that she was contributing for the greater knowledge of medical science.

Participation in the study is a big commitment; 6 in-person visits, 25 safety telephone calls, app surveys over a period of 25 months. Also, if a subject is diagnosed with COVID-19 there are extra visits associated with it as well. After completing the screening process, we scheduled my first appointment for September 3, 2020. I reviewed the 24 page consent form, had a few additional questions about the potential side effects and signed the consent form and was officially enrolled. The 1st visit was intense and long, over 3 hrs filled with medical examinations, blood draws, etc. Finally, I was assigned a unique patient number and the COVID-19 vaccine was delivered for injection.

This study is a Double-Blind Placebo Controlled trial; both the subjects and researchers do NOT know if a placebo vaccine (saline) or the experimental vaccine is given to the research subjects. Further, it's a random assignment, a flip of a coin to determine if the placebo or experimental is given.

I received my first injection on September 3, 2020 and was confident during the first few days, I received the experimental vaccine. I had some of the common symptoms (headache, fatigue, injection site pain) that were listed in the consent form. They resolved with supportive care. However, at Day 9, I developed unusual gentito-urinary symptoms that were extremely painful and concerning. These symptoms progressively worsened throughout the next 10 days that necessitated a visit to a Urological specialist, who diagnosed me acute non-bacterial prostatitis. After discussing with the research team, Dr. Novak and my urologist, we had thought my diagnosis of prostatitis was unrelated to the experimental vaccine. I underwent aggressive treatment and my prostatitis and associated symptoms completely resolved by October 6, 2020.

Therefore, after receiving clearance from my urologist, Dr. Novak and myself, I received my 2nd COVID-19 injection in the research center on October 7, 2020. On October 8, the same genito-urinary symptoms returned, consistent with acute non-bacterial prostatitis. Given the timing of the 2nd vaccine and the return of symptoms, both Dr. Novak and my urologist determined that this was a moderate adverse event caused by the Moderna mRNA-1273 COVID-19 vaccine. I am still currently receiving treatment for prostatitis and my symptoms have improved. I am hopeful that I will not have chronic, long-term health effects and that I should return to my pre-trial health status soon.

After experiencing 2 episodes of acute non-bacterial prostatitis, likely caused by an experimental COVID-19 vaccine, would I consider participating again in a trial like this? My answer is no. Even the common side effects experienced shortly after receiving the vaccine such as fatigue, headache were quality of life impairing. More importantly, my two episodes of prostatitis were significantly painful and affected my quality of life severely.

As we obtain more data, especially in male research subjects (the prostate is a male reproductive gland), we can learn more if my moderate adverse event was directly associated with the vaccine, or a rare occurrence. We must understand if the vaccine is safe and also efficacious, in protecting us from COVID-19.

We must always weight the risk and benefits of any medicine, procedure, etc. If a COVID-19 vaccine(s) becomes approved under the Emergency Use Authorization program by the FDA, we must be very cautious at determining if the COVID-19 vaccine benefits outweigh the risks of administration. For example, if a person is a front-line health care worker who treats COVID-19 patients, or is a nursing home resident, a worker in a confined space (meat processing plant), flight attendant, etc., these specific professions may benefit from receiving the COVID-19 vaccine as their risk of contracting COVID-19 is higher than the general population. However, if one works from home and has done a successful job at maintaining vigilance throughout the pandemic, it may be worthwhile to wait to see how more individuals respond to the COVID-19 vaccines (assuming FDA approval).

I hope my personal experience in the Moderna COVID-19 vaccine trial will help our listeners make a better informed decision about receiving a vaccine that has been expedited by Operation Warp Speed and planned EUA approval by the FDA.