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As the Pfizer COVID-19 vaccine begins its journey to hospitals and healthcare facilities around the world, many benefits industry professionals are watching and preparing for their own vaccine distribution efforts. Several promising vaccine candidates are right on the heels of the Pfizer shot, and I was honored to be part of the COVE phase three study for the Moderna mRNA vaccine, administered by Emory University. I want to share my experiences during the trials, along with my expertise as a benefits industry leader, to help employers and the public better understand the safety and effectiveness of this vaccine.
I first learned of the COVE study at Emory University while on a business trip with Dr. Cynthia Holbrook, Corporate Director of Employee Health and Wellness at Emory Healthcare. She mentioned that Emory was a trial site for the Moderna vaccine. As a physician, I had seen patients participating in clinical trials throughout my career. Those with serious, chronic medical conditions found so much hope and fulfillment as participants in trials for new treatments, new drugs, or new procedures. My step-daughter works as an ICU nurse, and I’ve seen the toll the pandemic has taken on her and her colleagues. I wanted to do something positive to help fight the COVID-19 pandemic, and the vaccine trial seemed like an ideal way to get involved, do something proactive, and hopefully find the light at the end of the tunnel.
My first step was to sign up for the trial at clinicaltrials.gov, which involved filling out a form and choosing Emory as my study site. Within a day or two, I received a phone call from a student who was helping administer the study, and we spent about an hour on the phone filling out a pre-trial questionnaire. They asked questions about my background, work, and health history. I was told on the spot that I met the criteria for the study, and the trial team followed up with a mountain of reading material in late July.
The materials they sent me included a number of legal documents, including a 21-page informed consent document that outlined all of the potential risks and adverse events that could happen as part of the vaccine trial. The next step was an initial office visit with the physicians administering the trial. In a roughly 5-hour appointment, I reviewed and signed all the documents, shared my medical history, underwent a physical exam, and had my blood drawn. Then, in a second visit in August, I was given the first dose of the Moderna mRNA vaccine.
The first dose didn’t cause any side effects for me, just a little soreness around the injection site, similar to what you might experience after the annual flu shot. I was instructed to download a mobile app to record any symptoms and side effects each day. A nurse from the Emory team called me once a week to check on me and capture anything of note. Both the Moderna and Pfizer vaccines are being given in two doses, with Pfizer’s requiring 21 days between doses and Moderna’s requiring 28 days. I had the luxury of a nurse checking on me and reminding me when it was time for my second dose. Those receiving the vaccine in the general public are unlikely to get this type of care and reminder, so it’s important that patients understand the spacing and remember to return for the second dose.
After the 28-day period, I returned for my second dose of the vaccine. This time it did cause significant side effects for me. I experienced approximately 36 to 48 hours of an intense headache, painful muscle aches, and severe chills that caused my teeth to chatter. The chattering was so intense that I was afraid I would damage my teeth! I experienced these side effects along with 15 to 20 percent of patients in the study, with approximately 5 percent of participants experiencing extreme side effects. After about 2 days, the side effects faded and I was back to normal activity. The nurses continue to follow up with me, and I still speak with them about once a month as they gather long-term data from the phase three trial.
The side effects I experienced were unpleasant, but I want to emphasize that this indicates an effective immune response. My body was recognizing the vaccine and mounting an impressive immune response, which is exactly what the trials hoped to discover. After I took the second dose of the Moderna vaccine, I was exposed to COVID-19 at a dinner with a friend. I notified the team at Emory and they had me come in for a COVID-19 test, which was negative. I later took a COVID-19 antibody test and found I was positive. This means that I very likely received the Moderna COVID-19 vaccine instead of a placebo shot. Emory did notify me, along with other study participants, that anyone who received the placebo will be alerted so they can plan to receive the real vaccine when it's available.
There are a few things I want employee benefits professionals to know about my experience and how vaccine distribution may work for self-insured employers.
I hope in sharing this experience in the COVE Moderna vaccine trial that I can shine some light on the safety, effectiveness, and incredible promise of the COVID-19 vaccines. Vaccine development efforts have been an unprecedented collaboration that we have never seen in the history of medicine before. Governments, the private sector, researchers, and medical professionals around the globe have come together to make this happen. To have multiple vaccines rolled out in roughly 9 months is mind-blowing. This effort has brought hope to me and many others who have felt the effects of COVID-19 on their loved ones, and my hat is truly off to everyone who worked so hard on this.