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December 22, 2020

My Experience in the COVID-19 Vaccine Study: A Benefits Industry Perspective

Dr. Monte Masten
Chief Medical Officer
Marsh and McLennan Agency

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.

  • The Pfizer vaccine famously requires extremely cold temperature storage. The Moderna vaccine also needs cold temperatures, but not as cold as Pfizer. While the Pfizer vaccine is already being administered in healthcare centers, the Moderna vaccine is more likely to be available at retail settings like pharmacies, clinics, and primary care offices. It recently received emergency authorization from the FDA, so it’s likely to be the vaccine option that’s widely available to the general public. 
  • Historically, just 35-40% of people get vaccinations. There is a lot of skepticism and misinformation out there around COVID-19, and this may affect the number of people willing to take these new vaccines. Employers and their healthcare partners (advisors, providers, and carriers) will play a key role in educating employees and their families. They need to help members understand that this is safe and effective, and they may need to remind people to get their second dose.
  • MMA employer clients are already asking our team where they might fall in the vaccine allocation process behind healthcare workers and high-risk individuals. This pandemic is unprecedented, and we just don’t know yet how and when self-insured employers will be able to purchase vaccine doses for their members. However, we are warning our clients to be on guard against scams or black-market vaccine doses. There will be irreputable vendors that pop up and try to take advantage of the demand for this vaccine, so patience and caution is critical.
  • Employers are also asking about costs for the vaccine. At this time, the federal government has purchased and is distributing all the available doses, and they have also discussed retail partnerships with pharmacies around the country. The vaccine will be covered in-network without cost sharing for plan participants. The vaccine will also be covered out-of-network without cost sharing during the COVID-19 Public Health Emergency Period (and without balance billing). Plan costs should be limited to the cost of delivering the vaccine, which include the health care providers’ cost to store the vaccine, supplies, and charges for a provider to administer the vaccine. Grandfathered health plans (under the Affordable Care Act) are not subject to the vaccine coverage mandate.
  • Both the Pfizer and Moderna vaccines have shown roughly 95% effectiveness, but there are still questions about if someone who was vaccinated can be infected with COVID-19 or even spread COVID-19. For this reason, employers should be prepared to continue requiring masks in the workplace, encouraging physical distancing, and promoting hand-washing until enough people have received the vaccine. It takes time to build immunity following vaccination, so we can’t let our guards down immediately.
  • My colleague Lisa Comerose, RN and the National Director of Clinical Management at MMA, is working alongside employers to plan for vaccination clinics. She and her team of nurses help employers host clinics for the flu vaccine, shingles, and other vaccines that employers offer to members through onsite clinics or annual events. We expect that self-insured employers will play a role in distribution to the general public after priority groups have received their shots.
  • Employers are trying to build expertise in vaccine literacy now so they can confidently speak to the safety, effectiveness, and necessity of the COVID-19 vaccine. We see them attending webinars, tapping clinical resources, and asking for resource guides to help them set the right tone and say the right things. We’re already seeing government and healthcare clients starting to educate their employees now, and we hope their efforts will pay off with wide adoption. MMA’s clinical experts are assisting with these education campaigns to help the public understand that the side effects I experienced during the trials are not only expected, but a good sign about the strength of this vaccine.

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.

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