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Last month, I did something that would’ve surprised my family and me six months earlier. I signed up to take part in a COVID-19 vaccine clinical trial.
As an avid advocate for vaccines who knows that they save lives, I still found myself personally and professionally skeptical about the speed with which COVID-19 vaccines were being developed and how they were being politicized. Once I arrived at the point where I was sitting in a clinic office waiting to get my first injection, I knew it would be important for me to share how I worked through my own hesitancy.
I’m a pediatrician. Answering questions and concerns about vaccines is part of my job. I welcome the conversations. I tell parents that I am the expert in child health, and they are the expert in their child. Together we try to find the best way for them to be healthy and grow to be happy and successful.
But I also understand and acknowledge that doctors and others in the medical community have a history of violating the trust of patients and communities that look like me. Black and brown people have been experimented on, left to suffer and willfully neglected by the very profession that takes an oath to “do no harm.” So just because I am a Black MD does not mean I am not suspicious. I therefore aim to listen, reflect, and share my expertise, knowing that it may not change a parents’ decision. However, I hope we both leave understanding more about each other’s concerns for their child’s health.
When it came to the COVID-19 vaccine, I initially did not feel like an expert. I had to do my homework. I read about the development of the vaccines, listened to the New England Journal of Medicine’s weekly podcast and found helpful tools like the New York Times’ COVID-19 vaccine tracker. I also talked to experts I knew and trusted. I learned that previous vaccine trials for SARS-CoV and MERS-CoV (COVID’s “cousins”) were a foundation for the science behind many COVID-19 vaccine trials.
Talking with experts and following these resources helped me overcome my initial hesitancy. There are three main reasons these vaccines were developed so quickly: 1) the technology didn’t require cultures to be grown in a lab, a process that takes months. 2) We are in a pandemic, which means there is a lot of virus floating around. In order to know if a vaccine is effective, we need an individual to be exposed to the virus. When the virus is everywhere, it doesn’t take as long. 3) There never have been so many scientists or so much money focused on a single problem or vaccine. Never before have this amount of brain power and resources targeted one challenge.
Once I felt ready to get a vaccine, I had another decision to make. Should I wait for one of the first approved vaccines as a healthcare worker who was likely to get priority? Or should I participate in a COVID-19 vaccine trial? In the Twin Cities, my employer was the first to begin enrolling participants in a trial. You may have heard of the AstraZeneca/Oxford trial that had to be paused; that was the one. The researchers running it realized there had been a mistake in some of the initial doses, with some participants only getting half a dose.
Thing is, those participants had a better response! Yet a miscalculation was made. The other option available in the Twin Cities is with Janssen Pharmaceuticals. Both use a more “traditional” approach of a genetically modified virus to teach the immune system how to make a protective response.
In choosing between trials, some might think the answer is obvious: Go with the trial that didn’t have to be halted, the one that hadn’t made a mistake, right? Well, to me, the halting of the trial, the concern for accuracy and safety, told me that those running the trial were not cutting corners and were willing to admit mistakes.
In addition, the AstraZeneca/Oxford trial has one thing in Minnesota that the Janssen trial doesn’t: Dr. Zeke McKinney. Zeke and I go back to medical school, where we worked together at the Student National Medical Association, helping fill our fellow students’ gaps in education around the social determinants of health before it became a more regular part of the curriculum.
Dr. McKinney continues that education today as chief medical editor of Minnesota Medical Association’s MN Medicine, a member of Minnesota Association of African American Physicians and a lead investigator of the Minnesota AstraZeneca/Oxford trial. In an article in the Minnesota Spokesman-Recorder, he spoke about how the COVID-19 trials help protect human rights, and this resonated with me. As someone with family around the world, particularly in Cameroon where my parents grew up and a number of family members still live, I also wanted to support a vaccine that could truly be global.
The Pfizer and Moderna mRNA vaccines, which already have been approved, require ultra-low freezers and cold chains, which aren’t going to work in much of Africa. Knowing the Oxford scientists used their leverage to get AstraZeneca on board with making their vaccine on a not-for-profit basis worldwide for the duration of the pandemic, and always at cost to low- and middle-income countries, was also a critical factor for me.
Now I was reassured about the speed of the vaccine development and considering two trials. I decided on the AstraZeneca/Oxford trial because I trusted their scientific process and Dr. McKinney, and I wanted to contribute both locally and globally to making a safe and effective vaccine. Along the way I also was inspired by several doctors who shared their experiences enrolling in a COVID-19 trial, including one of my mentors, Dr. Dipesh Navsaria, as well as a number of Black women doctors who shared their experience on Twitter.
So, how has the process of enrolling in a phase 3 clinical trial gone thus far? To start, I submitted a prescreen questionnaire that asked about my baseline health, occupation/exposure risk, age, gender, and race/ethnicity. Based on those answers, I was deemed to qualify.
I then scheduled an appointment and was sent a thorough consent packet via email. I learned that I had a two-in-three chance of getting the actual vaccine versus a placebo. I also learned how frequently I would have to check in personally versus virtually, and the planned length of the trial, which was two years. I also learned participants get $100 for every in-person visit (of note, this financial incentive was not advertised at all).
When I showed up for my appointment, I had some questions of my own: Were they doing a half-dose first shot as part of their protocol given the early results? No, I was told. This was not yet planned in the U.S. Could I get results of my antibody tests (part of the blood draw they did)? No, they go to a third-party vendor. Did I really need another nasal swab (joking, but that was now my fifth one since COVID-19 arrived. I’m not a fan). Had there been any discussions about ending the trial early if efficacy and safety are significant, given the ongoing surge, to allow those who received placebo to get an actual vaccine?
Initially I was told there wasn’t a decision on this yet. A week later I learned that once I was offered the actual vaccine through my employer I could be “unblinded” and find out if I got the actual shot or the placebo as part of the trial. If I didn’t get the shot as part of the trial, I could get it from my employer and still participate in the trial.
It was then time to get my arm prepped and in went the needle! It was as routine as my annual flu shot (which I got back in September). I have had to answer a questionnaire on an app on my phone each week to monitor symptoms and then call in any to the clinic.
Since my enrollment in the trial the FDA has approved the two mRNA vaccines that are now being rolled out across the country. While doing my research I spent a fair amount of time learning about the mRNA vaccine technology used by Pfizer and Moderna vaccines, as it wasn’t commonly taught when I was in medical school. As I learned more about the history of mRNA technology and the companies utilizing it and reviewed the clinical trial data, I was reassured that the process had been consistent and safe.
It is true that we still don’t know all the possible short/medium/long-term side effects of these vaccines. But based on the overall history of vaccine development, any side effects are likely to be rare. Additionally, most proven, vaccine-related long-term side effects have shown up within months of a new vaccine being distributed, not years. If they exist, they will be caught quickly, and I am reassured that we haven’t yet seen any significant number of side effects in thousands of participants who received these vaccines months ago.
We also need to remember that vaccines have always been about managing risk. COVID-19 presents a significant and even deadly risk to many of our communities. One in 800 Black Americans has died of COVID-19 this year, more will die before the pandemic is brought under control, and an uncounted number more will deal with the long-term effects of surviving their illness. When my family, friends, and patients ask me about balancing the risks, my response is that the unknown short/long term risk of a mRNA or any COVID-19 vaccine is still much more acceptable to me than the risk of getting COVID-19.
That is why when offered the Pfizer COVID-19 shot through my work I got that one as well (and only experienced a sore arm for 24 hours). I truly believe vaccines save lives. I am sharing my path dealing with my hesitancy because it needs to be OK to ask questions, and it’s normal to have some hesitation whenever there is a new medication or treatment. A COVID-19 vaccine trial may not be for you, but hopefully everyone, whether it be by masking, socially distancing or getting your own COVID-19 shot, finds ways to help protect our communities.