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The bumpy road to vaccine trial participation–Part III

shows two vials with bright yellow tops with printing on the sides reading: VAC31518 COVID and Janssen Vaccine
Johnson & Johnson has been working with it's affiliate company, Belgian-based Janssen Pharmaceuticals to develop and test a one-shot dose of COVID vaccine that's been in Phase 3 trials since last year. The Food and Drug Administration is poised to give emergency use authorization to the vaccine candidate later this week. If that occurs, some 2 million doses will be available in the U.S. as early as March 1. Photo courtesy: Johnson & Johnson

By Melba Newsome

Dec. 11, 2020. I consider that my first official day as a participant in the Johnson & Johnson/Janssen vaccine clinical trial.

I’d volunteered a month earlier and gone in twice before but that’s the day I finally got the jab. Months would pass before I knew for sure whether I’d been given saline or a real therapeutic.

I drove home with a long list of instructions and a host of mixed feelings.

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I was to record my health data daily for the first week, then continue to do so every Monday and Thursday after that. I was supposed to seek emergency medical attention if I experienced stroke-like symptoms, blood clots (how would I know?), confusion, bluish lips or face, or new difficulty breathing.

I experienced no side effects from the injection, which led me to believe I’d received a placebo.

Damn.

Nonetheless, the chore of constantly checking my breathing, blood pressure and body temperature increased my anxiety.

My next visit to the research site was scheduled for about a month later, in mid-January, just as cases were surging in North Carolina and across the country. At that point, I suspected my two-year trial commitment as a lab rat might be cut short. Two vaccines – Pfizer/BioNTech and Moderna – had already been approved, a fact that seemed like game changers for participants in the J&J/ Janssen trial, especially for those in the placebo group. When more than two Americans were dying of COVID every minute, it would be medically unethical to continue a double-blind study for two years rather than give all participants a life-saving vaccine.

While I waited for the trial to be unblinded, I went about my life as I had for the past year — social distancing, wearing a mask, washing my hands, and staying home.

I wasn’t taking any chances. As Rev. William Barber had advised during a February “fireside chat” with state Health and Human Services Secretary Mandy Cohen, “don’t swim all the way across the ocean just to drown in a creek.”

All effective

I followed every twist and turn of the vaccine rollout. I found the early state and national data showing the racial and ethnic disparities of who was getting vaccinated, coupled with anecdotal and polling data about hesitancy among people of color particularly distressing. We were being disproportionately impacted by the virus both economically and in terms of our health, yet we were at the end of the line for the cure.

During my Feb. 16 visit, the study assistant explained that, when the FDA eventually issued the emergency use authorization for the J&J/Janssen vaccine at the end of the month, study participants would be unblinded and those who received the placebo would be offered a vaccine shortly thereafter.

The Pfizer/BioNTech and Moderna vaccines, made using messenger RNA, require two injections four weeks apart. The J&J/ Janssen vaccine uses an adenovirus that has been engineered to carry the genetic code for the SARS-2 spike protein. Its “one and done” shot was shown to be 66 percent protective against moderate to severe Covid infection, meaning that two-thirds of the recipients were protected against getting even moderate cases of COVID. The vaccine turned out to be 85 percent effective in protecting against severe disease.

My research told me not to get caught up in comparing numbers because the vaccines have not been tested in head-to-head trials. The upshot is that all of the vaccines have proven effective at preventing the most severe COVID outcomes, including hospitalization and death.

Good enough!

Who gets to go first?

The EUA for the J&J/Janssen vaccine came on Feb. 27, making it the third coronavirus vaccine available in the US.

I watched as vaccination rates ticked up around the state and waited anxiously for a call, text or email telling me it was my turn. On March 6, Novant Health held a mega vaccine clinic at the Spectrum Center in Uptown Charlotte where, according to news accounts, they vaccinated around 4,000 people; 2,000 of those people received the J&J vaccine.

Seriously? So, I volunteer to be a lab rat for the sake of medical science and any ole Joe off the street gets vaxxed ahead of me?

“Yes, there are vaccination clinics going on for J&J under the EUA approval for citizens around the country,” the infinitely patient study manager emailed in response to my inquiry. “I hope you can understand that we have limited control on this process. I assure you as soon as we have been given the approval to move forward we will communicate to all participants.”

And they did. A week later, I returned to the clinical trial site for a 30-minute appointment to learn my fate. After preliminary health screening questions and completing more informed consent paperwork, I had another blood draw and took another COVID test.

Full social calendar

Finally, the doctor revealed what I’d long suspected: my initial injection was a placebo.

This shot definitely was not. For about 10-15 seconds, the injection burned at the site and all the way down to my elbow. But that was it. Unlike nearly everyone who’d told me about their post-vaccine side effects, I had no chills, aches, pains or any other flu-like symptoms.

My trial participation is scheduled to continue for nearly two more years. What’s the point if we already know the vaccine is safe and effective?

It turns out that continued safety monitoring is standard procedure even after vaccines have been approved for use. The research will also help determine how long the protection will last. This might involve periodic blood draws to determine antibody levels.

Meanwhile, I haven’t been this excited about going places, doing things and seeing people since college spring break.

My April social calendar is almost full. When a friend and I made lunch plans, I told her “and I’m gonna hug you when I see you, too!”

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