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Vacuna, Coronavirus, ensayos, Vaccine

This is How to Participate in One of the Coronavirus Vaccine Trials

Two days after writing a report on the start of Phase 3 clinical trials in Florida, I was knocking on the research center’s door again. This time as a study subject

By Leila Macor:

A key facet in the frenetic global fight that Pfizer, Moderna, and other pharmaceutical groups have undertaken to develop a viable coronavirus vaccine is the recruitment of tens of thousands of volunteers willing to participate in clinical trials.

AFP’s Miami correspondent Leila Macor participated in the phase 3 trial organized by Moderna, the U.S. biotechnology firm that announced on Monday that its experimental COVID-19 vaccine is nearly 95% effective.

Why did Macor, who suffers from asthma, decide to be one of Moderna’s 30,000 study subjects? Here he recounts his experience, which began a few weeks after his own father died from COVID-19 in Chile.

A Delicate Decision

My father died three weeks before the Pfizer and Moderna clinical trials began in late July. He died alone, as people die from this virus.

While my siblings, my mother, and I were trying to deal with the loss from our confinement in different countries, I was facing another dangerous reality: Miami, and Florida in general, was becoming a principal focus of the virus in the United States. And my job was to cover that story.

The idea of actively doing something to help defeat this plague offered me some peace.

I talked it over with friends and family, and they all helped me conclude that, because I am an asthmatic, the danger of a potential side effect from the vaccine could not be greater than the risk I was running if I got the coronavirus.

And so I decided to participate.

Reporter Leila Macoren at the Research Centers of America during the Phase 3 trial for the COVID-19 vaccine. (AFP)

Two days after writing an AFP report on the start of Phase 3 clinical trials in Florida, I was knocking on the research center’s door again. But, this time, as a study subject.

The Research Centers of America, in the north Miami suburb of Hollywood, were developing the Pfizer and Moderna trials. They were alternating. One day one, another day the other.

Dozens of other research centers in the rest of the country were also recruiting volunteers. Anyone could volunteer, as long as their chances of infection were high: waiters, doctors, cab drivers… or reporters.

I made the appointment for a Tuesday, which turned out to be a Modern Day.

Vaccine or placebo?

They put a sticker with my name on it and took me to an office, where they explained to me what I would later read in a 22-page document.

The test consisted of two doses. The volunteers would receive $2,400 over the two-year study period. We were warned of possible side effects, from pain at the injection site to fever and chills.

The 30,000 subjects were to be divided into two groups: half would receive the vaccine, the other half the placebo.

“We don’t know which is which,” the nurse told me, as I sought to find out if I would fall into the placebo group. Only the people in Moderna know, but not until I compile and analyze their data.

I asked what would happen if I took an antibody test, but she said the results would be inconclusive.

“Uncertainty is going to kill me,” I said.

Then the nurse, who was taking my blood pressure at the time, looked up and spoke to me very seriously: “Placebos are as important as vaccines. It’s impossible to do the trial without the control group. You are helping humanity in the same way.

I felt guilty for obsessing about my role in the clinical trial instead of focusing on the bigger picture: helping us all get through the pandemic. And I stopped asking.

The story in two doses

The nurse took my blood to fill six or eight tubes,” I lost count. I took a pregnancy test. They were very insistent about using birth control. “We don’t know yet the effect of the vaccine on the fetus,” they told me several times.

Then two people came with the vaccine in a little refrigerator. Or the placebo. They laughed when I asked them to let me take a picture. What for me was a historical moment, for them was just any Tuesday.

The shot didn’t hurt. They took me to a waiting room, where they kept me for half an hour for observation. Three or four other volunteers looked indolently at the phone.

A Cuban nurse was wearing a red Superman cape.

(Facebook)

“Why the cape,” I asked.

“Because we are all heroes here, Mommy,” he said.

They gave me several stickers, a T-shirt, and a mask, all with the slogan “Covid Warriors,” and made me download an application where I occasionally report my temperature and symptoms.

By the time I got home, the injection site was already hurting. Could it be that I got the vaccine, I thought. I spent the next three days googling if a serum injection produced muscle pain. But I didn’t get any answers.

The second dose was in mid-September. It hurt a lot more, and for two days the injection site was swollen and hot.

Still, it is impossible to be certain. I’ve adjusted to the idea of waiting for Moderna to inform me one day whether I’m vaccinated or not.

Then I realized that participating in the clinical trial had been a way for me to process my grief. To my father and to the world that the virus is leaving us as a gift.

As tiny as it was, it was the only weapon I could wield to give me the illusion that we were defending ourselves.

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