Dans les Research Centers of America le 18 août 2020 Photo: AFP
health

What is it like to take part in a vaccine trial?

9 Comments
By Leila MACOR

A key facet of the global mad scramble by Pfizer, Moderna and other pharma groups to develop a viable coronavirus vaccine is the recruitment of tens of thousands of volunteers willing to participate in clinical trials.

AFP's correspondent in Miami, Leila Macor, took part in such a trial organized by U.S. biotech firm Moderna, which announced this week that its experimental vaccine was nearly 95 percent effective.

Why did Macor, who suffers from asthma, decide to be one of Moderna's 30,000 test subjects?

Here, she recounts her experience, which began just weeks after her own father died of COVID-19 in Chile.

Three weeks before Pfizer and Moderna launched their coronavirus vaccine clinical trials in late July, my father passed away -- alone, as so many have in this crisis.

As our family lived through the trauma, and said goodbye as best we could, I was confronting another stark and dangerous reality -- Miami was becoming a major U.S. virus hotspot, and my job was to cover the story.

But my life has been irrevocably changed. I lost my dad, and I have asthma, which could lead to serious complications if I were to be infected. The idea of taking action to help bring this deadly medical emergency under control offered me some inner peace.

Let me be clear, this was a totally personal decision that had nothing to do with work. I talked it over with friends and family, who helped me decide that any possible side effects from the trial would not be worse than getting Covid-19.

So I took the plunge.

Two days after writing a story about the start of phase 3 trials in Florida, I once again knocked on the door of a lab -- this time as a potential subject.

Research Centers of America, located in the Miami suburb of Hollywood, was working on trials for Pfizer and Moderna, alternating every other day.

Dozens of other labs were recruiting volunteers across the United States. Anyone was eligible, as long as they were in high-risk jobs: doctors, taxi drivers, grocery store workers... and reporters.

I made an appointment for a Tuesday in mid-August. That happened to be a Moderna day.

Lab staff put a name tag on me and brought me to an office, where they explained what would happen. They also gave me a 22-page document with all the details.

The trial consists of two doses. Volunteers are paid $2,400 over the course of the two-year study. They warned of possible side effects -- from pain at the injection site to fever and chills.

The 30,000 subjects are divided in two groups: those who get the vaccine and those who get a placebo.

"Even we don't know which is which," the nurse told me, when I asked about my group. Only Moderna knows.

I asked about getting an antibody test, but the nurse said the results were not foolproof.

"Not knowing is going to kill me," I said.

As she took my blood pressure, the nurse looked up at me and said, in a quite serious tone: "Placebos are as important as the vaccine. The trial needs a control group. You are helping humanity either way."

I felt guilty for obsessing over my status, rather than concentrating on the overall goal -- helping everybody overcome this pandemic. So I stopped asking questions.

The nurse took six to eight vials of my blood -- I lost count. They gave me a pregnancy test, and stressed the importance of using contraception during the trial, saying the potential side effects for a fetus were unknown.

Then two people came in with the vaccine in a cooler. Or maybe it was the placebo. They laughed when I asked to document the moment in a picture. For them, it was just another Tuesday.

The injection didn't hurt. They took me to a waiting room, where I stayed for half an hour of observation as a precaution. Three or four other volunteers scrolled through their phones as they waited.

One of the nurses wore a Superman cape.

"Why the cape?" I asked.

"Because we are all heroes here, girl," she said.

I got a bunch of swag -- stickers, a t-shirt, a mask -- with "COVID warriors" or "COVID superheroes" written on it.

The lab had me download an app to track my temperature and any eventual symptoms.

When I got home, my arm was a bit sore. I wondered -- did I actually get the vaccine? Three days of internet searches about "vaccine injection site," "muscle pain" and other terms got me nowhere.

The second dose came in mid-September. It hurt a lot more, and for a while. A hard, red knot emerged at the injection site.

But I still have no idea if it was the placebo or the vaccine. I have to wait for Moderna to tell me -- someday.

I eventually realized that taking part in the trial was a way to process my grief -- over losing my father and seeing the world turned upside down.

It was a small gesture, but it was the only way I knew how to make myself believe we are fighting back.

© 2020 AFP

©2020 GPlusMedia Inc.


9 Comments
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For people that understand how much science has improved the life of all humans being a volunteer for a vaccine trial is not such a big sacrifice, in a way is like donating blood; you get something back, a little bit of money for your inconveniences and a chance of being immunized, but the real purpose is to benefit everybody.

For people that deny science this is unconceivable, their minds are full of conspiracies where all doctors and nurses of the world are willing to kill and maim their patients, friends and family so someone else can get money. So, volunteers are just risking themselves to help hiding that truth, for them no vaccine, no drug is helpful, no evidence will ever be enough to prove they are safe, that is why they try to ridicule and diminish the people that choose to participate and go to regular checks, even when they themselves benefit from the trials.

1 ( +5 / -4 )

It’s like swimming with some sharks , as they look so cuuute... lol

-5 ( +1 / -6 )

If the women on the trial are taking birth control, couldn't that affect how the medicine from the vaccine works? Like mixing medicines? Would it work the same on women who aren't taking birth control? I don't know much about medicine, I'm genuinely asking.

1 ( +2 / -1 )

If the women on the trial are taking birth control, couldn't that affect how the medicine from the vaccine works? Like mixing medicines? Would it work the same on women who aren't taking birth control? I don't know much about medicine, I'm genuinely asking.

They would ask participants before the vaccine what drugs they are taking, so as to be able to track if there are any issues with women taking birth control.

But as this is a respiratory illness, and birth control is reproductive, I don't imagine there would be much crossover. That's speculation though.

1 ( +3 / -2 )

If the women on the trial are taking birth control, couldn't that affect how the medicine from the vaccine works?

The vaccine is not directly producing an effect on the virus but only stimulating the body to produce immunity. Birth control is in essence just modifying the normal cycle to skip the ovulation. (Or even less, depending on the kind of birth control used). There is no real possibility that this would interfere with the normal production of immunity, if that were the case it would have been found a long time ago (because women would be too obviously very susceptible to infections while in one part of the cycle).

1 ( +3 / -2 )

"Volunteers are paid $2,400 over the course of the two-year study."

Risk your life/well-being for a mere 2400 $ , a covid hero t-shirt and watch Big Pharma

make billions off it...

-3 ( +1 / -4 )

Human trials of a Big Pharma pharmaceutical are not just to determine if a substance actually has any effect on the targeted condition, but even more importantly, to see if the substance looks as though profits from its sale will be greater than the liability judgements paid to its users from heinous, and possibly lifelong, side effects. If the drug looks like it can be marketed successfully and passes the profitability test, regardless of any significant effect on the disease or condition and side effects will be unprovable or minimally expensive in tort proceedings, it has passed Human trials. For example, if you look at the fine print in your drug ad and it says "This concoction is effective when combined with diet and exercise" and you know that diet and exercise are all you really need to do anyway...well, think about it. Taking ANY pharmaceutical is spinning a big 'wheel of fortune' whose only grand prizes are not suffering side effects because of the many individual physiological (and psychological) differences between us Humans that make ALL substances risky for somebody, including milk. The only real difference between Human trials and lab rats is that the Human (probably) won't be dissected at the end (unless an autopsy is necessary). Regarding vaccines for Covid, it appears that in America, at least, we will be getting the vaccine months (April) after we will see max infections (circa January) and the peak has begun to decline on its own. And just America will have 500,000 fatalities by then. Stay safe!

-3 ( +1 / -4 )

Moderna is a company that has never produced anything to my knowledge.

Their untested and unproven vaccine causes cells to be ‘programmed’ as a real virus would using mRNA.

Straight from the lab to human trials-what could go wrong?

In another 3-6 months the virus causing the pandemic should be of a mutated form no longer dangerous to humans thus any need for a vaccine will no longer be relevant.

-3 ( +1 / -4 )

Human trials of a Big Pharma pharmaceutical are not just to determine if a substance actually has any effect on the targeted condition, but even more importantly, to see if the substance looks as though profits from its sale will be greater than the liability judgements paid to its users from heinous, and possibly lifelong, side effects.

Wild imaginations stated as if they were facts do not make them so. In all developed countries every single lot of vaccine is tested for safety and efficacy, making the whole "profitability above safety" easily proved as false.

There are many health interventions that are not made for profit, and many human trials performed by people that do not benefit economically from them.

The real purpose of testing is not to make sure there is absolutely no risk whatsoever (something impossible) but to demonstrate that not taking the drug/vaccine means more risk, scientifically.

Try reading more about how human trials are performed, your oversimplification is too easy to demonstrate as mistaken because you have no knowledge about it.

Moderna is a company that has never produced anything to my knowledge.

Their untested and unproven vaccine causes cells to be ‘programmed’ as a real virus would using mRNA.

Most companies have never produced a vaccine, it the norm. For all the diseases with easy vaccines there have been one for decades, a new disease means a new chance for any company to make its first vaccine because no extraordinary hurdle is there.

And no, RNA do not "program" the cell, it is not DNA, it never goes inside the nucleus, it cannot even self replicate. It gets translated into a protein using the cells usual, normal programming and gets degraded in a few days at much, leaving enough clues for the immune system to be activated. Before trying to explain how mRNA supposedly works it would be better if you could understand it yourself.

Straight from the lab to human trials-what could go wrong?

Read the requisites for human trials, this is completely false.

In another 3-6 months the virus causing the pandemic should be of a mutated form no longer dangerous to humans thus any need for a vaccine will no longer be relevant.

Magic crystal ball arguments are invalid. The virus has mutated endlessly since the first patient, that is what RNA viruses do, but in a whole year the immunity produced still can neutralize every strain isolated. It is not realistic to say that this process will magically change in just another few months, specially when it is based on absolutely no data.

1 ( +2 / -1 )

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