‘Without them, we would not have a COVID-19 vaccine’: Meet the people who volunteered to take an experimental dose

One early morning in mid-October, Jonathan and Patricia Liedy woke their three daughters before dawn, loaded them into the car they'd packed the night before and set out from the north Florida home they had barely left in months.

Destination? A medical facility three hours away in Georgia.

The couple had appointments that would give them membership in a small worldwide club that has played a critical role in paving the way for a vaccine. They volunteered to be injected with an experimental vaccine to make sure it was safe for the world.

I mean, that really is our philosophy of life," Patricia, 36, said, speaking via Zoom from their home in Tallahassee.

Instead of sitting there, hoping that someone will do something, get up and be the person to do something. We can't always do that, but this time we could."

The scale of the coronavirus pandemic has spawned a massive global undertaking. Chinese scientists posted the coronavirus genome - basically the map of its DNA - online in January, and just shy of a year later, doses of the first approved vaccine are being injected into seniors living in the United Kingdom. Observers have heralded the process as science done at blistering speed.

Jonathan, who works in IT, and Patricia, who takes care of their kids, are two of the over 43,000 people who participated in the final phase of testing for the vaccine developed by Pfizer and German startup BioNTech, which is expected to be approved for use in Canada as early as this week.

It's already got the green light in the U.K., and on Tuesday, 90-year-old Margaret Keenan of Coventry became the first person in the world to get the Pfizer vaccine outside of a trial. The retired jewelry shop attendant told the Guardian it was a privilege."

The dose that went into Keenan's arm, and all the ones that will follow, were helped along by the thousands of people who volunteered to test it first.

If you say there's 30,000 people per trial, and there's 20 trials now in play, that's over half a million people around the world who came forward and volunteered for these vaccine trials," Alan Bernstein, the CEO of CIFAR, a Canadian-based global research organization, and a member of Canada's COVID-19 Vaccine Task Force, said in October.

I think we owe them a huge debt of gratitude for doing that. Because without those volunteers, we would not have a vaccine."

The success of the vaccine has also now prompted questions about those same volunteers. To see if the vaccine actually works, some study participants are given a placebo, while others get the real deal.

The study is blinded," which means volunteers aren't told which they're getting so it doesn't affect their behaviour. Even the syringe used for the injection is covered.

But while the studies are meant to continue for two years - to get as much information about long-term effects as possible - some are arguing it's only fair to let those in the placebo group know early, so they can benefit from the protection of the vaccine they helped create.

Like most of the volunteers the Star has spoken to, the Liedys saw this as an opportunity to play a role, however small, in stopping the pandemic that has killed more than 1.5 million people around the world. Florida, where they live, has lost almost 20,000 people alone. One was Jonathan's colleague.

It was so hard not to be super-angry after that," said Jonathan, 44. We're watching people say this is a hoax, or it doesn't matter, or it's just the flu, when I've already had to hire for his position and clean out his office so his wife didn't have to do it."

That's when they started looking into trials, but both Moderna and Janssen wanted people who lived closer to their test sites, Patricia said. But Pfizer said if they were willing to drive for a six-hour round trip, they were in. They didn't hesitate.

For Jenny Hamilton, 57, a former police officer who now does security on film sets, the pandemic made her think of the last time a virulent virus had swept the globe, and of her grandparents, who had lived through Spanish Flu in 1918.

Back then, they didn't even have the option of having vaccines," she said. Then, when they started developing vaccines, people in prisons and mental institutions and minorities and other vulnerable people would be subjected to experimentation, and wouldn't have the choice to be able to say, I want to take this or I don't want to take it.' "

Now that she had the choice? Hamilton said yes. A lot of other people I've heard from that are part of the trial feel the same way, that this is a historical event. And, you know, it's an all-hands-on-deck type of emergency."

She was also in the final phase of testing of Pfizer's vaccine and got her shots at one of the three trial locations in Atlanta.

It's kind of funny. People worry that we might be rushing a product into people that has never been tested at all," says Ian Haydon, 29, who works in communications at the University of Washington in Seattle. He signed up for a Moderna trial after someone posted about it on his office's Slack messaging app.

I think that ignores people like me, and the thousands of others who are real people," he says. These are obviously unusual times, and this is a very fast development timeline, but these trials really are happening."

A clinical trial has three stages. In the first, researchers are still trying to sort out basic safety and protocol so they need a relatively small number of volunteers. Several vaccine makers also tried different dose strengths early on.

Phase 2 expands the trial to more people and starts looking at how effective the dose is. Phase 3 is when the trial is rolled out to the world, with thousands of volunteers enrolled to try and make sure the vaccine works on as many people as possible.

Haydon is relatively unusual in that he was part Moderna's Stage 1 trial. At that point researchers had just 120 volunteers and were still trying to figure out how much vaccine was needed, so were trying five different doses.

According to Haydon, he was given the highest dose being tested, which, it turns out, may have been too high. He got some arm pain after his first dose, but it was his second that was a bit more eventful," as he puts it.

I woke up with a pretty high fever. I was nauseous. I had a headache. I had basically all the stuff that we had been asked to look out for." He contacted the trial organizers, who recommended that he go to urgent care, where he was met by someone from the study.

He went home, where slowly his symptoms started to fade. A few days later he says he was told his immune system had basically overreacted to a dose that was too strong. But as a result of that trial, Moderna was able to narrow down how much vaccine to use, and Haydon says he's proud of the part he played.

I had a pretty unpleasant evening," he says. But looking at it now, the fact that my illness, however brief, seemed to matter for the trial? That's very comforting for me."

To know that it helped make the later phases of the trial even just a little bit safer for the other volunteers seems well worth it. I certainly have no regrets."

(One of the later volunteers who may have benefited from that was Haydon's own mother. She worried about her son participating in a trial, so she and Haydon had several long phone conversations about the risks and benefits. In the end, she volunteered for a later trial herself, Haydon says.)

The risk to personal health versus the benefit to the vaccine effort was something every volunteer had to weigh.

I'm sort of a walking co-morbidity," Jenny Hamilton says and laughs. With asthma and a thyroid autoimmune condition, she's at higher risk for COVID-19, but she says the study organizers were open to people with some conditions.

Her past as a police officer made the risk easier to contemplate, she said: Sometimes you think this is a routine call, and then all hell breaks loose after you get there."

I'm used to getting a call where I don't know what's going to happen when I get there."

Hamilton suspects she got the real thing, as she had symptoms after both shots.

You basically feel like you do the day or two before you get the flu, you know, where you're exhausted and you don't know why."

When asked if they think if they got the real vaccine, the Liedys immediately look at each other and laugh. They're both in a Facebook group for study volunteers and this is a very popular topic of discussion.

After getting their first shot, the Liedy's took their daughters out for Greek food and took a short tourist drive into Alabama - after months of isolation the trip felt almost like an adventure, but they also wanted to stay close to the centre in case either had a bad reaction. Finally they headed home. Both had sore arms and were tired, but that could have been chalked up to dragging five people six hours in the car," Jonathan notes.

For the second, they were warned by others in the Facebook group that any side effects tended to be a bit worse so they drove straight home after.

Patricia had a very sore arm and had flu-like symptoms for a few hours, including an elevated temperature and body aches. They were gone in a few hours. Jonathan however, had the same reaction he had the first time. Both were tired, but weren't sure if that was related or not.

In many ways, volunteering for a trial is signing up for never-ending introspection.

The weirdest thing about being part of a blinded trial like this is that you're always second-guessing," Jonathan says. Am I getting body aches? Am I going to get sick? Is it the virus or am I causing it myself because I think I got the vaccine?"

In fact, the question of whether or not volunteers got the real vaccine or not is becoming a matter of some importance now that the vaccines they helped develop are proving to work. Volunteers signed up to be followed for two years to study the long-term effects, but there is now a push to unblind" the studies so that those in the placebo group can get the real vaccine.

The argument for keeping the studies blind is that it will allow researchers to continue collecting data on the long-term effects, important for public safety.

But an open letter from dozens of trial volunteers, including the Liedys, and posted to Change.org in November argues that keeping the study blinded isn't fair to those who stepped up.

Although maintaining a larger placebo group for a longer period of time would provide more data, in this case, it would do so at the cost of preventing people at high risk of contracting the virus, or high risk of having a severe outcome from the virus, from seeking a potentially life-saving vaccine."

Regardless, the couple say they don't regret participating. Doing so helped start the grieving process for Jonathan's co-worker, Patricia says.

It's been healing to know I'm doing a small part to not just protect his parents, but it's protecting other people's parents, and our immunocompromised friend," she says.

He can't do stuff like this. He's been locked up in his apartment since March," Jonathan adds, and Patricia nods.

It's been a relief to just be able to help. To just be part of the answer."

Alex Boyd is a Calgary-based reporter for the Star. Follow her on Twitter: @alex_n_boyd