Trial Trio: Trust Us. Get The Vaccine

Andrew Giering joined because he misses seeing his elderly parents.

Laura Rosado signed up because she found herself back home with time to spare after college classes moved all online.

Arturo Pineda enlisted because they wanted to contribute to ending this pandemic — even as some wary family members prefer homeopathic remedies to vaccines.

The three New Haveners have spent the past few months participating in the New Haven-based Covid-19 vaccine trial run by the global pharmaceutical giant Pfizer, the German research company BioNTechSE, and the Yale Center for Clinical Investigation (YCCI).

Pfizer and Yale have enrolled around 250 local participants since August in the roughly 44,000-person worldwide study.

As a federal Food and Drug Administration (FDA) advisory board prepares to meet on Thursday to discuss the drugmaker’s application for emergency authorization for the vaccine, these three New Haveners spoke with the Independent about their experiences on the frontlines of one of the most consequential pharmaceutical experiments in generations.

They described the process all trial participants have gone through over the past few months:

• Filling out hours worth of liability-related paperwork at YCCI’s offices at 2 Church St. South.

• Visiting those offices to receive two dosages of either a placebo or the experimental vaccine (no participant is told which one they’re getting) separated by a three-week interval.

• Getting paid $100 after each dosage, and another $5 for every weekly log they submit in which they track their symptoms, such as fevers, coughs, sore throats, or chills.

Each came to the study for different reasons. Each has had varying reactions to the two-dosage treatment — as well as different opinions on whether they think they’ve received a placebo or the real deal.

And all three have have drawn virtually the same conclusion they’d like to pass along to their fellow New Haveners as a Covid-19 vaccine becomes a near-term reality for millions of Americans: When a vaccine is approved (or multiple vaccines) and made available to the public, do your part to stem the spread of the virus — and get a shot.

“I really trust the people who worked to develop it and the system to approve it and make sure it’s safe,” said Rosado.

Giering agreed.

“These are real people who live in New Haven and surrounding towns and who work for the hospital, who work for Yale Medicine,” he said about the local clinicians he has interacted with over the course of the trial.

Skepticism of vaccines is certainly warranted given this country’s history of wanton experimentation on communities of color, he said. ​“But it’s harder to believe in those conspiracy theories [in this particular case of Covid-19 vaccine development] when you look at the ground level. I trust these people.”

Pineda stressed that, while they personally are convinced of the safety of the vaccine, drugmakers and the government still have a ways to go to win the trust of African American and Hispanic populations in particular.

“I think a lot about the work that has to be done by Pfizer and any other company,” they said. These companies cannot and should not assume that they’ll be welcomed with open arms by historically marginalized groups.

Pineda: Building Trust In Minority Communities

Pineda is a 23-year-old local reporter for the Arts Paper who graduated from Yale in 2019, lives in Dixwell, and is the child of Mexican immigrants. Their family is spread out across South Carolina and Georgia. (Pineda uses they/them pronouns.)

They told the Independent that their family health history played a key role in inspiring them to sign up for Pfizer’s local vaccine trial.

“My older brother and older sister are both nurses down South, and they’ve both been around Covid patients,” Pineda said. ​“My mother is a cancer survivor. I myself have a history of lung issues. In my mind, it just made sense to do the one thing I felt I could do, which is volunteer and participate.”

They said their family isn’t thrilled about Pineda’s participation in the study. ​“They still worry, and they probably will not be comfortable until I’m six months out,” they said. ​“There’s a lot of skepticism among different communities, especially communities of color, around medical trials and general treatment by the government. A clinical trial really exacerbated those worries around who should be tested and what testing means.”

Pineda said that their family practices widely-accepted public health measures to stem the spread of Covid, such as wearing face masks and trying to maintain six-foot social distances. They said their parents have also encouraged them to consume a lot of ginger-lemon tea as well as garlic and lime. (“You cut up a clove of garlic, four limes, and chug it as a shot,” they said.)

Pineda didn’t encounter skepticism only from his family upon signing up for the trial. They also met a bit of resistance from an unexpected source — the Uber driver who ferried them to 2 Church St. South back in September when they were first signing up to join the trial.

“My Uber driver was really opposed to it,” they said. ​“She asked me if I had a partner. Did I care about my family? What if I died?”

Her name was Susie. A Jamaican woman, she had a lot of similar concerns as their family did around government experimentation on minority communities.

Pineda said that they and Susie have bonded in the three months since they first met.

“I text her every single week to let her know I’m alive,” Pineda said. She asks about how the vaccine trial is going. About what kind of vaccine they’re receiving.

“She usually says she’s just praying for me,” they said. ​“That kind of embodies everybody’s concern for everybody.”

In a subsequent interview, Susie the Uber driver confirmed Pineda’s recounting of their fateful first trip together — and of their subsequent texting relationship.

Susie — whose real name is Idelier Pettigrew-Watson—is a longtime Beaver Hills resident who was laid off from her construction job towards the beginning of the pandemic She took up rideshare driving to supplement her income, get out of the house, and meet people.

At first, she said, she thought Pineda was selfish for signing up for the trial: What if they got hurt or sick? How must their family feel about Pineda volunteering to be a ​“sacrificial lamb”?

But after talking with them about their reasons for joining — about their concern for their family’s health, about wanting to be a ​“pillar for them — she came to a different conclusion: ​“Something decent is inside of this young person as a human being.”

Whenever she watches television and sees news updates about new virus cases exploding across the country, about overwhelmed hospitals in the Midwest, she thinks of Pineda: ​“This little guy here, putting [their] whole body at risk just so [they] can help.”

Will she get the vaccine if and when one is approved? ​“I’m on the fence,” Pettigrew-Watson said. ​“I’m 52 years old. Cancer runs in my family. I don’t know if anything in there will speed up the growth of those genes.”

But after following Pineda’s story, she feels a bit more confident in such a vaccine. ​“If it’s an option, I would consider it,” she said. ​“But if it’s something forced and I must have it, I would feel a little funny.”

When asked about minority outreach during the vaccine trial, a Pfizer spokesperson told the Independent by email, ​“COVID-19 is an urgent health crisis that disproportionately impacts diverse communities — including Hispanics and African Americans — with resultant higher rates of COVID-19, more severe COVID-19 illnesses, hospitalizations, and increased mortality. Pfizer and BioNTech are committed to decreasing health disparities in underrepresented populations through the clinical trial process.”

He said that Pfizer has selected investigator sites in diverse communities, worked with advocacy partners to raise awareness about the importance of participating in the trial, and worked to mitigate barriers to access in minority communities by making available patient-focused materials in a number of languages — including Spanish, Haitian Creole, and Tagalog — and by ​“partnering with grassroots organizations which are trusted voices in minority communities and share Pfizer’s commitment to equity in clinical trial recruitment.” Click here to read more about the company’s recruitment efforts.

Giering: To ​“Unblind” Or Not To ​“Unblind”

Giering, a 33-year-old federal public defender who lives in City Point, has parents who live a mile away. He’s barely seen them at all since the start of the pandemic in March.

He told the Independent that he signed up for the Pfizer trial to seize a ​“once-in-a-lifetime opportunity to be a part of something that, if it works out, would be a really big victory for humanity.” He also wanted to to do what he could to expedite his being able to spend time in person with his parents again.

Giering said he was likely one of the last New Haveners to be accepted into the local trial: ​“I think I’m number 254 of around 256.”

He got his first shot on Oct. 15, his second on Nov. 13.

After the first shot, he hardly felt a thing, Giering said, ​“other than a little soreness in my arm for a few day at the injection site.”

His response to the second shot was a bit different. ​“I got sick that night,” he said. ​“I had chills and sweats all night, and nausea. The next day, I took my temperature. I had a 103-degree fever.”

He said all of his symptoms passed in roughly 24 hours. (Pineda relayed a similar reaction after their second dosage. They said they had a headache, a ​“small fever, and I couldn’t taste food very well. Overall, they were very mild.”)

“I was sure I had Covid,” Giering said. So he got tested three different times in the wake of his coming down with symptoms. Every test came back negative. Giering said he joined a Facebook group of vaccine trial participants, and read testimonies from fellow participants who have had similar reactions.

He thinks that his developing Covid-like symptoms while testing negative for the virus likely means he received the vaccine and not a placebo.

That would be encouraging if it were true, he said. Giering said he’d be able to email his office and let his colleagues know that, if anyone didn’t feel comfortable going to a prison for a client visit, he’d be able to fill in.

“I would definitely encourage people to take it because, as unpleasant as the side effects were for me, they were quick and they were short,” he said. And they were significantly less severe than the risks posed by actually contracted Covid-19.

Per the terms of the trial, Giering does not know — and likely will not know anytime soon — whether or not he really received the vaccine or a placebo. That’s because trial participants are not told up front which one they are getting. That way trial investigators can monitor the control and experimental groups over the course of a two-year period to see if the true vaccine has a true, satisfactory, measurable positive impact in comparison to just a saline solution.

There is a current ongoing debate among pharmaceutical companies, scientists, and trial volunteers across the country and world about the ethics of ​“unblinding” trial participants.

That is, if a verified vaccine is approved and distributed to the general public before the two-year trial is up, should companies let participants know whether or not they received the true vaccine or just a placebo? Should they encourage placebo-recipients to drop out and get the real deal, and thereby sacrifice the integrity of the experiment in favor of getting as many people vaccinated as possible?

“That would be a truely selfless move” to stay in the trial and not know whether or not one has received a vaccine or the placebo even after a vaccine is made available to the general public, Giering said. ​“I don’t know if I would do it, because I want to see my parents again. I want to spend as much with them as I can.”

In response to a request for comment about whether or not Pfizer plans to ​“unblind” placebo recipients once a vaccine is approved by the federal government, a Pfizer spokesperson responded with a copy of a letter that was sent to all trial participants in the wake of the company’s Nov. 9 preliminary announcement that the vaccine appears to be effective at warding off Covid-19.

“We know that access to a potential vaccine, if an Emergency Use Authorization (EUA) or similar approval is granted, is top of mind for many trial participants,” that letter read. ​“Pfizer and BioNTech are actively exploring potential ways to change the study to create a process that would allow interested participants in the placebo group who meet the eligibility criteria for early access in their country to ​‘cross-over’ to the vaccine group in the study. To make a change like this, the companies would first need input and approval from regulatory authorities. We will update you as we have more information on this.”

Rosado: Be Patient. Not A ​“Catchall”

Rosado, meanwhile, is a 20-year-old student at MIT who has been back in her family’s Dwight-Edgewood home since last spring after classes moved all online near the start of the pandemic.

She said she chose to participate in the trial study in part because, ​“growing up in New Haven, I was always participating in various studies that Yale and the Child Study Center would put on.” She recalled participating in one study as a kid in which she had an MRI taken while she performed basic tasks like reading and sorting objects, and the study’s investigators monitored her brain activity.

In comparison to that, getting two shots separated by three weeks and then logging one’s symptoms seemed like a relatively modest ask. Plus, this experiment took place under much more pressing global circumstances than any she had participated in before.

Furthermore, she was home and — especially over the summer — had some time to spare. ​“My college went virtual for the semester,” she said. ​“I was here in New Haven. I’ll probably be here for a little while longer. It seems like a good opportunity” to participate in a world-historical study and do her part to further the common good. (A bit camera shy, Rosado declined to share a photo of herself for this story.)

So she and her parents all signed up. Rosado said she was something like the fifth person to sign up for the local trial, and the first female participant.

She got her first injection on Aug. 27. ​“It wasn’t bad at all,” she said. Three weeks later, she received her second, with no adverse reaction.

In between those two dosages, she got a flu shot, which resulted in a bit of a sore arm. Since the two trial dosages had no effect and the flu shot did cause some discomfort, she figured she likely received the placebo.

That speculation appears to have been confirmed when she volunteered to be a poll worker at Barnard School on Election Day — and subsequently came down with Covid-19.

“It was pretty by the books,” she said. ​“Three days after Election Day, I experienced mild symptoms.” She had a slight discomfort in the throat, felt cold, and then had chills for a morning.

She said some 850 ballots were cast at Barnard School that day, but many more people than that came through over the course of her shift. That number was orders of magnitude higher than any number of people she had been in contact with before Election Day. ​“It was pretty clear that that was the likely” cause of her catching the novel coronavirus.

Fortunately, she said, ​“I was able to isolate within my home. It was relatively painless.”

Since she came down with Covid-like symptoms while participating in the trial, Rosado said, she had to self-administer a Covid nasal swab test, which was sent directly to Pfizer’s and Yale’s lab through the study. She got another test at Yale New Haven Hospital, which confirmed that she was indeed positive.

When asked about the debate around ​“unblinding” one half of the trial participants, Rosado said, ​“From a purely scientific point of view, I completely understand how the integrity of the trial would be compromised if all the placebo recipients were suddenly inoculated.”

If she was offered a vaccine relatively early on in its public distribution, she said, given the vaccine’s likely limited supply, ​“I would be wary to take it because I know other people who need it far more than I do, and especially with me having been infected already. I would not feel right about trying to jump the line.”

Rosado said she has two big-picture takeaways from her experience in the trial study so far that she’d like to communicate with the general public.

The first: Once a vaccine is approved and starts making its way into the general population, ​“Be patient.” Don’t equate an inability to get the vaccine immediately with an outright failure of the system, she said. The approval is just one key part of what promises to be a long and challenging process of manufacturing, distributing, storing, and administering the vaccine.

The second: Don’t view the vaccine as the magic bullet for the pandemic. ​“I hope it doesn’t seem like a catch-all,” she said.

Just as clinicians and public health officials have cautioned as a viable vaccine draws near, people will still need to wear masks and practice social distancing in public for a while yet, as more and more of the population gets inoculated and scientists and public health officials determine how long immunity lasts.

“We’re coming at it from all fronts,” Rosado said. ​“The vaccine is just another thing to mitigate the pandemic.”