Toward the end of July, news anchor Dawn Baker got a call from her physician. He wanted to know if Baker would take part in a Phase 3 covid-19 vaccine trial.
On July 27, Baker, who is based in Savannah, Ga., got a shot in her arm and became the first United States participant in a late-stage covid-19 vaccine trial. “It honestly did not click until after I did it how big of a deal that was,” she said of the trial, which was developed by biotechnology company Moderna in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID).
Later that same day, about 1,000 miles north of Savannah, in Rochester, N.Y., Anastasia Polashenski, 26, got her shot as part of Pfizer and BioNTech’s late-stage covid-19 vaccine trial after completing a physical, bloodwork, a covid-19 test and a pregnancy test. (Women who are pregnant or breastfeeding cannot participate, though some experts have reportedly argued that leaving pregnant women out of vaccine trials puts them at risk.)
When it came time for Polashenski’s shot, she was specifically told to look away, so she wouldn’t know what she was being injected with — a potential covid-19 vaccine or a placebo.
In each of these late-stage trials, half of the participants get two shots of a vaccine and half get two shots of a placebo. They don’t know which one they receive.
These two late-stage covid-19 vaccine trials will each take place at dozens of study locations across the U.S., with researchers currently in the process of seeking about 30,000 participants for each who haven’t had covid-19 to test the safety and efficacy of their vaccines on a large scale. There’s no guarantee that either of these vaccines will prove successful.
Following each of their shots, participants have to monitor themselves for side effects — things like redness or swelling at the injection site, fever, aches or pains, vomiting or diarrhea. (Some covid-19 vaccine trial participants have been asked not to publicly discuss any specific details about the study, such as symptoms they have or haven’t experienced.) Over the next approximately two years, participants will have to complete several check-ins and follow-up visits, and researchers will monitor how many people in each group contract covid-19.
What would happen to the participants if a vaccine becomes available to the public depends on several factors. For example, if an Emergency Use Authorization (EUA) is issued for the Moderna/NIAID vaccine before Phase 3 is complete, “the individuals who are in the placebo limb should be given the option of being unblinded and should be given the vaccine if they so wish,” explained Anthony S. Fauci, director of the NIAID, in an email response.
Polashenski, who works as a nanny in the summertime and an elementary school music teacher during the school year, said she had been feeling helpless over the last few months as covid-19 ravaged the country. She’d been nervously anticipating the return to school in the fall, and keeping some distance from her mother, who has Stage 4 cancer. “Our relationship just hasn’t been the same, and that’s okay, because her safety is obviously the most important,” she said.
Polashenski wanted to contribute, but she wasn’t sure how. That’s what drew her to the vaccine trial. She applied for Phase 1 of the study but was rejected due to her asthma, she said, and so she reapplied for a later phase.
“This is something that I’m absolutely eligible to do, and I’m happy to do it,” Polashenski said. She’s excited about “participating in history.”
Polashenski said she knows that there’s a risk involved and that others may see her as a “guinea pig.”
“It is my choice to take that risk and I’m happy to do it,” she said. “If people like me aren’t willing to do that, then we’re going to be suffering the effects of this pandemic much longer.”
As a family physician in Kenner, La., Victoria Smith, 52, has seen three of her patients die as a result of the virus, she said. On July 30, Smith received her first shot in the late-stage Pfizer and BioNTech trial.
“Knowing that the really most effective way for us to get control of this disease is going to be through a vaccine, I really wanted to be part of that effort,” she said.
Smith is hoping that she received the vaccine, and that it proves to be protective, but she was also drawn to participate because of how this pandemic has disproportionately impacted Black and Latino people. “I wanted to be part of any efforts to decrease this scourge,” she said. “Also, as an African American, knowing that, in the past, scientific research has been done sometimes upon African Americans, not with our consent and active participation, so I wanted to be part of a trial that I was an active protagonist in.”
Smith said she hopes she’ll be a role model for getting vaccinated. As a doctor, she encounters many people “who really have mistrust of all kinds of vaccines.”
Mary Dixson, 48, a lecturer in the department of communication at the University of Texas at San Antonio is enrolled in the Pfizer trial through Clinical Trials of Texas in San Antonio. She says she wants to be “a voice for the vaccine process.”
“You imagine the people in these trials,” she said, “and I don’t think people imagine their next-door neighbor or their friend on social media.”
Dixson said she feels a bit split on not knowing whether she received the vaccine. “There’s part of you that just desperately wants to know,” she said, “but I do have a fear that if I was 100 percent certain that I had the vaccine, that maybe I would behave in a way that was less responsible, just sort of psychologically.” She said not knowing ensures she will continue taking all the necessary precautions.
Sophie Tintori, 34, a postdoctoral research fellow in biology at New York University, is participating in the Pfizer trial through New York University’s Langone Health. She initially considered joining Phase 1 of the trial, but after doing her own research, decided she felt most comfortable proceeding with a later stage of the study. She said she thinks “the risk is quite low at this point” of the trial, but notes that “it is an experiment, it’s an unknown, the effects of the substance are not yet known — that’s why this experiment is happening.”
As a scientist, getting to bear witness to that research is part of what drew her in, and she’s happy to participate in the process. “That’s probably the main motivation at this part,” she said. “But then, of course, there’s also the less altruistic sense that it’s going to be a long time until any of these drugs are approved, and if I do get vaccinated on the way then I have no problem with that possibility.”
Trial participants do get varying amounts of compensation — some of the women spoken to for this article said they’ll receive $119 per site visit — but none of the women interviewed said payment was their main reason for enrolling.
Polashenski said she initially really wanted to get the vaccine, and that it would be a “bonus” if she were protected. She’s come to understand that researchers need both the vaccine and placebo groups to test the vaccine, and wants to be part of providing the information they’re looking for.
It’s all about helping the greater good, she said: “I think that is absolutely my purpose right now.”
