When she graduated from Boston College’s Connell School of Nursing in the 1980s, Nancy Mignosa never could have imagined the impact that COVID-19 would have on the medical world. She also could not have predicted the crucial role she would come to play in the fight against the pandemic by volunteering to be a subject in Pfizer’s vaccine clinical trials. But given Mignosa’s history working as a clinical research coordinator for almost 20 years, participating in the Pfizer trial just made sense.
“As soon as there was talk of coronavirus vaccine development, I knew that was something I would be interested in,” Mignosa, BC ’86, said.
Mignosa knew from a young age that she wanted to become a nurse. In high school, Mignosa was a candy striper—an antiquated term for a hospital volunteer, she said—which pushed her toward a path in nursing.
Mignosa began her nursing studies on the Heights in the summer of 1982, where she made fond memories with her nursing friends at BC—the program was a very cohesive group, she said. She remains friends with many of her nursing classmates to this day, and the professors she had made lasting impressions on her.
To pay it forward for the professors who helped her along the way, Mignosa now precepts BC nurse practitioner students like Kaley Grammatico, CSON ’20.
“Nancy was the greatest preceptor that I could’ve asked for,” Grammatico said. “She truly was so knowledgeable about all things pediatrics, and the fact that she was a BC graduate was really helpful. I could’ve never done it without her.”
After seven years at Boston Children’s Hospital, both on the medical surgical floor and in the neonatal ICU, Mignosa became a nurse practitioner. In 1993 Mignosa became a double Eagle when she returned to the Heights and received her master’s of science in nursing. Soon after, she began working at Woburn and North Andover Pediatrics Associates in Woburn, Mass., where she still works today.
Woburn and North Andover Pediatrics Associates, a large pediatric office with 20,000 patients, hosts clinical research in collaboration with big pharmaceutical companies to complete vaccine clinical trials. Mignosa got involved early in Woburn’s introduction to clinical research, where she worked for 17 years.
Mignosa said she learned a lot about vaccine and drug development during her time as clinical research coordinator, which fostered her faith in scientific advancement. This trust in the rigor of clinical trials led Mignosa to volunteer in several vaccine clinical trials over the years. She even enrolled her children in the meningitis vaccine clinical trials, she said.
With the onset of COVID-19 last spring, Mignosa’s interest in vaccine clinical trials became all the more relevant.
In what became a competitive search among health care workers, Mignosa began hunting for COVID-19 vaccine clinical trials, investigating both Pfizer and Moderna. From early on in the pandemic, Mignosa had been reading deeply about vaccine development, she said, seeing it as a way to combat COVID-19.
Mignosa ended up getting into a Pfizer study in Warwick, R.I. through Velocity Medical Clinical Research, although she would have gladly enrolled in either study, she said.
Mignosa’s husband and son also enrolled in the Pfizer vaccine clinical trials, she said. Her daughter, Kate Mignosa, CSON ’19, enrolled in the Moderna vaccine clinical trials.
“Our family had a competition—we were team Pfizer versus team Moderna,” Mignosa said. “It was all very lighthearted, but we were racing to see which vaccine would receive FDA approval first.”
Mignosa received one dose of the trial vaccine in August and the other in September. Before each shot, volunteers had bloodwork done and agreed to a nasal swab. Mignosa completed a weekly online diary, answering questions about how she was feeling.
“I was really excited,” Mignosa said. “That first day was crazy, when I came out with my shot. I sent pictures to my whole family with my Band-Aid. It was historic, and it was life-changing.”
Following her initial appointment, Mignosa had to complete an electronic diary once a week, noting any COVID-19 symptoms. Those participants who experienced symptoms had to perform an at-home nasal swab COVID-19 test and send it in for testing, which Mignosa did once, she said.
Three weeks after the initial dose, Mignosa received her second trial vaccine after more bloodwork and a nasal swab. She returned a month later for additional bloodwork and another nasal swab, she said.
There’s a catch to these vaccine clinical trials—half of the participants always receive a placebo, and Mignosa was one of them.
In December, when the FDA authorized the Pfizer vaccine for emergency use, Pfizer unblinded healthcare professionals who participated in the trial, Mignosa said.
In mid-December, Mignosa found out that she received the placebo vaccine.
Though she wasn’t very surprised to have received the placebo, she said, Mignosa couldn’t help but marvel at her bad luck. Luckily, her participation in the trial meant that she was able to receive the actual vaccine soon after.
“I was like, ‘Of course I got the placebo,’” Mignosa said. “Fortunately, I was able to go back to the study site a few days later, and had my first vaccine on Dec. 21.”
Study participants are followed very closely after trials, Mignosa said. If Pfizer had not unblinded placebo participants, they would have had to return to the study site for bloodwork and a nasal swab every six months for the next two years, Mignosa said.
Receiving the vaccine has instilled a sense of hope in Mignosa.
“It’s been unbelievable,” Mignosa said. “The day I got the real vaccine was truly one of those goosebumps, teary-eyed moments.”
Mignosa has suffered no severe side effects from the Pfizer vaccine, she said.
“After the first vaccine, my arm hurt a little bit, like I had just gotten a flu shot,” Mignosa said. “But, either way, I wasn’t worried about the side effects—I just focused on comparing the potential risks and benefits of the vaccine.”
Still, Mignosa does acknowledge the fear that some people have of the COVID-19 vaccine and its side effects, she said.
“I know that people are so worried about the side effects, and it’s true that some people do have a day of side effects,” Mignosa said. “But we just have to think of any side effects as the body’s strong immune response, showing that we are going to be protected. If we got the virus, we would likely have more than a day of some side effects.”
Due to her participation in the trial, Mignosa witnessed firsthand the credibility of the vaccine development, she said.
“I don’t support the notion that this vaccine has been too rushed,” Mignosa said. “The amount of money and the cooperation of scientists behind this has helped us to move things along faster than any standard clinical trial.”
While Mignosa is not a vaccine expert, she said that scientists have been advancing vaccine technology for a long time, which has assisted in the efficient and better development of vaccines. In the face of mounting academic setbacks for children, a troublesome economy, increased rates of depression and anxiety, and the overall struggle of pandemic fatigue, Mignosa believes that the vaccine will make a big difference.
“As we can get the health care professionals, elderly people, and teachers immunized, we will get closer to returning to a more social society,” Mignosa said. “I really think that the vaccine is our only answer to coming out of this pandemic.”
Mignosa recently volunteered in a vaccine clinic for a day, administering the shot to providers in her office.
“People are just ecstatic. There’s a sense of hope that I feel like we’ve been missing for almost a year,” Mignosa said. “The vaccine, to me, means hope.”
Photo Courtesy of Nancy Mignosa