MEET NO. 17
Connecticut man was one of first to join Pfizer vaccine trial: ‘I couldn’t sit around and do nothing’
NEW HAVEN — Meet No. 17. In a combination of civic duty and a love of science, Anthony Lupinacci became the 17th volunteer enrolled in the local Phase 3 trial site for the COVID-19 vaccine developed by Pfizer and its German partner, BioNTech.
“I couldn’t sit around anymore and do nothing,” Lupinacci said, about watching the number of deaths climb and the stark division in the country over adhering to the precautions needed to hold the virus at bay.
When Yale New Haven Hospital and the Yale Center for Clinical Investigation were chosen to participate as part of the trial, Lupinacci downloaded the 21-page questionnaire and showed up for his first appointment three days after the program started in late August. Myriad Connecticut-based scientists and clinical trial volunteers from across the state have been involved in the Pfizer-involved COVID-19 vaccine trials. The New Haven research cen
“They should not be afraid of something that will help stop them and others from getting sick.” Anthony Lupinacci, vaccine trial volunteer
ter is among the 150 clinical testing locations around the world testing the COVID-19 vaccine being developed by the German company and pharmaceutical giant Pfizer, which has a research and development center in Groton.
Lupinacci was among the more than 43,500 volunteers who received either the vaccine or a placebo in double-blind trials scheduled globally. None of the subjects has been told whether they were given the vaccine or the placebo.
Pfizer and BioNTech have applied for U.S. Food and Drug Administration Emergency Use Authorization for the vaccine, which has been found to be 95 percent effective. If approved, it could be available as early as December for some Americans.
While he doesn’t know if he received the vaccine or the placebo, Lupinacci said he did not have side effects as a result of participating in the trial. According to Pfizer, its data shows the vaccine was “well tolerated across all populations” enrolled in the trial. There were “no serious safety concerns observed” with the “only Grade 3 adverse event greater than 2% in frequency was fatigue at 3.8% and headache at 2.0%,” according to the company.
Pfizer also reported that most adverse reactions resolved shortly after vaccination.
Lupinacci, a self-described science nerd and longtime marketing director for the Shubert Theatre in New Haven, said he did his research and was convinced, because of the technology behind the vaccine, it was not a risky proposition for himself and the trial would allow him to do something concrete.
“Rather than using the part or whole of the actual virus in an inactive form to create immunity, this vaccine candidate uses a genetic code (modified RNA) to make the body generate proteins that resemble the SARS CoV-2 virus spike protein, thereby causing development of antibodies against it,” was the description of the process in YaleNews.
“Vaccines traditionally contain either weakened viruses or purified signature proteins of the virus. But an mRNA (modified RNA) vaccine is different, because rather than having the viral protein injected, a person receives genetic material — mRNA — that encodes the viral protein,” according to Science Alert.
According to Pfizer, there were 10 “severe cases of COVID-19 observed in the trial, with nine of the cases occurring in the placebo group and one in the BNT162b2 vaccinated group.” As of Nov. 13, 41,135 trial participants had received a second dose of the vaccine candidate, Pfizer also has reported.
As Lupanacci saw it, the new vaccine was a package delivering an instruction kit to your body on how to assemble the antibodies through a synthetic RNA strand.
Given his 31-year association with the Shubert, Lupinacci said he also was inspired by another theater lover, Sir Andrew Lloyd Webber of “Cats” fame, who had participated in the Oxford/AstraZeneca vaccine test.
“He said he would do anything he could to help show that it was safe to go back to live theater when a vaccine was developed,” sentiments Lupinacci shared.
Lupinacci said the last eight months at the Shubert have been painful, with his colleagues laid-off and all the ancillary businesses connected to the arts institution out of work. Multiply that by thousands of other industries suffering because of the response to the pandemic as the U.S. looks for economic stability, he said.
Lupinacci said when he showed up on his first visit to the trial site, a clinician went through the 21-page report, which he already had filled out, and read through every question to make sure he understood the process.
He said any additional personnel who came in always double-checked his ID bracelet and his test number for accuracy. He said he was never rushed. Three weeks after he received the first injection, he reported for the second. An estimated three weeks after that, he had blood drawn.
Lupinacci, 61, said he signed in daily for a week after the first injection and continues, through an app, to file a weekly report as they check to see whether he has symptoms. He said he has been symptom-free and will be followed by Yale for two years.
Dr. Anthony Fauci, the top U.S. infectious disease doctor, has said the length of protection from the vaccine is not yet known. He said coronaviruses don’t usually last for decades.
Lupinacci compared the pandemic to the 9/11 attacks on the United States, when the seriousness of the threat was immediately clear and the country was united in its response.
He said the country was not alerted to the seriousness of COVID-19 given the mixed messages coming from the federal government with the number of cases now reaching more than 11 million in the U.S. and deaths approaching 250,000.
Hope for others
Lupinacci said he is speaking out about his experience with the vaccine as a kind of town crier to encourage people to get vaccinated as soon as it is available, first for the most vulnerable and then later for the general public.
“I feel like we need ambassadors with first-hand knowledge,” Lupinacci said.
He said he is concerned when he hears that people may be afraid to get a vaccine, based on misinformation or concerns about how vaccines up to this model were developed.
“They should be afraid of the virus, but not the vaccine,” he said. “They should not be afraid of something that will help stop them and others from getting sick.”
He said he hopes he can reach the skeptics.
The well-known New Haven figure said if only half of the population feels comfortable getting vaccinated, it is not going to be effective and allow for a return to normalcy.
The image that comes to him is of the heroes on 9/11 over Pennsylvania, when the passengers on the doomed plane headed for Washington, D.C., rushed the cockpit where the terrorists had taken control and aborted the flight to save others on the ground.
“They were helping people they didn’t even know,” Lupinacci said of the last major crisis facing America.
He views the virus as the “greatest risk to planet Earth.”
Lupinacci said he hopes Americans do the right thing and roll up their sleeves and get vaccinated to help not only themselves, but front-line workers in immediate jeopardy, as part of a worldwide effort to emerge from this destructive scourge.
Luppinaci, who in addition to his love of the arts, said he developed his interest in biology in high school.
“I loved all of that stuff. I was fascinated by the way things actually function. That is why I love nature,” he said, which is evident in the time he puts into his garden, which is only second to his love of the Shubert.
He credits his father with his advice to himself and his siblings to learn to think for themselves.
“He wanted us to know how things work. Don’t just hear it from someone else — know and learn so that we could come up with our own conclusions. Become curious to find out the truth,” he said.
“When I understood the technology — of the virus — it made it so much clearer to see how effective the virus can be at infecting so many people so quickly and the devastating results it has on our bodies. It completely uses our body as a host — it is a parasite,” Lupinanci said.
This in turn made it easy to understand why washing your hands, wearing a mask and socially distancing to protect yourself, made sense, he said. They all work to keep the virus from entering your body.
Lupinaci said another aspect of the Pfizer vaccine he was happy about was the company’s decision to not take federal money for purposes of research and development of the vaccine itself.
It does have a $1.95 billion contract with the government for 100 million doses, and the ability to buy 500 million, once it is approved, the company has reported. Americans would have free access to it.
Pfizer has said it distribution approach “will be to largely ship” from its site direct to the “point of use” but it also will use its existing distribution centers in Wisconsin.