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NOTE: The following information was published December 20, 7, 2020. For current vaccination information, visit LVHN.org/vaccines.
Kenneth Miller, a respiratory care educator at Lehigh Valley Health Network (LVHN), received a new identity Sept. 3. He became known as clinical trial subject 01-008.
That was the date Miller received his first dose of either a placebo (inactive substance) or the vaccine being produced by Pfizer and partner BioNTech to protect against SARS-CoV-2, the virus that causes COVID-19. Miller is among about 75 LVHN employees, patients and community members who consented to participate in the phase 3 trial for the vaccine to determine if it is effective and safe.
“Working in respiratory therapy I’ve seen the horrors of COVID-19 firsthand and wanted to reduce the threat or spread of the virus,” Miller says. “I wanted to help get society back to some level of normalcy.”
Like all participants in the trial, Miller received two vaccinations, the second one about three weeks after the first. He and the other participants will continue to be followed for two years even if the vaccine receives emergency authorization from the Food and Drug Administration (FDA) and public distribution begins. On Nov. 18, Pfizer announced preliminary results show the vaccine was 95 percent effective in preventing the disease among trial volunteers who had no evidence of prior coronavirus infection. The investigational vaccine is an RNA-based vaccine and does not contain the whole virus, or the parts of the virus that can make a person ill. The company says it will have manufactured enough doses by the end of the year to immunize 15 million to 20 million people.
At LVHN, the Network Office of Research and Innovation (NORI) and the Infectious Disease department are jointly leading the health network’s participation in the Pfizer trial with Joseph Yozviak, DO, LVHN Internal Medicine, serving as the study’s principal investigator.
LVHN is the only location in the region participating in the trial with the other closest sites in New Jersey, New York and Maryland.
“The main outcome of this study is to look at the number of participants who develop COVID-19,” Yozviak says. “We compare people who received the vaccine to those who received a salt water placebo. The question is, does the vaccine prevent disease?”
Yozviak says one of the requirements was participants between 18 and 85 years of age needed to work, live or be involved in situations where they were at risk for being exposed. “We wanted to track those who likely would encounter the virus,” he says.
After enrollment the study involves blood and nasal swab specimen collection, two doses of either study vaccine or placebo, tracking of symptoms in an electronic diary and six in-person visits at Lehigh Valley Hospital (LVH)–17th Street, approximately over a two-year period. Participation is voluntary and those enrolled can withdraw at any time. Any participant who develops symptoms that may be consistent with COVID-19 undergoes a virtual evaluation and performs a nasal swab to test for SARS-CoV-2.
Miller, 65, considers himself fairly healthy, goes to the gym and has several conditions like asthma and hypertension that are controlled. He also says in his 46-year career at LVHN, he’s gotten to know a number of people involved in research and says he knew early on he’d be interested in helping with the study if selected.
“I understand those who don’t like shots in addition to the possible side effects,” Miller says. “But this is a disease that has no preference for age, sex or ethnic group—it takes advantage of all individuals. If we work as a team, get this under control and eradicate it, we can move on with our lives.”