IOWA CITY — When a U.S. Food and Drug Administration committee meets later this week to discuss emergency use authorization of a second COVID-19 vaccine, University of Iowa coronavirus expert Stanley Perlman will be at the table — just like he was last week for the Pfizer-BioNTech debate.
The Pfizer discussion lasted all day, with the committee’s 22 voting members logging into the virtual event and ultimately voting 17-4, with one abstention, to recommend the FDA give emergency approval to the first COVID-19 vaccine to come to market.
Perlman was among those who voted yes, and told The Gazette he doesn’t know exactly why those opposed cast “no” votes — noting, however, the group had a long discussion about whether 16- and 17-year-olds should be included in the authorization.
“But I don’t remember them even saying anything,” he said. “In fact, that’s one thing that I’d like to know. I’m going to try to figure that out. Because we’re going to have another meeting about the Moderna vaccine this week, and I’m hoping that we’ll have more information about why people voted against it.”
As a temporary voting member of the FDA’s Vaccines and Related Biological Products Advisory Committee — due to his expertise in the field — Perlman last Thursday received presentations on the vaccine from Pfizer and BioNTech, from the U.S. Centers for Disease Control and Prevention and others.
Considering all that information and his own knowledge in the area — which is extensive — Perlman found the science behind the vaccine’s purported 95-percent efficacy sound.
“A few things were persuasive,” he said. “First of all, in terms of safety, we know that most safety issues occur in the first two months. And this vaccine has been around for two months, so we should have pretty good knowledge about the safety.
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“In terms of efficacy, it was better than anyone could imagine,” he said. “It’s more protective, and with minimal side effects.”
The vaccine, which gained FDA approval one day after Perlman’s committee recommended it, made its way Monday into the arms of front line health care workers across the United States — including those at Perlman’s home institution: the UI Hospitals and Clinics.
Patricia Winokur, executive dean of the UI Carver College of Medicine and principal investigator for UI’s Pfizer clinical trial site, was among UIHC leaders who received a vaccine dose Monday. In comments to reporters, she praised Perlman’s work as having paved the way for rapid COVID-19 vaccine development this year.
“One of the things that is remarkable is Iowa has been at the forefront of this, and a lot of it is due to Stan Perlman, who for 30 or 40 years has been working on coronaviruses and creating the science that helped us get this vaccine produced so quickly,” Winokur said.
Perlman, a professor of microbiology and immunology and pediatrics, has shared his 40 years of coronavirus research and expertise with numerous national and international groups in the wake of COVID-19 spread — in fact, participating in the international committee that named the virus SARS-CoV-2.
In addition to his participation with the FDA advisory committee and others, Perlman helps advise the CDC’s Advisory Council on Immunization Practices, which develops recommendations on how to use vaccines.
Although the public might perceive the COVID-19 vaccine as having been developed in only a matter of months, Perlman’s years of work was its launchpad and serves as evidence for the need to continue funding scientific research.
“I was working with coronaviruses many, many years ago,” he said. “The only disease that people got from coronavirus was the common cold, so it wasn’t really an area a lot of people were working in … but we just kept plowing forward and learned about the virus and learned about SARS and MERS and we also worked with mice … and so it became easier to move forward with vaccines and other therapy when COVID-19 hit.”
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Perlman said a lot more research remains to be done in the field and with COVID-19 specifically, including whether the authorized vaccines prevent asymptomatic spread, can be safe for children and pregnant women, and how long the protection lasts.
As he heads toward his second meeting Thursday on a Moderna-produced COVID-19 vaccine promising as much efficacy as the first, Perlman said the country as a whole should be learning lessons from this pandemic to prepare for a next time.
Those lessons, he said, include staying aware of viruses emerging globally, maintaining stores of protective equipment and ventilators, shoring up testing and contact tracing plans and procedures. And, he said, remaining vigilant against disinformation and politicization around public health issues.
“This country is so polarized,” he said. “You have to have leadership, and you have to have a belief that this is a real disease. There was so much misinformation about how it didn’t really matter and that it was a minor illness, and you can’t do that because people are going to believe it. And things like wearing a mask becomes a political statement, which is really unfortunate.”
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