An internationally recognized physician-scientist, Beth Kirkpatrick, M.D., has a decades-long history of leadership in the field of vaccine testing and development. In 2001, she launched the UVM Vaccine Testing Center (VTC), and since then, the VTC has grown to assume a prominent role in the development and evaluation of vaccines for globally important infectious diseases. The VTC has garnered support from the National Institutes of Health, the Bill & Melinda Gates Foundation, and the U.S. Department of Defense, among others. Kirkpatrick is also principal investigator and director of UVM’s Translational Global Infectious Disease Research Center of Biomedical Research Excellence and Chair of the Department of Microbiology and Molecular Genetics.
This article appears in the fall issue of UVM Magazine.
VM: How are past successes in vaccine development informing the work going on across the globe on a COVID-19 vaccine? On the flip side, what is unprecedented about this effort?
BK: “We have multiple twenty-first-century tools at our disposal that are transforming the vaccine field. They have grown out of concerns that vaccine development was too slow to respond to epidemics, including influenza and Ebola epidemics. For example, there’s been a lot of progress with computational means of understanding the parts of the pathogen necessary to put in a vaccine. We also have new vaccine platforms or types, including those based on genetic sequences; these allow the rapid construction of new vaccines. The field has also figured out how to overlap clinical trial designs, which also speeds things up. All of these new measures save us a significant amount of time and makes vaccines that are more precisely designed. And what we understand about the human immune response is just phenomenal now. Immunophenotyping—getting a display about what exactly is going on in the immune system—has been transformational.
The other thing that’s unprecedented in COVID vaccine development has nothing to do with the science, and that’s the financial investment. The government is doing what they call at-risk vaccine development, manufacturing the vials of vaccine to have them ready even before we know whether the specific vaccines work. If they don’t work, these vials will all be thrown away. If they do work, we’ve saved ourselves years of time in manufacturing vaccines. The only way any COVID vaccine could even have a prayer of coming out in 2020 or 2021 is through this type of approach. In the past, the fastest vaccine ever developed was about six years, and that was the Merck Ebola vaccine. Most of the time, they take probably twelve to twenty years, and now we are trying to do this in about a year, so that’s really unprecedented too.”
VM: What are the key questions researchers are focused on as theywork towards a vaccine? How can wide use of (and trust in) the vaccine be promoted once we have one that has been thoroughly tested?
BK: “The goal isn’t going to be one corona- virus vaccine. It’s multiple, first-generation coronavirus vaccines. Over the next few years, though, I would not be surprised if we have better vaccines. The top issue is always safety, safety, safety. After that, we want to know about immunogenicity—the immune response your body has that suggests you’re going to be protected. And then finally, the efficacy. In vaccine world, this means that when you’re confronted in your real life with the infection, how well will the vaccine pre- vent you from getting sick.
I would say the foundation for vaccine safety review has been quite robust and has stood the test of time. Generally, until recently at least, there has been trust of the system. At the same time, and especially now, there has to be transparency with this data and this process. I would anticipate that any company that has Phase 3 data will release much of it through the publication process. For those of us who work on vaccines, I think we also have an obligation to educate the public about the process. I do think we need to help people regain trust in this system because of the politicalization.”
VM: How are UVM researchers involved in efforts to develop and test a COVID-19 vaccine?
BK: “We are part of a National Institutes of Health group called the COVID-19 Prevention Network, or CoVPN. The NIH has taken its hundreds to thousands of investigators who are funded by the NIH as part of all clinical trial networks related to vaccines or therapeutics and combined them into one quite amazing team of scientists and investigators across the country. Together, the team works on the Phase 3 studies of coronavirus vaccines in a harmonized way. It’s a very impressive network of established and trusted scientists and investigators. We’re lucky UVM is part of that group.”