Illinois Medicine

that causes COVID-19. Illinois Medi- cine has played a pivotal role in targeting different aspects of the disease through clinical trials, leading to groundbreaking developments in vaccine protection and potential treatments that offer hope for improved patient outcomes. "Tackling COVID-19 is the moon shot of our generation," says Jerry Krish- nan, MD, PhD, professor of medicine and public health and associate vice chancellor for population health sciences. "With a new virus we had never seen before, many different sectors, including government, industry and academia, needed to come together to learn how to best care for patients and prevent this new disease." To simplify processes on a national level, federal agencies and industry joined forces in two public-private partner- ships created to accelerate the response to the pandemic. The National Institutes of Health (NIH) launched Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), while the Trump administration set Operation Warp Speed (OWS) into motion. ACTIV established a collaborative framework for prioritizing vaccine and therapeutic candidates, streamlining clini- cal trials by tapping into existing clinical trial networks and coordinating regulatory processes. The framework helped the re- search community sift through more than 100 potential preventives and treatments. While OWS' goal is to produce and deliver 300 million doses of safe vaccines in the U.S., its overall strategy accelerated the development, manufacture and distribution of COVID-19 therapeutics and diagnostics as well as vaccines. Congress allocated almost $10 billion to fund the effort. "This approach not only provided funding; it cut administrative red tape, removed the financial risk companies take on as they develop drugs and created new review processes that increased collabo- ration among those working to combat COVID-19," says Krishnan. "Creating such public-private partnerships had never happened before, especially in such a short time frame." A sense of urgency and a new collabor- ative environment set the stage for vaccine candidates that progressed from concept to creation in record time using breakthrough vaccine delivery technology. Illinois Medi- cine played a key role in ensuring that speed did not sacrifice safety. A new era of vaccines THE RACE FOR A COVID-19 VACCINE began in January 2020 when Chinese researchers posted the genetic sequence of this novel coronavirus from an in- fected patient to a public database. Using the sequence information and previous knowledge obtained from studying other coronaviruses, scientists from the National Institute of Allergy and Infectious Diseases (NIAID) designed a stabilized spike antigen that aided the development of potential vaccine candidates. Biotech company Moderna and pharmaceutical giant Pfizer became the front-runners in the ensuing race to develop a vaccine, basing their candidates on an mRNA delivery platform that instructs the body to produce spike protein antigens itself. This revolutionary approach allowed Moderna to go from genetic sequence to the first dose of the vaccine ready for hu- man testing in an unprecedented 63 days. By eliminating much of the manufactur- ing process, this new technology holds the potential of changing vaccine development well beyond COVID-19, but first it needed to be proven in human trials. Putting the new vaccine to the test ILLINOIS MEDICINE WAS A KEY PARTNER in the phase 3 clinical trial for Moderna's mRNA-1273 vaccine candidate. "While mRNA vaccine delivery had been studied in preclinical development for other viruses such as Ebola, this has been the first time it has been used in an ap- proved vaccine," says Richard Novak, MD, professor and chief of infectious diseases and lead investigator of the UIC Moderna trial. "An mRNA vaccine provides some advantages. It gets into cells easily, and it's quickly and efficiently translated into a viral protein, and then is degraded. In addition, mRNA is very easy to mass produce." More than 30,000 participants at 100 clinical research sites were included in Moderna's phase 3 trial, known as COVE. UIC is leading the trial in Chicago and ex- pects to obtain more than $5 million from the NIAID and the Biomedical Advanced Research and Development Authority (BARDA) for enrolling 442 participants at UIC and a satellite site at the University of Chicago. Reaching out to those most affected IN THIS RANDOMIZED, double-blind study, volunteers in the phase 3 trial received the vaccine or a placebo. Both consisted of two single injections, 28 days apart. As part of the study, researchers collected basic demographic and health information, monitored symptoms weekly, and took blood samples from participants to test for antibodies. "Because we know that COVID-19 is more severe in older people and that it disproportionately affects ethnic and racial minorities, it was important that our trial represented these individuals," says Novak. "We reached out to the community and drew from the 8,000 people who volun- teered through the national registry." On a national level, the study included more than 7,000 Americans over age 65 and 11,000 participants from communities of color, the latter of whom represented 37% of the study population, similar to the diversity of the U.S. "In the UIC study, at least 40% of participants were more than age 65, and 75% represented minority populations," says Novak. Study yields spectacular results EFFICACY AND SAFETY were key priori- ties in this trial, and the Moderna vaccine delivered, according to an independent data P H O T O : L L O Y D D E G R A N E Illinois Medicine | 13 " " Because we know that COVID-19 is more severe in older people and that it disproportionately affects ethnic and racial minorities, it was important that our trial represented these individuals. Richard Novak, MD (facing page) Chief of Infectious Diseases, UI Health Lead Investigator of the Moderna Trial

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