Frequently asked questions: Novavax investigational COVID-19 vaccine trial
Our South Texas community will be contributing to an investigational vaccine clinical trial that may help end the COVID-19 pandemic. Dr. Barbara Taylor, the principal investigator for the local study site, answers questions about the importance of the program and how it will be conducted.
Dr. Taylor is an associate professor of infectious diseases at UT Health San Antonio and a physician caring for patients at University Health System, now referred to as University Health.
Question: University Health and UT Health San Antonio are enrolling volunteers to participate in this COVID-19 investigational vaccine clinical trial. The biotechnology company Novavax developed the vaccine candidate. Why does it appear to be promising?
Dr. Taylor: This trial with human volunteers is the third phase of testing for the vaccine candidate. In previous testing, it appeared to produce high levels of antibodies when given to a small group of 131 humans. There were no severe side effects. In another study, it appeared to protect monkeys from becoming infected with the novel coronavirus.
Question: How could this vaccine be effective in protecting against COVID-19?
Dr. Taylor: A protein vaccine introduces a small piece of the virus into our bodies so that our immune system responds to it and develops antibodies. These antibodies then allow our bodies to fight against the virus that causes COVID-19 if we are exposed to it. Our hope is that this vaccine will train our immune systems to recognize the virus that causes COVID-19 and fight it off before it makes people sick.
Question: How will University Health and UT Health San Antonio contribute to the Novavax trial?
Dr. Taylor: We are a part of the COVID-19 Prevention Network, a group of testing sites located in the United States and other countries. The study is expected to enroll around 30,000 human volunteers in this phase of the trial. Here in San Antonio we expect to enroll 500 healthy adult volunteers.
Question: How will the vaccine be administered?
Dr. Taylor: This vaccine is delivered in a shot in your arm. It’s given in two doses that are 21 days apart. Two-thirds of the volunteers will receive the vaccine while the other third will receive a placebo.
Question: What do we know about any side effects?
Dr. Taylor: In the Phase 1 and Phase 2 studies, there were no severe adverse events related to the vaccine or the placebo. The most common side effects were some mild pain and tenderness where the shot was given. Some experienced fatigue or muscle aches, but no one had a fever, and headaches were just as common for volunteers who received the placebo as for those who received the vaccine.
Question: Who can participate in this trial?
Dr. Taylor: We would encourage people who are interested in participating to contact us through the website UTHealthResearch.com or call (210) 469-3206. We will specifically reach out to people who are at risk for exposure to COVID-19 or serious illness, such as those with diabetes or heart disease and people of color, who we know have been severely impacted by the epidemic.
Question: Why is it important for UT Health San Antonio and University Health to participate in testing this vaccine candidate?
Dr. Taylor: This is the best and safest way for us to get a vaccine that will protect people, particularly those who are at greatest risk for developing serious illness because of COVID-19. Without this large randomized control trial, we will not know if a potential vaccine is safe or if it actually protects us against COVID-19. We are excited that UT Health San Antonio and University Health will have an opportunity to take part in this important step towards ending the COVID-19 pandemic.
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The University of Texas Health Science Center at San Antonio, also known as UT Health San Antonio, is one of the country’s leading health sciences universities and is designated as a Hispanic-Serving Institution by the U.S. Department of Education. With missions of teaching, research, patient care and community engagement, its schools of medicine, nursing, dentistry, health professions and graduate biomedical sciences have graduated more than 37,000 alumni who are leading change, advancing their fields and renewing hope for patients and their families throughout South Texas and the world. To learn about the many ways “We make lives better®,” visit www.uthscsa.edu.
About University Health System, now referred to as University Health
University Health System, now referred to as University Health, is San Antonio’s only locally owned health system and the only academic medical center in South Texas. Its University Hospital serves as the region’s Level I trauma center for adults and children, and is the only area hospital to be state-designated at the highest level for both its Maternity Center and Neonatal Intensive Care Unit. Outpatient care is provided through a comprehensive network of urgent, primary and specialty care centers. For more than 100 years, University Health has been committed to delivering compassionate, culturally competent and high-quality healthcare, based on a strong foundation of outcomes‐based research and innovative teaching. Learn more at UniversityHealthSystem.com. Follow us on Twitter and Facebook.