Maryland-based vaccine development company Novavax may soon follow Moderna and Pfizer in securing approval for its COVID-19 vaccine. The company is currently seeking participants in San Antonio for late-stage testing of the vaccine.
Some San Antonians will have the chance to participate in Novavax’s international COVID-19 vaccine clinical trial beginning later this month, UT Health San Antonio and its clinical partner University Health system announced in a joint statement Thursday. The company is the fifth to reach phase 3 clinical trials for a COVID-19 vaccine, according to the statement.
In phase 3 trials, a vaccine is given to thousands of people and tested for efficacy and safety. After a phase 3 clinical trial, the vaccine developer submits a Biologics License Application to the Food and Drug Administration for approval of the vaccine.
As part of the COVID-19 Prevention Network, an international effort created by the National Institute of Allergy and Infectious Diseases at the National Institutes of Health to help respond to the pandemic, UT Health associate professor of infectious diseases Dr. Barbara Taylor will oversee the local study site.
“We are proud to offer this vaccine clinical trial to the people of San Antonio and surrounding counties,” Taylor said. “Our community has made many sacrifices throughout this pandemic and worked hard on masking and social distancing. We are excited to do our part and work toward a protective vaccine, which would provide another tool to help end the COVID-19 pandemic.”
Taylor added that she and her team are particularly interested in seeing participation from people at higher risk for COVID-19, including older participants. In this phase 3 trial, Novavax is seeking to enroll approximately 30,000 volunteers at up to 110 study sites across the U.S. and abroad. Locally, the company is seeking 500 participants.
The phase 3 trial will enroll adults age 18 and older across different ages, races, ethnicities, medical conditions, living situations, or work environments, according to the joint statement. Moderna and Pfizer both also included participants from San Antonio in their phase 3 trials.
Participants will randomly receive either the Novavax vaccine or a placebo in two doses 21 days apart. Two-thirds of volunteers will receive the vaccine and one-third will receive a placebo. Participants will be followed for two years to determine whether the vaccine reduces the risk of COVID-19.
The vaccine candidate was shown to be overall very safe and to bring about a strong immune response in a phase 1 trial. Results for phase 1 were published in August. Phase 2 trials are ongoing, with data from these trials expected in the coming weeks.
The vaccine candidate, called NVX-CoV2373, is a protein engineered from the genetic sequence of the SARS-CoV-2 virus that causes COVID-19. It will familiarize the body with the virus to help train the immune system to learn to fight it, the joint statement said.
Study participants will be seen at both University Health and UT Health San Antonio locations. For more information or to potentially participate in the study visit UTHealthResearch.com or call 210-469-3206.
