As Novavax clears a key step on the path to FDA authorization, researchers with the UNC Institute for Global Health and Infectious Diseases hold hope for a COVID-19 vaccine that can address vaccine inequity and demand.
Dr. Cindy Gay, associate professor of infectious diseases in the infectious diseases division in the School of Medicine, led the phase 3 Novavax study at Carolina and is co-chair for the overall study. She answers questions about the vaccine in a new UNC Health video.
How is the Novavax vaccine different from the other three vaccines?
There are different ways to design a vaccine. The Moderna and Pfizer mRNA vaccines use a strategy whereby the vaccine delivers an instruction code that gets delivered inside our cells. Then, our own cells are instructed to make a piece of the virus to elicit an immune response which provides protection against COVID-19 illness.
Novavax is a protein-based vaccine using a much more traditional vaccine platform. Several vaccines approved for infections have been using this platform for decades. With this strategy, the vaccine itself delivers the piece of the COVID-19 virus that we want to elicit the immune response to. It’s the same spike protein that is eliciting a response with the other COVID-19 vaccines, but in this case, it’s being delivered directly in the vaccine.
What does Novavax clinical trial data show?
The Novavax vaccine was 90.4% effective in preventing symptomatic COVID-19 illness. The data submitted to the FDA covers an early period in the study, including when the delta variant was circulating and when the omicron variant had yet to emerge.
However, Novavax looked at immune responses to the omicron variant and, more importantly, neutralizing responses. The Novavax vaccine did elicit immune responses to the omicron variant, but it provided less protection compared to the initial Wuhan strain and the other variants, as we’ve seen with all of the currently available COVID-19 vaccines. Studies also looked at responses after a booster dose, provided in this phase 3 study. Results showed substantial increases in response, including to the omicron variant.
What is the UNC School of Medicine’s role in the Novavax trial?
UNC was a site for the phase 3 study of the Novavax vaccine through the Institute for Global Health and Infectious Diseases. This is a two-year study, and we are continuing to follow participants for safety monitoring and additional immunological testing. In addition, UNC was a site for the enrollment of adolescents on the study, from age 12 to 17, and we continue to follow them as well.
What are the benefits and advantages of the Novavax vaccine?
Given where we are with vaccination rates in the U.S., it’s most likely that Novavax, if approved for emergency use authorization, would be used as a booster dose. However, emergency use authorization submission and approval would be for an initial or primary series. Many of us are hopeful that individuals who remain unvaccinated and concerned about newer mRNA vaccines will be willing to try this more traditional approach to a vaccine. It’s already been approved in several other countries, including the European Union, and cleared by the World Health Organization. There have been no safety issues with the phase 3 study in the U.S. and Mexico, or in a large U.K. study.
One key advantage is that Novavax does not have to be frozen. In many ways, this will make it a much more accessible vaccine once it becomes widely available, as transportation and access to freezers can be an issue with other COVID-19 vaccines. The logistics and storage required to deliver the Novavax vaccine to rural settings and low resource countries would be much easier, making this is an important vaccine for getting more individuals vaccinated while addressing vaccine inequity.
Learn how the built-in infrastructure of Carolina’s Clinical Trials Unit in the Institute for Global Health and Infectious Diseases brought COVID-19 vaccine trials to UNC-Chapel Hill, starting with Moderna.