Chemical engineering alumna helping bring COVID-19 vaccine to production

The coronavirus has upended daily routines in the United States and according to health officials, the importance of developing a vaccine to ward against COVID-19 and return to normal life cannot be overstated. Several biotechnology companies have answered the call to develop a safe and effective vaccine against SARS-CoV-2, including Maryland-based Novavax Inc. where Auburn University alumna Katie Windham is working to help bring the vaccine to fruition.

Novavax, a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, has been working on a COVID-19 vaccine since January. In early May, the company announced that the Coalition for Epidemic Preparedness Innovations (CEPI) will invest up to $384 million in funding to advance clinical development of Novavax’s coronavirus vaccine candidate against SARS-CoV-2. Novavax has since launched a Phase 1/2 clinical trial of its coronavirus vaccine candidate. Preliminary immunogenicity and safety results from the Phase 1 portion of the trial are expected in July.

“Our development team began working on this in the middle of January and within three months, they had what they thought was a viable vaccine candidate," said Windham, who earned a bachelor’s degree in chemical engineering from Auburn in 2016. "They have since gone ahead with animal tests and have shown in mice that the selected antigen is highly immunogenic, meaning there is a significant immune response in the mice. We have taken this candidate forward to the manufacturing stage.” 

In her role as a manager of tech transfer at Novavax, Windham works closely with both the process development group and the manufacturing team, ushering a vaccine candidate through production.

“When I talked with Katie shortly after she started at Novavax, I recall her telling me that she was one of only two engineers working together on scale-up of production. Katie successfully took on a very challenging assignment in an area in which she had limited prior experience,” said Elizabeth Lipke, the Mary and John H. Sanders Professor in Auburn’s Department of Chemical Engineering.

“Katie’s foundation of chemical engineering skills and her biological background initially prepared her to take on her role as a bioprocess engineer. Longer-term I am certain that it was her abilities to learn independently, bring resources together and problem solve that have made her successful,” she added.

Windham explained that given the urgent need for this vaccine, Novavax is working with the Food and Drug Administration to secure emergency use approval. With the additional CEPI funding, Novavax is advancing their vaccine candidate to clinical trials and expects to be able to scale up production to potentially allow for the manufacturing of up to 100 million vaccine doses by the end of this year.

“This isn’t our first time working on an accelerated timeline,” Windham said. “We targeted Zika when that was big. We created a vaccine for Ebola. We’re using the same base process for all of these. There is a lot of data that we’ve collected over the years that can be applied and that gives us additional assurance that what we’re making is safe and stable.” 

While she is still relatively new to the biotech industry, Windham is encouraged to see the industry come together to achieve this common goal to help return a sense of normalcy to the American public.

“The main goal is to get a vaccine to people to return to normal life. It’s a shift in what I’ve encountered before in this industry but to all be aligned for this one target is really something. It takes a lot of people to get it done and we’re all doing our best while working from home,” she said. “It’s been a fascinating and encouraging project to work on because of the community effort. We’re being cautious but aggressive to achieve this goal.”