UW Medicine researchers conducting phase 3 trial of Novavax COVID-19 vaccine

The race to develop and administer a COVID-19 vaccine continues. It comes as scientists are predicting an increase in COVID cases from the holidays.

The glimmer of hope, however, comes in the form of these vaccines. Pfizer and Moderna's versions are being rolled out to healthcare workers and people 65-years-old and older, but Maryland-based Novavax is currently conducting its Phase III trial on their COVID-19 vaccine.

From a vaccine profile standpoint, researchers note both similarities and differences to the vaccines developed by Pfizer, BioNTech and Moderna. 

"It's a particle vaccine. It should be safe. The world needs it. The volunteers engaged in this trial are helping many, many people," said Dr. Greg Glenn, Novavax President of Research and Development.

According to the National Institutes of Health, Phase I trials of the Novavax vaccine version,  have shown "higher levels of antibodies" than those who fully recovered from clinically significant COVID-19. Phase III trials are currently underway in the United Kingdom.

"I think people look at our vaccines and see the immune profile looks good, it looks really safe. We've had really good response in our Phase I and Phase II trials," said Dr. Glenn.

Minimal side effects, like acute pain around where the shot is administered, have been reported so far, according to researchers.

"Some people may have a sore arm or mild flu-like symptoms for a day or two after receiving the vaccine but in general these vaccines are well-tolerated," said Dr. Anna Wald, professor of medicine, epidemiology and laboratory medicine and pathology, and director of the Virology Research Clinic at the University of Washington.

In terms of the vaccine profile, it's more of a traditional route and is the first of the protein-based vaccines that are being rolled out, said Dr. Glenn.

Unlike the Pfizer and Moderna versions, which use mRNA to tell your body's cells how to make a spike protein, and create an immune response, Novavax's version provides the spike protein in the shot itself.

The purified protein can neither cause COVID-19 nor replicate the virus, according to Novavax developers.

"So, it's a lot like traditional vaccines like we already use. For example, the adult shingles vaccine is made in the same way, said Dr. Scott McClelland, Professor of Medicine, Epidemiology and Global Health for the University of Washington.

It's also traditional in terms of storage.

"It can be mass-produced and it can be stored up to 8-degrees Celsius. which is the temperature of a lot of approved vaccines that we currently use now," said Dr. McClelland.

Researchers at the University of Washington are currently looking for 1,000 participants to take part in the trial. Novavax is looking to recruit 30,000 participants in 125 sites in the U.S. and Mexico.

Trial participants must not have had COVID-19 previously. Unlike other trials, researchers are making an effort to provide this trial to more diverse populations and demographic groups most impacted by the virus. According to a Novavax Press Release, enrollment goals include providing the vaccine to more than 25% of people 65-years-old and older, more than 15% African-African, between 10%-20% LatinX, and 1%-2% American-Indian.

"It is important that we provide equitable access to the trial for people from the communities that have been hardest hit by COVID-19, particularly the Latinx, Black and Native American communities," said Dr. McClelland.

Also, two-thirds of study participants will get the actual vaccine, said Glenn. Other studies have conducted a 1:1 ratio when it comes to vaccine-placebo distribution.

"That means there's a two-thirds chance of getting the active vaccine, which I believe will incentive people to join up in the trial," said Dr. Glenn.

Volunteers 18 and older can enroll with the Virology Research Clinic in several ways:

Complete the volunteer screening registry and enter site code "UWVR"

Email: joinuwcovid19vax@uw.edu

Call: 206.520.4212

Visit: www.uwvteu.org for more information.