Novavax opens Phase 3 trial for COVID-19 vaccine candidate

Tampa General Hospital, USF Health are a site for clinical trial testing
Posted at 10:15 PM, Dec 28, 2020
and last updated 2020-12-28 23:32:30-05

TAMPA, Fla. — Another vaccine candidate is taking a step forward. Novavax announced Monday it is starting a phase three trial for its vaccine candidate in the United States and Mexico. Tampa will host a site for the clinical trial.

The study will look at the efficacy, safety and immunogenicity of NVX-CoV2373.

“It’s been a momentous mobilization of the U.S. biotech industry. We’re very glad to be participating in it. I think this is a sign that you know we’ve reached a really important milestone with the development of our vaccine,” said Dr. Gregory Glenn, the president of research and development for Novavax.

The study is with support from Operation Warp Speed partners. It is looking to enroll around 30,000 participants age 18 and older. Two-thirds of the participants will be assigned to randomly receive the vaccine, while one third will randomly receive a placebo vaccine.

“We are actually making the spike protein. We’re much more traditional. Most vaccines you would give your kids today are made with the kind of technology we are making. So we make the spike protein, we make a very strong immune response,” said Glenn.

The company is also emphasizing older adults, those with conditions that place them at a higher risk of complications from COVID-19 and communities and demographic groups most impacted by the disease.

“We hope to because in the U.S. we see so much of the disease is in the older adults, old people like myself, over 65, also in the African American community, the Hispanic community and Native Americans, so we have quotas if you will,” Glenn said in wanting to develop confidence in the vaccine.

The company is looking to enroll at least 25% of the study 65 years and older, at least 15% African American, 10% to 20% LatinX and 1% to 2% American Indian.

The company said trial sites were selected in locations where transmission rates are currently high.

USF Health and Tampa General Hospital were one of about 125 sites selected as a site for the clinical trial testing.

“I think that this is actually very exciting in the sense that really there has been a significant effort to bring this to a successful step so I think this additional platform again expands the possibility of other vaccines being available to the public so this is a really exciting way to expand the armament against this virus,” said Dr. Carina Rodriguez, the principal investigator and the division chief of pediatric infectious diseases at USF Health

She said they are starting to enroll participants this week, with a goal of about 250.

“This is a different platform so it’s a protein-based vaccine. So indifference from the previous vaccines instead of giving the mRNA of the virus this actually gives the protein, so the spike protein already preformed so it’s a different platform, doesn’t require such stringent conditions to actually be kept in the offices,” said Rodriguez.

Rodriguez said those interested in participating locally can call 813-853-1149 for those ages 18-25 years old, and 813-844-2673 for those 26 years and older. Those interested can also visit their website to submit information.

Novavax expects to have trial data potentially in the spring. It also has a phase three trial underway in the U.K.

“This is a virus that needs vaccination. We need many many vaccines. This vaccine would make an important contribution and if people volunteer for the trial they’ll be able to take pride in this years from now and look back and say I did something for global public health,” said Glenn.