For the last year, COVID-19 has dominated the headlines. The viral pandemic, present in over 200 countries and territories across the globe, is responsible for 86.7 million cases worldwide, and an associated 1.87 million deaths. In the United States alone, there are 21.1 million cases with an associated 357,000 fatalities. However, things might soon change with the onset of a vaccine. Many pharmaceutical companies are currently developing vaccines, with some even being administered to the company. Now, Novavax is enrolling adult volunteers in a Phase 3 clinical trial designed to evaluate NVX-CoV2373 as a potential vaccination for COVID-19.
Novavax Vaccine
Within this Phase 3 trial, Novavax will evaluate the safety, efficacy, and tolerability of NVX-CoV2373 in protecting against COVID-19. The trial is funded by the National Institute of Allergy and Infectious Diseases, as well as the Biomedical Advanced Research and Development Authority. To run this clinical trial, Novavax is also working in conjunction with Operation Warp Speed (OWS). According to the HHS, the ultimate goal of OWS is:
to produce and deliver 300 million doses of safe and effective vaccines with the initial doses available by January 2021, as part of a broader strategy to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.
NVX-CoV2373 is the fifth vaccine to be tested in this level of clinical trials. Researchers believe multiple vaccines and approaches are needed to properly and effectively address COVID-19.
Enrollment
Altogether, an estimated 30,000 volunteers will enroll in this clinical trial throughout the U.S. and Mexico. 115 testing sites will be used. Volunteers will be split into two groups based on age, with the former being 18-64 and the latter being volunteers over age 65. However, researchers hope that 25% (7500 participants) will be in the latter age group. Researchers are also encouraging those in minority ethnic groups, or those with comorbidities, to enroll.
To begin, researchers source blood and nasopharyngeal samples from participants. Next, participants will receive either NVX-CoV2373 or a placebo; however, they will be unaware which they are given. Approximately 3 weeks after the initial injection, participants will receive a secondary injection. Throughout the trial, researchers will analyze adverse reactions, as well as test for immune response or other information available by analyzing blood. Ultimately, the clinical trial seeks to understand whether the vaccine can prevent COVID-19, or at least reduce its impact.
NVX-CoV2373
Developed by Novavax, NVX-CoV2373 uses the company’s proprietary MatrixM, as well as a stabilized version of the coronavirus spike protein. Because the protein is purified and stabilized, NVX-CoV2373 cannot, in any way, cause the transmission of COVID-19.
When tested on animal models, NVX-CoV2373 inhibited COVID-19 from binding to cells through the development of antibodies. Next, in a Phase 1 study, researchers determined that NVX-CoV2373 produced high levels of COVID-19 antibodies.
Interested in enrollment? Learn more about the clinical trial here.
