The randomized placebo-controlled trial of the NVX-CoV2373 candidate vaccine developed by Novavax Inc. will involve about 30,000 people from 115 medical centers.
During the tests, scientists will evaluate the safety and effectiveness of the drug. According to the company, the first phases of the tests showed a good immune response, the body’s production of antibodies, and the vaccine’s tolerance. In late September 2020, Novavax began phase three trials of its vaccine in the UK.
The National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH, leads the research and the Office of Advanced Biomedical Research and Development (BARDA), part of the US Health and Human Services Administration (HHS).
“Addressing the unprecedented health crisis caused by COVID-19 has required tremendous efforts from government, academia, industry, and society. The launch of this study, the fifth COVID-19 vaccine candidate to be tested in a Phase 3 trial in the United States, demonstrates our determination to end the pandemic by developing several safe and effective vaccines,” NIH director Anthony Fauci, MD, said in a statement.
“We have come this way very quickly, but we need to get to the finish line. This will require multiple vaccines using different approaches to ensure that each person is reliably and effectively protected from this deadly disease,” adds NIH director Francis Collins, MD.
Volunteers will be grouped into two cohorts: people aged 18 to 64 years and over 65 years. The second group will make up at least 25 percent of all participants. Trial organizers are also focusing on recruiting people at increased risk for severe COVID-19: Blacks, Native Americans, Latinos, and people with comorbidities such as obesity, chronic kidney disease, or diabetes.
Because the trial will be double-blind, neither the researchers nor the participants will know who gets the candidate vaccine and who gets the placebo. The second injection will be made 21 days after the first.
Participants will be closely monitored for potential side effects, and blood samples will be taken at specific points in time after each injection and over the next two years.
Scientists will analyze blood samples to detect and quantify the immune response to SARS-CoV-2. Specialized tests will be used to identify differences in immunity due to natural infection and immunity caused by the vaccine.
The study’s main end goal is to determine whether NVX-CoV2373 can prevent symptomatic COVID-19 disease seven or more days after the second injection compared to placebo.
The Novavax NVX-CoV2373 vaccine is made from a stabilized form of the coronavirus spike protein using recombinant protein nanoparticle technology. The purified protein antigens in the vaccine cannot replicate and cannot cause COVID-19.