The first participant in the National Institute of Allergy and Infectious Diseases-funded (NIAID), Phase 1 clinical trial of a COVID-19 vaccine received their first dose this week, officially beginning an approximately six-week program.
The investigational vaccine, mRNA-1273, will be tested on 45 healthy adult volunteers at the Kaiser Permanente Washington Health Research Institute (KPWHRI) in Seattle. This action represents the first step of many in the clinical trial process, which will also include different doses of the experimental vaccine and its ability to create an immune response. The institute was chosen for its place among NIAID’s Infectious Diseases Clinical Research Consortium.
“Finding a safe and effective vaccine to prevent infection with SARS-CoV-2 is an urgent public health priority,” NIAID Director Anthony Fauci said. “This Phase 1 study, launched in record speed, is an important first step toward achieving that goal.”
NIAID developed the vaccine alongside scientists at biotechnology company Moderna, Inc. The Coalition for Epidemic Preparedness (CEPI) also aided efforts by supporting the manufacturing of the vaccine candidate. The speed of this undertaking has been fueled by the fact that no approved vaccines or treatments for SARS-CoV-2 — the virus that causes COVID-19 — currently exist.
The investigational vaccine was created through mRNA and works by pushing the body’s cells to express a virus protein that would, in turn, cause a significant immune response. It was built off of previous research into coronaviruses such as SARS and MERS. The new trial will be led by Dr. Lisa Jackson, a senior investigator at KPWHRI, and consists of two vaccine doses by injections, with 28 days between.
“This work is critical to national efforts to respond to the threat of this emerging virus,” Jackson said. “We are prepared to conduct this important trial because of our experience as an NIH clinical trials center since 2007.”
Participants will be studied for a year after the second shot. Despite this, researchers hope to begin putting up initial data from the trial within three months. NIAID has also cautiously noted that if the vaccine shows promise, larger studies could be initiated, which would potentially enroll thousands of people. NIAID researchers noted that, in the best-case scenario, a COVID-19 vaccine would not be widely available for at least a year or more.
According to the World Health Organization figures, COVID-19 has infected more than 167,500 people worldwide since its discovery in December last year. This includes more than 6,600 killed by the disease. In the last month, cases in the United States have reached more than 4,200 cases, according to the Associated Press, including 74 deaths as of March 16.