A second U.S. company, Inovio Pharmaceuticals, has begun safety tests for a vaccine against coronavirus and COVID-19, the disease it causes.
Inovio said Monday that the U.S. Food and Drug Administration (FDA) has accepted the company’s Investigational New Drug (IND) application for INO-4800.
It is the company’s DNA vaccine candidate designed to prevent COVID-19 infection.
FDA’s acceptance paved the way for Phase 1 clinical testing in healthy volunteers beginning this week.
According to the company, the Phase 1 study will enrol up to 40 healthy adult volunteers in Philadelphia and Kansas City.
Screening of potential participants has already begun.
The first dosing is planned for Monday. Each participant will receive two doses of INO-4800 four weeks apart, and the initial immune responses and safety data from the study are expected by late summer.
Additional preclinical trials, including challenge studies, will continue in parallel with the Phase 1 clinical trial, according to the company.
“This is a significant step forward in the global fight against COVID-19,” said Inovio’s President and CEO Joseph Kim.
“Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods. It also demonstrates the power of our DNA medicines platform to rapidly develop and advance a vaccine for COVID-19 into Phase 1 clinical testing,” he said.
The study is a first step to see if the vaccine appears safe enough for further larger tests. Even if the research delivers positive results, it is expected to take over a year before any vaccine is widely available.
The first safety test in people of a different vaccine candidate, developed by Moderna Inc. and the U.S. National Institutes of Health, began in Seattle last month.
Dozens of research groups around the globe are racing to create a vaccine as COVID-19 cases continue to grow rapidly worldwide.
Robert Schooley, professor of medicine at the Division of Infectious Diseases and Global Public Health at the University of California, San Diego, told Xinhua studies need to be done to uncover which vaccine presents the most protein in the best cells and thus induces the most potent and relevant immunity to the virus.
“This can be figured out by sophisticated studies of the antibodies and T-cell responses directed at the virus, and offers the best protection when a vaccinated person is subsequently exposed to the virus,” he said.
“Under the most optimistic circumstance, we would be looking at a vaccine to be widely available very late 2021,” Schooley said.
The number of COVID-19 cases in the United States topped 368,000 as of Monday night, with over 10,900 deaths, according to the Center for Systems Science and Engineering at Johns Hopkins University.