Another coronavirus vaccine will begin clinical trials this week, according to a release from manufacturer Inovio Pharmaceuticals. The vaccine, partially funded by the Bill and Melinda Gates Foundation, showed promise in earlier trials.
This is the second coronavirus vaccine to begin human testing in the last month. But a finished vaccine is still at least a year away from being approved by the FDA.
Each participant will receive two doses of the drug, INO-4800, four weeks apart. The initial immune responses and safety data from the study are expected by late summer, according to Inovio.
Preclinical data has shown “promising immune response results across multiple animal models,” the company said in the release.
“This is a significant step forward in the global fight against COVID-19. Without a new safe and effective vaccine, the COVID-19 pandemic is likely to continue to threaten lives and livelihoods,” J. Joseph Kim, Inovio’s president and CEO, said in the release.
Unlike other vaccines that force the body to produce antibodies to specific diseases, the coronavirus vaccine will have to give the body some help.
The Inovio DNA vaccine candidate works by injecting a specifically engineered plasmid (a small, independent genetic structure) into a patient so that their cells can produce a desired, targeted antibody to fight off a specific infection. DNA vaccines, while available and approved for a variety of animal infections in veterinary medicine, have not yet been approved for human use.
That said, Inovio’s work isn’t starting from scratch: The company previously completed a Phase 1 study for a DNA vaccine candidate for Middle East Respiratory Syndrome (MERS), where it showed promising results and a high level of antibodies produced in subjects that persisted for an extended period of time.
Some scientists are worried that no vaccine will be 100 percent effective and that protection may only be for a limited time. Those are problems that may be worked out in clinical trials. It’s also one reason the FDA approval process takes so long.
It’s unclear just how much the FDA will relax its protocols to hurry a vaccine to market. But with the virus set to make another appearance next year, it may be a race to develop one before we’re once again under threat.