A nasal vaccine for COVID-19 – based on technology developed at Washington University in St. Louis – is poised to enter a phase 1 clinical trial in the U.S. after an investigational new drug application from Ocugen, Inc. was approved by the Food and Drug Administration (FDA). Ocugen, a U.S.-based biotechnology company, licensed the innovative technology from WashU in 2022.

The trial will be sponsored and conducted by the National Institute of Allergy and Infectious Diseases (NIAID), of the National Institutes of Health (NIH). The FDA’s action is a critical first step toward initiation of the phase 1 trial, planned for this spring.

While cases of COVID-19 have fallen dramatically since the early years of the pandemic, the virus continues to circulate and still causes significant illnesses and deaths. The nasal vaccine technology is designed to induce strong immunity in the nose and upper respiratory tract, right where the virus enters the body, thereby potentially stopping transmission of the virus in addition to reducing serious illness and death. Most COVID-19 vaccines are injected into the arm or leg, and while they are effective at reducing illness and death, they do not halt transmission. The new trial will evaluate the safety and efficacy of the vaccine administered via two routes: inhaled into the lungs and sprayed into the nose.