A thriving culture of innovative research at Washington University has produced the world’s first nasal vaccine for COVID-19.

Based on technology developed and licensed at the university, the vaccine was approved in India in September 2022 for emergency use. In January 2023, Indian Health Minister Mansukh Mandaviya launched the vaccine, sold as iNCOVACC, on Republic Day, a national holiday in India. It is offered as both a primary vaccine and a booster.

Washington University scientists developed the nasal vaccine in collaboration with Bharat Biotech International Limited in India, a global leader in vaccine innovation and a developer of vaccines for infectious diseases.

Studies in 2020 and 2021 led to the breakthrough vaccine. Conducted by Washington University co-inventors Michael S. Diamond, MD, PhD, the Herbert S. Gasser Professor of Medicine, a professor of molecular microbiology, and of pathology & immunology, and David T. Curiel, MD, PhD, the Distinguished Professor of Radiation Oncology, the research demonstrated that the vaccine is effective in mice and nonhuman primates. Bharat Biotech licensed the technology from Washington University in 2020, refined the delivery device, and scaled up manufacturing.

The company launched two clinical trials of the nasal vaccine in India: a phase 3 trial involving about 3,100 previously unvaccinated people who received two doses of the nasal vaccine, and a booster trial with about 875 people who received a single dose of the nasal vaccine after two doses of another COVID-19 vaccine. These trials indicated that the vaccine is safe and effective at eliciting a strong immune response in people when used either as a primary vaccine or as a booster.

Pooling their expertise, Diamond, Curiel, and members of their laboratories inserted a spike protein that causes COVID-19 into an adenovirus that triggers the common cold. They tweaked the adenovirus, rendering it unable to cause illness. The harmless adenovirus carries the spike protein into the nose, and the body begins to mount a defense against the SARS-CoV-2 virus. Importantly, the design of the vaccine makes it relatively quick and easy to update when new variants emerge, simply by switching out the current spike protein with one from a new variant.

“This pandemic has been dragging on because new variants continue to emerge that are capable of causing a lot of infections and transmission among people who were already vaccinated,” Curiel said. “A cost-effective nasal vaccine may be what we need to finally break the cycle of transmission. I am very excited about the potential of this vaccine to reach the 3 billion people worldwide who are not yet fully vaccinated against COVID-19 and help bring this pandemic to an end.”

The nasal vaccine may soon become available in other countries. The university has licensed the rights to develop, manufacture, and commercialize its proprietary COVID-19 vaccine in the United States, Europe, and Japan to Ocugen Inc., a U.S.-based biotechnology company focused on developing and commercializing novel gene and cell therapies and vaccines.

These efforts underscore Washington University’s mission to improve the health and well-being of people in communities and countries around the world.