A nasal vaccine for COVID-19—considered to provide greater protection against the virus than current injectable vaccines—is on the path to becoming available in the U.S., Europe and Japan. Technology for the vaccine has been developed at Washington University, and the university has licensed the rights to develop, manufacture and commercialize the vaccine in the United States, Europe and Japan to Ocugen Inc. Ocugen is a U.S.-based biotechnology company focused on developing and commercializing novel gene and cell therapies, and vaccines.

Current injectable vaccines help prevent severe illness and death but do little to prevent infections, especially as highly contagious newer variants continue to spread. The advantage of the nasal vaccine is that it delivers a boost to immunity in the nose and upper respiratory tract, right where the virus enters the body, thereby potentially preventing infections altogether.

Ocugen intends to work closely with U.S. government agencies tasked with pandemic preparedness and response to initiate clinical trials and manufacture the intranasal vaccine. The company also is interested in the potential for the nasal vaccine to be a universal booster, regardless of a person’s previous COVID-19 vaccination history.

“Despite the many challenges of a global pandemic, our accomplished, dedicated faculty have continued to push the boundaries of discovery,” says Dedric Carter, PhD, Washington University’s vice chancellor for innovation and chief commercialization officer. “The licensing of the nasal vaccine technology highlights the culture of innovation we’re developing at Washington University. All of our faculty’s extraordinary efforts in research innovation are with the goal of translating insights from the laboratory into improvements in the health and lives of people in our communities and across the globe.”

The Washington University nasal vaccine technology was previously licensed to Bharat Biotech International Limited in 2020 for development in India and limited parts of the world. In September 2022, health authorities in India approved the vaccine for emergency use in that country, making it the world’s first intranasal vaccine for COVID-19 to be approved. Then, in November 2022, the nasal vaccine was approved for emergency use in India as a booster for people who have already received two doses of other COVID-19 vaccines.

The investigational nasal vaccine was co-developed by Washington University scientists David Curiel, MD, PhD, and Michael Diamond, MD, PhD, with members of their laboratories. They started collaborating in early 2020, as the virus that causes COVID-19 first began its rapid spread across the globe.

Curiel had long worked on using harmless, deactivated cold viruses called adenoviruses to deliver gene therapies for cancer and other diseases. Diamond, an expert in viruses and infectious diseases, was already studying the virus that causes COVID-19 in his laboratory, having obtained a sample from the National Institutes of Health (NIH) in the first weeks of the pandemic. Curiel and Diamond teamed up to create and test their adenovirus-based nasal vaccine for COVID-19.

“In recent months, we have seen COVID-19 continue to spread—despite high levels of vaccination the U.S., Europe and Japan have achieved,” Diamond says. “Because the vaccine can be delivered directly into the nose, it is specifically designed to block infection at the portal of virus entry, and we believe it may help prevent transmission as well as provide protection against new COVID-19 variants.”

Early studies at Washington University showed that nasal delivery of this vaccine creates a strong immune response throughout the body, especially in the nose and respiratory tract. In animal studies, the nasal vaccine entirely prevented infection from taking hold in the nose and lungs, suggesting that vaccinated individuals would be able to fend off the virus before it could multiply and cause an infection.

“Another advantage to a nasal vaccine is that it doesn’t require a needle,” Curiel says. “Many people who are hesitant to receive an injection are willing to inhale a vaccine. This vaccine also could be used to boost immunity in people who were previously vaccinated with any of the other vaccines. I think it could be very helpful in the ongoing effort to reduce SARS-CoV-2 infection and transmission here in the U.S. and worldwide.”

Shankar Musunuri, PhD, chairman, CEO and co-founder of Ocugen, adds: “Washington University’s COVID-19 nasal vaccine technology has been shown to induce strong mucosal immunity with potential to reduce SARS-CoV-2 infection, transmission and the emergence of new variants. As the effort to end the pandemic focuses on effective booster options, Ocugen is excited about the potential for this vaccine to be a universal booster, regardless of previous COVID-19 vaccination history. We look forward to working with U.S., European and Japanese regulators to expedite development.”

Originally published by Washington University School of Medicine at medicine.wustl.edu/news