The nasal vaccine against Covid-19, based on a technology developed at Washington University in St. Louis will enter clinical tests in the United States.
According to Washu Medicine, the Administration for Food and Medicines (FDA) has approved the request of Ocugen, Inc., which allows the start of phase clinical studies this spring. The study will be conducted by the National Institute of Allergy and Infectious Diseases (NIAID) and will include 80 participants between the ages of 18 and 64.
The vaccine will be administered in two ways: by nasal spray and inhalation, in different doses. The main purpose is to evaluate the safety of the vaccine, but the researchers will analyze it and efficiency, measuring the level of antibodies and the number of post-vaccination infections.
Unlike the existing injectable vaccines, which reduce the risk of serious illness and death, but does not prevent the spread of the virus, this new technology could stop the transmission from the initial phase of the infection. The vaccine acts directly on the nasal mucosa and the upper respiratory tract, where the virus enters the body.
“I am pleased to see that this nasal vaccination technology, created by Washu Medicine scientists, is advancing to clinical trials. This innovation has the potential not only to control Covid-19, but also to reduce the impact of other global respiratory infections”, Dog E. Frantz, a vice-cancelar for innovation and marketing in Washu, said.
In animal studies conducted between 2020 and 2021, the nasal vaccine completely prevented the infection in the nose and lungs, suggesting that vaccinated people could stop the spread of the virus before it causes the disease.
The vaccine was developed by a team of researchers from Washu Medicine, led by Michael S. Diamond, codororer of the Center for Vaccines and Immunity to Microbian pathogens and David T. Curiel. The specialists have inserted a gene of the SARS-COV-2 virus in a harmless virus known as adenovirus, which transports viral protein in the nose and triggers a strong immune response.
“It is great to see that the vaccine we have conceived and tested initially approaches the availability in the USA“Said Michael Diamond, professor of molecular medicine, microbiology and immunology.
A variant of this vaccine is already used in India in 2022, due to a partnership between Washu Medicine and Bharat Biotech.
If the US clinical study will demonstrate the safety and efficiency of the vaccine, technology could be adapted to other dangerous respiratory viruses, such as seasonal flu, avian flu and syncytial respiratory virus (RSV).
“All effective vaccines reduce the disease and death, but the Covid-19 vaccination by nasal and oral appears to contribute to the stopping of the virus“, David Curiel, a teacher of medicine and obstetrics and gynecology in Washu, said.
