A University of Houston professor has developed a COVID-19 vaccine that can be administered through the nose, with hopes to soon test on humans.
Dr. Navin Varadarajan, a professor of chemical and biomolecular engineering at UH, has devoted much of his post-doctoral work to immunology and understanding how the body protects itself.
His background in immunology gave him the idea for an intranasal vaccine, which can be effective in triggering a strong immune response at the site of pathogen infection.
“A lot of people don’t like needles, so intranasal is more convenient because it provides the vaccine straight through your nostril,” Varadarajan said. “In addition to stability, it makes for easier distribution.”
Along with Dr. Xinli Liu, associate professor of pharmaceuticals at the UH College of Pharmacy, Varadarajan launched a biotech company AuraVax Therapeutics Inc., to develop the vaccine.
So far, the scientists have tested the drug on mice and ferrets in a laboratory setting; early results show comprehensive COVID immunity within seven days, Liu said.
“We’re optimistic and hopeful it will make a difference,” Varadarajan said. “Vaccines that most of us get are intramuscular vaccines, so it goes everywhere in the body except the mucosal areas. Since COVID comes in through the nostrils, this is a blind spot for immunity.”
Researchers know that mucosal vaccines have the capacity to prevent an infection from establishing itself in a person’s body because it targets the virus on first contact in the nose, Varadarajan said.
The three vaccines approved for use in the U.S. — Pfizer-BioNTech, Moderna and Johnson & Johnson — are intramuscular, given in the arm’s deltoid muscle, which the National Institutes of Health reports leads to a greater systemic immune response in the body and reduces the likelihood of bad side effects at the injection site.
“Mucosal vaccination can stimulate both systemic and mucosal immunity and has the advantage of being a non-invasive procedure suitable for immunization of large populations,” Varadarajan said.
To increase the efficacy of the vaccine, scientists add an adjuvant — a naturally-occurring or synthetic molecule specifically chosen to enhance the body’s immune response by triggering a “danger signal.” And that’s where Liu’s expertise comes in. Before the pandemic, she worked on developing nanoparticles in various anti-cancer drugs.
Liu and Varadarajan knew the intranasal vaccine would need an adjuvant to boost the immune response activity. Varadarajan proposed they use nanotechnology to introduce the adjuvant into the vaccine’s particles.
“It generates memory immune cells that can play a role in the vaccine’s efficacy,” Liu said. “This is quite important.”
In September, Liu and Varadarajan published an article in iScience, detailing their experimental vaccine and plans to test in human clinical trials in the second quarter of 2022.
Varadarajan is not alone in developing intranasal vaccines, he said. He has been following the progress of a similarly-made vaccine in India that is in the first phase in human trials.
Drs. Peter Hotez, Maria Elena Bottazzi and their team at the Texas Children’s Hospital Center for Vaccine Development are also researching intranasal, oral and sublingual (under the tongue) vaccines, but none have been licensed.
Their COVID-19 vaccine marketed as Corbevax is the furthest along in development, Hotez said. The recombinant protein vaccine can be produced in large quantities for a low cost — $1.50 per shot — which he hopes will help increase vaccination rates and save lives in lower income countries.
Hotez said the vaccine shows 85 percent efficacy after one dose.
Currently, Corbevax is licensed in India and Indonesia. Within a few months, Hotez hopes 100 million doses of vaccine can be produced per month in those countries.
Other low- and middle-income nations want Corbevax access now, Hotez said. A billion people in sub-Saharan Africa and half a billion in Latin America cannot wait until 2023 or 2024 to become vaccinated, he added.
“Everyone has been so focused on innovation with mRNA and particle vaccines that they haven’t stepped back to see how they will make 6 billion doses for the world’s low- and middle-income countries,” he said. “We make global, low-cost health vaccines.”
Varadarajan is still at the beginning of the intranasal vaccine development journey, but he has hopes for the first phase of human trials to start by mid-2022.
He is proud of the work he and Liu have completed so far, including showing proof that the vaccine works in small animals and the published article in a medical journal.
“First step is giving the animal the vaccine and challenging it to see if it protects it,” Varadarajan said. “When both of these steps are done, you make the move to manufacture it and bring your findings to the FDA. Eventually, we can bring this technology to humans.”