Intranasal COVID Vaccine Offers Hope Against Subvariants

The possible new intranasal COVID vaccine can help prevent the threat of new variants.

As new Omicron subvariants like BA.2 raise concerns globally about yet another wave of COVID-19 infections and deaths, Codagenix, Inc. is entering the vaccine arena with a possible new frontrunner in vaccine protection: CoviLiv, an intranasal COVID vaccine.

CoviLiv is a novel intranasal, codon deoptimized live attenuated COVID-19 vaccine that presents all of the proteins present in SARS-CoV-2 to the immune system. What’s special about CoviLiv is that it can help build mucosal immunity which can slow the rate of transmission. Additionally, because the vaccine introduces the body to all SARS-CoV-2 proteins, there is less of a need to focus on changing the vaccine to address mutated proteins on emerging virus variants.

In Phase I study results, Codagenix shared that CoviLiv provided mucosal antibody response and blocked nasal replication of SARS-CoV-2, which means it has the potential to reduce viral transmission. Excitingly, the T-cells of patients who were dosed in 2021 before the Omicron variant was widespread showed cellular immunity of a robust anti-Omicron response.

“We actually made an anti-Omicron response before Omicron existed,” said Codagenix CEO J. Robert Coleman in an interview with BioSpace. “It sounds glib, but it really speaks to why a live vaccine is great. It provides broad durable immunity without the need for reformulation.”

There are many other benefits of live attenuated vaccines that may help bridge gaps in current vaccination plans. In some countries throughout Africa and Southeast Asia, vaccination rates are low because of disproportionate vaccine availability, sometimes due to the lack of technology to keep current COVID-19 vaccines refrigerated. The intranasal COVID vaccine (CoviLiv) does not require refrigeration and is more accessible because it isn’t injected, making it a prime choice for first-line vaccination.

Codagenix is also evaluating the efficacy of its vaccine in people who have already received mRNA vaccinations and boosters throughout the pandemic.

“We’ll be looking at giving the vaccine to people that already have had an mRNA vaccine and see if we can renew their immune response and help give them mucosal immunity that the first-generation vaccines don’t make,” said Coleman, noting that the intranasal vaccine may provide relief in “booster fatigue” that some people may feel with current vaccination standards.

CoviLiv (intranasal COVID vaccine) may also be on track to become pan-variant, although nothing is for certain yet, given that unknown variants cannot be tested clinically. Codagenix is prepared to test cellular immunity in patients dosed against future variants. Coleman shared that in animal studies, animals could be challenged with new variants after initial vaccination and still show protection against the virus.

“What puts us ahead of the others is that we’re not chasing a spike protein to make an immune response,” Coleman said. “We provide all the proteins of the virus and, in particular, some of the proteins that don’t mutate as frequently.”

Of course, people may be worried about an intranasal COVID vaccine that delivers a live-attenuated version of the virus. However, live attenuated vaccines do not cause illness and can result in lifelong immunity. Additionally, many people have already received live attenuated vaccines during childhood for diseases such as measles, mumps and chickenpox.

Codagenix is part of the World Health Organization (WHO) Solidarity Trial Vaccines program, which brings companies together to evaluate the efficacy and safety of promising new COVID-19 vaccines. Looking forward, Codagenix will take part in a placebo-controlled trial as part of the program and anticipates dosing participants by mid-2022. Beyond COVID-19 vaccines, Codagenix is also working on universal influenza vaccines and pursuing oncological targets.