Inhaling away the virus: Is the next generation of COVID vaccines on its way?

Trials for the next generation of COVID-19 vaccines have begun in London. The first dose of a new nasal vaccine developed by the US company Codagenix and administered in a quarantine facility in London was announced on Monday morning.
"This vaccine is one of the first next-generation COVID-19 vaccines. It is a needle-free, intranasal, live attenuated single-dose COVID-19 vaccine." Cathal Friel, Executive Chairman of Open Orphan, said the company in a statement.
To achieve this goal, the vaccine must demonstrate in three step-by-step experimental “phases” that it is safe and effective - a process that can take many months.
However, this vaccine, called COVI-VAC, is different from the vaccines currently available on the market. It uses a "weakened form of the naturally occurring virus that does not cause disease but creates a strong immune response," said Robert Coleman, CEO of Codagenix, PHD. "In the past, live attenuated vaccines have been very effective because they offer long-lasting and broad immunity and are typically single-dose dependent."
Meanwhile, Coleman said, "The current mRNA-, VLP- and adenovirus-based vaccines only target the spike protein and limit the range of antibodies that can be produced."
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And as Sybil Tasker, MD, MPH, Codagenix's chief medical officer, notes, COVI-VAC could be more effective in combating mutant strains of the virus that may appear in the future: “As a live attenuated vaccine, COVI-VAC has broader potential Provide immune response compared to other COVID-19 vaccines that target only part of the virus, which could prove critical as new variants of SARS-CoV-2 emerge. "
COVI-VAC was developed using an algorithm that essentially recodes viral genes, explains Coleman, “to cause slow, inefficient translation of viral genes in human cells in a process Codagenix calls 'de-optimization'.
“We enter the sequence of the target virus into our algorithm and the software digitally de-optimizes the viral gene. We then synthesize the corresponding DNA and exchange it for the genome of the natural virus. This process essentially converts the natural virus from enemy to friend - which makes it harmless but can provoke a broad immune response. "
Using live attenuated virus in a vaccine is nothing new: “Most of the vaccines we receive as children are what are known as live attenuated vaccines. That is, they can cause infection, but they do it so weakly that there is no danger of infection, but immunity is created in the same way as the normal virus, ”said Ian Jones, professor of virology at Reading University.
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PHOTO: Codagenix President and Chief Scientific Officer Steffen Mueller at his Farmingdale, New York facility on November 2, 2016. (J. Conrad Williams, Jr./Newsday via Getty Images, FILE)
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“The main problem with this approach is that historically it has taken a lot of trial and error to create the weakened load. This new approach makes the weakened load in one step. "
Because the Codagenix vaccine uses a weakened form of the live virus, there is a small chance that volunteers will spread the virus in the community or even suffer from a disease. To minimize these potential risks, the trials will be conducted in a secure quarantine facility in East London.
"It's an added level of caution," Andrew Catchpole, the research director in charge of the studies, told ABC News, adding, "There are no legal requirements for testing the vaccine in a quarantine facility."
Catchpole is hVIVO's Chief Scientific Officer and is also expected to lead the team that will conduct the first human challenge trials for a COVID-19 vaccine.
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"Codagenix was looking for an inpatient facility with vaccine and live virus expertise and an on-site laboratory for the initial human COVI-VAC assessment to enable thorough product safety assessment and voluntary real-time monitoring," said Coleman.
The first small group of young healthy adult volunteers receive the dose by dropping it into their noses. They are then closely monitored and regularly tested. The study follows a standard dose escalation method.
"The first phase of this study is expected to provide evidence of this expectation of a short duration of virus shedding, in addition to showing that the vaccine virus is actually severely weakened and not causing disease," Catchpole told ABC News.
Unlike the approved vaccines, Codagenix believes that its vaccine could provide long-term immunity to COVID-19, requiring only a dose or two over the course of a lifetime, similar to MMR or chickenpox vaccines.
“Most live attenuated vaccines cannot fully replicate viruses. This vaccine differs in that it can. Being able to do this maximizes the immune response and maintains the most natural immune protection possible, as if the person were exposed to the actual virus, ”added Catchpole.
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However, it is early days as the hurdles to further phases of clinical trials lie ahead. "This trial will facilitate the vaccine and then move into clinical trials for efficacy and immunogenicity testing phase 2," said Catchpole.
Even so, Codagenix is ​​confident and has worked in a flash to get to this stage, partnering with the world's largest vaccine maker, the Serum Institute of India.
“As soon as it became clear that the SARS-CoV-2 outbreak was becoming a global problem, our scientists took action to develop a live attenuated vaccine against COVID-19. Codagenix and our global partner, Serum Institute of India, are committed to meeting the unmet need to protect against COVID-19, especially in lower income countries around the world. "
Coleman hopes that the ease with which this vaccine can be given - simply injected into someone else's nose - and the ease with which it can be made and transported will make him a major player in the global fight against COVID-19 .
Jones warns, however, that there is still a long way to go: "They are way behind current vaccines. So whether they can get anywhere fast enough to make a difference is not clear."
Inhaling the virus: is the next generation of COVID vaccines on the way? originally published on abcnews.go.com

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