02:04 PM
Tuesday 15 December 2020
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Books – Sayed Metwally
Pharmaceutical services company Open Orphan announced that it has received approval from the Independent Medicines and Healthcare Products Regulatory Agency (MHRA), and is ready to conduct the first phase study of the Covi-Vac, COVID-19 nasal vaccine, in cooperation with the American biotech company Codgenix.
Open Orphan will be assessing the safety and immunity of a single dose of the candidate nasal vaccine in 48 healthy adult volunteers at its facility in Whitechapel, London.
It is scheduled that a nasal vaccine against Corona will be subject to trials after it received approval from the Independent Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, which could mean a much simpler way to protect against the virus, according to the British “express” newspaper.
Open Orphan CEO, Kathhal Friel, said: “It is the first stage, but as we have seen, the first stage can move to the third stage within months in this new world of rapid development of a vaccine.”
He continued: “Britain is the world leader in testing vaccines by a million miles – nobody does it like we do, people have been doing it for a very long time here in East London, so our friends in New York had to come to London to test our vaccine, it’s really exciting.” It is the new generation, it is the future, it is an intranasal vaccine, and it is a small, live virus. “
Covi-Vac, is one of the few vaccines that use live attenuated virus (the entire virus is in weak form), unlike most other vaccines that only contain the viral mutation, it is a needle-free, single-dose vaccine.
Open Orphan said that the vaccine has the ability to stimulate broader antibodies, cellular and mucosal immunity with a single dose inside the nose, and it could be one of the first vaccines to provide long-term immunity from Corona, and trials are expected to begin in January 2021.
Freel said: “So this vaccine if it is approved late next year, which is the possibility that it will spread around the world, and it is neither frozen nor cold chain, it is inhalable, you can spray it in your nose, imagine the simplicity of a vaccine that you can inhale through your nose, No injection, no bad reactions. “
The company has begun recruiting volunteers for the clinical trial, and according to Freel, those attending his East London facility will be supervised in a safe and controlled clinical environment.
If the experience demonstrates safety and immunity, hVIVO will support Codagenix as it moves into Phase II and III of the larger program.
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