A Herculean race is on to develop, test and launch a vaccine for the Covid 19 virus and once this has been achieved, to make it affordable and distribute it widely in the shortest amount of time.
A British company, Stabilitech Biopharma that owns the IP for thermally stable capsules for the administering of vaccines could be a front runner to be first past the post with a solution to the global pandemic with its Covid-19 vaccine which will offer double immunity and can be self- administered, saving even the most vulnerable from a high-risk visit to a healthcare professional.
Human trials on Stabilitech’s OraPro-COVID-19 vaccines are due to start next month and could be available by the end of the year. The company, that has already developed a successful Zika virus vaccine, is currently raising R140m to complete human trials and begin manufacturing. This should get underway before the end of the year.
What sets this vaccine apart from other proposed vaccines currently under development is it comes in capsule form and can even be delivered to users in the mail. They can also be widely and cost-effectively distributed, even in the hottest climates without need for refrigeration. A single dose of the orally administered vaccine will take up to three weeks to become effective while other Coronavirus vaccines in the pipeline may require more than one dose and take longer to provide immunity.
Wayne Channon, chairman of Stabilitech, says that delivering a COVID-19 vaccine in the shortest time possible is only half the challenge. “Delivering a vaccine that works is more important. COVID-19 infects the mucous membranes, or linings, of the ear, nose throat and lungs. That is why we are targeting our vaccine to hit COVID-19 where it sits – in mucosal cells. Other vaccines are currently only targeting the systemic immune system, but we know from our research that COVID -19 is a mucosal virus, therefore all vaccine developers should also be looking for a vaccine that targets both mucosal as well as systemic immunity. This is what OraPro- COVID-19 will deliver in a single capsule.”
According to Channon, because Stabilitech’s COVID-19 capsules contain a freeze-dried COVID-19 vaccine and are thermally stable, means they do not need refrigeration, as most other vaccines do. It can be simply mailed and self-administered: “Even the most vulnerable and shielded can benefit without a high-risk visit to a healthcare professional. Once it has been delivered via post, you can simply swallow the capsule. No injections, no needles, no nurse or doctor’s visit, therefore no need for PPE that’s still in such short supply. And no expensive cold-chain storage is required like most other vaccines currently under development’, he said.
Stabilitech’s founder and Chief Scientific Officer Dr Jeff Drew – a virologist who has over 40 biotech patents to his name – says: “To generate protective immunity, first we insert the Spike-protein DNA from COVID-19, the S-protein cargo, into a non-replicating adenovirus, the viral vector. OraPro’s thermal stability technology is applied and packaged within an acid-resistant capsule that protects the vaccine as it passes through the stomach before being dissolved in the gut. Because it is thermally stable, the vaccine is unharmed by the high – 37 degrees centigrade – temperatures in the stomach.
“The viral vector delivers the S-protein cargo DNA to mucosal intestinal cells, which produces copies of the COVID-19 S-protein. These cells deliver the S-protein to the cell membrane that results in mucosal and systemic immunity. It takes two to three weeks for the immunity to develop.”
Initial animal safety trials have been successfully concluded and the next stage of Stabilitech’s OraPro COVID-19 development is clinical trials, under the supervision of the regulator, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
Trials are set to start in June, and a vaccine could be available by the end of the year. To achieve this, Stabilitech requires £6m (R150m) in funding for the clinical trials and manufacturing the capsule. Innovate UK, the government agency for funding research, requested Stabilitech to repurpose its Zika funding to start the research and development of OraPro-COVID-19 but the greater investment is required to finance this next vital stage of development.