TORONTO — An Ontario-based biotechnology company and researchers from McMaster University have teamed up to develop a potential new method for delivering COVID-19 vaccines that would use an oral strip instead of a needle.
The thin strips, which would be infused with COVID-19 vaccine, would dissolve in the recipient’s mouth in approximately 11 seconds – much like a breath strip.
Mark Upsdell, the CEO of Rapid Dose Therapeutics (RDT), the biotechnology company developing the strips, explained that as the strip dissolves, the vaccine dose, or antigen, crosses through the blood-brain barrier in the mouth and travels into the bloodstream.
“What we’ve developed is an oral thin film strip that is precise, convenient, and a discreet way to deliver drugs,” he told CTV’s Your Morning on Wednesday.
While the product is still in its early stages of development, RDT recently announced the results of a preclinical study on animal models that showed their strips were effective at delivering model proteins through the buccal or sublingual route (strip placed on the inside of the cheek or under the tongue) to elicit an immune response.
These first results also showed that the proteins infused in the oral strips remained stable at 40 C, which would eliminate the need for refrigeration to store them. Given that some COVID-19 vaccines, such as those produced by Pfizer-BioNTech and Moderna, require storage at temperatures ranging from -15 C to -80 C, the oral strips could be especially useful from a transportation perspective.
“With the ability to infuse the product and stabilize it at 40 C, which is above room temperature, now we can distribute the strip with a vaccine across the globe,” Upsdell said.
He said that many warm countries still in need of COVID-19 vaccines might not have the same supply of freezers and shipping methods for temperature-controlled products as Canada, so the vaccine strips could be a beneficial option for those places.
“When you start looking at where the warm countries are and the logistics or the infrastructure to support that logistics system, the ability to put it into a strip and deliver it is, we believe, is game changing,” he said.
Jason Lewis, senior vice president of RDT, added that the majority of the world “struggles with obtaining and distributing” needle-based therapies.
“Cold-chain storage and transportation requirements, the need for highly trained personnel for administration, the cost of procurement and delivery of vials and syringes, not to mention the very real human fear of needles, can result in prolonged duration of a pandemic,” he said in a recent press release.
“A shelf-stable, individually-administered, orally-delivered vaccine would alleviate many of these challenges.”
Following the results of the first study, RDT announced they’re entering into the second stage of animal studies that aims to infuse the oral strips with SARS-CoV-2 spike proteins, provided by the National Research Council of Canada, to see if they will stimulate an immune response.
“We’ve been able to stabilize the vaccine, we’ve been able to check the box that it dissolves in your mouth and enters the bloodstream. The current processes is we’re now measuring what they call the immune response and that is how much was delivered into the system,” Upsdell said.
Upsdell said the oral strips could be of use in the future if there is a need for booster doses of COVID-19 vaccines or for other medications and treatments.
“It could be for a booster shot. It could be for the flu vaccine, it could be dengue [fever], West Nile virus, so it’s just not limited to the COVID vaccine,” Upsdell said. “The delivery system will facilitate a lot of these other vaccines and I’ll say serums.”
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