South Africa has been struggling with its plans to achieve the herd immunity through vaccinations, with widespread vaccine hesitancy, largely fuelled by social media misinformation.
There is also a strong anti-vaccination lobby, including some political parties.
“We expect to rapidly complete this study and hope to advance into pivotal trials for emergency use approval in countries where our oral Virus-Like Particles (VLP) vaccine would have the greatest impact,” Oramed Chief Executive Officer Nadav Kidron said in a statement.
“South Africa is a great location for the Phase 1 study, as it is currently experiencing a surge in COVID cases and has struggled to obtain sufficient vaccines.
“It is our firm belief that an oral vaccine which eliminates syringes and eases distribution and administration, can significantly help increase vaccination rates for South Africa and similar countries,” Kidron said.
The open-label trial involves participants who have not received either a COVID-19 vaccine or contracted the virus. Participants will be administered one dose of the oral vaccine at the beginning of the trial and a second dose three weeks later.
The trial’s endpoints will include safety and tolerability as well as efficacy by measuring the presence of an immunogenic response.
Kidron said the trial phase would be short to show as quickly as possible that this oral vaccine works very well on humans before seeking phase two approvals.
Oravax said its oral vaccine targets three SARS CoV-2 virus surface proteins, including proteins less susceptible to mutation, thus making the vaccine potentially more effective against current and future variants of the COVID-19 virus.
“Oravax’s VLP vaccine technology is highly scalable for manufacturing and is easily transferable for logistical wide scale distribution as there is no need for subfreezing storage,” it added.
Oravax Medical Inc. was established earlier this year by Oramed Pharmaceuticals and other shareholders with a mission to bring an oral COVID-19 vaccine to the market.
Specialising in ways to deliver drugs orally, Oramed is currently in an advance stage of trials for the first commercial oral insulin capsule for the treatment of diabetes.