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As new variants of the COVID-19 continue to rear their heads, the need to get more people vaccinated in order to shore up protection against the virus has become a top priority for governments and health officials worldwide.
With approximately 273 million cases and 5.34 million deaths recorded, a new variant, Omicron, is sending the world back to enforced lockdowns. Scientists are racing against time to find an effective remedy to stop the virus in its tracks before it wrecks further havoc on the human population.
Currently, the U.S. Food and Drug Administration (FDA) has approved vaccines from Moderna Inc. MRNA+ Free Alerts, Johnson & Johnson JNJ-0.02%+ Free Alerts and Pfizer Inc. PFE-0.02%+ Free Alerts /BioNTech SE BNTX+ Free Alerts. Just like vaccines, the booster shots are currently administered only through injection.
More than 100 million people in the U.S. have received at least one vaccine shot so far as new variants like Delta and Omricon are spreading quickly. The story is significantly worse in areas with lower vaccination rates, leading to a significant uptick in worldwide severe disease, hospitalization and death from coronavirus.
Administering Vaccines Through Injections
Some vaccine hesitancy comes from the issue of trypanophobia – the fear of needles. While needles are used in some of the most common and vital procedures, like vaccines, about 25% of U.S. adults fear them. It is estimated that approximately 16% of that percentage may skip a procedure involving needles.
Getting people with trypanophobia to overcome their nervousness to receive injections against viruses can be challenging.
Oramed Pharmaceuticals Inc. ORMP+ Free Alerts ORMP+ Free Alerts
is resolving this challenge and others with novel technology. The company has a proprietary platform technology allowing for the oral delivery of drugs and vaccines currently delivered only via injection.
Oral Vaccines
Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. The company is seeking to transform the treatment of diabetes through its proprietary lead candidate, ORMD-0801, which is being evaluated in two pivotal Phase 3 studies and has the potential to be the first commercial oral insulin capsule for the treatment of diabetes and other indications.
The advantages of oral drug delivery position it as a preferred route of drug administration for many people. Some of the known benefits include increased patient comfort and compliance, reduced risk of infection, first-pass metabolism preceding systemic exposure and cost-effectiveness.
Oramed’s subsidiary, Oravax Medical Inc., has embarked on a mission to bring an oral COVID-19 vaccine to the market. The company’s technology will be suitable for people with trypanophobia and those hesitant about taking the coronavirus vaccine.
An oral pill eliminates a lot of challenges with current vaccines. Current vaccination efforts are hampered by the need to keep vaccines at freezing temperatures and have qualified people to administer the shots.
If approved, the vaccine would not have to be kept below freezing temperatures or administered at central locations – people would be able to take them from the comfort of their homes. An oral vaccine could pave the way to a pandemic-free world because the most vulnerable people could be quickly vaccinated.
Oravax’s oral vaccine targets three surface proteins, making it potentially more effective against current and future variants. Oravax’s oral vaccine should offer critical advantages, including logistics, distribution and delivery in less vaccinated regions.If approved, the oral vaccine could be used as a standalone or as a booster for previously vaccinated individuals.
Clinical Trials
Oramed announced on December 14 that its subsidiary, Oravax, has screened and enrolled the first participant in Phase 1 clinical trial of its oral virus-like particle (VLP) COVID-19 vaccine in Johannesburg, South Africa.
The open-label trial anticipates enrolling 24 participants who have not received a COVID-19 vaccine or contracted the virus. Participants will receive 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. Oravax’s oral VLP 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.
“We expect to rapidly complete this study and hope to advance into pivotal trials for emergency use approval in countries where our oral VLP vaccine would have the greatest impact. 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,” Nadav Kidron, CEO of Oramed, said.
He added that, “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.”
Pre-Purchase of 10 million Doses
Oramed on December 29 announced that Oravax had signed a cooperation and purchase agreement with Vietnam-based Tan Thanh Holdings Investment Joint Stock Company to pre-purchase 10 million doses of oral COVID-19 vaccines.
The agreement grants Tan Thanh Holdings the right to sell Oravax’s oral vaccine in development throughout the Association of Southeast Asian Nations (ASEAN), which includes Vietnam, Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar, the Philippines, Singapore and Thailand.
The parties have agreed to negotiate follow-on orders potentially worth hundreds of millions of dollars after purchasing the initial doses.
Read more about Oramed at www.oramed.com and Oravax at www.ora-vax.com.
This post contains sponsored advertising content. This content is for informational purposes only and not intended to be investing advice.