Following emergence of COVID-19 Omicron variant and pharmaceutical giant Pfizer CEO Albert Bourla’s recent remarks stating “I made a projection months ago that the most likely scenario is that we would need after the third dose, annual revaccination against COVID”, it is assumed that those nations which already are continuing vaccinating their people need to buy COVID vaccines for years, which certainly will be a difficult task even if those countries start domestically producing injectable vaccines. The only solution to this herculin task is somehow getting access to COVID-19 oral vaccines.
In October this year, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that its majority-owned subsidiary, Oravax Medical Inc., has received clearance from the South African Health Products Regulatory Authority to commence patient enrollment in a first in human, Phase 1 clinical trial, for its oral COVID-19 vaccine and preparations to begin the trials are now underway.
Oravax’s virus-like particle (VLP) vaccine technology 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 and easily transferable.
“We believe that Oravax’s oral COVID-19 vaccine candidate could offer an exciting potential solution to the COVID pandemic, whether as a booster or for the unvaccinated. An oral COVID-19 vaccine would eliminate several barriers to rapid, widescale distribution, potentially enabling people to administer the vaccine themselves at home,” stated Oramed CEO Nadav Kidron. “Following this Phase 1 trial, our intention is to move forward with a Phase 2/3 trial for emergency use approval in relevant countries,” Kidron concluded.
Oravax Medical Inc. was established in 2021 by Oramed Pharmaceuticals Inc., the largest shareholder in Oravax, along with Premas Biotech, MyMD Pharmaceuticals, and certain other shareholders with a mission to bring an oral COVID-19 vaccine to the market. Oravax combines cutting-edge vaccine technology acquired from Premas Biotech and the proprietary POD™ oral delivery technology of Oramed Pharmaceuticals.
Oramed Pharmaceuticals Inc. (Nasdaq/TASE: ORMP) is a platform technology pioneer in the field of oral delivery solutions for drugs currently delivered via injection. Established in 2006, with offices in the United States and Israel, Oramed has developed a novel Protein Oral Delivery (POD™) technology. Oramed 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. In addition, Oramed is developing an oral GLP-1 (Glucagon-like peptide-1) analog capsule.
In July 2021, the Jerusalem Post in a report said, Israel is about to become the first country in the world to test the oral COVID-19 vaccine developed by Oramed Pharmaceuticals, the company’s CEO Nadav Kidron told The Jerusalem Post.
Oramed’s subsidiary, Oravax Medical, is gearing up to commence clinical trials of its vaccine at Sourasky Medical Center in Tel Aviv after receiving approval for its study protocol from the hospital’s Institutional Review Board. It is now waiting for approval from the Health Ministry, which is expected within a few weeks.
Oravax already completed GMP manufacturing in Europe of several thousand capsules that would be available for the Israeli trial and eventually in other countries.
Advantages of COVID-19 oral vaccines
The advantages of an oral vaccine go beyond safety and efficacy because oral medications tend to have fewer side effects.
The vaccine can be shipped at refrigerator temperatures and even stored at room temperature, making it logistically easier to get it anywhere around the world.
Finally, an oral vaccine would not require professional administration.
Oramed Pharmaceuticals develops oral insulin for diabetic patients
Diabetic patients may no more need to suffer from injectable insulin on a daily basis. Instead, they can switch to oral insulin, which is being developed by Oramed Pharmaceuticals, an Israeli company.
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