Israel Prepares To Try Oral COVID-19 Vaccine, Here Are Its Advantages

JAKARTA - Israel will be the first country in the world to test an oral COVID-19 vaccine developed by Oramed Pharmaceuticals, said company CEO Nadav Kidron.

Oramed subsidiary Oravax Medical is preparing to begin 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.

In his statement to The Jerusalem Post quoted Friday, July 23, Kidron said his party was awaiting approval from the Ministry of Health, which is expected in the coming weeks.

Previously, Oravax had completed manufacturing of GMP in Europe from several thousand capsules, which will be available for trials in Israel before being tested in other countries.

Oramed is a clinical-stage pharmaceutical company based on the technology developed by the Hadassah-University Medical Center Jerusalem. In March, they announced a joint venture with India-based Premas Biotech to develop a new oral vaccine.

Together they form Oravax. The vaccine is based on Oramed's 'POD' oral delivery technology and Premas vaccine technology, which has been working on developing a vaccine against the novel coronavirus since March.

Oramed's technology can be used to deliver a number of protein-based therapies orally, which would otherwise be given by injection. Oramed is currently undergoing Phase III clinical trials through the United States Food and Drug Administration (FDA) of oral insulin capsules for Type 1 and Type 2 diabetes.

"The new Oravax vaccine candidate targets three structural proteins of the coronavirus, in contrast to the single spike protein targeted by the current Moderna and Pfizer vaccines," Kidron said.

"Therefore, this vaccine must be much more resistant to the COVID-19 variant. Even if the virus goes through one pathway, there is a second pathway and if it goes through a second route, there is a third pathway," he explained.

The vaccine is being tested in preclinical studies against variants of COVID-19, including the Delta variant. The manufacturer has previously completed animal experimental studies and found that the vaccine promotes the development of Immunoglobulin G (IgG) and Immunoglobulin A (IgA) antibodies. IgA is required for long-term immunity.

The inaugural Phase I/II trial protocol that the company hopes to continue at Sourasky will involve 24 volunteers who have not been inoculated with another vaccine.

Half of the group will take one capsule, and the other half will take two, Kidron said. He explained that there was no placebo group in this trial, because the goal was to measure antibody levels and other indicators of immunity.

"The idea here is, we want to show a proof of concept that works for people. I pray and hope we will. Imagine we can give someone an oral vaccine and they get vaccinated. This will be a revolution for the whole," Kidron said.

"The oral COVID-19 vaccine will remove some of the barriers to rapid large-scale distribution, potentially allowing people to take the vaccine themselves at home. While ease of administration is critical today to accelerate vaccination rates. Oral vaccines could be even more valuable if the COVID-19 vaccine is 19 can be recommended every year as a standard flu shot."

The advantages of oral vaccines go beyond safety and efficacy, as oral medications tend to have fewer side effects, Kidron said. In addition, human vaccines can be shipped at refrigerator temperature, even stored at room temperature. So it is logistically easier to distribute them. He added that the Phase I/II trial is expected to take about six weeks from recruitment. Meanwhile, Phase III trials with a number of volunteers and seeking approval for use, only then request FDA authorization.

If the trial is successful, Kidron will try to get approval for emergency use as soon as possible in countries where it is most needed, such as Latin America where there is not enough COVID-19 vaccine.