An oral vaccine could potentially allow for people to self vaccinate at home.

By MAAYAN JAFFE-HOFFMAN
MARCH 21, 2021 21:50

An Israeli-American pharmaceutical company is preparing to launch a Phase I clinical trial for what could become the world’s first oral COVID-19 vaccine. Oramed Pharmaceuticals Inc., a clinical-stage pharmaceutical company based on technology developed by Hadassah-University Medical Center, announced over the weekend a joint venture with Premas Biotech to develop a novel oral vaccine. Together they formed the company Oravax Medical Inc.

The vaccine is based on Oramed’s “POD” oral delivery technology and Premas’s vaccine technology. Oramed’s technology can be used to orally administer a number of protein-based therapies, which would otherwise be delivered by injection. Oramed is in the midst of a Phase III clinical trial through the US Food and Drug Administration of an oral insulin capsule for type I and type II diabetics. Premas has been working on developing a vaccine against the novel coronavirus since March. The companies connected earlier this year, according to Oramed CEO Nadav Kidron, and quickly realized that they could revolutionize the marketplace.“An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, potentially enabling people to take the vaccine themselves at home,” Kidron said. “While ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable in the case that a COVID-19 vaccine may be recommended annually like the standard flu shot.” The company completed a pilot animal study and found that the vaccine promoted the development of Immunoglobulin G (IgG) antibodies and Immunoglobulin A (IgA). IgA is necessary for longer-term immunity.

The new Oravax vaccine candidate targets three structural proteins of the novel coronavirus, Kidron explained, as opposed to the single spike protein targeted via the Moderna and Pfizer vaccines. As such, “this vaccine should be much more resistant to COVID-19 variants,” Kidron claimed. In addition, it is a yeast-based vaccine, making the time and cost of production much cheaper than its already-approved competitors. The advantages of an oral vaccine go beyond safety and efficacy, Kidron continued. He said that oral medications tend to have fewer side effects; around 10% of people who are inoculated by Pfizer or Moderna report having some adverse effects.

In addition, 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,” Kidron said.

Finally, an oral vaccine would not require professional administration. Oravax anticipates commencing a clinical study during the second quarter of 2021. Kidron said that it is applying for trials in multiple countries, including the United States, Israel, Europe and Mexico. It hopes to also target Africa, where such an oral vaccine could prove essential.

Kidron said he expects Phase I human trial data to be available within three months. In February 2020, shortly after the start of the COVID-19 pandemic, another Israeli team began development on what they hoped would be an oral coronavirus vaccine. Scientists from the Galilee Research Institute’s biotechnology group who had been developing a vaccine against avian coronavirus, which had been proven effective in preclinical trials and they believed would translate to a human vaccine, said that they were primed to develop their vaccine within a few short months. The Jerusalem Post followed up with the institute’s researchers and spokespeople multiple times over the past several months for a status update, but none was provided.