Israeli company claims oral vaccine COVID-19 on the way

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 new oral vaccine. Together, they formed the company Oravax Medical Inc. The vaccine is based on Oramed’s oral POD technology and Premas vaccine technology.

Oramed’s technology can be used to orally deliver a range of protein-based therapies that would otherwise be administered by injection. Oramed is in the middle of a Phase III clinical trial, through the U.S. 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 new coronavirus since March.

The companies connected earlier this year, according to Oramed’s CEO, Nadav Kidron, and quickly realized that they could revolutionize the market.

“An oral COVID-19 vaccine would eliminate several barriers to rapid, large-scale distribution, allowing people to get the vaccine alone at home,” said Kidron. “Although ease of administration is critical today to accelerate inoculation rates, an oral vaccine could become even more valuable if a COVID-19 vaccine is recommended annually as the standard flu vaccine.”

The company completed a pilot animal study and found that the vaccine promoted the development of antibodies Immunoglobulin G (IgG) and Immunoglobulin A (IgA). IgA is required for long-term immunity.

The new Oravax candidate vaccine targets three structural proteins from the new coronavirus, explained Kidron, as opposed to the single peak protein targeted by the Moderna and Pfizer vaccines. As such, “this vaccine must be much more resistant to variants of COVID-19,” said Kidron.

In addition, it is a yeast-based vaccine, making production time and cost 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; about 10% of people who are inoculated by Pfizer or Moderna report having an adverse effect.

In addition, the vaccine can be shipped in refrigerator temperatures and even stored at room temperature, “making it logistically easier to obtain it anywhere in the world,” said Kidron.

Finally, an oral vaccine does not require professional administration.

Oravax anticipates the start of a clinical study during the second quarter of 2021. Kidron said he is applying for tests in several countries, including the United States, Israel, Europe and Mexico. He also hopes to reach Africa, where such an oral vaccine may be essential.

Kidron said he expects Phase I human testing data to be available within three months.

In February 2020, shortly after the start of the COVID-19 pandemic, another Israeli team began to develop what they hoped was an oral coronavirus vaccine. Scientists in the biotechnology group at the Galilee Research Institute who developed a vaccine against avian coronavirus, which has been proven in preclinical tests and which they believed would translate into a human vaccine, said they were prepared to develop their vaccine in a few months.

The Jerusalem Post has followed the institute’s researchers and spokespeople several times in the past few months for a status update, but none have been provided.

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