Israeli COVID-19 vaccination pill trial to take place in SA

An Israeli company has been given the green light to begin clinical trials for a COVID-19 vaccination pill in South Africa, which could be a game-changer for the pandemic.

On 29 November, Oramed Pharmaceuticals, a clinical-stage pharmaceutical company focused on the development of oral drug delivery systems, announced that its majority-owned subsidiary, Oravax Medical, had received clearance from the South African Health Products Regulatory Authority to commence patient enrolment in a first human, phase-1 clinical trial for its oral COVID-19 vaccine. Preparation to begin the trial is now underway.

“Oravax’s oral COVID-19 candidate has many benefits including ease of use. Who wouldn’t prefer a pill to a shot?” says Nadav Kidron, the chief executive of United States-listed company, Oramed Pharmaceuticals. South Africa is the first country to run a clinical trial for this possible vaccine.

Asked why South Africa was chosen, Kidron says, “We were speaking to a number of places to begin clinical trials. South Africa was chosen because of the low incidence of the population being vaccinated against COVID-19 [just about 20% of the population is fully vaccinated]. In addition, one of Oramed’s board members, Leonard Sank, is from South Africa, and he’s been very involved, introducing us to relevant experts and authorities.”

The trial in South Africa is expected to run concurrently with a Tel Aviv trial that will start when approvals by Israel’s health ministry are finalised.

Kidron says 24 unvaccinated people will participate in the phase-1 clinical trial, which will take place in Johannesburg. “This follows a pre-clinical study that showed that the oral COVID-19 vaccine promoted both systemic immunity through immunoglobulin G [IgG], the most common antibody in blood and bodily fluids that protect against viral infections, and immunoglobulin A [IgA], which protects the respiratory and gastrointestinal tracts against infection,” he says.

In addition to the preference for a pill over a shot, the oral vaccine could allow for “easier distribution, as it doesn’t require a freezing supply chain as other vaccines do, nor does it require a professional to administer,” says Kidron. Though the tablets may need to be refrigerated, the hope is that the trials will show that they are stable at room temperature. They will also be cheaper to produce than shots.

In addition, tablets would lead to less bio-hazardous waste. “As the world meets at the climate summit, it’s worth noting that an oral vaccine cuts the need for syringes and other waste,” he says. “Importantly, Oravax’s vaccine targets three SARS-CoV-2 virus surface proteins, including proteins less susceptible to mutation, making our vaccine a better candidate to provide protection even against emerging mutated viruses. And since it’s not an injection, it should have fewer side effects.”

The vaccine pill could also minimise the cost of training and mobilising healthcare personnel, and eliminate occupational needle-stick injuries. It could even be used as a booster, and could potentially enable people to administer the vaccine themselves at home. Following this phase-1 trial, their intention is to move forward with a phase 2/3 trial for emergency use approval in relevant countries.

No South African media outlet has yet mentioned Oravax’s Israeli connection. Responding to this, Kidron says, “Oravax is actually not an Israeli company although Oramed, the majority stakeholder of Oravax, is a proud Israeli-American company. Our technology was developed in Israel and our offices are in Jerusalem. We are proud to be part of the thriving Israeli innovation ecosystem.” He says that they haven’t received any backlash from the Boycott, Divestment, Sanctions movement in South Africa.

“We’re very excited to begin clinical trials in South Africa,” Kidron says. “We believe that the Oravax vaccine has many advantages, both in terms of ease of use and distribution, but also in being effective against variants and having fewer side effects than injections. An effective, safe, and easy to distribute vaccine could be a game-changer for emerging from the pandemic.”