The Israeli inventors of an oral coronavirus vaccine have received the green light to start clinical trials in South Africa, and expect to be up and running next month.
Oramed Pharmaceuticals has received clearance from the South African Health Products Regulatory Authority to start patient enrollment in a Phase 1 clinical trial for its Oravax pill.
“We’re excited to be moving ahead with clinical trials of our oral COVID-19 vaccine in South Africa,” Nadav Kidron, CEO of Oramed, the company behind the pill, told The Times of Israel, adding that as boosters are increasingly recommended, his pill could provide an effective way of keeping vaccinations up to date.
The South Africa trial is expected to run concurrently with a Tel Aviv trial that will start soon when approvals by Israel’s Health Ministry are finalized.
The vaccine will be suitable for use as an initial inoculation or a booster, Kidron added, noting that for either use it has “many benefits.”
He said: “These include ease of distribution and the fact that most people prefer to take a pill rather than a shot, especially in Africa. Especially in countries with low vaccination rates, a safe, effective and easy to swallow vaccine could be a game-changer in combatting the virus and getting life back to normal.”
Oravax is a single-dose oral version of a prospective vaccine being developed in partnership with India-based Premas Biotech, and in March announced that it had successfully generated antibodies in pigs.
It hopes that the pill will be suitable as a simple initial vaccination, as it won’t need to be stored at low temperatures and eliminates the need to have professionals administering injections.
“We believe that Oravax’s oral COVID-19 vaccine candidate could offer an exciting potential solution to the pandemic, whether as a booster or for the unvaccinated,” said Kidron.
“An oral COVID-19 vaccine would eliminate several barriers to rapid, wide-scale distribution, potentially enabling people to administer the vaccine themselves at home. Following this Phase 1 trial, our intention is to move forward with a Phase 2 and 3 trial for emergency use approval in relevant countries,” he added.
Source: Nathan Jeffay – TOI