US drug maker to run trial for Covid-19 oral vaccine in SA
Regulatory body gives permission for trial of vaccine in pill form
As the race to develop cheaper and easy-to-administer vaccines against Covid-19 continues, a US drug maker has been given the green light to run a phase 1 trial in SA for an orally delivered vaccine candidate.
US-listed Oramed Pharmaceuticals said on Friday the South African Health Products Regulatory Authority had given permission for the company to begin enrolling patients for the first phase of trials of its pill-based vaccine, Oravax.
The trial, which will involve 24 volunteers, will be conducted in Johannesburg with results anticipated by mid-2022, Oramed CEO Nadav Kidron told the Sunday Times.
The company had pushed to trial its candidate vaccine in SA as the country was undervalued by international companies yet offered great potential, said Kidron.
“You get a very high level of medicine and committed people [at] a reasonable price,” he added.
While SA has hosted a number of vaccine trials, this will be only the second trial of an oral vaccine.
First phase trials in Khayelitsha in the Western Cape of a candidate oral vaccine developed by ImmunityBio, a US company owned by SA-born Patrick Soon-Shiong, are complete, with the drug now in phase 2 trials.
Kidron said oral vaccines could be a game-changer for Covid-19 vaccine delivery and acceptance.
Oravax’s virus-like particle technology targets three SARS-CoV-2 virus surface proteins, including those less susceptible to mutation, the company said, potentially offering lasting immunity.
Kidron is hoping that Oravax phase 2 trials could be complete by mid-2022, after which the company will put the vaccine into production.
ImmunityBio’s oral vaccine is in phase 2 trials in which it is offered as a booster shot to health-care workers inoculated with the Johnson & Johnson vaccine under the Sisonke trial.
“The main point is are there any side effects,” said professor of medicine at the University of Cape Town Graeme Meintjies, who is leading ImmunityBio's trial in SA.
The trial showed the vaccine had been “very well tolerated” to date, he said.
South African Medical Association chair Dr Angelique Coetzee said many people were scared of needles, while an oral vaccine would also be easier to distribute and store.
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