Amid rising cases of Covid-19 driven by the infectious Delta variant, Israel is gearing up to host the first clinical trials of an oral Covid-19 vaccine, which could help boost access to vaccines around the world and serve as a more convenient booster in the future.
Oravax Medical, a company focused on developing ways to deliver drugs by mouth, is preparing to begin clinical trials of its oral Covid-19 vaccine in Israel after getting the green light from the review board at Ichilov Hospital, Tel Aviv’s main hospital.
The trials—pending recruitment and final approval from the country’s health ministry in coming weeks—will initially serve as a “proof of concept” for the capsule vaccine, said Nadav Kidron, CEO of Oravax’s parent company Oramed Pharmaceuticals, in an interview with The Jerusalem Post.
The first trial will involve 24 unvaccinated volunteers, each taking one or two pills, and will investigate the vaccine’s safety and indicators of immunity, moving on to larger Phase 3 trials to demonstrate efficacy if successful.
The vaccine should be “much more resistant to Covid-19 variants,” Kidron said, as it trains the immune system against three viral proteins instead of the single protein targeted by Pfizer and Moderna shots.
Oravax is also developing the capsule as a booster for people who have been vaccinated against Covid-19 before, though its plans to test this are unclear .
WHAT TO WATCH FOR
Should the trials prove a success, it could be a long while before the oral vaccine is approved in the U.S. Kidron said the company’s priority would be getting the vaccine to those who need it most first, only seeking FDA authorization at a later date. Oravax would seek expedited emergency approval in countries that have not been able to acquire enough vaccines, Kidron said, though it is unclear how this goal will work alongside developing the vaccine as a booster. Given the vast disparities in vaccine access around the world, World Health Organization head Dr. Tedros Adhanom Ghebreyesus slammed the “greed” of pharmaceutical companies lobbying for booster shots while many people have yet to be vaccinated at all.
An oral vaccine would help eliminate many of the barriers hindering widespread immunization around the world. They are easier to transport and store, are unlikely to require the ultracold temperatures Pfizer and Moderna’s shots need and, importantly, are not administered with needles. No-needle vaccination is a boon to those scared of needles, it cuts down on equipment and the risk of blood borne diseases and can be administered by people without medical training. Despite their benefits, few oral vaccines are in widespread use owing to the hostile nature of the digestive tract. Those that are—notably for polio, cholera, rotavirus and typhoid—often feature more robust pathogens capable of withstanding the conditions.
Israel to become first in world to test oral COVID-19 vaccine (Jerusalem Post)