COVID-19 Vaccine in Pill Form Scheduled to Enter First Clinical Trials

A coronavirus vaccine that exists in pill form could enter the early stages of clinical trials this year.

Oravax, the company working on the substance, announced in a press release that it expects to begin the first phase of human clinical trials in June.

The step is only the earliest phase of vaccine development. There is no guarantee of success, and even if it works, it could be a year or more before it is licensed for use (Moderna and Pfizer began their first human trials in March and May 2020, respectively).

Oral vaccines are an option being evaluated for “second generation” vaccines, which are designed to be more scalable, easier to administer, and easier to distribute.

Oravax is a joint venture of two companies: the Israeli-American company Oramed and the Indian company Premas Biotech. Its press release on Friday said the trials could begin in June.

An oral vaccine could “potentially [enable] have people vaccinate themselves at home, “said Nadav Kidron, CEO of Oramed, in the statement.

The vaccine could be shipped in a normal refrigerator and stored at room temperature, Kidron said, “making it logistically easier to get anywhere in the world,” the Jerusalem Post reported.

In an email sent to Insider, Professor Paul Hunter, a professor of medicine at the University of East Anglia, made a note of caution.

“We would need properly conducted studies to show [oral vaccines’] it’s worth it, “he said.

“But they can also be of value in people with severe needle phobia and can be easier and faster to administer.”

Oral vaccines could also offer other benefits over arm vaccines, Hunter told Insider.

“The thing about systemic vaccines (injections in the arms) is that they are generally very good at preventing serious disease,” but they are often not great at preventing infection.

The theory is that because the infection occurs first in the nose and throat, vaccines focused on those areas will help stop the infection before it becomes worse.

Data on the Oravax vaccine have not been published to date. “The results of the animal studies are encouraging,” Hunter told Insider. “But don’t assume that animal results always translate into human results.”

“We need human studies to be sure,” he said.

Other types of second-generation vaccines are being investigated, such as vaccines that are given by aerosol through the nose. Scientists are also studying whether the vaccines could be administered via patches.

Professor Sarah Gilbert, lead scientist on the Oxford / AstraZeneca vaccine development, said Oxford is evaluating the possibility of developing oral nasal spray tablets and vaccines, The Independent reported on February 25.

The University of Oxford declined to answer Insider’s questions about oral vaccines before publication.

Another company, ImmunityBio, is conducting phase 1 clinical trials of an oral version of the vaccine. However, this would be used more as a booster dose of the intramuscular vaccine, rather than the vaccine alone.

The only test of an oral COVID-19 vaccine conducted in humans so far has failed.

At the end of 2020, a company called Vaxart announced good results in animal trials, but in early human trials it got disappointing responses.

This article was originally published by Business Insider.

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