World’s first oral vaccine to fight the pandemic in the works

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Researchers may have a real shot at creating an oral COVID-19 vaccine, one that can protect against variants.  A pill can be self-administered anywhere, anytime providing access to those in remote locations and the most vulnerable who cannot safely leave their homes would now have equal access to protection. If annual or semi-annual COVID-19 vaccines become necessary, as many experts suspect, the benefit of oral exponentially increase.

The world’s leading oral drug delivery company Oramed partnered with India’s Premas Biotech, a developer of recombinant proteins for vaccine development, to deliver an oral COVID-19 vaccine that produces antibodies after a single dose. It could be the world’s first oral vaccine to fight the pandemic. 

A pilot study in pigs showed efficacy after a single oral administration, promoting both systemic and anti-viral properties.

Accelerating the development process to bring the oral vaccine to market, Oramed has formed a new company Oravax Medical based on its proprietary POD™ oral delivery technology and Premas Biotech’s novel vaccine technology. Oravax will commence a clinical study in second quarter of 2021 and expects trial data within three months.

Offering triple protection against COVID-19 variants, Oravax’s COVID-19 vaccine is a triple antigen virus-like particle (VLP) vaccine that targets three structural proteins of the virus including Spike, Membrane, and Envelope. The top three injectable vaccines used today only target the Spike protein.  Oravax’s triple antigen VLP has demonstrated in animal and GLP-Tox studies that it is safe and effective. Of the three surface antigens, Spike is known for high number of mutations, whereas Membrane and Envelope proteins have been found to be more stable. The VLP is manufactured using Premas’ proprietary D-Crypt™ platform which is highly scalable for largescale manufacturing.

Self-administration of oral vaccines can significantly accelerate widespread distribution by minimizing the need for trained healthcare workers. Lives can be saved and costs can be cut by up to 25% according to an article in Advanced Drug Delivery Reviews which reports that training and mobilization of health care personnel represents one-quarter of the costs of introducing a new vaccine.

Global healthcare organizations are racing to overcome enormous logistical and financial challenges to rapidly vaccinate the world’s population against COVID-19. 118 million people have become infected and 2.6 million have died, with 67 million recovered, some after lengthy hospital stays. The need for an oral vaccine has never been clearer.

Impeding vaccination efforts is the huge logistical effort required for the injectable vaccines currently approved.  Challenges include supply shortages and high barriers to distribution because people need to be dosed by skilled healthcare workers in designated facilities.

If Oravax’s oral COVID-19 vaccine proves successful in advanced stage trials, it may be the first of many based on Oramed’s platform technology which can also be used for other vaccines including the seasonal flu.

Oramed is publicly traded on the NASDAQ under the ticker ORMD, and Premas is privately held.