The novel coronavirus, SARS-CoV-2, has led to an unprecedented international health crisis and is continuing its spread across the world, with more than 218 million confirmed cases of COVID-19, including more than 4.5 million deaths, reported to the WHO as of 3 September 2021. (1)
More than one year into the pandemic, the vaccines for the COVID-19 have been developed in record time as a potentially effective prophylactic strategy. However, despite the amazing progress, there is a strong demand for more options that are more accessible, easier to store, and more effective vaccines. In developing countries, the critical issue is a lack of access to vaccines, or no infrastructure and personnel to deliver the injections en masse. In developed countries, the key issue is the lack of willingness to get vaccinated, an aversion to needles, and a lack of trust for the vaccines and injections in general. To date, with 40.4 % of the world population fully vaccinated, more options are sorely needed. (2)
The good news is that an oral virus-like particle (VLP) COVID-19 vaccine by Oravax , an Israeli pharmaceutical Oramed is being tested in preclinical studies against COVID-19 variants including the Delta variant. Study data demonstrated that the oral COVID-19 vaccine promoted both systemic immunity through Immunoglobulin G (IgG), the most common antibody in blood and bodily fluids that protects against viral infections, and Immunoglobulin A (IgA), which protects the respiratory and gastrointestinal tracts against infection. (3) If you want to get more information on COVID-19 and pharma, Pharmasouce would be your best choice.
Based on existing technologies, the scientists have designed synthetic particles that mimic three key structures of the coronavirus pathogen: the spike protein, the envelope protein, and the membrane protein, that includes more elements than the currently approved vaccines, which should enable the pill to better protect against current and future variants of the COVID-19 virus. As we know that the current vaccines in circulation focus on the spike protein, so adding more of these can help boost the overall effectiveness of vaccines.
How will the oral vaccine work? A challenge is the difficulty ensuring that the vaccine survives the acidic environment, Oramed believes they can create a capsule that is strong enough to withstand the stomach acid as necessary since the company has previously had experience working with protective coating for insulin with Avram Hershko, a Nobel-winning biochemist, showing that it is possible to create capsules.(4) Oramed hopes to use the same technology for the oral VLP COVID-19 vaccine development.
Oravax claims oral COVID-19 vaccine is safe, efficacious, and well-tolerated at normal to high doses, and generates high titers of neutralizing antibodies, which can potentially be more effective against current and future variants of the COVID-19 virus. The VLP vaccine can also be used both as a standalone vaccine and a booster for people who have been previously vaccinated for COVID-19.(3)
The oral VLP COVID-19 vaccine is poised to begin clinical trials during the second quarter of 2021, first in Israel, then in additional clinical sites in multiple countries, including the United States, Europe, and Mexico. The clinical study protocol has been approved by the Institutional Review Board (IRB) at Ichilov Hospital in Tel Aviv Sourasky Medical Center, Israel's leading multidisciplinary healthcare institution, and is now pending approval from the Israeli Ministry of Health. GMP manufacturing for the oral vaccine is underway. As with other vaccines, the trials will move in phases to show success, safety, and efficacy. If the trials prove successful, Oravax hopes to seek emergency approval in countries that are facing vaccine deficits, in particular, developing countries. (5)
Oral vaccines come with a variety of advantages. They can be taken at home and reduce the need for medical professionals who have to administer them, an especially big concern in developing countries. In developed countries, oral vaccines offer an advantage for people who fear needles. Oral vaccines cut out the need for freezing equipment for transportation and storage and eliminates bio-hazardous waste problem. Take together, the oral vaccines may offer relative advanta...
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