BFTP clients US Specialty Formulations (USSF), a cGMP pharmaceutical manufacturer, and VaxForm, a vaccine development company, announced positive results from pre-clinical safety and immunological studies for their oral-dosage COVID-19 vaccine, demonstrating the formulation is safe to proceed to human clinical trials.
The USSF/Vaxform CoV-OGEN1 vaccine presented serum antibodies specific to SARS-CoV-2 in mammals ingesting the vaccine within 2 days after consumption. This data gives USSF great confidence the oral vaccine allows recipients to present antibodies in the mucosal (mouth, nose and throat) systems as well as blood sera (conventional vaccine).
“These results, combined with other pre-clinical data, support our decision to continue to ramp-up production to provide this much needed oral vaccine to global markets,” said Kyle Flanigan, Ph.D., CEO of USSF. “Much of the world still needs safe and effective shelf-stable vaccines that are not dependent upon administration by trained medical staff.”
The initial 75 person human clinical trial for the oral vaccine will proceed in Summer 2021. More via USSF.