USSF Oral Covid-19 Vaccine Cleared for Phase One Clinical Trials
Allentown, PA, MAY 25, 2021 — 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. These trials will demonstrate safety in Humans as well as preliminary efficacy of this oral vaccine as a standalone. Future trials will demonstrate use as a booster to the other vaccines already approved and on the market. USSF is seeking partnerships to initiate Phase II/III human clinical trials globally.
“Developing an oral vaccine is extremely challenging, and these data demonstrate our success,” commented Garry Morefield, Ph.D., COO of USSF and president of VaxForm. “Transferring our technology and refining the manufacturing process over the past year resulted in a scalable and robust manufacturing process yielding the highest quality products. The USSF and VaxForm teams will continue their collaborative efforts to add more production capacity as appropriate to meet global demands.”
About VaxForm, LLC
VaxForm LLC is an advanced research company focused on vaccine research and development. As part of its R&D efforts, VaxForm has developed formulation platforms for oral administration (liquid suspensions and capsules) as well as the traditional injectable immunization. Additionally, VaxForm provides contract development and consulting services to many of the world’s leading vaccine manufacturers.
About US Specialty Formulations, LLC
US Specialty Formulations LLC (USSF) is a Current Good Manufacturing Practice (cGMP) manufacturer of sterile injectable, topical, and specialty pharmaceuticals. The company is headquartered in Allentown, Pennsylvania with a 41,000 sq. ft. fully qualified cGMP manufacturing facility. USSF manufactures its own branded prescription products in addition to providing clinical materials for investigational new drug applications (INDs), specialty formulations, adjuvants and fermentation and purification services requested by a variety of biotech companies. US Specialty Formulations is a minority-controlled business.
Dr. Kyle Flanigan
US Specialty Formulations LLC
Main Office: 610-585-9536