300,000 Doses Per Month Could Be Available By Mid-2021
Bethlehem, Pennsylvania, December 14, 2020 — The first of two oral Covid-19 vaccines is slated for mid-2021 distribution by US Specialty Formulations, a cGMP pharmaceutical manufacturing company. 300,000 doses will be available monthly for worldwide distribution by mid-2021 pending federal approval.
US Specialty Formulations (USSF) is securing funding to scale-up manufacturing and regulatory infrastructure with a $5.2 million incentive package from the state of Pennsylvania. The first generation of the oral virus is a drinkable liquid that can be stored at ambient temperatures and doesn’t require medical staff to administer. A second form of the vaccine in capsule form is also being developed for future release.
The company received a $291,000 Pennsylvania First grant from the state Department of Community and Economic Development. In addition, USSF has been encouraged by Pennsylvania Governor Tom Wolf to apply for a $2.4 million Pennsylvania Industrial Development Authority loan to help with the expansion.
“There is a global shortage of pharmaceutical manufacturing capacity, made worse by the Covid-19 pandemic, and limited capacity for clinical investigators to obtain appropriately documented clinical grade materials. USSF has been able to address both of these challenges,” said Governor Wolf. “My administration is eager to support the growth and job creation of businesses stepping up and offering solutions as we continue to battle this virus and keep our communities healthy and safe,” he added.
Clinical trials of the first version of the oral vaccine are scheduled to begin in February of 2021. USSF is ramping up production with a distribution goal of 300,000 doses per month. An FDA Emergency Use Approval for the release of a Covid-19 oral vaccine may be granted by by mid-2021.
“We are eager to develop an oral vaccine program that doesn’t require cold chain distribution or medical personnel for remote locations with limited resources. There will be many vaccines needed in the coming years to properly vaccinate the entire world against Covid-19. This funding will allow USSF to meet the growing demand for oral vaccines as well as support development of our other pharmaceutical products,” said Dr. Kyle Flanigan, CEO of USSF.
USSF partnered with VaxForm, a vaccine development company, to develop the oral vaccines. In 2017, Vaxform began working on an oral vaccination program for worldwide pandemics. When Covid-19 struck in 2020, the focus shifted to Covid-19. The partnership has developed two forms of an oral COVID-19 vaccine that have shown positive results in pre-clinical trials.
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 at Ben Franklin TechVentures in Bethlehem, Pennsylvania with a 14,000 sq. ft. full cGMP manufacturing facility also in Bethlehem.
USSF manufactures its own branded prescription products in addition to providing clinical materials for investigational new drug applications (INDs) and specialty formulations requested by health networks and healthcare providers worldwide. US Specialty Formulations is a Black-Owned Business.
About VaxForm LLC
VaxForm LLC is an advanced research company focused on vaccine 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.