Two Lehigh Valley companies announced recently that, with expansion funding from the state, they are developing oral and injectable COVID-19 vaccines that may see approval and distribution early next year.

US Specialty Formulations and VaxForm, both Ben Franklin Technology Partners business incubator graduates, have partnered on oral vaccine development for years and retasked their efforts to meet the current health crisis.

VaxForm President Dr. Garry Morefield said while their work follows tried and true injectable methods other companies are now testing to meet worldwide need, their parallel oral vaccine research will aim for different markets. The main challenge to effectiveness, he said, is to get the vaccine into the bloodstream before being digested.

The target for initial human trials is February 2021 and it must then be approved by the Federal Drug Administration. But one advantage of using liquid and capsule form is that it won’t require the cold chain infrastructure of the common injectable candidates – these vaccines need to be transported and stored in extreme freezing temperatures, which limits which hospitals and facilities will be able to carry them.

“This program actually started before COVID … with the goal in the case of pandemics having a technology that wouldn’t be as reliant on cold chains and medical professionals for administration that could reach not just large cities but rural areas and third-world nations,” Morefield said.

Their goal is a vaccine that is at least 95 percent effective and produce 300,000 doses per month by March 2021, USSF CEO Dr. Kyle Flanigan said, with priority being Pennsylvania markets. “I believe there will be many vaccines needing to be administered globally over the course of several years before the bulk of the population is vaccinated properly. So this is a clear need.”

Flanigan said both companies anticipate the success of this technology and are preparing to expand their facilities and staff. His company, which produces clinical materials, currently employs 14 in Allentown; VaxForm, a medical research group, employs five at Ben Franklin TechVentures in Bethlehem.

Department of Community and Economic Development Secretary Dennis Davin said, “DCED supports early-stage technology companies and established manufacturers as they help us innovate to recovery from COVID-19.

“USSF and Vaxform are outstanding examples of young companies that have responded swiftly and effectively to this pandemic.”