PENNSYLVANIA — Two Pennsylvania companies are working together on groundbreaking, orally-administered coronavirus vaccines and hope to have their vaccines available by early to mid 2021. Clinical evaluations in humans are slated to begin in February 2021.
During a news conference Thursday, US Specialty Formulations (USSF) CEO Dr. Kyle Flanigan and VaxForm President Dr. Garry Morefield described the two versions of the vaccines their companies are teaming up to develop and produce at an Allentown plant.
The vaccines will be offered in a liquid form and a capsule form. Morefield said the oral vaccines are anticipated to be equally as effective as injectable vaccines.
Flanigan said the trials should be completed by May, and at that point the companies will apply for an emergency use authorization from the Food and Drug Administration. However, exact timelines for vaccine production, approval, and distribution are difficult to establish.
"That could happen quickly or take a little longer depending on how they view the data," he said.
About oral vaccines
Oral vaccines are not dependent on cold chain or the same material supply sets standard pharmaceuticals do, Flanigan said. Additionally, injectable vaccines need to have very high safety and sterility levels compared to what is needed for an oral system, Flanigan noted.
Morefield said due to less logistics of transporting oral vaccines, he hopes their vaccines will be able to reach more people, such as those living in remote rural areas.
The oral vaccine development began years before the coronavirus pandemic hit the globe, Morefield said
According to Gov. Tom Wolf's office, the oral platform has been successfully tested to show that it produces the antibodies required to generate immunity to diphtheria, tetanus and pertussis. Once the COVID-19 genomic structure was identified, scientists determined it could be used to produce the proper immune response in mammals.
Developing the oral vaccine in Pennsylvania
Morefield said by July this year, the companies were administering prototype vaccines to animals.
Once trials are completed and they await approval from the FDA, USSF and VaxForm said they will continue producing their vaccines so they have ample supply to release when the time comes.
"During that time however, USSF in January will begin scaling up production to have a stockpile available to release once the FDA gives its approval," Flanigan said.
The goal is to have 300,000 doses produced by March.
Vaccines will be distributed based on demand. Flanigan said they plan to prioritize conversations with state officials to ensure Pennsylvanians get access to the vaccine.
In places such as Philadelphia, officials say vaccination priority will be given to healthcare workers who routinely deal with coronavirus patients.
As for doses, Morefield said they are still working to determine if one or two will be needed to establish coronavirus immunity in humans.
Expanding the Allentown facility
To have these vaccines ready by early to mid 2021, USSF must expand its 4,100-square-foot Allentown facility, make renovations, acquire equipment, and hire new employees. And that is possible through a funding proposal from the Department of Community and Economic Development for a $291,000 Pennsylvania First grant.
The company also received more than $225,000 in funding from DCED through the COVID-19 Vaccines, Treatments and Therapies program to support the rapid advancement of vaccines, treatments and therapies by qualified biotechnology entities in response to the coronavirus pandemic.
"Completion of the USSF expansion will add a significant capability and capacity for our offerings and specifically to the oral vaccine platforms," Flanigan said. "As we continue the ramp for our Generation 1 and Generation 2 oral platforms, USSF will have the manufacturing space and human resources to deploy vaccines throughout PA and the world."
Flanigan said with the expansion, USSF will also be able to support other vaccine development companies, as well as other clinical material builds.
USSF also was encouraged to apply for a $2.4 million Pennsylvania Industrial Development Authority loan.
The company has committed to invest at least $5.2 million into the project and it will create 97 new jobs and retain 14 more positions.
"There will be a global demand for COVID-19 vaccines, and investments like this can help position our commonwealth for success in recovery from this pandemic," Wolf said. "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."
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