Lehigh Valley firms hope to bring COVID-19 vaccine to market by next year

Two Lehigh Valley companies that have partnered to develop and manufacture a pair of COVID-19 vaccines said they may have a vaccine to market by spring of next year.

Aseptic medical manufacturer US Specialty Formulations and vaccine developer VaxForm, are currently developing two potential vaccines for the COVID-19 virus, an oral vaccine that a person would drink and a traditional injectable vaccine.

With positive clinical trials — both vaccine formulations produced antibodies in 100% of mice in pre-clinical trials—Kyle Flannigan, co-founder and CEO of USSF, said they will be ramping up production of the two vaccines in November with the goal of being able to produce around 300,000 vaccines per month by April.

Flanigan said there are many companies both large and small working on COVID-19 vaccines, but he doesn’t worry about competition.

“There’s room for plenty of vaccines,” he said. “With around 7.5 billion people in the world no one manufacturer has the capability to produce that amount in a reasonable amount of time.”

He also said that their vaccines have a competitive advantage – especially the oral version – because of their ability to produce the needed vaccines and because of their ease of use.

He said in the industry many of the players are either vaccine developers or vaccine manufacturers.

Once a developer has a viable vaccine they need to find a manufacturer willing and capable of bringing it to market.

Since the partnership of USSF and VaxForm gives them both development and production capabilities they can skip that step.

Flanigan said one of the biggest concerns in the industry right now is the supply chain. With such an overwhelming demand for new vaccine products and so many companies producing them, there will likely be a shortage of things like syringes, vials and needles that will be needed for the vaccines.

Such a shortage would create a slowdown in the manufacturing and distribution process.

With the oral option, the raw materials are different and will be easier to source and they won’t experience the same delays as other companies.

He said once to market he expects there to be a strong demand for an oral vaccine because it is easier to use and poses less of a risk.

Rather than relying on doctors, nurses and pharmacists to give out the vaccines, a person can take it themselves.

“When you’re trying to get a vaccine out to a large population quickly, that is an advantage,” he said. “We will be able to supply vaccines to a lot more people.”

With the positive clinical trials, Flanigan said the companies will be asking the Food and Drug Administration for emergency use authorization, which should speed the approval process from two to three years to a few months.

That is why they are beginning manufacturing soon, so they’ll have product ready to ship out when that approval comes.

USSF, which recently moved into a larger manufacturing facility in Allentown, began working with VaxForm while they were both tenants of Ben Franklin Technology Partners’ TechVentures in Bethlehem where VaxForm is still located.

VaxForm had been working on other vaccine trials, including one for Strep, when the COVID-19 pandemic began.

Wayne Barz, entrepreneurial services manager of TechVentures, said the two businesses decided to switch their focus to address the COVID-19 crisis.

As the pandemic unfolded we were information sharing with all our clients, feeding them information and helping them find resources,” Barz said.

He noted that many of the incubator’s clients began working on projects to help fight the disease, and this has been one of the more significant successes.

He pointed out that OraSure in Bethlehem, which is also a Ben Franklin graduate, is currently hiring around 170 people to help produce a rapid in-home test for COVID-19 that it hopes to have out by the end of the year.

He said stories like this are what Ben Franklin and TechVentures are all about. By helping upstarts with new ideas get off the ground they have the running start to develop novel tests and treatments to meet society’s needs.

“For us to be on the forefront of new technologies and creating jobs you’ve got to plant the seeds,” he said.

Flanigan said he hopes that the public interest in the vaccine industry generated by the pandemic will help develop support for planting those seeds in vaccinations.

“Vaccine developers usually don’t find any glamor in the industry,” he said. “All of a sudden everyone is interested in vaccines. It’s refreshing.”

He hopes it inspires people to realize the importance of investing in vaccine development, having a strong supply chain and stockpiling.

“We’ve now found that when it happens it’s too late,” he said. “Some of the decisions, globally, could have been better in the past.”