Allentown pharma firm hopes to soon have oral vaccine to market

Kyle Flanigan of U.S. Specialty Formulations, right, poses with Garry Morefield of VaxForm at the Ben Franklin Tech Ventures in Bethlehem. PHOTO/FILE –

With Phase 1 testing now complete and showing positive results, U.S. Specialty Formulations of Allentown is moving forward with the oral COVID-19 vaccine that it is producing. 

The company is working with VaxForm of Bethlehem, to bring a vaccine to market that company leaders believe will be easier to tolerate and more effective than the current injection vaccines on the market. 

Kyle Flanigan, founder, CEO and president of U.S. Specialty Formulations said his company is now looking to attract venture capitalists to help fund Phase 2 and Phase 3 trials, which he will be conducting while attempting to get Emergency Use Authorization from the U.S. government, as well as other governments around the globe. 

“It is in our best interest to make sure other countries have vaccines too, so they don’t bring that disease here,” he said. 

He is looking for between $5 million and $15 million in funding depending on what the regulatory bodies want to see in the next level of testing. 

He said, so far, much of the federal funding for vaccine research has gone to the “Big Five” pharmaceutical companies, like Moderna and Johnson & Johnson. 

That’s leaving smaller developers looking for private funding. 

But what they found in Phase 1, he said, is promising enough that he believes investors will be easy to attract. 

“We’ve already generated the data that a venture capitalist would want to look at,” he said. 

Phase 1 testing, which was conducted in New Zealand because of its relatively isolated population and high vaccine rate, showed the vaccine U.S. Specialty Formulations is developing could be a highly desirable addition to the vaccine options currently available. 

“It’s been really exciting,” Flanigan said. “The vaccine we adapted for COVID-19 seems to perform better than some of the platforms that are already on the market.” 

He said the testing showed his oral vaccine was about 43% more effective for subjects who took it compared to those who took other vaccines on the market. 

Also, the oral vaccine has shown that it fights all three major variants of COVID-19, and Flanigan hopes to show that it can fight all variants of the disease.  

“That’s the Holy Grail in this,” he said. 

The oral vaccine is also showing that it is easier to tolerate than the injectable vaccines currently available on the market. 

With no injection, Flanigan said it may attract those that were avoiding the vaccine to avoid the needle stick. 

He also said it’s showing less general side effects, like muscle soreness. 

One of the biggest benefits, he said, is that the oral vaccine is proving to be extremely shelf stable and can tolerate high heat, which would make it easier to transport, store and deliver to hotter regions around the globe. 

And because it can be taken orally, no health care professional is needed to provide the vaccine, which makes distribution to more remote regions much easier. 

Flanigan said he hopes to receive Emergency Use Authorization to begin distribution of the vaccine while the second and third phase trials are underway. He said the fact that it has been proven to be safe will help his company’s case. 

If things go well, he hopes to have the vaccine to market this fall. 


Allentown biopharmaceutical firm calls oral COVID-19 vaccine a game changer

Kyle Flanigan and Garry Morefield of U.S. Specialty Formulations. PHOTO/COURTESY OF U.S. SPECIALTY FORMULATIONS –

An Allentown biopharmaceutical firm is making progress on an oral vaccine for the COVID-19 virus that could be a game changer in the fight against the disease. 

Kyle Flanigan and Garry Morefield of U.S. Specialty formulations said the ease and safety of the vaccine is what’s needed in the next stage in the fight against COVID-19 in the U.S. and around the globe. 

“It’s of strategic importance and an advantage to the U.S.,” said Morefield. 

The week of March 13 is Patient Safety Week, and the safety of vaccine is one of its key advantages, said Flannigan. 

“What we’ve done is created and shown that an oral platform works. It’s stable at normal and even higher temperatures,” he said. “It doesn’t require a healthcare professional to administer it and it doesn’t require any special kind of shipping,” he said. 

It’s the partners’ hope that the ease of the oral vaccine will help get the vaccine to more impoverished countries with less health care infrastructure or even more rural regions of the country where people don’t have easy access to health care. 

“There’s some places even in the U.S. where people may have to drive 70, even 80 miles just to get to a pharmacy let alone a health care provider,” Flanigan said. “With this they don’t need to visit a health care provider it can be mailed to them. 

There is also an advantage to the safety of the patient receiving the vaccine. 

“It has a very good patient experience. You’re not stabbing someone with a needle,” Flanigan said. 

The hope is that the lack of a needle stick might make the oral vaccine more attractive to people who have been holdouts on getting the vaccine. 

Morefield said that in early clinical trials patients reported very few side effects. With no injection there was no arm pain, and most of those who received the vaccine reported milder reactions and didn’t need the two or three days of recovery that some people have needed with the vaccines that are currently in use. 

The partners don’t have an estimate, yet, on when the vaccine could be available to the public. They are currently getting ready to start the second phase of clinical trials, which will involve a greater number of people and will provide a broader picture of the efficacy and impact of the vaccine. 

It would then move onto a phase three trial, which could take up to 12 months. 

However, because of the global health crisis caused by the COVID-19 pandemic, Morefield said the Federal Drug Administration in the U.S. and the health governing bodies of other countries have been granting Emergency Use Authorization (EUA) for many of the vaccines that have been developed and most have been given EUAs while still in phase three clinical trials. 

Manufacturing should also be easier than for a traditional injectable vaccine. 

“Because it is oral it doesn’t require the same type of sterile manufacturing facility that an injectable does,” said Flanigan. 

That could have production up and running much faster than traditional vaccines would. 

Morefield said getting the vaccine to market will be a major step towards stopping the spread of COVID-19 around the globe. 

“It can have a huge impact in other parts of the world,” he said. “Until the entire global community is protected, there’s going to be variants that will make it back to the United States.” 

OSHA’s vaccination requirements for large businesses a week away 

The Department of Labor’s Occupational Safety and Health Administration (OSHA) is expected to release its new rule requiring businesses with over 100 employees to require their workers to be fully vaccinated or mandate weekly COVID-19 tests next week.

The Biden Administration announced the new requirements last week but details on what the mandate will look like when enacted have been light. In its announcement, the administration said that OSHA had two weeks to issue guidance on the mandate through an Emergency Temporary Standard (ETS).

The ETS will require that all businesses with over 100 employees must mandate vaccinations for their staff or enforce weekly testing company wide. Companies that fail to comply with the mandate will face fines per employee.

In anticipation for OSHA’s rulemaking, companies should begin gathering information from their workforce about their vaccination status, said Morgan Hays, an associate attorney specialized in health care and labor and labor and employment litigation at Saxton & Stump.

Hays spoke during a Lancaster Chamber hosted “Ask an Attorney” webinar on Wednesday. During the webinar, Hays outlined what is currently known about the new OSHA rules and how that could change next week.

“We have another six or seven days before we can expect anything from OSHA at all and it’s unclear what we will get,” she said. “At this point the recommendation is to start gathering information from your workforce about vaccine status, about how many folks you have that are adamantly opposed to the vaccine and you want to be careful about how you acquire this information.”

Hays went on to say that companies should be careful not to single out a particular group of people when asking for this information.

Some of the details that are still unknown regarding the new rules include: if OSHA will require record keeping for tested employees, how it expects companies to pay for testing, if remote workers will be part of the same mandates and the amount of money businesses will be fined per non-compliant employee.

The new ETS will act as a supplement to OSHA’s previous ETS that it adopted in June. The ETS required facilities to conduct a hazard assessment, have a written plan to mitigate virus spread and provide employees with N95 respirators or other personal protective equipment.

“OSHA gives authority to set these standards,” said Hays. “They can take effect immediately to up to six months. At that point if the circumstances continue after that sixth month, a new ETS can be issued.”

Health care providers of all sizes will also be impacted by Biden’s plan through a vaccination requirement by the Centers of Medicare and Medicaid Services that impacts providers that receive either Medicare or Medicaid reimbursements.

Over 50% of Pennsylvanians received first dose of COVID-19 vaccine

Over 50% of the Pennsylvania population received their first dose of the COVID-19 vaccine, according to the Centers for Disease Control and Prevention.

As of Friday morning, May 7, Pennsylvania has administered first doses of the COVID vaccine to 51.6% of its entire population, the department of health reports.  43.4% of Pennsylvanians age 18 and older are fully vaccinated.

Pennsylvania currently ranks 5th among all 50 states for total doses administered.

As of May 7, there were 2,986 additional positive cases of COVID-19, bringing the statewide total to 1,169,678, the department of health reports. There are 2,047 individuals hospitalized with COVID-19. Of that number, 448 patients are in the intensive care unit with COVID-19. Most of the patients hospitalized are ages 65 or older, and most of the deaths have occurred in patients 65 or older.

The trend in the 14-day moving average number of hospitalized patients per day is starting to come down, after peaking at 2,661 patients which is slightly below what it was at the height of the spring 2020 peak of 2,751 patients on May 3, 2020.

More data is available here.

LVHN to administer 5,000 doses of COVID vaccine at Dorney Park mass vaccination event

Lehigh Valley Health Network will hold a mass vaccination drive-through on Wednesday, May 12 at Allentown’s Dorney Park & Wildwater Kingdom. The theme park will host the event from 8 a.m. to 4 p.m., the health network reports.

The Allentown-based LVHN expects to administer 5,000 first doses of the Moderna vaccine for free to everyone 18 and older at the event.

Appointments are required. Those wishing to attend can make an appointment by visiting mylvhn.com, the health network’s patient portal, or by calling 833-584-6283 (833-LVHN-CVD).

LVHN will hold a drive-thru COVID-19 vaccination event April 29 at Northampton Community College

Lehigh Valley Health Network will hold its next COVID-19 mass vaccination drive-through event in Northampton County at Northampton Community College in Bethlehem Township on Thursday, April 29.

On this date, the Allentown-based LVHN expects to administer 3,500 first doses of the Moderna vaccine for free. Those 18 and older who schedule an appointment for the drive-through clinic are eligible to receive the vaccine. The drive-through clinic will be held from 8 a.m. to 4 p.m. Those without an appointment will not be eligible for the vaccine.

Appointments for the drive-through clinic can be scheduled by visiting the LVHN website or calling the COVID-vaccine hotline at 1-833-LVHN-CVD.