Hello and welcome to Living In The Lehigh Valley, where our focus is your health and wellness.

I'm your host, Brittany Sweeney.

While we've seen a decline in cases, Covid-19 remains a global threat, especially as populations in poorer countries go largely unvaccinated.

Our own Grover Silcox is here with some news about a Lehigh Valley biotech company that's hoping to change the situation.

Grover, always great to see you.

- Great to be here.

- So tell us about this company and their plan to get more people vaccinated.

- Yes.

US Specialty Formulations, based in Allentown, is now developing and testing a new oral vaccine for Covid to get more people immunized and vaccinated worldwide.

- So if more people are vaccinated, that means less cases.

Cases go down, hospitalizations go down, deaths decrease.

- That's what public health organizations such as the CDC and NIH claim.

- OK, so how do they plan to get this out internationally?

- Well, they are now in the testing phase of the vaccine, and it still remains a big challenge globally to get everyone immunized.

According to the CDC, 65% of Americans are considered fully vaccinated against Covid, and 77% have had one shot.

Now this is in stark comparison to poor countries, where only 11.3% of people are vaccinated.

And this is why USSF's oral vaccine holds so much promise, not just for the US, but people around the world.

Scientists Kyle Flanigan and Garry Morefield brought their companies, US Specialty Formulations and VaxForm, together in Allentown to develop a new oral vaccine for Covid, which promises to substantially increase the number of people vaccinated.

- It's actually pretty interesting.

One It's oral, so you drink it.

So rather than coming in a vial, it comes in a bottle.

You would strip this off, strip off the seal and drink it.

There's many medical deserts, even in the United States, where there's not professionals available to inject people.

So we're reducing that requirement.

- Taking an oral vaccine over getting a shot might be all some folks need to get a Covid vaccination.

- There's a needle phobia.

People are afraid of needles and I have quite a few patients where that is the only reason why they're not getting a vaccine.

Remove the needle focus, that is a big step forward.

- USSF's oral vaccine offers another big benefit.

It doesn't need to be refrigerated, which injectables, such as those from Moderna, Pfizer and Johnson and Johnson do require.

- That's a big difference, from a logistics and storage capability, you don't require a cold chain to ship it.

If you want to drone drop it to someone, you could drone drop it without an issue.

- You can think of countries around the globe that have no existing infrastructure in health care or logistics, and being able to ship it to the Sahara Desert or to India and not worrying about the vaccine still being viable.

- Before a vaccine is approved, it must go through three phases or clinical trials on humans.

- We've completed the dosing for phase one.

We've analyzed the data from that.

We saw that there were no adverse events from taking the vaccine.

- The team is now preparing for the next phase.

- And once you've shown that there's no adverse events, which hasn't been with our oral vaccine, you can then move on to phase two, which usually is hundreds to a thousand people that will be administered with the vaccine.

And then you can start collecting efficacy data to actually show that the vaccine is efficacious, not just safe, actually works.

- Here we have a spectrophotometer.

We use this to monitor the potency of our vaccines.

Over here we have a HPLC instrument.

We use this to monitor some of our small molecule products.

Over this way, we have a particle size analyzer and this we use for our injectable products to make sure there are any undesirable particles and for our vaccine products to make sure that we produce our oral platform to the correct size for administration.

- After completing phase two, the vaccine enters the third phase, involving the most recipients, ranging from 30,000 to 40,000 people.

- It's a study that's well controlled.

Compare the vaccine against what's called placebo or just kind of a dummy shot and show that it's effective, not because the person believes the fact that it's truly effective.

- About midway through the phase one, we started getting positive data back.

We saw significant antibody production increase over the participant's baseline, and that gave us the confidence to allocate the funds and the resources to start working on setting up the phase two.

Phase twos and phase threes are very significant endeavors.

You really want to be confident that you're going to be successful going down those pathways.

- After the vaccine successfully completes all the clinical trials, it goes to the FDA for approval.

Once approved, USSF plans to distribute the vaccine globally from its lab and manufacturing center in the Lehigh Valley.

- Until we get a majority of people globally vaccinated against Covid, we are always going to have the continued threat of new variants popping up and with how interconnected the world is now of travel, those will always make it back around the world.

And so we really need to not just vaccinate United States, but really globally to really get this under control.

- In order to address health in this country, we must address worldwide health.

Whatever happens in the developing world will come to us, whether we like it or not.

- The USSF oral vaccine also provides another advantage in terms of preventing infection.

- When we get infected with the SARS-CoV-2 virus, it gets into the nose, the mouth, it colonizes the throat.

The best way to fight that is to actually develop an immune response in that same area.

So when you administer a vaccine orally, if you are exposed to the virus, it will be blocked as early as possible and really will improve the immunity against it and really reduce transmission as well.

- We're looking at a two-dose regime as we continue through the clinicals, we are looking to see if there's some modifications that we can do to that.

- Another advantage of this platform is the ease in which to make combination variant vaccines, so you can imagine mixing vaccine for Alpha and Delta.

- So how much longer will it take USSF to complete the trials on their oral vaccine?

- I would say it has at least a year and a half more before it could be ready to sell.

Realistically, probably about two years.

- For many frontline physicians and health care providers, the next wave of vaccines hopefully will help increase the number of people vaccinated and thus immunized to get control of Covid and its variants once and for all.

- I think the next generation will focus on acceptability, tolerance, less side effects.

That's where the emphasis can be.

A vaccine that's more acceptable to the public, easier to take, easier to transport to distant sites and yet not lose the efficacy that the first generation has.

- The science behind USSF's oral vaccine is fascinating.

It uses a protein created from bacteria to mirror Covid's protein spikes, which then triggers a vaccinated person's immune system to recognize and destroy the virus, particularly where it enters the body in the mouth and throat.

- So, Grover, this seems like a pretty big undertaking.

How much vaccine do they anticipate to release and get out into the world?

- Well, according to USSF's Gary Morefield, they project that they'll be able to make and distribute between one million and 1.5 million doses per month.

- Wow, that seems like a game-changer if this goes through.

- That's the way they look at it.

- We'll have to wait and see.

Grover Silcox, as always, thank you so much for joining us.

- My pleasure.

- And that'll do it for this edition of Living In The Lehigh Valley.

I'm Brittany Sweeney, hoping you stay happy and healthy.