How one small bio-tech company started from the ground-up to develop a safer, easier oral COVID-19 Vaccine
ALLENTOWN, Pennsylvania – Injectable vaccines were administered as an initial solution to help protect people from COVID-19. But the race to bring an oral vaccine to the market continues. In that hurdle to the finish line, is Dr. Kyle Flanigan, Ph.D. and his small bio-tech company, US Specialty Formulations LLC (USSF). Since the onset of the pandemic, he, along with Co-Founder Dr. Garry Morefield, Ph.D. and their team have worked tirelessly to develop an easy to administer oral vaccine that will offer not only protection against COVID-19, but with less side effects with more accessible storage and transport options than existing injectable vaccines.
Dr. Flanigan is one of the very few Black owners of a biotech company. Since co-founding USSF with just $100,000, he has grown the site into a successful biotech and pharmaceutical facility. With a credentialed portfolio that includes a range of vaccine candidates and small molecule formulations along with botanical pharmaceutical grade extracts, Dr. Flanigan and Dr. Morefield have the expertise and equipment to bring their safe, accessible mucosal vaccine to market. Their formula is pivoted from an oral DTaP (Diphtheria), a childhood vaccine most of the population has received that was originally targeted for human clinical trials in early 2020.
How will USSF’s oral vaccine help the fight against COVID-19?
- Protect against mutations:Every COVID-19 infection provides an opportunity for the virus to mutate. Mutations will have a high chance to breakthrough previous rounds of vaccines so it’s imperative we be ready with new and improved vaccines. USSF’s oral vaccine is uniquely positioned to update thoroughly as new variants are identified.
- Reduce Risk of Transmission: Recent data shows that even immunized people ‘shed’ live virus after exposure into their surroundings. This mucosal type vaccine also acts to significantly reduce the quantity of virus in the mucosal cavities, thus reducing the ‘shedding’ effect and risk of transmission.
- Less side effects and longer-lasting protection: Conventional mRNA (Messenger RNA) injectable vaccines can be developed and made to work quickly, but they can be full of side effects. While there are high levels of protection early on, the levels drop off. Initially it was important to get a vaccine on the market; speed was important. This oral vaccine has shown that the acceptable levels of antibodies persist for a significant time and that after administration of the vaccine no meaningful side effects are observed. Adding a mucosal oral vaccine to the worlds vaccine mRNA arsenal allows populations to protect against COVID-19 for much longer due to ease of use and less discomfort to those taking the vaccine.
- Supplying the demand: USSF’s oral vaccine is a solution to global vaccine demand, which is higher than the current three U.S. suppliers can meet. The components used in producing the oral vaccine come from a separate supply chain extending from conventional pharma markets, which is why it is not constrained by persisting supply chain issues. The manufacturing requirements to produce this vaccine safely are also significantly different, thus allowing USSF to ramp to significant quantiles quickly as various organizations place orders. It doesn’t require cold chain storage (refrigeration) to be transported and distributed, making it far more accessible for remote locations in the USA as well as global populations.
- Convenience: USSF’s oral vaccine doesn’t require medical administering in order for it to be issued. To administer the vaccine, one merely has to open the bottle and drink.
USSF completed the first stage of clinical trials and is proceeding into the second and third stages, which often requires government funding. Succeeding in these trials will prove Dr.Flanigan and his team’s oral vaccine provides equivalent or better protection than that of injectable vaccines through use of two lines of defense, (IgA Mucosal and IgG blood stream delivery), plus, less side effects – another step closer to a safer population in the USA and abroad.
To learn more about USSF, please visit its website.
This press release contains forward-looking statements within the meaning of the amended Private Securities Litigation Reform Act of 1995. In some cases, forward-looking statements can be identified by terminology such as “will,” may,” “should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “continues” or the negative of these terms or other comparable terminology. Not all forward-looking statements contain these words. The forward-looking statements in this press release are neither promises nor guarantees. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors, many of which are beyond US Specialty Formulations LLC’s control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. Except as required by law, US Specialty Formulations LLC disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on US Specialty Formulations LLC’s current expectations and speak only as of the date of this press release.
EDITOR’S NOTE: For more information about USSF and to arrange to speak with a company spokesperson, please contact Nancy Trent or Pamela Wadler at 212-966- 0024 or pam@trentandcompany.com.
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