Fact sheet

March 28, 2023
What’s an oral vaccine?

Oral vaccines are designed to generate immune responses, including mucosal and systemic responses. Administration is far easier, as this type of vaccine just has to be swallowed through the mouth.

How are oral vaccines different, and in some cases more advantageous, than injectables?

Like injectable vaccines, Oral vaccines provide systemic protection which includes antibodies in the blood serum. Oral vaccines also provide an additional level of protection in that they also stimulate production of high levels of mucosal antibodies. Common mucosal locations are nose, throat and intestinal tract. Having a high level of antibodies in the nose and throat are thought to reduce the spread of the vaccine by reducing levels of nasal shedding. Additionally, the virus is being attacked by antibodies prior to entering the blood stream, while injectable vaccines require a person to become infected before the serum-based antibodies can attack the virus.

Oral vaccines are also easier to produce and distribute than injectable vaccines. USSF platform also offers enhanced thermal stability (up to 143oF) and does not require a healthcare professional to deliver the vaccine.

USSF’s oral vaccine is a solution to global vaccine demand, which is higher than the current U.S. suppliers of injectables can meet. Having an oral vaccine on the market will ensure more people can get vaccinated worldwide.

Does USSF’s oral vaccine need to be refrigerated in cold chain storage to work, like injectables or some other oral medications?

No, USSF’s oral vaccine does not require cold chain storage, which is why it is so easy to transport, distribute and store to places, even hard to reach ones, around the globe. Studies have shown it is stable beyond 60˚C or 143˚F

How would someone take USSF’s oral vaccine?

The oral vaccine does not require medical administering to use, so any adult can administer to themselves or someone they care for.

Can taking the USSF mucosal vaccine make me sick?

Historically, oral vaccines have very mild side effects and users do not experience the wide range of unpleasant side-effects observed from the mRNA injectable. They may also offer longer protection. Clinical trial data of the USSF vaccine indicated a much more pleasant user experience post vaccination.

When will USSF’s COVID-19 vaccine be available?

USSF completed most of the Phase One clinical trials, the initial 75-person human clinical trial demonstrated safety in humans as well as preliminary efficacy of this oral vaccine as a standalone.

Before going to market, oral vaccines require three phases of clinical trials, which will demonstrate USSF vaccine’s use as a booster to the other vaccines already approved and on the market. USSF is seeking partnerships to initiate Phase II/III human clinical trials globally.

To learn more about US Specialty Formulations LLC (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. Exceptas 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 ofthis 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

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