Vaxart Inc. – Unlocking the Full Potential of Oral Vaccines

Vaxart Inc. was founded by Dr. Sean Tucker 13 years ago with a singular mission: to provide the world with a better way to get vaccinated — by a pill instead of via injection — and, therefore, transform public health.

He knew injections could be inconvenient and terrifying. Oral vaccines, he concluded, would make it more likely that more people would get vaccinated. That, in turn, would lead to a healthier world. Vaxart’s mantra that it is developing the pill that moves the needle, captures the revolutionary potential of its oral tablets to improve global public health.

Vaxart is now a clinical-stage biotechnology company developing oral recombinant vaccines using its VAAST delivery platform. Vaxart believes this unique platform allows it to manufacture oral versions of currently marketed vaccines and to develop recombinant vaccines for novel purposes. Vaxart is developing tablet vaccines against coronavirus, norovirus, seasonal influenza and respiratory syncytial virus (RSV), as well as a therapeutic vaccination for human papillomavirus (HPV), Vaxart’s first immuno-oncology indication.

Vaxart has several different vaccine programs in its pipeline, but for the past two years, it has devoted significant efforts to develop an oral tablet COVID-19 vaccine.

The COVID-19 epidemic validated Dr. Tucker’s foresight. While the development of injectable vaccinations in less than a year was a near-miracle, the global struggle against COVID-19 highlighted the limitations of injectable vaccine programs and the need for alternatives that are easier to distribute and administer and face less resistance from the public.

Preclinical animal study results suggested that its vaccine candidates could inhibit the transmission of the COVID-19 virus and be cross-reactive against the virus’ major variants. Clinical results in humans from Vaxart’s Phase I trials showed that its vaccine candidate would trigger protection in the mucosal parts of the body — the nose, mouth and eyes — rather than the serum.

This is a critical difference for Vaxart’s vaccine approach. Viruses infect through the mucosa. Rather than prompt a response in the bloodstream, as the traditional injectable vaccines do, Vaxart’s Phase I trials showed that its vaccine candidate could serve as a first line of defense against infection in the mucosa, where viruses invade.

Vaxart is now in Phase II clinical trials in the United States, the first time an oral pill vaccine for COVID-19 has progressed this far. Vaxart expects to conduct clinical trials internationally later this year.

While Vaxart emphasized developing a COVID-19 vaccine candidate in 2020 and 2021, it has other important vaccine candidates in its pipeline, including vaccines for norovirus, influenza, RSV and HPV.

Norovirus is the leading cause of acute viral gastroenteritis in the U.S., causing 19 to 21 million cases of acute gastroenteritis a year, infecting 15% of young children and 7.5% of older adults and leading to as many as 71,000 hospitalizations and 570 to 800 deaths. Vaxart has completed two Phase I clinical trials and has launched a Phase II norovirus trial.

Vaxart has already undertaken Phase II influenza vaccine trials against an illness that is a major cause of morbidity and mortality worldwide. Existing vaccines have suboptimal efficacy, and only 47% of eligible U.S. citizens were vaccinated in 2016-2017.

RSV infection is responsible for 177,000 U.S. hospital admissions annually costing more than $1 billion. There is no vaccine to protect against RSV, and Vaxart aims to develop a state-of-the-art oral RSV vaccine.

On HPV, Vaxart is developing its first therapeutic vaccine targeting HPV-16 and HPV-18.

Vaxart is a growing company doing cutting-edge science in pursuit of a profound impact on global health. A room temperature oral pill that is easily distributed can be a game-changer. Oral tablet vaccines would be the pills that move the needle on better lives worldwide.


Quotes (Persons to be quoted, CEO Andrei Floroiu and Founder and Chief Scientific Officer Dr. Sean Tucker).


Dr. Sean Tucker:

“I founded this company in the hopes of having a transformative impact on global public health. I’m proud of the work we have done developing COVID-19, norovirus and other oral tablet vaccines. The resulting data confirms for me that our science can make the world a healthier place, one pill at a time.”


CEO: Andrei Floroiu

“Vaxart made significant progress in 2021 that has us well-positioned to achieve several important milestones in 2022. Our potentially transformative oral vaccine programs continued to advance in clinical development. We have improved our manufacturing capacity, added to our research and manufacturing ranks, and hired top leadership talent. We anticipate building on 2021’s momentum, and we are excited about the continued progress we expect to make in 2022.”