Alcanza Clinical Research

Now that I work on “the other end of the needle” in the clinical research industry, I cherish the access and exposure I have to the latest advances in vaccine administration.

One development that really catches my eye and causes my arm muscles to relax — and that I expect clinical trial sites will be just as excited about — is Vaxart’s recent announcement of the FDA clearing its investigational new drug (IND) application for an oral vaccine for COVID-19 [1]. While being immersed in clinical trials of intramuscular COVID-19 vaccine candidates is an important privilege for any study site, the opportunity to be among the first to enroll participants for an oral vaccine trial positions research sites at the true vanguard of medical research.

With results from its animal challenge studies expected in October, and its Phase 1 study currently recruiting at the WCCT research institute in California [2], Vaxart’s oral vaccine is making strong progress to compete with the candidates from Pfizer and Moderna, which are nearing completion of their Phase 3 studies. Like those investigational vaccines, it consists of two doses spaced about four weeks apart, but also offers three unique advantages from end-user, logistics, and supply chain perspectives.

User Choice

No matter how effective a vaccine is, people must choose to receive one. For many, the route of administration is one factor that influences that decision. One survey of the prevalence of immunization non-compliance showed that needle fear was present in two-thirds of children and in one-quarter of adults, leading to vaccine non-adherence in one of 12 children and adults [3].

Access and Convenience

People who do opt for a vaccine must be able to easily go to a place where the vaccine is administered. This presents significant challenges in the distribution and administration of injectable vaccines across a large geography such as the U.S. It also means subjecting vaccine recipients, especially the elderly and those with multiple chronic conditions, to increased risk of coming in contact with a coronavirus-positive person when they have to leave their homes to get their shot. A tablet-based vaccine that can be acquired from a nearby pharmacy or delivered to the person’s home solves those concerns.

Temperature Stability

You are not likely to find a -70/-80° Celsius freezer of the kind used in vaccine cold chain distribution on every corner, and a large enough shipment of even refrigerated vaccines can overrun the storage capacities of many pharmacies and clinics. Indeed, addressing concerns related to likely requirements that a future COVID-19 vaccine be stored at extremely low temperatures, Dr. Nancy Messonnier, director of the CDC’s National Center for Immunization and Respiratory Diseases, recently said that the complexities of vaccine storage and handling “will have a major impact on our ability to efficiently deliver the vaccine.” Oral vaccine delivery platforms such as Vaxart’s, which is optimized for room temperature stability, remove this bottleneck from the vaccine administration pathway as their simpler storage requirements enable cheaper and faster distribution to even the most remote regions.

In a nutshell, Vaxart’s investigational COVID-19 oral vaccine resolves with one stroke – or one tablet, if you will – several common challenges faced in conventional vaccine administration, which are all the more critical in the context of a global pandemic. In addition, its underlying mechanism is highly efficient, targeting the small bowel to engage the gut’s immune system to generate both systemic and mucosal immune responses [2]. The company is also developing a liquid formulation of the vaccine for both children and adults who are unable to ingest tablets.

Taking this innovative, person-centered vaccine administration design forward, Vaxart’s ambitious R&D team has plans already in the pipeline to apply it to additional infectious diseases, including norovirus, influenza, RSV, and HPV.

We are excited about the road ahead and the opportunity for members of the population to participate in oral vaccine trials.

https://investors.vaxart.com/news-releases/news-release-details/vaxart-announces-fda-clearance-ind-application-oral-covid-19
https://vaxart.com/tablet-vaccines/
https://doi.org/10.1016/j.vaccine.2012.05.011