VaxiPatch™ Prototype "elegantly simple"
Verndari is developing VaxiPatch™ a new, unique and proprietary delivery technology that eliminates needle phobia, the cold chain and sharps waste. VaxiPatch allows Verndari to walk-the walk with relevance in global health care needs while delivering proprietary differentiated products with desirable features in the commercial markets of the developed world. These new vaccines will serve large and profitable markets.
VaxiPatch is as a complete vaccination kit. The kit contains a wipe to clean the vaccination site, the VaxiPatch device and a spot bandage to cover the vaccination site after vaccination if desired. This complete vaccination kit is contained in a foil pouch roughly 5” X 7” by 0.25” deep. The kit is room temperature stable for the period on the vaccine label. Data today indicates our quadrivalent rHA influenza vaccine will be stable at room temperature for 4 months whereas the live attenuated measles vaccine will be stable at room temperature for 3 months. These features allow the VaxiPatch kits to be shipped globally by common carrier or in the mail. In addition, VaxiPatch administration is simple and easy. The clear protective tab is peeled off the white paper removing the dome and exposing the microneedles. The microneedles are placed on the cleaned skin and the logo pressed with light force until an audible click is heard. Upon hearing the click the force is removed and the VaxiPatch is worn as a medical adhesive for 5 minutes. After administration the VaxiPatch peeled off the skin, placed in the pouch, sealed and discarded as medical waste.
VaxiPatch was designed to facilitate high-volume automated manufacturing. This proprietary manufacturing system is being designed to produce 250 VaxiPatch kits/minute in a single production lines.
In the manufacture of VaxiPatch a precise dose of vaccine is loaded on the microneedles in a liquid dispensing step. Microfluidic dispensing of 10 – 20 nL per microneedle is used.
On VaxiPatch the liquid is not dried on the outside of the needle, rather the liquid is dried in a well inside the microneedle. This keeps the microneedles sharp so a light force of under 10 Newtons is used in delivery. This compares to microneedle technologies that require 25 Newtons, 45 Newtons or even more for delivery. These higher forces cause significant and unacceptable tissue damage. The lack of tissue damage with VaxiPatch can be seen in figure 2 below.
Our microneedle array raw material is a very thin sheet of medical grade stainless steel (SS). We use photochemical etching to create arrays in two dimensions (x, y axis). Each individual tip is precisely formed and remains connected to the SS sheet by a pre-formed hinge. The microneedles are formed with a sharp point and chiseled edges, and each has a pre-formed well designed to subsequently receive the appropriate vaccine.
A state-of-the-art microfluidic dispensing instrument is used to deliver a precise amount of vaccine into each pre-formed well. This microfluidic dispensing equipment is capable of simultaneously and accurately applying the fluid into hundreds of wells outlined on the stainless-steel sheet. The small amount of vaccine dries immediately and adheres to the well of the microneedles.
The adjacent figure shows 1.2 cm circular microarray of 37 microneedles. The microneedles have been tilted into the Z-plane. The wells for microfluidic dispensing are clearly visible. We are using this design for our first product, a quadrivalent seasonal influenza vaccine.
Our seasonal influenza vaccine uses recombinant influenza hemagglutinin (rHA) as antigen active ingredient. The rHA functions in the FDA approved single-radial immunodiffusion (SRID) potency test. This FDA approved surrogate marker for potency enables rapid manufacturing and stability testing. Our influenza vaccine configuration also allows the use of the FDA approved surrogate marker of influenza vaccine efficacy, the testing of the patient vaccine response by the hemagglutination inhibition test (HAI). This shortens clinical trial times to six weeks.
The Big Four VaxiPatch Features
- VaxiPatch eliminates needle phobia.
- VaxiPatch is room temperature stable.
- VaxiPatch is easy to administer.
- VaxiPatch also addresses a significant safety issue; there is no sharps waste.
Vaccine compliance is another large issue. For example, some vaccines require 3 doses. However, the completion average for some of these three dose vaccines protocols is often only 1.5 doses of the required 3 doses. This creates a health care problem due to inadequate vaccination.
Vaccine hesitancy and anti-vaxxers is also a large issue. The highly publicized measles outbreaks are symptomatic for these problems. But, what if we could make vaccination desirable in the eyes of children, perhaps even fun? An advantage of the VaxiPatch format is that we can make microarrays in any pattern we wish. We can also add a dye to the vaccine.
We have fabricated VaxiPatch microneedles in a circular “happy face” format. The idea is to make vaccination fun and enjoyable by creating a transient “tattoo happy face” with a dye that disappears after a few hours at the site of vaccine administration. Figure 2 shows a happy face tattoo on live rat skin immediately after treatment. The happy face format could be used in measles vaccination. Measles is still a problem due to vaccine hesitancy and anti-vaxxers. A measles vaccine the children enjoy may increase vaccine compliance. But a VaxiPatch happy face measles vaccine could be much more. A measles VaxiPatch could be the face that launches measles vaccination for the global eradication of measles, a global health goal of significant importance.
VaxiPatch™ Prototype "elegantly simple"