Verndari was founded with the goal to eliminate needle phobia and the need for the cold chain with a cost-effective simple-to-use vaccination kit that can be mass produced.
There are significant major uses of such a vaccination kit:
- Global Health,
- Pandemic Preparedness and
- Improving vaccine cost and vaccine compliance in developed countries.
VaxiPatch™ is an “elegantly simple” complete single-dose vaccination kit. It is easy-to-use, delivers a painless vaccination experience and can be shipped at room temperature. VaxiPatch also does not create a sharps waste problem. Verndari has been awarded US Patent 10,022,436 and has additional pending patents on the VaxiPatch technology.
As a verbal construct VaxiPatch is simply another good idea. But VaxiPatch was designed from the ground up for high-volume automated cGMP manufacturing. Conceptual work with four automation vendors and integrators envisions a single automated production line capable of producing 100 – 250 VaxiPatch kits/minute. The manufacturing process is robust and for a new “fill/finish” capability, comparatively inexpensive. This enables VaxiPatch to do more than “talk-the-talk” of pushing vaccination forward. Our vision is to “walk-the-walk” by delivering a solution.
VaxiPatch is a platform technology for delivering both existent and new vaccines. It is our hope VaxiPatch will substantially lower the cost of vaccination.
Vaccines, with few exceptions, are known somewhat pejoratively as jabs (Fierce Vaccines Weekly Newsletter) and require refrigeration. The jab induces needle phobia and surprisingly, nearly 25% of US adults avoid vaccination due to needle phobia. In addition, the major cost of most vaccines is not the vaccine sales price from the Pharmaceutical Industry, but rather the distribution and delivery of the vaccines. Distribution requires a cold chain which means refrigeration which in turn means reliable electricity. Administration requires a health care professional who can maintain sterility of the vaccine from the vial, to a hypodermic syringe and needle, to intramuscular injection. For example, the breakdown of the reimbursements in October 2015 for a flu shot was $12 for the vaccine, and $33 for the administration of the vaccine.
Today, Verndari is focused on the influenza vaccine. We have developed a new method for making the influenza vaccine antigen in mammalian cells. This presentation of the influenza vaccine allows the use of the FDA approved surrogate markers of potency and efficacy. These surrogate markers enable rapid development of manufacturing capacity and rapid clinical trial demonstration of efficacy. This new method of influenza vaccine antigen production coupled with the high-volume automated production of a room temperature stable single-dose vaccination kit may enable a rapid response platform capable of addressing pandemic biological threats.
A Pre-IND Meeting with the FDA was held in August 2018 and additional meetings are planned. The FDA has agreed to start reviewing not only our API and VaxiPatch device, but also our automated manufacturing plans.
Can Vaccines Ever Be Fun?
VaxiPatch may also enable a new concept in vaccination, a concept where children may find vaccination enjoyable, even fun. The VaxiPatch microarray can contain a harmless dye that produces a happy face concurrent with vaccine administration. An inexpensive, room-temperature stable and painless measles vaccination producing a transient (2 hour) happy face tattoo may help eradicate measles.
New Vaccines and Efficacy
Vaccine delivery to the skin also presents new vaccine opportunities. Immunologists have shown that the skin contains a higher concentration of professional antigen presenting cells (APCs) such as mast cells, Langerhans cells and dendritic cells than any other location in the body. An immunologist attempting to use the adaptive immune system to produce vaccines for infectious diseases, to design vaccines to destroy tumor cells or trying to induce immune tolerance for the treatment of allergies must access APCs. Arguably, VaxiPatch can reach more APCs than other forms of vaccination.
For example, vaccination with proteins delivered to skin frequently enables the use of a smaller dose of vaccine. Also, vaccination of mRNA vaccines to the skin of animals induce unusually high levels of circulating protective antibodies. And immunologists have also shown an ability to induce tolerance in animals to certain allergens.
As another example, a VaxiPatch complete vaccination kit may aid in the global eradication of measles.
The worldwide market for infectious disease vaccines today is approximately $15 billion and growing at over 12% per year. In developed countries, vaccines have had a profound effect by preventing at least twelve infectious diseases in children. Much work remains to be done in improving the use and compliance of vaccines in developed countries, in influenza pandemic preparedness and in global health. VaxiPatch may be able to help.