Mass Vaccination Using

a Microneedle Patch

Sebastien Henry, MS, MBA

Laboratory of Mark Prausnitz, PhD

Georgia Institute of Technology

Atlanta, GA, USA

Microneedle patch

Microneedle patches are designed to replace syringes/needles and vials

Conventional syringes and needles

Vaccine vial

Microneedles

Microneedle patch next to standard

hypodermic needle and syringe

100 microneedles

Intact skin serves as a barrier

Epidermis

Dermis

cross-section of skin

stratum corneum (barrier)

Vaccines do not get absorbed

through intact skin

Epidermis * barrier (stratum corneum)

Dermis

Vaccine

Skin cross-section

Skin abrasion

Slow / inefficient delivery

Bifurcated needle

Variable dosing

Vaccines must be delivered

past the skin’s barrier

Injection

Expert administration

Microneedles deliver vaccine to the skin

using a simple patch

650 um

Green dye represents

location of vaccine

Microneedles deliver vaccine to the skin

using a simple patch

Epidermis

Dermis

Microneedles penetrate only the upper layers of skin

Standard (hypodermic) needle goes much deeper

Microneedles target cells of the immune

system present in skin

Epidermis

Dermis

Microneedles dissolve and release their vaccine

Microneedles target cells of the immune system (Langerhans, dendritic cells) present in skin

Vaccine

Microneedles dissolve rapidly in skin

a

b

Microneedles dissolve rapidly in skin

a

b c

Storage Administration Protection

Manufacturing Distribution Disposal

- Fast

- High volume

- Low cost

Step 1: Prepare microneedle mold

Step 2: Cast vaccine formulation into mold cavities

Step 3: Cast matrix formulation onto mold surface

Step 4: Dry and remove microneedle patch

Mass vaccination needs

Storage Administration Protection

Manufacturing Distribution Disposal

Sharps waste disposal 10 ten-dose vials

100 needles and syringes

Cold-chain storage

- Small patch size - No refrigeration

100 microneedle

patches

Storage Administration Protection

Manufacturing Distribution Disposal

- Small patch size

- No refrigeration

Storage Administration Protection

Manufacturing Distribution Disposal

Apply patch Press to skin

and leave on skin

Remove from skin Vaccination is complete

Storage Administration Protection

Manufacturing Distribution Disposal

- Administration by healthcare workers (HCW)

- Administration by minimally-trained personnel

- Self-administration with HCW supervision

- Self-administration

Snaplicator data

Storage Administration Protection

Manufacturing Distribution Disposal

- Microneedle insertion

Storage Administration Protection

Manufacturing Distribution Disposal

Normally

vaccinated

Normally

unvaccinated

Projected increase in vaccination coverage by

19 percentage points

(from 46% to 65%)

Martin Meltzer

CDC

Paula Frew

Emory

Storage Administration Protection

Manufacturing Distribution Disposal

Storage Administration Protection

Manufacturing Distribution Disposal

- No sharps waste

- Small disposal volume

Storage Administration Protection

Manufacturing Distribution Disposal

• Microneedle-based vaccination induces a strong

immune response

• Microneedle-based vaccination is similar or better

than syringe/needle injection

Microneedle and IM vaccination provide

full protection against virus challenge

Storage Administration Protection

Manufacturing Distribution Disposal

Inf = not vaccinated

IM = syringe/needle vaccination

MN = Microneedle vaccination

Anthrax Becton Dickinson

BCG Georgia Tech/CDC

Chikungunya virus Queensland

Cholera toxin Leiden

Diptheria toxoid Leiden, Osaka

Hepatitis B Apogee/Georgia Tech, Urumqi Gen. Hospital

Hepatitis C Georgia Tech/Karolinska

HPV Queensland

Influenza Leiden, Georgia Tech/Emory, Novartis, Osaka Nanopass/Antwerp, BD/Sanofi/academics

Japanese encephalitis Becton Dickinson

Malaria Osaka, Cork Measles Georgia Tech/CDC Polio (inactivated) Georgia Tech/CDC/WHO/Gates Rotavirus (inactivated) Georgia Tech/CDC Smallpox Cyto Pulse Sciences

Tetanus Osaka West Nile virus Queensland

Status of vaccination using microneedles

Thank you