Mass Vaccination Using a Microneedle Patch Sebastien Henry, MS, MBA

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1 Mass Vaccination Using a Microneedle Patch Sebastien Henry, MS, MBA Laboratory of Mark Prausnitz, PhD Georgia Institute of Technology Atlanta, GA, USA

2 Microneedle patch Vaccine vial Microneedles Conventional syringes and needles Microneedle patches are designed to replace syringes/needles and vials

3 Microneedle patch next to standard hypodermic needle and syringe 100 microneedles

4 Intact skin serves as a barrier stratum corneum (barrier) cross-section of skin Epidermis Dermis

5 Vaccines do not get absorbed through intact skin Skin cross-section Vaccine Epidermis * barrier (stratum corneum) Dermis

6 Vaccines must be delivered past the skin s barrier Injection Expert administration Bifurcated needle Variable dosing Skin abrasion Slow / inefficient delivery

7 Microneedles deliver vaccine to the skin using a simple patch Green dye represents location of vaccine 650 um

8 Microneedles deliver vaccine to the skin using a simple patch Microneedles penetrate only the upper layers of skin Epidermis Standard (hypodermic) needle goes much deeper Dermis

9 Microneedles target cells of the immune system present in skin Microneedles dissolve and release their vaccine Vaccine Epidermis Microneedles target cells of the immune system (Langerhans, dendritic cells) present in skin Dermis

10 Microneedles dissolve rapidly in skin a b

11 Microneedles dissolve rapidly in skin a b c

12 Mass vaccination needs Manufacturing Distribution Disposal Storage Administration Protection - 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

13 Manufacturing Distribution Disposal Storage Administration Protection 10 ten-dose vials Sharps waste disposal 100 needles and syringes Cold-chain storage 100 microneedle patches - Small patch size - No refrigeration

14 Manufacturing Distribution Disposal Storage Administration Protection - Small patch size - No refrigeration

15 Manufacturing Distribution Disposal Storage Administration Protection Apply patch Press to skin and leave on skin Remove from skin Vaccination is complete

16 Manufacturing Distribution Disposal Storage Administration Protection - Administration by healthcare workers (HCW) - Administration by minimally-trained personnel - Self-administration with HCW supervision - Self-administration

17 Manufacturing Distribution Disposal Storage Administration Protection - Microneedle insertion Snaplicator data

18 Manufacturing Distribution Disposal Storage Administration Protection Martin Meltzer CDC Paula Frew Emory Normally unvaccinated Normally vaccinated Projected increase in vaccination coverage by 19 percentage points (from 46% to 65%)

19 Manufacturing Distribution Disposal Storage Administration Protection

20 Manufacturing Distribution Disposal - No sharps waste Storage Administration Protection - Small disposal volume

21 Manufacturing Distribution Disposal Storage Administration Protection Microneedle-based vaccination induces a strong immune response Microneedle-based vaccination is similar or better than syringe/needle injection

22 Manufacturing Distribution Disposal Storage Administration Protection Microneedle and IM vaccination provide full protection against virus challenge Inf = not vaccinated IM = syringe/needle vaccination MN = Microneedle vaccination

23 Status of vaccination using microneedles Anthrax BCG Chikungunya virus Cholera toxin Diptheria toxoid Hepatitis B Hepatitis C HPV Influenza Japanese encephalitis Malaria Measles Polio (inactivated) Rotavirus (inactivated) Smallpox Tetanus West Nile virus Becton Dickinson Georgia Tech/CDC Queensland Leiden Leiden, Osaka Apogee/Georgia Tech, Urumqi Gen. Hospital Georgia Tech/Karolinska Queensland Leiden, Georgia Tech/Emory, Novartis, Osaka Nanopass/Antwerp, BD/Sanofi/academics Becton Dickinson Osaka, Cork Georgia Tech/CDC Georgia Tech/CDC/WHO/Gates Georgia Tech/CDC Cyto Pulse Sciences Osaka Queensland

24 Thank you

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