Elsevier

Journal of Controlled Release

Volume 240, 28 October 2016, Pages 135-141
Journal of Controlled Release

Microneedle patches for vaccination in developing countries

https://doi.org/10.1016/j.jconrel.2015.11.019Get rights and content

Abstract

Millions of people die of infectious diseases each year, mostly in developing countries, which could largely be prevented by the use of vaccines. While immunization rates have risen since the introduction of the Expanded Program on Immunization (EPI), there remain major challenges to more effective vaccination in developing countries. As a possible solution, microneedle patches containing an array of micron-sized needles on an adhesive backing have been developed to be used for vaccine delivery to the skin. These microneedle patches can be easily and painlessly applied by pressing against the skin and, in some designs, do not leave behind sharps waste. The patches are single-dose, do not require reconstitution, are easy to administer, have reduced size to simplify storage, transportation and waste disposal, and offer the possibility of improved vaccine immunogenicity, dose sparing and thermostability. This review summarizes vaccination challenges in developing countries and discusses advantages that microneedle patches offer for vaccination to address these challenges. We conclude that microneedle patches offer a powerful new technology that can enable more effective vaccination in developing countries.

Section snippets

Barriers to vaccination in developing countries

According to 2014 WHO estimates, 1.5 million children die each year from vaccine-preventable diseases for which there are vaccines recommended by the WHO and 29% of deaths among children 1–59 months old are vaccine preventable [1]. For example, measles vaccine is 97% effective after two doses [2], yet, as of 2010, more than 100,000 children under the age of five died each year from measles, most of whom were unvaccinated children [3].

Vaccines are currently administered in developing countries

Overview of microneedles for vaccination

Microneedle patches (MNPs) have been proposed to improve vaccination in developing countries and are the subject of increasing research in academia and industry (Fig. 1). Microneedles are less than 1 mm long and deliver vaccines to the skin's epidermis and dermis, as compared to conventional injection into deeper tissues in the muscle or subcutaneous space by hypodermic needle and syringe. In a MNP, an array of microneedles is attached to a backing such that it can be applied to the skin by hand

Directions for future research and development

MNPs have great potential to improve vaccination in developing countries, but more work needs to be done to realize this potential. Overall, translation of preclinical studies into clinical trials of MNP vaccination is strongly needed, as is commercial manufacturing that can mass produce MNPs at suitable cost. Additional considerations follow.

  • Increased vaccine effectiveness has been shown for a number of vaccines in animal models, but has not yet been established in human subjects, and the

Conclusions

Many lives could be saved by improved vaccination in developing countries. MNPs offer advantages that could improve vaccination through increased vaccine effectiveness, reduced need for trained healthcare providers, simplified supply chain, reduced risk of sharps, reduced vaccine wastage, no need for vaccine reconstitution and reduced cost of vaccine/vaccination. With continued development, especially translation into clinical trials and advanced manufacturing, MNPs have great potential to

Acknowledgments

The authors would like to thank Darin Zehrung for a critical reading of the manuscript and providing insight and references concerning the barriers to vaccination in developing countries, and Kimberly Haight and Daniel Pardo for their help in gathering information for this review. This work was supported in part by a grant to Mark Prausnitz from the National Institutes of Health (Grant Number - U01EB012495) and an ORISE fellowship to Jaya Arya funded by the Centers for Disease Control and

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