Painless Patches Offer the Promise of Wider Vaccine Acceptance

Credit: Gary Meek; Georgia Institute of Technology; Aug. 12, 2011

Vaccination is undoubtedly one of the most important advances in the history of medicine. It has led to the eradication of smallpox, among the deadliest pathogens mankind has ever encountered. The successful implementation of vaccines across the globe may also put polio on the eradication list. And over the last decade, Human Papillomavirus strains that lead to cervical cancer are, too, becoming less prevalent among young adults after the introduction of Gardasil and other HPV vaccines.

Despite these achievements, campaigns sometimes emerge to undermine global public health efforts. Outbreaks of measles occurred this year in the United States and Europe after religious leaders in both countries convinced church parishioners not to vaccinate their children.

Fear of vaccines are often specific to socio-political situations. It was reported by a U.S. news agency in February that some people in Pakistan and Nigeria believe rumors that the polio vaccine is a plot by the CIA to sterilize Muslim children.

Putting these more complex issues aside, there is one universal dread. Quite simply, some patients are just scared of getting a shot. Although this fear should be minimal, there is the small risk of needles puncturing and contaminating someone other than the intended patient with blood borne disease.

So forget the needle and welcome the era of the vaccine patch. The patch is an adhesive about the size of a Band-Aid that delivers a vaccine through microneedles that cause little or no pain to the wearer.

Vaccines work by introducing weakened pathogens — not the full-blown virus–into a healthy person. This allows the body to establish an immune memory response so that when a person is exposed to a stronger form of the virus from an infected person, the vaccinated individual will experience a less severe form of the illness.

The patches also allow for the vaccine to be taken up by resident immune cells that are below the surface of our skin, such as dendritic cells and Langerhans cells, and processed into presentable parts called antigens. These antigen-presenting cells will travel to the nearest lymph node and activate B and T cells to produce an effective and robust immune response, leading to long-term memory against that pathogen contained in the vaccine.

In 2006, scientists in Michael Cormier’s group at ALZA Corporation in California found that the higher the dose of antigen loaded on the patch, the greater immune response was to the antigen of interest. Extremely short microneedles and a relatively small patch size could be used, yet still be highly effective.

These microneedle patches may be new to the vaccine world but are not new to medicine. Such innovative delivery devices have been used in the past decade for other drugs such as: desmopressin for uncontrolled urination; insulin for diabetes mellitus type 1 and late-stage type 2; parathyroid hormone for treatment of osteoporosis; growth hormone; and erythropoietin for anemia due to kidney failure.

This groundbreaking development in vaccine delivery, however, led to a subsequent study on an influenza vaccine in mice by Prausnitz’s group at Georgia Institute of Technology in 2009. Inactivated influenza virus was used to coat microneedle patches and was tested against intramuscular delivery–the gold standard for vaccines–of the same antigen. The vaccine patch was found as effective as getting an injection, for example, in one’s arm. Both groups of mice survived the influenza and the virus was subsequently cleared from the lungs. However, the mice that received the microneedle patch had fewer clinical symptoms, reduced inflammation in the lungs, and antibody responses were also detected earlier in the microneedle patch group indicating more robust memory response to influenza.

Prausnitz’s group also developed a microneedle patch in 2011 to protect against tuberculosis, by using the bacillus Calmette-Guérin (BCG) in guinea pigs. Again, this application of the vaccine patch was found to be highly immunogenic.

Current work has been focusing on vaccines using recombinant techniques for diseases such as avian (H5N1) influenza using DNA instead of whole virus and malaria using recombinant virus. Measles, rotavirus (the cruise ship diarrhea bug), and Hepatitis B virus vaccines have also been tested with microneedle patches in rodents, all with promising results. Research is now being done to see if these patches can be further modified to increase stability of antigen, as well as make them dissolvable so as to not have the need for removal by a clinician. While there are no human studies yet published, medicine is fully on track to begin human trials within the next decade. With successful implementation of these novel vaccine microneedle patches, the need for refrigeration or the risk of cross contamination of bystanders can be finally eliminated and greater access to vaccination can finally be achieved.

The patches also provide options for developing nations. Vaccines are extremely effective in keeping humans and other animals free of disease, but their transportation and storage requirements have made it difficult for their use in developing countries–places where communicable disease is the most prevalent.

Refrigeration is almost always required for a vaccine, regardless of whether it’s delivered by injection, ingestion, or inhalation. Developing nations do not always have adequate access to refrigeration, and many vaccines do not survive transport and are rendered inactive and ineffective once at the clinic. Therefore, it is extremely important that scientists develop a type of vaccine that can survive these less-than-ideal conditions.

The patch offers the possibility of addressing social and religious reservations about taking vaccines, too. If microneedle patches are easy to transport and use, volunteer-driven campaigns could not only better inform populations, but certified volunteers could be trained to administer the patches within their communities.

The question now: when will they available to everyone?

by Dana Catalfamo

The article originally appeared October 22, 2013 at

Dana Catalfamo is a physician assistant and holds a Ph.D. in microbiology and immunology. She can be reached on Twitter @DanaLynnCat.


G. Widera, J. Johnson, L. Kim, L. Libiran, K. Nyam, P.E. Daddona, M. Cormier. Effect of delivery parameters on immunization to ovalbumin following intracutaneous administration by a coated microneedle array patch system. Vaccine. 2006. Volume 24, issue 10. Pages 1653–64.

Y.C. Kim, F.S. Quan, D.G. Yoo, R.W. Compans, S.M. Kang, M.R. Prausnitz. Improved influenza vaccination in the skin using vaccine coated microneedles. Vaccine. 2009. Volume 27, issue 49. Pages 6932–8.

C.H. Dean, J.B. Alarcon, A.M. Waterston, K. Draper, R. Early, F. Guirakhoo, T.P. Monath, J.A. Mikszta. Cutaneous delivery of a live, attenuated chimeric flavivirus vaccine against Japanese encephalitis (ChimeriVax-JE) in non-human primates. Human Vaccines. 2005. Volume 1, issue 3. Pages 106–11.

M. Cormier, B. Johnson, M. Ameri, K. Nyam, L. Libiran, D.D. Zhang, P. Daddona. Transdermal delivery of desmopressin using a coated microneedle array patch system. Journal of Controlled Release. 2004. Volume 97, issue 3. Pages 503–11.

L. Nordquist, N. Roxhed, P. Griss, G. Stemme. Novel microneedle patches for active insulin delivery are efficient in maintaining glycaemic control: an initial comparison with subcutaneous administration. Pharmaceutical Research. 2007. Volume 24, issue 7. Pages 1381–8.

P.E. Daddona, J.A. Matriano, J. Mandema, Y.F. Maa. Parathyroid hormone (1–34)-coated microneedle patch system: clinical pharmacokinetics and pharmacodynamics for treatment of osteoporosis. Pharaceutical Research. 2011. Volume 28, issue 1. Pages 159–65.

J.W. Lee, S.O. Choi, E.I. Felner, M.R. Prausnitz. Dissolving microneedle patch for transdermal delivery of human growth hormone. Small. 2011. Volume 7, issue 4. Pages 531–9.

E.E. Peters, M. Ameri, X. Wang, Y.F. Maa, P.E. Daddona. Erythropoietin-coated ZP-microneedle transdermal system: -preclinical formulation, stability, and delivery. Pharmaceutical Research. 2012. Volume 29, issue 6. Pages 1618–26.

Y.C. Kim, F.S. Quan, D.G. Yoo, R.W. Compans, S.M. Kang, M.R. Prausnitz. Enhanced memory responses to seasonal H1N1 influenza vaccination of the skin with the use of vaccine-coated microneedles. Journal of Infectious Diseases. 2010. Volume 201, issue 2. Pages 190–8.

Y. Hiraishi, S. Nandakumar, S.O. Choi, J.W. Lee, Y.C. Kim, J.E. Posey, S.B. Sable, M.R. Prausnitz. Bacillus Calmette-Guérin vaccination using a microneedle patch. Vaccine. 2011. Volume 29, issue 14. Pages 2626–36.

J.B. Carey, F.E. Pearson, A. Vrdoljak, M.G. McGrath, A.M. Crean, P.T. Walsh, T. Doody, C. O’Mahony, A.V. Hill, A.C. Moore. Microneedle array design determines the induction of protective memory CD8+ T cell responses induced by a recombinant live malaria vaccine in mice. 2011. PLoS One. Volume 6, issue 7. Epub.

Y.C. Kim, J.M. Song, A.S. Lipatov, S.O. Choi, J.W. Lee, R.O. Donis, R.W. Compans, S.M. Kang, M.R. Prausnitz. Increased immunogenicity of avian influenza DNA vaccine delivered to the skin using a microneedle patch. 2012. European Journal of Pharmaceutics and Biopharmaceutics. Volume 81, issue 2. Pages 239–47.

C. Edens, M.L. Collins, J. Ayers, R.A. Rota, M.R. Prausnitz. Measles vaccination using a microneedle patch. 2013. Vaccine. Volume 31, issue 34. Pages 3403–9.

S. Moon, Y. Wang, C. Edens, J.R. Gentsch, M.R. Prausnitz, B. Jiang. Dose sparing and enhanced immunogenicity of inactivated rotavirus vaccine administered by skin vaccination using a microneedle patch. 2013. Vaccine. Volume 31, issue 34. Pages 3396–402.

L. Guo, Y. Qiu, J. Chen, S. Zhang, B. Xu, Y. Gao. Effective transcutaneous immunization against Hepatitis B virus by a combined approach of hydrogel patch formulation and microneedle arrays. 2013. Biomedical Microdevices. Epub ahead of print.

One clap, two clap, three clap, forty?

By clapping more or less, you can signal to us which stories really stand out.