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Dissolvable patch developed for flu vaccine

28 June 2017

The patch has a hundred tiny hair-like microneedles on its adhesive side that penetrate the skin's surface. They are with Public Health England's National Infections Service.

The study, published online June 27, 2017, in The Lancet, was led by Nadine Rouphael, M.D., associate professor of medicine and Mark J. Mulligan, M.D., distinguished professor of medicine, Emory University School of Medicine, in collaboration with Mark R. Prausnitz, Ph.D., Regents Professor and J. Erskine Love Chair in Chemical and Biomolecular Engineering, Georgia Institute of Technology.

While dissolvable microneedle arrays are already used in the cosmetic industry, including for the delivery of botox, the new study looked at their potential in flu vaccination. The study was carried out under an Investigational New Drug Application authorized by the FDA. Experts hope this alternative will increase the number of people who get vaccinated each year. The vaccine also remains potent in the patch, without refrigeration, for at least a year. "The phase 1 clinical trial confirms that the microneedle patch technology is safe, immunogenic, easy to use, and preferred by people", says Dr. Prausnitz, who adds that, "Micron is leveraging these excellent results to continue the pre-clinical and clinical development of its microneedle patch product portfolio". The vaccine is stored in the refrigerator, and the used needle must be disposed of in a safe manner.

Scientists in the USA have developed a patch with microneedles containing a vaccine which would allow patients to immunise themselves. Local skin reactions to the patches were mostly faint redness and mild itching that lasted two to three days.

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They also wanted to compare the self-administered patch with the patch administered by a healthcare professional.

"It would remove the bottleneck of actually going to a health care provider to actually receive the vaccine, and it could put people less at risk of acquiring influenza in the hospital and clinic by just receiving it at their home", Rouphael said.

Writing in an editorial that was published alongside the new study in The Lancet, Katja Höschler and Maria Zambon, both of Public Health England, said that the "microneedle patches have the potential to become ideal candidates for vaccinations programs, not only in poorly resourced settings, but also for individuals who now prefer not to get vaccinated".

The patch can be thrown in the bin after it is used because the microneedles dissolve away.

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In a separate test, researchers found the vaccine patches could be stored for a year at temperatures ranging from 5C to 40C without the vaccine losing its potency. The patch's manufacturer, Global Center for Medical Innovation in Atlanta, is investigating using the device for other vaccines, including for measles, mumps and rubella. The pain-relieving benefits of yoga were also confirmed by researchers: 74 percent of study participants reported yoga lessened pain.

Researchers wanted to assess the safety and tolerability of the flu vaccine patch compared to the standard intra-muscular injection and a placebo patch (dummy treatment).

A close-up of the microneedle vaccine patch, which contains tiny needles that dissolve into the skin.

The authors summarize: "Influenza vaccination using microneedle patches is well-tolerated, well-accepted, and results in robust immunologic responses, whether administered by health care workers or by the participants themselves".

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But the patch is expected to be cheaper because it can be sent through the mail and self-administered. "In addition, this technology holds promise for delivering other vaccines in the future".

Dissolvable patch developed for flu vaccine