A new medical development is going to change the way many of us look at getting the flu vaccine. A painless flu vaccine skin patch is making needles and vials a thing of the past. Researchers from the Georgia Institute of Technology and Emory University have shown that a flu vaccine can be administered safely and comfortably with this new patch, which delivers the vaccine through a matrix of tiny dissolving microneedles.
Besides the obvious advantage of no needle jab, the vaccine produced a strong immune response against the flu virus in a clinical trial. And, not surprisingly, it was preferred by most of the participants over vaccination with a needle.
Results of the clinical trial were reported online June 27 in The Lancet.
The patch was developed by a team led by Mark R. Prausnitz, of the Georgia Institute of Technology. They designed the patch to be about the size of a dime and contain 100 needles just long enough to penetrate the skin. The patch is applied by to the skin and is held in place by adhesive on the patch. Gentle pressing allows the needles to contact the skin and release their vaccine. The needles are solid and the vaccine is encapsulated in the needles themselves and is released as the needle tips dissolve. After about 20 minutes, the patch is peeled off and thrown away like a used bandage. It no longer has any sharp points that might pose a disposal hazard.
Four groups of people took part in the first human clinical trial of the patches, which began in June 2015. One hundred people ages 18-49 participated in the phase 1 clinical trial authorized by the FDA. The trial was designed to test the patch's safety, the patch's ability to generate an immune response to the influenza virus, and general acceptance of the patch by recipients.
The researchers vaccinated Group 1 with the microneedle patch given by a health care provider. Participants in Group 2 self-administered the microneedle patch. Group 3 received standard vaccination by intramuscular injection from a health care provider, and Group 4 received a microneedle patch that didn't contain any vaccine, administered by a health care provider.
The vaccine, no matter whether delivered by patch or by injection, contained vaccines against three different influenza strains — the same ones in the flu vaccine given to the general public in the 2014–2015 flu season — H1N1 (the swine flu), H3N2, and influenza type B.
There were no serious reactions reported by any of the study participants. Tenderness and redness were reported by all groups, pain was reported by the groups receiving vaccination by injection, and itching was reported by groups who received the patch. All methods of immunization generated about the same amount of immunity to the different flu strains.
The patch had several benefits over traditional influenza vaccines. Users could easily apply the patch themselves, it could be stored or transported without refrigeration, and there is no needle to dispose of.
This bandage-strip sized patch of painless and dissolvable needles can transform how we get vaccinated. A particularly attractive feature is that this vaccination patch could be delivered in the mail and self-administered. In addition, this technology holds promise for delivering other vaccines in the future.
At this point, it will be a few years before this patch is available to the public since it has to go through phase two and three testing before FDA approval. Currently, the team is also working to develop microneedle patches for use with other vaccines, including measles, rubella, and polio, to make administration of all vaccines easier, safer, and less scary.
The flu is contagious and infected people can pass the virus on through coughing, sneezing or even talking a day before symptoms develop and up to seven days after developing symptoms. Flu symptoms often hit suddenly and may include fever, headache, cough, sore throat, body aches, runny nose, and fatigue. In most people, the flu resolves in about two weeks, but some people develop serious lung infections and inflammation of other organs like the heart and brain. Young children, adults 65 years and older, pregnant women, and people with chronic medical conditions are more prone to serious complications from the flu, complications that can require hospitalization and sometimes lead to death.
There are many strains of influenza viruses, mutations develop in the virus, and the viruses jump from birds and animals to humans, creating even more infectious flu strains. Flu vaccines are manufactured to protect against the influenza viruses that research indicates will be most common during the upcoming season.
Despite the availability of flu vaccine, about 48,000 people die each year from the flu in the US. Only about half the US population gets immunized against it.
The microneedle patch has the potential to revolutionize the way we get vaccinated, but more importantly, it may play a significant role in getting more people to accept the flu vaccine, preventing illness and deaths of countless people.