If you didn’t have to deal with needles, would you be more likely to get a flu vaccine?
That’s the impetus behind a new vaccine-infused adhesive patch that you can put on yourself.
Initial research shows it to be as effective as the traditional flu shot.
The hope is the patch will encourage more people to get annual inoculations.
That’s no minor issue.
The Centers for Disease Control and Prevention (CDC) reported that influenza contributed to the deaths of an estimated 56,000 people in the United States during 2014-2015.
Despite that number, less than 50 percent of adults under the age of 64 receive yearly flu vaccines.
Dr. Sherry Ross, OB-GYN, and women's health expert at Providence Saint John’s Health Center in California, said there are number of reasons some of her patients skip flu inoculations.
Among them is the belief they can contract the flu even when they get vaccinated. Others say they never get the flu, so vaccination is not needed.
Dr. Vinh Nguyen, a family medicine physician at Orange Coast Memorial Medical Center in California, said those are the same top two excuses he hears from his patients who don’t get their flu vaccines.
Ross believes “60 percent of [her] patients will get the flu vaccine every year, especially those with children, or [who are] over 65 years.”
Nguyen said approximately 40 percent of his patients get the flu vaccine.
How the patch works
Engineers at the Georgia Institute of Technology in Atlanta designed the microneedle adhesive patch to deliver flu vaccine.
Working with the Georgia Tech engineers, researchers at Emory University in Atlanta undertook a study, which ran from June through September 2015, to test the safety and effectiveness of the new device.
Both the patch development and the study were funded by the National Institutes of Health (NIH).
The patch incorporates 100 solid, vaccine-infused microneedles barely long enough to penetrate the skin.
Within minutes of placing the adhesive-backed patch on the skin, the tips of the needles dissolve and release the vaccine.
Afterward, you simply peel away and discard the patch.
Volunteers try it out
Researchers enrolled 100 nonpregnant women from the Atlanta area between the ages of 18 and 49 in a randomized, partially blinded, placebo-controlled, phase I trial (TIV-MNP 2015).
The 100 study participants were divided into four equal groups. Three of the four groups received the flu vaccine. The fourth group was given a placebo.
Healthcare workers administered flu vaccines to three of the four groups.
One group received traditional flu shots.
Healthcare workers applied the new microneedle patch to participants in a second group.
Healthcare workers also applied the new microneedle patch to participants in a third group, but with a placebo in place of a vaccine.
The fourth group self-administered the vaccine using the microneedle patch.
The most common complaint from those given injections was tenderness at the injection site.
Among those who received or self-administered the microneedle patch, the most common complaint was itching in the area where the patch was placed.
Next was some tenderness. Less common was superficial reddening of the skin.
Advantages of the patch
One of the major advantages of the microneedle patch is it does not need refrigeration, unlike flu vaccines.
The ingredients inside the patch remain stable up to 100°F (37°C). This makes it easier to ship anywhere in the world.
The idea that in the near future people might be able to order a flu vaccine, have it shipped to them, and administer it themselves, is revolutionary.
“I like that the press-on patch is an alternative for patients,” said Ross. “If you had a choice between a needle and a patch to accomplish the same goal, I would think the least invasive option would be favored.”
The concentration of vaccine in the body after 28 days was similar in all groups that received the vaccine, regardless of the delivery method.
There did not appear to be any significant difference whether or not the vaccine was administered professionally or by the study participants themselves.
There was also no measurable difference in antibody response within the body.
In an interview with The Lancet, Dr. Nadine Rouphael, associate professor of medicine at Emory University and one of the study’s authors, said, “The vaccine delivered by microneedle patch was not only safe, but also resulted in excellent immune response to the different influenza strains contained in the vaccine, and was preferred over other vaccine delivery methods by the subjects themselves.”
Nguyen added that having people administer the patch themselves shouldn’t be a major issue.
“As long as all the proper steps are taken concerning the safety of the vaccine, I do not have much concern about self-administration,” he said.
More education would help
Nguyen told Healthline the microneedle patch is a novel idea with the potential to increase vaccination rates.
The fact it doesn’t need refrigeration and can be self-administered would be a big advantage in more impoverished and remote areas of the world, including some regions in the United States.
But, he warned, information needs to get out.
“We need to do more work to educate the public to show the value of vaccinations in general,” he said.
Nguyen feels that more education, when combined with new vaccine delivery vehicles such as the microneedle patch, could go a long way toward increasing the numbers of people who get yearly flu vaccines.
Ross agrees. She said a positive experience with the new patch might boost overall flu vaccination rates.
More study needed
While the results of this phase 1 trial are indeed encouraging, Rouphael issues a cautionary note.
"While it's a very promising step, more studies are needed on larger groups of subjects to confirm the safety and efficacy results of the microneedle patches to allow licensure,” he said.
Ross concurs. "I think more research is still needed to ensure there are no other side effects from this innovative microneedle delivery system. It's too early in the process to support the press-on patch as the latest and the greatest."