Every year, people looking to avoid the sniffles and stay healthy throughout winter receive a seasonal influenza vaccination that’s recommended by the Centers for Disease Control and Prevention (CDC).
The shot can reduce the risk of contracting the flu, which affects about 5 to 20 percent of the U.S. population each year, according to the CDC. Some steer clear of the flu shot, though, because of their fear of needles.
In Union County, N.J., however, residents can get the vaccination without the prick of a needle. The county’s Office of Health Management purchased needle-free flu vaccine injectors in 2009 as an alternative to conventional shots.
Jet injection company PharmaJet, based in Golden, Colo., developed the needle-free injectors with technology that forces 0.5 milliliters of vaccine liquid into the skin, said Kathleen Callender, the company’s founder.
“If you focus liquid through a very small hole and you accelerate the liquid quickly through a narrow chamber, it becomes a liquid needle and will poke a tiny hole in the skin in less than a third of a second,” Callender said. “It’s kind of the concept of a fire hose.”
The handheld devices look like flashlights, and the vaccine is hidden inside them. The injectors use a mechanical spring that when cocked, releases the vaccine. A hammer inside the injector pushes against a plunger to accelerate the liquid into the skin.
But just because a needle doesn’t prick the skin, doesn’t mean the injection is painless. Ella Shaykevich, a public health nurse for the Union County Office of Health Management, said the sensation from the injected vaccine is the same as a traditional hypodermic needle.
So why did Union County decide to provide a needle-free option?
In 2009, H1N1 — more commonly known as the swine flu — swept through the U.S. and became a global pandemic. At the height of the pandemic in December 2009, New Jersey had tallied 1,414 official cases of swine flu resulting in 40 deaths, according to FluCount.org, a website of worldwide H1N1 case statistics.
During the H1N1 scare, a number of New Jersey local governments purchased injectors and held clinics to combat the illness. In 2010, Newark purchased the injectors followed by Essex County in 2011.
|Jet injectors aren’t a new concept. In fact, the devices were invented in the 1860s and helped vaccinate large populations after World War II — an estimated 1 billion inoculations. By the 1980s, the technology had advanced, but concerns arose about the potential for blood to splash back into the injectors, which could create contamination between patients. As a result, the military and public health organizations limited their use of the technique. Since then, the development of disposable cartridges with a single-use nozzle have improved the safety of jet injectors.- Live Science|
Though New Jersey cities and counties purchased and used the injectors over the last two years to help protect patients from the flu, a statement from the U.S. Food and Drug Administration (FDA) in fall 2011 may have kept other public health departments from following suit.
Last October, the FDA recommended that health-care professionals use sterile needles and syringes to administer the influenza vaccine — not needle-free injectors. “Data to support the safety or effectiveness of inactivated influenza vaccines delivered by jet injector have not been submitted to FDA for evaluation,” the release stated, and the FDA therefore could not recommend that influenza vaccines be administered by this method.
The FDA has given general clearance for the use of PharmaJet’s needle-free technology. But the agency requires pharmaceutical companies to seek specific approval to use jet injection with their vaccines.
“If a manufacturer wants to include the jet injector as a method of vaccine administration in its vaccine labeling, the safety and effectiveness data to support administration of the vaccine using this delivery method must be included in their biologics license application and submitted to FDA for evaluation and approval,” said Hope Anderson, the FDA’s consumer safety officer.
According to a PharmaJet statement released in October 2011, the company received two marketing clearances for its needle-free technology, however, the FDA never specifically gave clearance for the injectors to administer the influenza vaccine.
The lack of FDA approval has caused state and local health departments, including the Los Angeles County Department of Public Health, to postpone plans to use the needle-free injectors.
Los Angeles County didn’t begin using the injectors last fall because of the FDA, Callender said. “They have the technology, and they are all set and ready to go — but they are in a hold position.”
Callender said PharmaJet plans to meet with the FDA early this year to discuss reversing the recommendation.