The Stratis needle-free jet injector … Researchers developed a new jet injection design by combining the drug reservoir, plunger and nozzle into a single-use disposable cartridge. Jet injectors, as a different delivery method, have the potential to change the characteristics of an approved vaccine, and vaccine preparations administered with them must be … FDA is aware of a study conducted in healthy young adults published in 2001 (Jackson, et al. If a manufacturer wants to include a 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 submitted to FDA for evaluation and approval. It is claimed by its manufacturer that it can deliver intramuscular injections and subcutaneous injections up to 1 milliliter. Afluria continues to be approved for intramuscular injection using a sterile needle and syringe for persons 5 years of age and older. All other inactivated influenza vaccines are approved for administration by sterile needle injection only. The device had a clinically acceptable safety profile, but was associated with a higher frequency of local injection site reactions than was the use of needle and syringe. Is it different than getting the vaccine through a needle and syringe? Inactivated influenza vaccines that are approved by the FDA have information in their labeling stating how the vaccines should be administered, such as, by intramuscular (IM) or intradermal (ID) administration. A: Using an air gun -- also called a jet injector -- is a fast way to deliver vaccines. FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices, including those used to administer drugs and biologics (such as vaccines). December 18, 1866: Jules-Auguste Béclard presented Dr. Jean Sales-Girons invention, Appareil pour l'aquapuncture to l'Académie Impériale de Médecine in Paris. A jet injector is a medical device used for vaccination that uses a high-pressure, narrow stream of fluid to penetrate the skin instead of a hypodermic needle… FDA has approved the use of Afluria administered by intramuscular injection with the PharmaJet Stratis Needle-Free Injection System for people 18 through 64 years of age, based on its evaluation of supporting safety and effectiveness data. Is it sterile? This device is regulated by FDA’s Center for Devices and Radiological Health (CDRH). Approval for administration of an inactivated influenza vaccine via jet injector will be based on the demonstration of the safety and effectiveness of that vaccine in a given population (e.g., children and the elderly). Will it hurt? 1954–1967: Dr. Robert Hingson partook in numerous health expeditions with his charity, Brother's Brother Foundation. [15], Fluid suck-back occurs when blood left on the nozzle of the jet injector is sucked back into the injector orifice, contaminating the next dose to be fired. A twist on Star Trek technology Others in the vaccine-delivery business are taking a different approach, using a new twist on a needle-free device called a jet injector that has been around … FDA will thoroughly evaluate any data submitted regarding the safety and effectiveness of an inactivated influenza vaccine administered with a jet injector. Another study by Simon, et al (Vaccine, 2011) reported that redness and swelling occurred more frequently in those vaccinated with a jet injector. It can deliver up to 1.6 ml in 0.03 ml increments, and is designed to last 3000 injections. [22] Another study used the device on a calf, then tested the fluid remaining in the injector for blood. An experiment using mice, published in 1985, showed that jet injectors would frequently transmit the viral infection lactate dehydrogenase elevating virus (LDV) from one mouse to another.
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