The Food and Drug Administration is recommending that health care professionals not use injector devices to administer flu vaccines.


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FDA: Don't use jet injectors for flu vaccinations

October 24th, 2011

WASHINGTON – The Food and Drug Administration is recommending that health care professionals not use injector devices to administer flu vaccines.

In a statement released Friday, the FDA said that currently there are no influenza vaccines that it has approved for administration by jet injector, a needle-free method of immunization. The agency noted that at this time it has approved only one vaccine — for measles, mumps and rubella (MMR) — for administration by jet injector and that it has no data to support the safety or effectiveness of other vaccines delivered in that manner.

Late Friday, Kroger Co. said its supermarket pharmacies and The Little Clinic retail health clinics have discontinued use of jet injector flu immunizations in line with FDA guidance.

"The Kroger family of pharmacies and The Little Clinic locations will continue to administer seasonal influenza vaccinations through traditional flu shots," Kroger stated. "Kroger is seeking guidance from the Centers for Disease Control and Food and Drug Administration regarding revaccinations."

Pharmajet Inc., a provider of needle-free injections, announced in late September that Kroger would offer its needleless injection system for flu immunizations at more than 800 in-store pharmacies nationwide — including its Kroger, Fry's and King Soopers banners — as well as at 79 Little Clinics.

And in early September, Kroger subsidiary Fred Meyer Stores said it was offering customers needle-free flu vaccines using an injector system from Bioject Medical Technologies Inc.

In its alert, the FDA explained that approval of a vaccine is based on scientific information demonstrating its safety and effectiveness in a given population and using a specific dose, schedule and method/route of administration. The agency noted that changes in the dose, route and/or method of administration could affect immunogenicity and, in turn, a vaccine's safety and/or efficacy.

"Influenza vaccines have been approved only for administration by needle injection or nasal mist sprayer. They have not been evaluated for delivery by jet injection," the FDA stated. "Jet injectors represent a different method of delivery that has the potential to change the characteristics of an approved vaccine."

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