Tuesday, October 25, 2011
Do Not Give Flu Vaccine by Jet Injection, FDA Says
From Medscape Medical News > Alerts, Approvals and Safety Changes > Medscape Alerts Robert Lowes October 24, 2011 — Clinicians should not administer influenza vaccines with needleless "jet injectors" because the vaccines have not been approved for such devices, the US Food and Drug Administration (FDA) has warned. The announcement, issued October 21, follows recent advertisements by major retailers such as Kroger stating that customers can receive such a needleless seasonal flu vaccine instead of the standard injection at their in-store pharmacies. Kroger announced October 21 that it had discontinued the use of this administration technique. A jet injector shoots a high-pressure stream of liquid medication that can penetrate the skin and deliver a dose to tissues underneath. Two manufacturers of jet injectors, PharmaJet and Bioject Medical Technologies, have contested the FDA warning, noting that their products already have received FDA clearance for delivering drugs and vaccines. FDA spokesperson Shelly Burgess told Medscape Medical News that the manufacturers are entirely correct on that point. However, influenza vaccines themselves need to be approved for specific administration methods, regardless of whether the device is approved, Burgess said. So far, the FDA has not cleared any influenza vaccine for jet injection. The agency is advising clinicians to abide by label instructions for administration, whether it is by needle injection or nasal spray. The only vaccine cleared for use with approved jet injectors is for measles, mumps, and rubella (MMR). "Jet injectors represent a different method of delivery that has the potential to change the characteristics of an approved vaccine," the FDA stated in its announcement. "Therefore, each vaccine preparation must be individually evaluated for administration by jet injector, and safety and effectiveness data for that vaccine must be submitted to [the FDA's Center for Biologics Evaluation & Research] for review and approval." The FDA has not received any reports of adverse events associated with jet-injected influenza vaccine, nor is it voicing specific safety concerns, Burgess told Medscape Medical News. "We just haven't studied it yet." When asked whether customers who received influenza vaccine by jet injection should get immunized again during the current influenza season, Burgess referred the matter to a spokesperson for the US Centers for Disease Control and Prevention (CDC). CDC spokesperson Thomas Skinner told Medscape Medical News that "based on current, though limited, information from publications, CDC and FDA believe that it is not necessary for people who got their flu vaccine via jet injector to be re-vaccinated." More information about the FDA announcement is available on the agency's Web site. To report adverse events related to jet injection of an influenza vaccine, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, online at http://www.fda.gov/medwatch, or by mail to MedWatch, FDA, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
Posted by Dr Tan Poh Tin at 7:01 PM