Important News Regarding Needle-Free Vaccines
On October 21, 2011, the FDA sent out an advisory on the use of jet injectors with influenza vaccines. That release can be found here.
You may be getting questions about this recent FDA communication advising health professionals not to use jet injector devices for flu shots. Even though these devices have been used for several years and were cleared by the FDA for use in delivery of liquids and vaccines in 2008, the FDA has not evaluated their use in delivering flu shots.
OPA has contacted CDC and FDA for some guidance for pharmacists. The CDC told OPA that they are deferring guidance to the FDA. The FDA said that while the jet injector device is safe and cleared for use, it has not been approved for influenza vaccines.
The FDA would like to evaluate, and if approved, then they would include wording in the package labeling of flu shots stating you can deliver using a jet injector device.
Patients who already received a flu shot with a jet injector may ask you if they need another flu shot. The FDA has told OPA that based on current limited data, they feel it is not necessary for patients to receive a re-vaccination.
The CDC and FDA are developing guidance for patients, and we expect it out in the near future. We’ll let you know as soon as the guidance is released.
If you have any further questions, please contact Antonio Ciaccia at OPA at (614) 389-3236.