FDA Recommends Use of Sterile Needle and Syringe for Administration of Inactivated Influenza Vaccines

November 4, 2011 4:19 pm Topics: Vaccinations

FDA has released a communication recommending that health care providers use a sterile needle and syringe to administer inactivated influenza vaccines. The communication was released in response to questions regarding the use of jet injector devices to administer inactivated influenza vaccines. FDA advises that “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.” Further, FDA clarifies its October 21, 2011 communication “to inform the public that inactivated influenza vaccines labeled for IM injection are intended for administration using a sterile needle and syringe. There is one inactivated influenza vaccine labeled for ID administration, this vaccine is supplied in its own pre-filled syringe. The live attenuated influenza vaccine is given through the nose as a spray; the sprayer is not a jet injector.” FDA also notes the following:

• Currently, there is only one vaccine, Measles, Mumps, and Rubella (MMR), that is approved and specifically labeled for administration by jet injector.
• Safety and effectiveness information that would support labeling inactivated influenza vaccines for delivery by jet injector have not been submitted to FDA.
• At this time, there are no inactivated influenza vaccines that are approved and specifically labeled by FDA for administration by jet injector.

FDA recommends that all approved vaccines, including influenza, be administered in accordance with their approved labeling, and FDA advises that if a vaccine has been approved for administration with a jet injector, information specifically addressing vaccine use with a jet injector will appear in the vaccine labeling. Additional background information is available in the FDA communication.