For the first time ever, the US FDA has approved a needle-free injection system to deliver the seasonal flu vaccine.
The approval allows for the administration of bioCSL’s flu vaccine Afluria with a needle-free injection device, known as the PharmaJet Stratis needle-free injection system, for intramuscular injection in adults 18 through 64 years of age.
Afluria is also approved for intramuscular injection using a sterile needle and syringe for persons five years old and older.Injector QuestionsIn the past several years the FDA said it has received questions regarding the use of jet injector devices to administer inactivated influenza vaccines.
But the agency notes that with the exception of Afluria, “all other inactivated influenza vaccines labeled for IM injection are approved for administration using a sterile needle and syringe only,” the agency says in a Q&A on the approval.
However, Sanofi Pasteur’s Fluzone Intradermal was approved for intra-dermal administration, though “this vaccine is supplied in its own microinjection system,” the FDA says, noting that MedImmune’s live attenuated influenza vaccine, FluMist, may also be administered through the nose as a spray.
More Side Effects
Although the needle-free injection system received FDA approval, the agency noted that “injection-related side effects were reported more frequently by those individuals who received Afluria via the PharmaJet Stratis Needle-Free Injection System, than those individuals who received Afluria by a sterile needle and syringe.”
The safety was evaluated in approximately 1,200 adults aged 18 through 64, with half receiving Afluria via the PharmaJet Stratis needle-free injection system and the other half receiving the vaccine via a needle and syringe. The most commonly reported injection-site side effects by individuals who received Afluria via the PharmaJet Stratis Needle-Free Injection System were tenderness, swelling, pain and redness.
Heather Potters, co-founder, co-chairman and global business development officer at PharmaJet, told us, "The PharmaJet Needle-Free injections had slightly higher local reactions than needle and syringe but these were mild in intensity, well-tolerated and mostly resolved within three days."
As far as immunogenicity, which was evaluated in approximately 1,100 adults, those who received Afluria via the PharmaJet Stratis needle-free injection system “had antibody levels against influenza virus that were non-inferior to those who received Afluria by sterile needle and syringe administration,” according to the FDA.
Two other studies that the FDA said it’s aware of found similar results in terms of immune response and side effects.As far as the delivery of other vaccines via the jet injector, the FDA warns that the jet injector “subjects the vaccine to a different pressure than it would receive during administration by sterile needle and syringe and as a result the effectiveness and the safety profile of the injected vaccine may be altered.
Therefore, jet injectors that have been cleared by FDA to deliver medications and vaccines should be used to deliver only those medical products that are labeled for use with a specific jet injector.”The injector itself is a reusable device, while the needleless syringe, which actually comes into contact with the patient, is single use, sterile, and disposable.