FDA Updated Communication on Use of Jet Injectors with Inactivated Influenza Vaccines
Date Issued: August 15, 2014
Audience: Healthcare professionals who administer inactivated influenza vaccines
Purpose: The Food and Drug Administration (FDA) is providing updated information to healthcare professionals on the administration of the inactivated influenza vaccine, Afluria (manufactured by bioCSL Pty Ltd.). On August 15, 2014 FDA approved the administration of Afluria for use with one jet injector device, the PharmaJet Stratis Needle-free Injection System (manufactured by PharmaJet Inc.) for intramuscular injection in adults 18 through 64 years of age. For adults 18 through 64 years of age, Afluria may be administered by intramuscular injection with either the PharmaJet Stratis Needle-free Injection System or with a sterile needle and syringe.
FDA continues to recommend that healthcare professionals use a sterile needle and syringe to administer Afluria to persons 5 through 17 years of age and to persons 65 years of age and older.
FDA continues to recommend that healthcare professionals use a sterile needle and syringe to administer other inactivated influenza vaccines.
- Summary of the Issue
- Background Information
- Safety and Effectiveness of Afluria Administered with PharmaJet Stratis Needle-Free Injection System
- Administration of Afluria to Other Age Groups and Administration of Other Inactivated Influenza Vaccines
- Recommendations/Actions
- Questions and Answers
- Contact Information
FDA has approved the administration of the inactivated influenza vaccine, Afluria (manufactured by bioCSL Pty Ltd.) for use with the PharmaJet Stratis Needle-Free Injection System (manufactured by PharmaJet Inc.) for intramuscular injection in adults 18 through 64 years of age. Afluria continues to be approved for intramuscular injection using a sterile needle and syringe for persons 5 years of age and older.
In the past several years FDA has received questions regarding the use of jet injector devices to administer inactivated influenza vaccines. 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. With the exception of Afluria, (which may also be administered IM with the PharmaJet Stratis Needle-Free Injection System to adults ages 18 through 64), all other inactivated influenza vaccines labeled for IM injection are approved for administration using a sterile needle and syringe only.
However, there is one inactivated influenza vaccine, Fluzone Intradermal (manufactured by Sanofi Pasteur Inc.) approved for ID administration; this vaccine is supplied in its own microinjection system. The live attenuated influenza vaccine, FluMist (manufactured by MedImmune, LLC) is administered through the nose as a spray; the sprayer is not a jet injector.
FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for regulating biological products, including vaccines. When FDA approves a vaccine, the approval is based on scientific information demonstrating the safety and effectiveness of that vaccine in a given population (e.g., children, adults or the elderly), using a specific dose, schedule and method/route of administration. Changes in the dose, route and/or method of administration have the potential to impact the effectiveness and the safety profile of a vaccine.
FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices, including those used to administer drugs and biologics (such as vaccines). Jet injectors that have been cleared by FDA to deliver medications and vaccines should be used to deliver only those medications and vaccines that have been approved and specifically labeled for use with a specific jet injector.
Safety and Effectiveness of Afluria Administered with PharmaJet Stratis Needle-Free Injection System
To date, Afluria is the only inactivated influenza vaccine FDA has approved for administration with the PharmaJet Stratis Needle-Free Injection System. Currently, this is the only jet injector that may be used to administer Afluria, and it may be used to administer Afluria only to adults 18 through 64 years of age. This approval is based on clinical data submitted to and evaluated by FDA.
The safety was evaluated in approximately 1,200 adults 18 through 64 years of age; half received Afluria via the PharmaJet Stratis Needle-Free Injection System and half received Afluria 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. These 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.
Immunogenicity was evaluated in approximately 1,100 adults 18 through 64 years of age; half received Afluria via the PharmaJet Stratis Needle-Free Injection System and half received Afluria via a needle and syringe. 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.
Administration of Afluria to Other Age Groups and Administration of Other Inactivated Influenza Vaccines
Afluria, for use in children and adolescents 5 through 17 years of age and adults 65 years of age and older is approved for administration with a sterile needle and syringe only. All other inactivated influenza vaccines are approved for administration by sterile needle injection only. The clinical studies submitted in support of approval of these other inactivated influenza vaccines did not include evaluation of safety and effectiveness following administration by a jet injector. If a manufacturer wants to include a jet injector as a method of vaccine administration in its vaccine labeling, the safety and effectiveness data to support administration of the vaccine using this delivery method must be submitted to FDA for evaluation and approval.
Afluria may be administered to adults ages 18 through 64 intramuscularly via the PharmaJet Stratis Needle-Free Injection System or by sterile needle and syringe.
Afluria, for use in children and adolescents 5 through 17 years of age is approved for intramuscular injection with a sterile needle and syringe only.
Afluria, for use in adults 65 years of age and older is approved for intramuscular injection with a sterile needle and syringe only.
If a vaccine is approved for administration with a jet injector, information specifically addressing vaccine use with the specific jet injector will appear in the vaccine labeling.
FDA recommends that all approved vaccines, including influenza, be administered in accordance with their approved labeling.
Are there data on the safety and effectiveness of inactivated influenza vaccine administered using a jet injector?
FDA has approved the use of Afluria administered by intramuscular injection with the PharmaJet Stratis Needle-Free Injection System for people 18 through 64 years of age, based on its evaluation of supporting safety and effectiveness data.
Data with other licensed inactivated influenza vaccines are limited. FDA is aware of a study conducted in healthy young adults published in 2001 (Jackson, et al. Vaccine 2001) that reported that the immune response to an inactivated influenza vaccine administered with a jet injector was comparable to that following administration using a needle and syringe. Those people vaccinated with the jet injector in this study tended to have more pain and redness at the injection site. Another study in young healthy adults by Simon, et al (Vaccine, 2011) reported that the immune response was similar following an influenza vaccine administered by syringe or jet injector; however, redness and swelling occurred more frequently in those vaccinated with the jet injector. Demonstration of non-inferior immune response following vaccination by jet injector compared to needle and syringe was not an objective of either study.
If a jet injector has been cleared by FDA for administration of vaccines, does that mean it can be used to administer inactivated influenza vaccines?
A jet injector may only be used to administer an inactivated influenza vaccine that is labeled for this method of administration; i.e., the specific jet injector will be identified in the vaccine label. Currently, Afluria is the only inactivated influenza vaccine labeled for administration via a specific jet injector, the PharmaJet Stratis Needle-Free Injection System.
A 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.
Does FDA recommend that inactivated influenza vaccinations be given by jet injector?
FDA recommends that inactivated influenza vaccines be administered with a needle and syringe, unless the FDA-approved vaccine labeling specifies otherwise. If a vaccine is approved for administration with a specific jet injector, information specifically addressing vaccine use with that jet injector will appear in the vaccine labeling.
What should I do if I got an influenza vaccine using a needle-free jet injector and the vaccine was not labeled for administration via jet injector? Do I need to get vaccinated again?
Based on limited information from recent publications using currently licensed inactivated influenza vaccines, FDA believes that people who got their influenza vaccine via jet injector do not need to be re-vaccinated.
Why is administration of Afluria with the PharmaJet Stratis Needle-Free Injection System only approved for adults ages 18 through 64?
Data submitted to and evaluated by the FDA regarding the safety and effectiveness of Afluria administered with PharmaJet Stratis Needle-Free Injection System was for only adults ages 18 through 64. FDA has not evaluated the safety and effectiveness of administration of Afluria with the PharmaJet Stratis Needle-Free Injection System for other age groups.
Will FDA approve administration of Afluria or other inactivated influenza vaccines with a jet injector in children or in the elderly?
FDA will thoroughly evaluate any data submitted regarding the safety and effectiveness of an inactivated influenza vaccine administered with a jet injector. Approval for administration of an inactivated influenza vaccine via jet injector will be based on the demonstration of the safety and effectiveness of that vaccine in a given population (e.g., children and the elderly).
What should I know about administration of a vaccine with a jet injector? Is it different than getting the vaccine through a needle and syringe? Is it sterile? Will it hurt? Are there any other side effects?
Jet injectors, like the PharmaJet Stratis Needle-Free Injection System, are needleless systems for vaccine or medication administration that utilize a high-pressure jet of liquid to penetrate the skin. During administration, the needleless syringe is placed against the injection site and as the medication or vaccine passes through the injector under high pressure it forms a jet of fluid that penetrates the skin.
The injector itself is a reusable device. The needleless syringe (the part which comes in contact with the patient’s skin) is single use, sterile, and disposable.
In a study published in 2001 (Jackson et. al. Vaccine 2001) participants vaccinated with a jet injector tended to have more pain and redness at the injection site. Another study by Simon, et al (Vaccine, 2011) reported that redness and swelling occurred more frequently in those vaccinated with a jet injector. These findings are also consistent with the study that supported approval of Afluria administered via the PharmaJet Stratis Needle-Free Injection System; the group who received Afluria via the PharmaJet Stratis Needle-Free Injection System reported tenderness, swelling, pain and redness more frequently than the group who received Afluria by a sterile needle and syringe.
Where can I find more information about the PharmaJet Stratis Needle-Free Injection System?
Information on the PharmaJet Needle-free Injection System is available on FDA’s website: http://www.accessdata.fda.gov/cdrh_docs/pdf8/k081532.pdf
This device is regulated by FDA’s Center for Devices and Radiological Health (CDRH). Questions about the PharmaJet Needle-free Injector System can be directed to CDRH at [email protected] or at 1-800-638-2041.
If you have questions about this communication, please contact CBER’s Office of Communication, Outreach and Development by phone at 1-800-835-4709, or email at [email protected].