FDA- Use of Jet Injectors with Influenza Vaccines

FDA Warns Pharmacies to Stop Pushing Needle-Free Flu Vaccine

For this year’s flu season, many pharmacies are for the first time offering painless, needle-free shots to ward off the disease. But there’s one big problem: The FDA says they may not work.

The agency on Friday warned doctors, nurses and pharmacists “not to use injector devices to administer influenza vaccines.” The agency’s alert notes it has not approved any “injector devices” for use with the flu vaccine.

“The FDA has no data to support the safety or effectiveness” of flu vaccines delivered by jet injector, the alert reads.

So patients who already received the shot may need to go back and get a jab in the arm with a needle after all.

PharmaJet, a Colorado-based company, has been marketing its device as a proven flu-fighting tool. In place of a needle, PharmaJet uses a high-pressure steam of liquid to pierce the skin and deliver the vaccine.

“PharmaJet’s needle-free injectors have received FDA marketing clearance for use with liquid medicines and vaccines and are available throughout the United States,” company president James Bowman said in a recent press release.

While the device has been approved for use with some drugs, FDA spokeswoman Shelley Burgess said flu vaccines are out of the question.

“Vaccines are labeled with specific instructions for how those vaccines should be administered,” Burgess said. “At this time, there are no vaccines for the prevention of influenza disease that are approved by the FDA for administration by jet injector.”

Heather Potters, chairman of PharmaJet, told ABC News company representatives have contacted top FDA officials to protest the move. Potters said there is nothing in FDA policy that should forbid medical professionals from using the PharmaJet injection device for flu vaccination and she insists jet injectors have been used for decades to successfully vaccinate people against many diseases, including influenza. The agency’s action, Potters said, came without warning.

Kroger Pharmacy, the fifth largest pharmacy chain in the United States, had been offering the PharmaJet injection to customers at some of its locations. On Friday, Kroger announced it had “immediately discontinued use of such clinical devices” at its pharmacies.

“Kroger is seeking guidance from the Centers for Disease Control and Food and Drug Administration regarding revaccinations,” a prepared statement released by the company said.

Bioject, an Oregon company, also makes a needle-free device that’s being used by several pharmacies to administer flu shots this year. Publix, one of the nation’s largest grocery chains, had announced it would test the Bioject jet injection in 52 of its stores in the Southeast.

As for those who still need to get vaccinated, if you truly hate needles, there’s still the nasal spray FluMist.

FDA Communication on Use of Jet Injectors with Influenza Vaccines
Date Issued: October 21, 2011

Audience: Health care professionals who administer influenza vaccines

Purpose: The Food and Drug Administration (FDA) is advising health care professionals not to use injector devices to administer influenza vaccines. Furthermore, the FDA recommends that all vaccines, including influenza, be administered in accordance with their labeling.

Summary of Issue

The FDA has recently received questions regarding the use of jet injector devices to administer influenza vaccines. Vaccines that are approved by the FDA have information in their labeling about how the vaccines should be administered. The information contained in the labeling is based on the scientific information submitted to the FDA in support of product approval, and it includes information that reflects how the vaccines were studied. Vaccines labeled for intramuscular (IM), subcutaneous (SC) or intradermal (ID) injection are intended for administration using a needle and syringe unless otherwise specified.

• Currently, there is only one vaccine, Measles, Mumps and Rubella (MMR), that is approved for administration by jet injector.
• The FDA has no data to support the safety or effectiveness of other vaccines delivered by jet injector.
• At this time, there are no vaccines for the prevention of influenza disease that are approved by the FDA for administration by jet injector.

Background Information

FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for regulating biological products, including vaccines. When the 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. This information is included in the Dosage and Administration section of the vaccine labeling. Changes in the dose, route and/or method of administration have the potential to impact immunogenicity, and therefore, the safety and/or efficacy of a vaccine.

Influenza vaccines have been approved only for administration by needle injection or nasal mist sprayer. They have not been evaluated for delivery by jet injection. Jet injectors represent a different method of delivery that has the potential to change the characteristics of an approved vaccine. 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 CBER for review and approval.

FDA’s Center for Devices and Radiological Health (CDRH) is responsible for regulating medical devices, including products used to administer drugs and biologics (such as vaccines).

Devices such as jet injectors are cleared to administer approved drugs or biologics in accordance with the drug or biologic’s approved labeling. Once a particular vaccine is approved and labeled for administration by jet injector, any jet injector system deemed by the FDA to be substantially equivalent to others in that class of administration systems may be used to administer that vaccine.

The FDA has approved only one vaccine, (MMR), for administration with a jet injector. None of the vaccines licensed for the prevention of influenza disease is currently approved for administration by this method.

Recommendations/Actions

The FDA recommends against using injector devices to administer influenza vaccines.

The FDA recommends that all approved vaccines, including influenza, be administered in accordance with their labeling.

The FDA recommends that health care professionals carefully review the Dosage and Administration section of approved vaccine labeling and the product labeling on injector devices prior to any vaccine administration.

Contact Information:

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 ocod@fda.hhs.gov.