FDA discourages injector use for flu vaccines; why are they approved?
The FDA warned against the use of jet injectors for administering influenza flu vaccines in an Oct. 21 statement. Now, Portland, Ore.-based Bioject Medical Technologies, a developer of needle-free drug delivery systems, is questioning why the FDA cleared two such devices for that use.
According to the FDA, vaccines cleared by the agency should be administered according to their labeling, and those labeled intramuscular, subcutanneous or intradermal are intended for use with a needle and syringe, unless stated otherwise. Currently, only the Measle Mumps and Rubella (MMR) vaccine is approved for administration by a jet injector.
“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,” the FDA stated. “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 the Center for Biologics Evaluation and Research for review and approval.”
Bioject’s Biojector 2000 and Bioject ZetaJet were both previously cleared by the FDA with indications for use with vaccines, according to the company.
“The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices, the Biojector 2000 and the Bioject ZetaJet, are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other drugs,” said Ralph Makar, president and CEO of Bioject. “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”
According to the FDA, vaccines cleared by the agency should be administered according to their labeling, and those labeled intramuscular, subcutanneous or intradermal are intended for use with a needle and syringe, unless stated otherwise. Currently, only the Measle Mumps and Rubella (MMR) vaccine is approved for administration by a jet injector.
“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,” the FDA stated. “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 the Center for Biologics Evaluation and Research for review and approval.”
Bioject’s Biojector 2000 and Bioject ZetaJet were both previously cleared by the FDA with indications for use with vaccines, according to the company.
“The FDA communication on the use of jet injectors with influenza vaccines was surprising given that Bioject’s Needle-Free Injection Devices, the Biojector 2000 and the Bioject ZetaJet, are both FDA 510(k) cleared with indications for use that describe their use in delivery of subcutaneous or intramuscular injections of vaccines and other drugs,” said Ralph Makar, president and CEO of Bioject. “We are looking into the matter to better understand the situation and the FDA’s concerns. A number of Bioject’s Needle-Free Injection devices have been on the market for many years and we are committed to resolving this matter with the FDA in a timely manner.”