BETHESDA, MD 24 October 2011—FDA on October 21 recommended against the use of "injector devices" to administer influenza vaccines, an announcement that appears to have caught the manufacturer of a jet-injection system off-guard.
Bioject Medical Technologies of Portland, Oregon, last month announced that some Publix Super Markets and Fred Meyer Stores locations would offer needle-free flu vaccines to customers this flu season, courtesy of Bioject`s gas-powered injector systems.
According to Bioject, the company has received FDA clearance to market two jet injectors for the subcutaneous or intramuscular delivery of vaccines and other injectable drugs.
The jet injectors are classified as medical devices, which are under the purview of FDA`s Center for Devices and Radiological Health. Influenza vaccines are regulated through FDA`s Center for Biologics Evaluation and Research (CBER).
FDA`s announcement, which appears on CBER`s portion of the agency`s website, states that vaccines are intended for administration "using a needle and syringe unless otherwise specified" in the product`s labeling.
Measles, mumps, and rubella vaccine is the only vaccine whose labeling currently specifies that the product may be administered using a jet injector, according to FDA.
The agency emphasized that vaccines are approved on the basis of safety and efficacy data from studies of a specific dose, administration schedule, and administration method. Changing the administration method may alter the vaccine`s immunogenicity, safety, and efficacy, according to FDA.
After a vaccine has been approved for administration with a jet injector, any jet injector that is classified as "substantially equivalent" to that device can be used to deliver the vaccine, the agency stated.
FDA clarified October 26 that people who have already received an influenza vaccine by jet injector do not need to be revaccinated.
Bioject stated that it understands FDA`s concerns and is committed to a timely resolution of the problem.
