The FDA has approved the first influenza vaccine formulation for administration via a novel intradermal microinjection system.
The Fluzone Intradermal vaccine uses an ultra-fine 0.06 inch needle that is 90% shorter than the typical 1 inch to 1.5 inch needle used to deliver the licensed intramuscular Fluzone formulation, according to a press release from the manufacturer Sanofi Pasteur.
The new formulation is indicated for adult patients aged 18 to 64 years for the subtype A and type B influenza virus, and consists of a either a 0.5 mL or 0.1 mL prefilled dosage with 15 mcg or 9 mcg of hemagglutinin, respectively, per strain of influenza.
The approval is based on data from a phase-3 clinical trial involving 4,276 adults that indicated that the intradermal formulation induced a similar immunologic response as the intramuscular vaccine and had comparable adverse events.
The most common adverse reactions to the vaccine included visible injection-site events such as redness, swelling, induration, pain and itching. Those in the intradermal group experienced more frequent adverse reactions with the exception of pain, which was similar in both groups. Other adverse events include headache, muscle ache and malaise.
The vaccine should not be administered to anyone with severe allergic reaction to any component of the vaccine, including egg protein, or to patients who have experienced anaphylaxis with previous doses of influenza vaccine, the manufacturers warned.