Aluminum-containing vaccine associated adverse events: role of route of administration and gender

Anthrax vaccine, adsorbed (AVA) is a vaccine containing aluminum hydroxide that is administered as six subcutaneous (SQ) doses over 18 months. It is the only aluminum hydroxide licensed for SQ administration. To optimize the vaccination schedule and route of administration, a prospective pilot study comparing the use of fewer doses administered intramuscularly (IM) as well as SQ with the licensed schedule and route was performed. Data from that study on injection site reactions were extracted for this report. Erythema and induration occurred more commonly when the vaccine was administered SQ compared to IM (P < 0.0001, P = 0.002, respectively). SQ nodules were found only among the SQ group (P < 0.0001). Erythema, induration and SQ nodules were more common in women compared with men (P < 0,001) after the first SQ dose of AVA dose. Reaction rates decreased when the interval between the first two doses of AVA was increased from 2 to 4 weeks. (C) 2002 Published by Elsevier Science Ltd.