Safety review of the purified chick embryo cell rabies vaccine: Data from the Vaccine Adverse Event Reporting System (VAERS), 1997-2005.
On October 20, 1997, the U.S. Food and Drug Administration (FDA) licensed Purified Chick Embryo Cell (PCEC, RabAvert) vaccine against rabies in humans following clinical trials demonstrating safety and efficacy. From October 1997 through December 2005, the Vaccine Adverse Event Reporting System (VAERS) received 336 reports of adverse events (AEs) following vaccination with PCEC vaccine in the U.S.; there were no death reports. Serious events, including 20 hospitalizations and 13 neurological events, were described in 24 (7%) reports. There was no pattern among the 13 neurological AEs suggesting a plausible relationship to vaccination. A total of 20 AEs, 3 serious, were classified as possible anaphylaxis. There were 312 non-serious AEs (93%). Nineteen reports (6%) described that the vaccination series was discontinued because of non-serious AEs. Most reported AEs are non-serious and consistent with pre-licensure safety data. The rabies risk must be carefully considered before vaccine discontinuation.
Dobardzic
Azra
A
Food and Drug Administration, Center for Biologics Evaluation and Research, 1401 Rockville Pike, Rockville, MD 20852, USA. azra.dobardzic@fda.hhs.gov
Izurieta
Hector
H
Woo
Emily Jane
EJ
Iskander
John
J
Shadomy
Sean
S
Rupprecht
Charles
C
Ball
Robert
R
Braun
M Miles
MM
D000293:Adolescent; D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems; D000368:Aged; D000369:Aged, 80 and over; D000707:Anaphylaxis; D001183:Arthus Reaction / Q000209:etiology; D002648:Child; D002675:Child, Preschool; D005260:Female; D006760:Hospitalization; D006801:Humans; D007223:Infant; D007231:Infant, Newborn; D008297:Male; D008508:Medication Errors; D008875:Middle Aged; D009422:Nervous System Diseases / Q000209:etiology; D011819:Rabies Vaccines / Q000008:administration & dosage / Q000009:adverse effects*; D013575:Syncope / Q000209:etiology
D011819:Rabies Vaccines