An assessment of the safety of adolescent and adult tetanus-diphtheria-acellular pertussis (Tdap) vaccine, using active surveillance for adverse events in the Vaccine Safety Datalink.
Using a new sequential analytic method, the safety of tetanus-diphtheria-acellular pertussis (Tdap) vaccine was monitored weekly among subjects aged 10-64 years during 2005-2008. Encephalopathy-encephalitis-meningitis, paralytic syndromes, seizures, cranial nerve disorders, and Guillain-Barré syndrome were selected as outcomes based on previous reports and biologic plausibility. The risk following Tdap was not significantly higher than the risk after Td. Statistical power was sufficient to detect a relative risk of 4-5 for Guillain-Barré syndrome and 1.5-2 for the other outcomes. This study provides reassurance that Tdap is similar in safety to Td regarding the outcomes studied and supports the viability of sequential analysis for post-licensure vaccine safety monitoring.
Yih
W Katherine
WK
Department of Ambulatory Care and Prevention, Harvard Medical School and Harvard Pilgrim Health Care, Boston, MA 02215, USA. katherine_yih@harvardpilgrim.org
Nordin
James D
JD
Kulldorff
Martin
M
Lewis
Edwin
E
Lieu
Tracy A
TA
Shi
Ping
P
Weintraub
Eric S
ES
D000293:Adolescent; D000328:Adult; D002648:Child; D003389:Cranial Nerve Diseases / Q000139:chemically induced; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects*; D004660:Encephalitis / Q000139:chemically induced; D005260:Female; D020275:Guillain-Barre Syndrome / Q000139:chemically induced; D006801:Humans; D008297:Male; D008581:Meningitis / Q000139:chemically induced; D008875:Middle Aged; D010243:Paralysis / Q000139:chemically induced; D011358:Product Surveillance, Postmarketing / Q000379:methods*; D018570:Risk Assessment / Q000706:statistics & numerical data; D012640:Seizures / Q000139:chemically induced; D055815:Young Adult
D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines