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Safety assessment of recalled Haemophilus influenzae type b (Hib) conjugate vaccines—United States, 2007–2008
Author(s) -
Huang WanTing,
Chang Soju,
Miller Elaine R.,
Woo Emily Jane,
Hoffmaster Alex R.,
Gee Jay E.,
Clark Thomas A.,
Iskander John K.,
Ball Robert,
Broder Karen R.
Publication year - 2010
Publication title -
pharmacoepidemiology and drug safety
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.023
H-Index - 96
eISSN - 1099-1557
pISSN - 1053-8569
DOI - 10.1002/pds.1909
Subject(s) - medicine , hib vaccine , bacillus cereus , conjugate vaccine , bacteremia , haemophilus influenzae , pediatrics , genotyping , adverse effect , virology , immunology , immunization , genotype , microbiology and biotechnology , biology , antigen , bacteria , antibiotics , biochemistry , gene , genetics
Purpose On 13 December 2007, Merck & Co., Inc. voluntarily recalled 1.2 million doses of Haemophilus influenzae type b (Hib) vaccines that had been distributed since April 2007 for concerns regarding potential Bacillus cereus contamination. Enhanced postrecall surveillance was conducted to detect vaccine‐associated B. cereus infections. Methods We reviewed reports involving recalled Hib vaccines received by the Vaccine Adverse Event Reporting System (VAERS) during 1 April 2007–29 February 2008. For each reported death, autopsy review sought evidence of B. cereus infections. For each specified outcome, the proportional reporting ratios (PRRs) were calculated to compare the recalled Hib vaccines with the manufacturer's nonrecalled Hib vaccines in the VAERS databases. On 20 December 2007, we used the Epidemic Information Exchange ( Epi‐X ) to solicit nongastrointestinal vaccine‐associated B. cereus infections, and requested B. cereus isolates for genotyping to compare with the manufacturing facility isolate. Results VAERS received 75 reports involving recalled Hib vaccines; none described a confirmed B. cereus infection. Comparative analyses did not reveal disproportionate reporting of specified outcomes for recalled Hib vaccines. The Epi‐X posting triggered one report of vaccine‐associated B. cereus bacteremia from a child who received a nonrecalled Hib vaccine manufactured by Merck; the genotypes of isolates from the patient and the manufacturing facility differed. Conclusions No evidence of vaccine‐associated B. cereus infection had been found in recipients of recalled Hib vaccines. Conducting laboratory surveillance through Epi‐X was feasible and may enhance public health response capacities for future vaccine safety emergencies. Published in 2010 by John Wiley & Sons, Ltd.