| アブストラクト | BACKGROUND: In March 2009, the U.S. Food and Drug Administration licensed an inactivated, Vero cell culture-derived Japanese encephalitis vaccine (JE-VC [Ixiaro]) for use in adults. The vaccine was licensed based on clinical trial safety data in 3558 JE-VC recipients. It is essential to monitor post-licensure surveillance data to evaluate the safety of JE-VC because rare adverse events may not be detected until the vaccine is administered to a larger population. METHODS: We reviewed adverse events reported to the U.S. Vaccine Adverse Event Reporting System (VAERS) for adults (>/=17 years) who received JE-VC from May 2009 through April 2012. Adverse event reporting rates were calculated using 275,848 JE-VC doses distributed. RESULTS: Over the 3 year period, 42 adverse events following vaccination with JE-VC were reported to VAERS for an overall reporting rate of 15.2 adverse events per 100,000 doses distributed. Of the 42 total reports, 5 (12%) were classified as serious for a reporting rate of 1.8 per 100,000 doses distributed; there were no deaths. Hypersensitivity reactions (N=12) were the most commonly reported type of adverse event, with a rate of 4.4 per 100,000 doses distributed; no cases of anaphylaxis were reported. Three adverse events of the central nervous system were reported (one case of encephalitis and two seizures) for a rate of 1.1 per 100,000; all occurred after receipt of JE-VC with other vaccines. CONCLUSIONS: These post-marketing surveillance data suggest a good safety profile for JE-VC consistent with findings from pre-licensure clinical trials. Post-licensure safety data should continue to be monitored for any evidence of rare serious or neurologic adverse events. |
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| ジャーナル名 | Vaccine |
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| 投稿日 | 2014/12/17 |
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| 投稿者 | Rabe, Ingrid B; Miller, Elaine R; Fischer, Marc; Hills, Susan L |
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| 組織名 | Arboviral Diseases Branch, Centers for Disease Control and Prevention, 3156;Rampart Road, Fort Collins, CO 80521, United States. Electronic address:;irabe@cdc.gov.;Immunization Safety Office, Centers for Disease Control and Prevention, 1600;Clifton Road NE, Atlanta, GA 30333, United States.;Rampart Road, Fort Collins, CO 80521, United States. |
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| Pubmed リンク | https://www.ncbi.nlm.nih.gov/pubmed/25498208/ |
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