Abstract:
BACKGROUND:Vaccines are one of the greatest achievements in public health. Prevalence and clinical significance of emerging postapproval, vaccine-related safety issues have not been systematically studied. OBJECTIVE:To explore postmarketing safety modifications in U.S. Food and Drug Administration (FDA)-approved vaccine labels. DESIGN:Retrospective cohort study. SETTING:United States. PARTICIPANTS:Initial and subsequent labels of all vaccines that were FDA-approved between 1 January 1996 and 31 December 2015. MEASUREMENTS:The primary aim was a descriptive analysis of the prevalence and characteristics of postapproval, safety-related label changes. The secondary aim was to describe the distribution of data sources triggering these modifications. RESULTS:The study cohort comprised 57 FDA-approved vaccines. Initial approval for 53 (93%) of the vaccines was supported by randomized controlled trials, with a median cohort size of 4161 participants (interquartile range, 2204 to 8634 participants). There were 58 postapproval, safety-related label modifications associated with 25 vaccines (49 warnings and precautions, 8 contraindications, and 1 safety-related withdrawal). The initial approval trial characteristics were similar in vaccines with and without postmarketing, safety-related label modifications. The most common safety issue triggering label modifications was expansion of population restrictions (n = 21 [36%]), followed by allergies (n = 13 [22%]). The most common source of safety data was postmarketing surveillance (n = 28 of 58 [48%]). LIMITATION:The data source of the initial signal triggering safety-related label changes may not necessarily represent all safety data received and processed by the FDA. CONCLUSION:Over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance. PRIMARY FUNDING SOURCE:None.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Tau N,Yahav D,Shepshelovich Ddoi
10.7326/M20-2726subject
Has Abstractpub_date
2020-09-15 00:00:00pages
445-449issue
6eissn
0003-4819issn
1539-3704journal_volume
173pub_type
杂志文章abstract::The competition for funds to conduct clinical research is intense, and only a minority of grant proposals receive funding. In particular, funding for patient-oriented research lags behind that allocated for basic science research. Grant writing is a skill of fundamental importance to the clinical researcher, and condu...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-142-4-200502150-00009
更新日期:2005-02-15 00:00:00
abstract::The association of the Epstein-Barr virus and two human malignancies, Burkitt's lumphoma and nasopharyngeal carcinoma, is reviewed. Seroepidemiologic, virologic, and immunologic evidence is summarized, and several hypotheses regarding a possible etiologic role for the Epstein-Barr virus in these tumors are presented. ...
journal_title:Annals of internal medicine
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doi:10.7326/0003-4819-86-3-323
更新日期:1977-03-01 00:00:00
abstract::The autoimmune lymphoproliferative syndrome (ALPS) affords novel insights into the mechanisms that regulate lymphocyte homeostasis and underlie the development of autoimmunity. This syndrome arises early in childhood in persons who inherit mutations in genes that mediate apoptosis, or programmed cell death. The timely...
journal_title:Annals of internal medicine
pub_type: 共识发展会议,杂志文章,评审
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更新日期:1999-04-06 00:00:00
abstract::Nine of 81 members of two families were found to have renal problems. Three patients in one family had renal-retinal dysplasia with probable recessive inheritance. Of the 6 patients in the second family, one received a kidney transplant from his brother who initially had no detectable renal abnormality but later devel...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-84-2-157
更新日期:1976-02-01 00:00:00
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journal_title:Annals of internal medicine
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doi:10.7326/M18-0343
更新日期:2018-08-21 00:00:00
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journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1984-05-01 00:00:00
abstract::We discuss here some of the last decade's diagnostic and therapeutic advances in the treatment of lung cancer, as well as current and future research objectives. Roentgenographs from selected patients illustrate the natural history of lung cancer. We present perspectives concerning selection from the growing diagnosti...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-83-1-93
更新日期:1975-07-01 00:00:00
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journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
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更新日期:1990-04-01 00:00:00
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journal_title:Annals of internal medicine
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doi:
更新日期:1995-04-15 00:00:00
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journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
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journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,评审
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更新日期:1989-02-15 00:00:00
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journal_title:Annals of internal medicine
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journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
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journal_title:Annals of internal medicine
pub_type: 杂志文章
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更新日期:1980-05-01 00:00:00
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更新日期:2006-05-16 00:00:00
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更新日期:2004-09-07 00:00:00
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journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-87-3-275
更新日期:1977-09-01 00:00:00
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journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
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更新日期:1997-04-01 00:00:00
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journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-98-4-478
更新日期:1983-04-01 00:00:00
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pub_type: 临床试验,杂志文章
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更新日期:2001-05-01 00:00:00
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pub_type: 杂志文章
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更新日期:1997-12-01 00:00:00