Postlicensure surveillance of human papillomavirus vaccine using the Vaccine Adverse Event Reporting System, 2006–2017
نویسندگان
چکیده
منابع مشابه
Postlicensure safety surveillance for quadrivalent human papillomavirus recombinant vaccine.
CONTEXT In June 2006, the Food and Drug Administration licensed the quadrivalent human papillomavirus (types 6, 11, 16, and 18) recombinant vaccine (qHPV) in the United States for use in females aged 9 to 26 years; the Advisory Committee on Immunization Practices then recommended qHPV for routine vaccination of girls aged 11 to 12 years. OBJECTIVE To summarize reports to the Vaccine Adverse E...
متن کاملThe Vaccine Adverse Event Reporting System (VAERS).
Immunizations against most vaccine-preventable diseases will be needed indefinitely unless the disease is eradicated. Public acceptance of immunizations may be threatened as vaccine coverage increases and disease decreases, however, due to the increase in both causally and coincidentally related vaccine adverse events. The post-marketing surveillance for such events in the USA in response to th...
متن کاملReporting Vaccine Complications: What Do Obstetricians and Gynecologists Know About the Vaccine Adverse Event Reporting System?
BACKGROUND Obstetrician-gynecologists are increasingly called upon to be vaccinators as an essential part of a woman's primary and preventive health care. Despite the established safety of vaccines, vaccine adverse events may occur. A national Vaccine Adverse Event Reporting System (VAERS) is a well-established mechanism to track adverse events. However, we hypothesized that many obstetrician-g...
متن کاملApplication to the Vaccine Adverse Event Reporting System
Background: Spontaneous Reporting Systems [SRS] are critical tools in the post-licensure evaluation of medical product safety. Regulatory authorities use a variety of data mining techniques to detect potential safety signals in SRS databases. Assessing the performance of such signal detection procedures requires simulated SRS databases, but simulation strategies proposed to date each have limit...
متن کاملPostlicensure safety surveillance for varicella vaccine.
CONTEXT Since its licensure in 1995, the extensive use of varicella vaccine and close surveillance of the associated anecdotal reports of suspected adverse effects provide the opportunity to detect potential risks not observed before licensure because of the relatively small sample size and other limitations of clinical trials. OBJECTIVES To detect potential hazards, including rare events, as...
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ژورنال
عنوان ژورنال: Perspectives in Clinical Research
سال: 2020
ISSN: 2229-3485
DOI: 10.4103/picr.picr_140_18