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The Vaccine Adverse Event Reporting System (VAERS) is a United States program for vaccine safety, co-managed by the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA). [1]
The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance program administered jointly by the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). [38] VAERS is intended to track adverse events associated with vaccines.
The VICP was adopted in response to concerns over the pertussis portion of the DPT vaccine. [1] Several U.S. lawsuits against vaccine makers won substantial awards. Most makers ceased production, and the last remaining major manufacturer threatened to do so. [1] The VICP uses a no-fault system for resolving vaccine injury claims. [1]
The CDC uses a number of tools to monitor the safety of vaccines. The Vaccine Adverse Event Reporting System (VAERS), a national vaccine safety surveillance program run by CDC and the FDA. "VAERS detects possible safety issues with U.S. vaccines by collecting information about adverse events (possible side effects or health problems) after ...
The NCVIA also mandates that all health care providers must report certain adverse events following vaccination to the Vaccine Adverse Event Reporting System (VAERS). [citation needed] The NCVIA also established a committee from the Institute of Medicine (IOM) to review the existing literature on vaccine adverse events occurring after immunization.
CDC Vaccine Information Statement for MMR Vaccine from April 2012. According to the 1993 amended National Childhood Vaccine Injury Act (NCVIA), a VIS must contain at least the following four components: (1) a description of the benefits of the given vaccine, (2) a description of its risks, (3) information about the National Vaccine Injury Compensation Program (VICP), and (4) other relevant ...
In the United States several reporting systems have been built, such as the Vaccine Adverse Event Reporting System (VAERS), the Manufacturer and User Facility Device Experience Database (MAUDE) and the Special Nutritionals Adverse Event Monitoring System. MedWatch is the main reporting center, operated by the Food and Drug Administration.
Until a vaccine is in use amongst the general population, all potential adverse events from the vaccine may not be known, requiring manufacturers to conduct Phase IV studies for postmarketing surveillance of the vaccine while it is used widely in the public. [103] [109] The WHO works with UN member states to implement post-licensing ...