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Nội dung text 16. STUDIES OF VACCINE SAFETY.pdf

PHARMD GURU Page 1 INTRODUCTION:  A vaccine is a biological preparation that improves immunity to a particular disease.  Vaccines are among the most cost-effective and prevalent public health interventions.  Morbidity & mortality declined where immunizations are practiced.  Vaccine safety is prime for  Public  Manufacturer  Immunization providers  Recipients of vaccines  No vaccine is completely safe or completely effective, while all known vaccine adverse events are minor and self-limited; some vaccines have been associated with rare but serious health effects.  Knowledge and research capacity has been limited by:  Inadequate understanding of biologic mechanisms underlying adverse events.  Insufficient information from case reports & case series.  Limitations of existing surveillance systems to provide evidence of causation.  To overcome these limitations:  Epidemiology is vital in providing scientific methodology for assessing vaccine safety. IMPORTANCE OF VACCINE SAFETY:  Decrease in disease risks and increased attention on vaccine risk.  Public confidence in vaccine safety is critical  Higher standard of safety.  Vaccines are generally healthy.  Lower risk tolerance = Need to search for a rare reaction  Vaccination is universally recommended and mandated. STUDIES OF VACCINE SAFETY


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