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Vaccines are among the safest tools of modern medicine that help in protecting against disease by inducing immunity. In all countries, routine immunization represents a fundamental service of the public health system, offering one of the most cost-effective methods of reducing morbidity and mortality among children less than five. A lack of complete vaccine coverage increases the risk of disease for the entire population. Pharmacovigilance is the science related to the safety of drugs and it helps prevent harmful effects of the drugs in population. It originated with thalidomide tragedy that caused 10000 birth defects in children. Regulatory systems were established soon to bring an improvement in post-marketing surveillance for the safer medicines.
Since the majority of vaccines are administered to a vulnerable (children) as well as healthy population, a strict safety supervision of vaccines is essential. Safety issues in vaccines may lead to rumors and undermine a general confidence in vaccination and, ultimately, have dramatic consequences on immunization coverage and disease incidence. Safety of vaccines, therefore, must be excellent to make it acceptable, since it usually has a deferred individual benefit, but immediate adverse drug reactions (ADRs). Vaccine pharmacovigilance is defined as the science and activities relating to the detection, assessment, understanding, prevention, and communication of adverse events following immunization, or of any other vaccine- or immunization-related issues. The WHO defines an adverse event following immunization (AEFI) as "a medical incident that takes place after an immunization causes concern, and is believed to be caused by the immunization." The goal of vaccine pharmacovigilance is the early detection and timely response to adverse events following immunization, in order to minimize negative effects to the health of individuals and lessen the potential negative impact on immunization of population.
Although vaccines are considered to be medicines with anti-infective activity that work by immunological action and administered for prophylaxis, pharmacovigilance for vaccines should be different from other drugs because of the following reasons.