title: Communicating vaccine safety during the development and introduction of vaccines.
abstract: Vaccines are the best defense available against infectious diseases. Vaccine safety is of major focus for regulatory bodies, vaccine manufacturers, public health authorities, health care providers and the public as vaccines are often given to healthy children and adults as well as to pregnant woman. Safety assessment is critical at all stages of vaccine development. Effective, clear and consistent communication of the risks and benefits of vaccines and advocacy during all stages of clinical research (including the preparation, approvals, conduct of clinical trials through the post marketing phase) is critically important. This needs to be done for all major stakeholders (e.g. community members, Study Team, Health Care Providers, Ministry of Health, Regulators, Ethics Committee members, Public Health Authorities and Policy Makers). Improved stakeholder alignment would help to address some of the concerns that may affect the clinical research, licensing of vaccines and their wide-spread use in immunization programs around the world.
authors: PATH, New Delhi, India. sonalikochhar@yahoo.co.in.
authors: Sonali
authors: S
authors: Kochhar
mesh_terms: D016907:Adverse Drug Reaction Reporting Systems; D003299:Cooperative Behavior; D017277:Drug Approval / Q000379:methods*; D055808:Drug Discovery / Q000379:methods*; D058015:Health Communication / Q000379:methods*; D006801:Humans; D017589:Immunization Programs; D007115:Immunization Schedule; D033183:Interdisciplinary Communication; D010342:Patient Acceptance of Health Care; D061214:Patient Safety; D011050:Policy Making; D065840:Protective Factors; D018570:Risk Assessment; D012307:Risk Factors; D035502:Trust; D014611:Vaccination / Q000009:adverse effects; D014612:Vaccines / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014612:Vaccines