How safe are vaccines?
A. Vaccine safety is very important to the American Academy of Pediatrics (AAP) and pediatricians. Vaccines are developed under the strictest safety guidelines and require years of testing before they can even be administered. According to the Centers for Disease Control (CDC), the United States has the safest and most effective vaccine supply in history.
Before vaccines are made available they are tested for safety and efficacy in clinical trials and then in mass trials. All vaccines marketed in Australia are manufactured according to strict safety guidelines and are evaluated by the Therapeutic Goods Administration to ensure they are efficacious and are of adequate quality and safety prior to marketing approval being granted. After introduction into immunisation schedules there is continuing surveillance of efficacy and safety through trials and post-marketing surveillance. In Australia there are regional and national surveillance systems actively seeking any adverse events following immunisation. This is necessary, as sometimes problems do occur after vaccines are registered for use. An example is rotavirus vaccine, which was licensed in the USA in August 1998. In pre-licensure trials, the vaccine appeared to be safe, but post-licensure surveillance detected a risk of intussusception associated with the vaccine. As soon as this risk