Safety of pneumococcal conjugate vaccine
At the request of SAGE, the Committee reviewed the safety of pneumococcal conjugate vaccines. A comprehensive review of all evidence on the safety of pneumococcal conjugate vaccines was conducted and presented. Data from 62 studies, including randomized controlled trials and post-marketing studies, were included in the review. While there has been a weak and inconsistent signal of increases in reactive airway conditions in some studies, these apparent effects have not been consistently observed.
The evidence on the safety of the 7-valent pneumococcal conjugate vaccine and other pneumococcal conjugate vaccines is reassuring. Reports since the licensure of the 7-valent pneumococcal conjugate vaccine in 2000 and widespread use in the United States and, more recently, in Canada and some European countries, have not identified any major safety concerns. There is substantial evidence that when introduced into developing countries, the presently available pneumococcal conjugate vaccines will have a considerable impact on pneumococcal disease and overall infant mortality. Nevertheless, as with the introduction of any new vaccine, it will be important to conduct surveillance for possible rare and unexpected effects.