Lack of association of Kawasaki disease after immunization in a cohort of infants followed for multiple autoimmune diagnoses in a large, phase-4 observational database safety study of 7-valent pneumococcal conjugate vaccine: lack of association between Kawasaki disease and seven-valent pneumococcal conjugate vaccine.

A large-scale, postmarketing observational database safety study was conducted following 7-valent pneumococcal conjugate vaccine (PCV7) licensure. A secondary outcome was the occurrence of predefined diagnoses among PCV7 vaccinees versus historic controls. Forty-two PCV7 recipients and 17 controls were hospitalized for Kawasaki disease (P = 0.

Safety experience with heptavalent pneumococcal CRM197-conjugate vaccine (Prevenar) since vaccine introduction.

Documentation of the safety of any vaccine is of paramount importance given the nature and scale of vaccination as a public health intervention. Prevenar was first approved for use in 2000, and includes seven pneumococcal serotypes conjugated to CRM(197), a carrier protein that has been used safely in multiple conjugate vaccines for more than 20 years. The safety profile of Prevenar was established prior to licensure in 5 clinical trials involving more than 18,000 infants and children.

Prevenar vaccination: review of the global data, 2006.

The 7-valent pneumococcal conjugate vaccine, Prevenar, was first licensed in the United States in 2000 for the prevention of invasive pneumococcal disease (IPD) caused by the serotypes included in the vaccine. It is presently approved in more than 70 countries, and more than 100 million doses of vaccine have been distributed to date. Within 1 year of routine use in the US, incidence of vaccine-serotype IPD had fallen dramatically among children younger than 2 years, with indirect effects noted among other age groups as well.