Dear Colleagues,

Vaccines have been one of the most successful medical and public health interventions, preventing disease and saving health care costs. The safety standards for vaccines are very high given the near universal use of many vaccines, vaccines are used among children, pregnant women, and other vulnerable populations, and vaccines are given to prevent illness rather than to treat disease. Clinical trials conducted before licensure ensures that common and serious adverse reactions do not occur due to vaccination in the populations studied for products that are licensed and widely used. However, clinical trials cannot detect adverse reactions that are rare because of limits to sample size. It is difficult to study adverse health outcomes with delayed onset in clinical trials as follow-up of participants is limited. Additionally, vaccines are often used in populations excluded from clinical trials. Consequently, post-licensure vaccine safety surveillance and observational studies are often employed for these purposes. Often the full safety profile of a vaccine is not fully characterized until hundreds of thousands to millions of people are vaccinated and appropriate studies are conducted. When a vaccine is found to be associated with an adverse health outcome, it is often important to understand the biological mechanism(s) causing the adverse reaction. The science of vaccine safety is particularly important given the success of many vaccines in preventing disease and a change in public focus from the risks of disease to the risks from vaccines, coupled with misinformation abundantly available on the internet and at times perpetuated in the media. This supplement will focus on vaccine safety studies, including laboratory studies, animal studies, clinical trials, post-licensure studies, and investigations into biological mechanisms causing vaccine adverse reactions.

Dr. Daniel Salmon
Guest Editor

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• adverse events following immunization
• vaccine adverse reactions
• vaccine safety
• immunization safety