This study used RWD to estimate background IRs to enable general population comparisons for newly vaccinated populations. As the use of RWD increases, it’s important to understand its strengths as well as its limitations to ensure the accuracy and reliability of results so that decisions made by regulators, healthcare providers, and patients are well informed to best serve public health.
This study highlights the utility of background rates and how they can be useful in identifying new safety signals for new vaccines. By using multiple case definitions and identifying outcomes that vary greatly depending on case definition, researchers can better target outcomes that would benefit from further refined definitions (algorithm development) and validation studies to provide more accurate results.
In future research, whether it be for the pneumococcal vaccines, COVID-19 vaccines, or other vaccines, researchers can consider the historical background IRs found in this study to contextualize further findings.
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