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In this MD Newsline exclusive interview with Dr. Tom Shimabukuro of the CDC’s Immunization Safety Office, we discuss why the CDC monitors vaccine safety.

MD Newsline:

Why does the CDC monitor the safety of vaccines once they have been authorized or licensed by the FDA? 

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Dr. Tom Shimabukuro:

“The standards for vaccine safety are quite high. These vaccines undergo rigorous testing for safety and efficacy prior to being authorized by the FDA. And the clinical trials for the COVID-19 vaccines have been fairly large, including tens of thousands of individuals.

These trials are very good at characterizing the basic safety profile of these vaccines and detecting and characterizing common adverse events, like local injection site reactions and systemic reactions. However, for adverse events that may be quite rare on the order of one per hundred thousand, or even rarer, it’s unlikely that they’d be detected in clinical trials. And so, it’s important that we monitor these vaccines after they’ve been authorized and approved and are being used in the community.

Another reason why the CDC monitors vaccine safety is that clinical trials tend to exclude individuals with certain chronic diseases and pregnant women. And of course, we are vaccinating people with these chronic diseases, and we’re vaccinating pregnant women. So the way we collect safety data on vaccination in these individuals is through post-authorization or post-licensure safety monitoring, which the CDC conducts routinely for all authorized and licensed vaccines.”


Responses have been condensed and lightly edited.

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