In the case of the COVID-19 vaccines, randomized controlled trials involving tens of thousands of people, which were reviewed by multiple groups of experts, revealed no serious safety issues and showed that the benefits outweigh the risks. to identify adverse events related to vaccination in near real time. The information is still valuable because it’s a way of being quickly alerted to a potential safety issue with a vaccine, which can then be followed-up by government scientists.Īnother monitoring system is the CDC’s Vaccine Safety Datalink, which uses electronic health data from nine health care organizations in the U.S. There is no screening or vetting of the report and no attempt to determine if the vaccine was responsible for the problem. As its website explains, VAERS “is not designed to detect if a vaccine caused an adverse event, but it can identify unusual or unexpected patterns of reporting that might indicate possible safety problems requiring a closer look.”Īnyone can submit a report to VAERS for any health problem that occurs after an immunization.
One key vaccine safety surveillance program is the Vaccine Adverse Event Reporting System, or VAERS, which is an early warning system run by the Centers for Disease Control and Prevention and FDA.
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In addition, the Food and Drug Administration inspects vaccine production facilities and reviews manufacturing protocols to make sure vaccine doses are of high-quality and free of contaminants.
No vaccine or medical product is 100% safe, but the safety of vaccines is ensured via rigorous testing in clinical trials prior to authorization or approval, followed by continued safety monitoring once the vaccine is rolled out to the public to detect potential rare side effects.
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