Postmarket surveillance programs largest source of safety data triggering vaccine label changes

1. Postmarketing surveillance programs of Food and Drug Administration approved vaccines were the most common source of safety data triggering safety label changes.

2. The most common safety label changes included changes in population restrictions and allergies.

Evidence Rating Level: 3 (Average)

Study Rundown: Food and Drug Administration (FDA) approved vaccines undergo postmarket surveillance to identify uncommon and long-term adverse events. For example, the Vaccine Adverse Event Reporting System (VAERS) is a national vaccine safety surveillance program established to monitor approved vaccines. The authors analyzed the initial and approved labels of a cohort of approved infectious disease vaccines to assess postmarket label changes. The most frequent reason for a safety modification was for changes to population restriction, allergies and postvaccination syncope. One vaccine (RotaShield) was withdrawn for safety issues identified through VAERS. The most common source of safety data was postmarketing surveillance. The study highlighted that the majority of vaccine safety label changes were not clinically significant. Moreover, it emphasized the importance of independent monitoring systems in assessing long term complications. However, the study was limited by the availability of public data as not all safety data received by the FDA was included in the study.

Click to read the study, published today in Annals of Internal Medicine

Relevant Reading: Vaccination errors reported to the Vaccine Adverse Event Reporting System, (VAERS) United States, 2000-2013

In-Depth [retrospective cohort]: In this retrospective cohort study, 57 FDA-approved vaccines were analyzed from 1996 – 2015. The most common approved vaccine was the season influenza vaccine (37%). 58 postapproval label modifications were analyzed. The most common safety issue triggering a label change was increased population restrictions (36%) to include immunocompromised patients, specific preexisting conditions, premature infants and pregnant women. The next most common label change was related to allergies (22%), mostly due to latex packaging. 21% were related to postvaccination syncope. The most common source of safety data was postmarketing surveillance (48%), followed by manufacturer warnings from changes in packaging materials (21%).

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