Researchers at the Tel Aviv Sourasky Medical Center in Israel examined the initial and subsequent safety-related label changes for 57 vaccines that received FDA approval between 1996 and 2015.
During this time period, the FDA required 58 label changes reflecting safety issues with vaccines. More than one-third of changes involved expanding restrictions of vulnerable patient groups who should not receive the vaccine. Twenty-two percent of labeling changes involved allergy warnings.
“A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance,” researchers concluded. “These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.”
To view the full study, click here.
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