Vaccines ‘Remarkably Safe’ Over Last 20 Years
Israeli researchers who looked at 57 vaccines approved by FDA between 1/1/1996 and 12/31/2015 report that the vaccines were found to be “remarkably safe” over the period. “A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance,” the report in the Annals of Internal Medicine says. “These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.”
The researchers found there were 58 post-approval safety-related label modifications associated with 25 of the vaccines, including 49 Warnings and Precautions, eight Contraindications, and one safety-related withdrawal. The most common safety issue triggering label modifications was
the expansion of population restrictions, followed by allergies, the report says. The most common source of safety data was postmarketing surveillance.