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Postmarketing Safety of Vaccines Approved by FDA
Quick Takes
- Vaccines approved by the FDA over the past 20 years are remarkably safe.
- Postapproval surveillance is effective in monitoring for safety of vaccines and modifying labeling if needed.
Study Questions:
What is the prevalence of postmarketing safety modifications for US Food and Drug Administration (FDA)-approved vaccines?
Methods:
This retrospective cohort study examined postapproval safety-related label modifications for FDA-approved vaccines within the United States between January 1, 1996, and December 31, 2015. The authors also examined what data sources triggered postapproval label modification.
Results:
Over the 20-year time period, 57 vaccines were approved by the FDA. Initial approval for 53 (93%) of the vaccines was supported by randomized controlled trials, with a median cohort size of 4,161 participants (interquartile range, 2,204-8,634 participants). The most common vaccine indication was seasonal influenza (n = 21 [37%]), followed by combinations of vaccines for diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, hepatitis B, and hepatitis A (n = 16 [28%]); meningococcus (n = 5 [9%]); human papillomavirus (n = 3 [5%]); and rotavirus (n = 3 [5%]). Most vaccine types (n = 47 of 57 [82%]) were inactivated, conjugated, recombinant, or toxoid-based (or vaccine combinations), and 10 of 57 (18%) were live attenuated. For 25 vaccines, a total of 58 postapproval safety-related label modifications were identified, including 49 warnings and precautions, eight contraindications, and one safety-related withdrawal. The initial approval trial characteristics were similar in vaccines with and without postmarketing, safety-related label modifications. The most common safety issue triggering label modifications was expansion of population restrictions (n = 21 [36%]), followed by allergies (n = 13 [22%]). The most common source of safety data was post-marketing surveillance (n = 28 of 58 [48%]).
Conclusions:
The authors concluded that over a 20-year period, vaccines were found to be remarkably safe. A large proportion of safety issues were identified through existing postmarketing surveillance programs and were of limited clinical significance. These findings confirm the robustness of the vaccine approval system and postmarketing surveillance.
Perspective:
These data suggest that vaccines are generally safe, with only one vaccine being withdrawn for safety reasons. Furthermore, postapproval marketing appeared effective for modifications if warranted.
Clinical Topics: Cardiovascular Care Team, Prevention
Keywords: Diphtheria, Hepatitis A, Influenza Vaccines, Neisseria meningitidis, Papillomaviridae, Papillomavirus Infections, Primary Prevention, Rotavirus Vaccines, Safety, Tetanus, United States Food and Drug Administration, Vaccines, Whooping Cough
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