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National Center for Emerging and Zoonotic Infectious Diseases
Vaccine safety updates
Advisory Committee on Immunization Practices (ACIP) meeting
June 23, 2023
Tom T. Shimabukuro, MD, MPH, MBA
Director, Immunization Safety Office
Division of Healthcare Quality Promotion
Centers for Disease Control and Prevention (CDC)
Session topics
▪Background on the CDC Immunization Safety Office (ISO) and ISO
efforts to evaluate studying the safety of the childhood
immunization schedule (Dr. Tom Shimabukuro)
▪The childhood immunization schedule and safety: Studies in the
Vaccine Safety Datalink (Dr. Matthew Daley)
▪Preliminary evaluation of aluminum content in childhood vaccines
and risk of asthma in a Danish nationwide cohort (Dr. Anders Hviid)
▪Discussion
2
CDC Immunization Safety Office (ISO) mission
▪Monitor the safety of vaccines given to children and adults
ISO key activities
▪Monitor newly recommended vaccines and new recommendations for existing vaccines
▪Monitor CDC priority vaccines, including seasonal influenza and COVID -19 vaccines
▪Conduct planned safety studies
▪Support data needs of the Advisory Committee on Immunization Practices (ACIP)
▪Assess individual risk factors for adverse events, conduct clinical case reviews, and provide
clinical consultation to U.S. healthcare providers and health departments about vaccine safety
questions for individual patients
▪Respond to vaccine safety inquiries
▪Conduct vaccine safety communication and education
▪Coordinate with state health departments
▪Prepare for pandemic and emergency responses3
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VSD CISA
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▪The lack of conclusive evidence linking adverse events to
multiple immunizations or other “schedule” exposures
suggests that the recommended schedule is safe.
▪The risks to participants' health, the cost and time involved,
and the ethical challenges all make the conduct of an
[randomized controlled trial] RCT unsuitable for addressing
the research questions, at least until further work with
secondary data has been conducted.
▪Although each new vaccine is evaluated in the context of the
overall immunization schedule that existed at the time of
review of that vaccine, elements of the schedule are not
evaluated once it is adjusted to accommodate a new
vaccine. Thus, key elements of the entire schedule —the
number, frequency, timing, order, and age at administration
of vaccines —have not been systematically examined in
research studies.
▪The most feasible approach to studying the safety of the
childhood immunization schedule is through analyses of
data obtained by [the Vaccine Safety Datalink] VSD. Institute of Medicine. The Childhood Immunization Schedule and
Safety: Stakeholder Concerns, Scientific Evidence, and Future
Studies. Washington (DC): National Academies Press (US); 2013.2013
6Four objectives of White Paper
1.Define types of alternative immunization schedules
and patterns of undervaccination that could be
evaluated, focusing on the first 24 months of age
2.Identify plausible adverse event outcomes that could
be related to the childhood immunization schedule,
with an emphasis on long -term adverse events
3.Suggest methodological approaches that could be
used to assess the safety of the recommended
schedule as a whole
4.Propose next steps for studying the safety of the
childhood immunization schedule within the VSD
White Paper on Studying the Safety of the Childhood
Immunization Schedule. For the Vaccine Safety Datalink (cdc.gov)2014
For more information, contact CDC
1-800-CDC-INFO (232 -4636)
TTY: 1 -888-232-6348 www.cdc.gov
The findings and conclusions in this report are those of the authors and do not necessarily represent the
official position of the Centers for Disease Control and Prevention.
Photo credit: James Gathany
(https://wwwn.cdc.gov/phil/
Details.aspx?pid=8876 )