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IOM: Recommended immunization schedule safe
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The current recommended childhood immunization schedule is safe, according to existing evidence, but better methods of communicating this safety are needed, according to a consensus report issued Jan. 16 by the Institute of Medicine.
Roughly 90% of American children receive most childhood vaccines advised by the federal immunization schedule by the time they enter kindergarten; however, some parents choose to spread out their children’s immunizations over a different time frame, and a small fraction object to having their children immunized at all.
Authors of the report, including Pauline Thomas, MD, associate professor at the University of Medicine and Dentistry of New Jersey, and colleagues, said the use of alternative schedules that do not follow recommended guidelines leads to increased risk for vaccine preventable disease. There are no data comparing outcomes of alternative schedules within guidelines (for example, providing immunization all on one day at 2 months or on different days), and the report encourages more data looking at this issue.
Pauline Thomas
Thomas cited individual reports that indicated delays in the schedule led to increased risks for hospitalizations and illness, and she said there is one study currently under way at Kaiser Permanente Colorado that is looking at this issue.
Regarding alternative schedules, Thomas said during a press briefing that “no one has looked at this at this time, but we know that delaying immunization is associated with increased risk of diseases, and that is well established.”
Until newer and bigger data collection systems can be harnessed, the Vaccine Safety Datalink (VSD) is the best available tool for exploring questions about the immunization schedule, should the need arise, Thomas and colleagues said. This database contains information on the immunization histories of more than 9 million people covered by nine participating managed care organizations.
However, the researchers said, VSD tracks people from only eight states and looks at a smaller percentage of low-income and minority people than is in the US population as a whole. Moreover, VSD’s usefulness depends on the continuing involvement of participating health plans. The Department of Health and Human Services and its partners should maintain their commitment to funding VSD and consider bringing in additional health plan members to enhance the data and make it more representative of the full US population, according to the consensus report.
Newer data collection and surveillance systems offer great potential to monitor rare adverse events that may be associated with the childhood immunization schedule, the committee said. When fully implemented, the Sentinel Initiative program being developed by the FDA to monitor the safety of approved drugs and other medical products will complement existing passive vaccine surveillance systems, according to the report.
The researchers said comparative trials that evaluate vaccine safety are unethical because not vaccinating children has known hazards.
For more information:
IOM. Childhood immunization schedule and safety: stakeholder concerns, scientific evidence, and future studies. Available at: www.iom.edu/Reports/2013/The-Childhood-Immunization-Schedule-and-Safety.aspx. Last updated Jan. 16, 2013. Accessed Jan. 16, 2013.
Disclosure: The study was sponsored by the HHS.