Vaccine Safety Forum Summaries of Two Workshops (1997) / Chapter Skim
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IMPROVING DETECTION OF AND RESPONSE TO ADVERSE EVENTS
IMPROVING DETECTION OF AND RESPONSE TO ADVERSE EVENTS
Pages 9-17
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From page 9... ...
9The material in this section is adapted from the discussion among panelists Bart Classen, Robert Chen, Linda Cowan, Susan Ellenberg, Gerald Fenichel, Barbara Loe Fisher, John Glasser, Marie Grimm, Luc Hessel, Robert Kohberger, John Martin, James Singleton, Paul Stolley, Gina Terracciano, Frederick Varricchio, and Robert Wise, and from comments of other speakers and participants.
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From page 10... ...
The speaker also suggested using funds from the U.S. Department of Health and Human Services to create a public education campaign designed to educate physicians and the public about the importance of monitoring children abler vaccination, reporting adverse events following vaccination to the government, and screening children for factors that would place them at higher risk of experiencing adverse events following vaccination.
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From page 11... ...
CDC, FDA, and Health Resources and Services Administration Division of Vaccine Injury Compensation are establishing a panel of medical experts to provide advice on analyses of difficult cases and are continuing to conduct studies to evaluate the biases present in the system, examining such issues as reporting delays and how they affect the analysis and validity of the data. To facilitate the VAERS reporting process and to increase the likelihood that physicians will complete VAERS forms, a vaccine manufacturer's representative suggested that the form might be made more specific.
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From page 12... ...
For example, a parent noted that no government representative had ever contacted him personally seeking more information about his son's death following vaccination with the hepatitis B vaccine. This death was misclassified as sudden infant death syndrome (SIDS)
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From page 13... ...
Lot sizes are needed as denominators for calculating adverse event rates. A parent of an injured child reported that she had obtained information about the vaccine lot from which her child's dose came and discovered that a number of other children had died or had been injured following receipt of VAERS data are available electronically in standard ASCII format by contacting NTIS at (703)
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From page 14... ...
This approach was developed in collaboration with scientists in the biological laboratories of the Massachusetts and Michigan public health departments, and the underlying model was validated with information about diphtheria and tetanus toxoids and pertussis vaccine administration inferred from vaccine inventories in county and regional public health departments throughout Michigan, which in turn distribute vaccine to the private sector. Although the observed and expected numbers of administrations of specific vaccine lots were concordant, an epidemiologist suggested that further work with vaccine manufacturers was needed to assess the accuracy of the predicted numbers of doses a particular lot administered.
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From page 15... ...
An FDA representative suggested developing computerized screening methods to identify clusters of potentially related events. Researchers could also develop statistical methods that could more effectively evaluate adverse events following vaccination.
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From page 16... ...
Even if a vaccine is shown to be safe in a large clinical trial, the potential for lot and batch variability and for variability in the use of vaccines require continual surveillance for adverse events. Several speakers suggested conducting more focused, powerful, larger, and better-designed postlicensure clinical studies to detect serious, rare adverse events of vaccines that are not possible to detect in a clinical trial.
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From page 17... ...
A consumer representative suggested that there be more government funding for studies designed to detect long-term adverse effects of vaccines or to identify individuals at high risk for adverse effects. It was also suggested that children given vaccines in clinical trials be followed for 5 to 10 years to help assess long-term adverse events that do not become apparent until children reach later stages of development.
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