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Safety data on meningococcal polysaccharide vaccine from the Vaccine Adverse Event Reporting System
R Ball1, M M Braun, G T Mootrey
1Division of Epidemiology, Office of Biostatistics and Epidemiology, Center for Biologics Evaluation and Research, US Food and Drug Administration, Rockville, MD 20852, USA. BallR@cber.fda.gov
Abstract:
Recent recommendations by the Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices may lead to the increased use of the meningococcal polysaccharide vaccine. The Vaccine Adverse Event Reporting System (VAERS) is useful for the detection of previously unrecognized reactions and for the monitoring of known reactions. Limitations of VAERS include underreporting and the inability to establish a causal relationship between vaccination and adverse events in most cases. From July 1990 through 31 October 1999, 110 adverse events were reported after receipt of meningococcal vaccine alone. Thirteen (12%) were serious, including 6 injection site reactions, 3 allergic reactions, 1 case of Guillain-Barré syndrome, and 3 miscellaneous events. Fever (30%), headache (17%), dizziness (15%), injection site hypersensitivity (13%), urticaria (12%), and paresthesia (10%) were among the most common events reported. Fever and injection site and allergic reactions are most likely causally linked to the vaccine. That there were few reports of serious adverse events, with >6 million doses having been distributed, and no clear signal of a previously unrecognized serious reaction is reassuring with regard to the safety of meningococcal vaccine.
Insights
Meningococcal vaccine use may increase following new guidelines. Analysis of over 6 million doses shows few serious adverse events, with fever and allergic reactions being most common and likely vaccine-related.
Area of Science:
- Immunology
- Vaccinology
- Public Health
Background:
- Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices recommendations may increase meningococcal polysaccharide vaccine use.
- The Vaccine Adverse Event Reporting System (VAERS) monitors vaccine safety and detects adverse events.
- VAERS has limitations, including underreporting and difficulty establishing causality.
Purpose of the Study:
- To analyze adverse events reported after meningococcal vaccination.
- To assess the safety profile of the meningococcal polysaccharide vaccine.
Main Methods:
- Retrospective analysis of adverse events reported to VAERS.
- Data collected from July 1990 to October 1999 for meningococcal vaccine alone.
- Categorization and frequency analysis of reported events, including serious adverse events.
Main Results:
- 110 adverse events reported; 13% were serious (e.g., Guillain-Barré syndrome, allergic reactions).
- Most common events included fever (30%), headache (17%), and dizziness (15%).
- Fever, injection site, and allergic reactions are likely causally linked to the vaccine.
Conclusions:
- Few serious adverse events were reported despite over 6 million distributed doses.
- No clear signal of previously unrecognized serious reactions was detected.
- The meningococcal vaccine appears reassuringly safe based on VAERS data.