H1N1 vaccination.

   

H1N1 vaccination.

A comprehensive vaccine safety monitoring and response program is necessary to detect

possible increases in adverse health events and formulate hypotheses for further investigation and testing. VAERS data can detect safety signals (i.e., new, unexpected or rare adverse events) but generally cannot be used to infer causality (3). Once a large enough number of vaccine doses have been administered in its member managed care organizations, VSD can better identify associations between vaccination and health events (4). Recently, new vaccine safety monitoring systems have been developed to augment existing surveillance systems by focusing on specific health events (e.g., Guillain-Barré syndrome or pregnancy outcomes) and to estimate background rates for selected medical conditions, conduct case-control studies, and assess causality (Table 3). These additional systems will enhance the ability to determine whether the difference in the VAERS reporting rate between H1N1 and seasonal influenza vaccines can be attributed to reporting bias or safety differences. To synthesize and evaluate data on H1N1 vaccine safety, a nongovernment working group has been established by the National Vaccine Advisory Committee§§ with members representing other federal advisory committees as well as experts in internal medicine, pediatrics, immunology, and vaccine safety. The group will meet every 2 weeks and will provide reports to the public through the National Vaccine Advisory Committee after considering data from the many available systems.

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References

Food and Drug Administration. Influenza A (H1N1) 2009 monovalent. Rockville, MD: US Department of Health and Human Services, Food and Drug Administration. Available at http://www.fda.gov/biologicsbloodvaccines/vaccines/approvedproducts/ucm181950.htm. Accessed November 25, 2009.

US Department of Health and Human Services. Federal plans to monitor immunization safety for the pandemic H1N1 influenza vaccination program. Washington, DC: US Department of Health and Human Services; 2009. Available athttp://www.flu.gov/professional/federal/monitor_immunization_safety.html#intro. Accessed November 25, 2009.

Varricchio F, Iskander J, Destefano F, et al. Understanding vaccine safety information from the Vaccine Adverse Event Reporting System. Pediatr Infect Dis J 2004;23:287--94.

Lieu TA, Kulldorff M, Davis RL, et al; for the Vaccine Safety Datalink Rapid Cycle Analysis Team. Real-time vaccine safety surveillance for the early detection of adverse events. Med Care 2007;45(10 Supl 2):S89--95.

Vellozzi C, Burwen DR, Dobardzic A, Ball R, Walton K, Haber P. Safety of trivalent inactivated influenza vaccines in adults: background for pandemic influenza vaccine safety monitoring. Vaccine 2009;27:2114--20.

Greenberg ME, Lai MH, Hartel GF, et al. Response after one dose of a monovalent influenza A (H1N1) 2009 vaccine---preliminary report. N Engl J Med 2009;361.

* Food and Drug Administration. 21 CFR Part 600.80. Postmarketing reporting of adverse experiences. Federal Register 1997;62:52252--3. National Childhood Vaccine Injury Act of 1986 (42 USC 300aa-25).

† Nonserious events are defined as all others not categorized as serious adverse events.

§ Because not all distributed doses of vaccine are administered, the reporting rate per million doses distributed will underestimate the true reporting rate; however, use of this

standard denominator enables comparisons with rates per million doses distributed for other vaccines. National data on numbers of doses administered are not available, and survey-based coverage estimates are available only with a time delay.

 Additional information available at http://www.brightoncollaboration.org/internet/en/index.html. Accessed November 27, 2009.

Stillbirth, spontaneous abortion, or preterm delivery.

 Additional information available at http://clinicaltrials.gov/ct2/searchAccessed November 27, 2009.

 Additional information available at http://www.hhs.gov/nvpo/nvac Accessed November 27, 2009.