Research articleH1N1 and Seasonal Influenza Vaccine Safety in the Vaccine Safety Datalink Project
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Background
The emergence of a novel H1N1 influenza virus of swine origin in North America in April 2009 prompted the rapid development of new H1N1 vaccines, which became available for use in October 2009. While the initial uncertainty of how the novel H1N1 pandemic would evolve led to heightened concerns about disease prevention, public anxiety about the safety of novel H1N1 vaccines also became apparent.1 Given the prior experience with the 1976 swine influenza vaccination program, where an excess risk
Study Population
The Vaccine Safety Datalink Project is a collaboration among eight medical care organizations and CDC, which has performed population-based research on vaccine safety in the U.S. since 1990.6, 7 These organizations include Group Health Cooperative (Washington); Harvard Vanguard Medical Associates & Harvard Pilgrim Health Care (Massachusetts); HealthPartners Research Foundation (Minnesota); Kaiser Permanente of Colorado (Colorado); Kaiser Permanente of Northern California (California); Kaiser
Vaccine Doses
As of May 1, 2010, there were 1,345,663 individuals vaccinated with MIV, 2,741,150 with TIV, 267,715 with LAMV, and 157,838 with LAIV in the VSD population. The percentages of children and adults vaccinated by age group for H1N1 and for seasonal influenza are shown in Figure 1. Coverage rates by age group varied from 10% to 54% for H1N1 and 15% to 81% for seasonal vaccines. Seasonal influenza vaccination rates were higher than H1N1 vaccination rates in every age group. Seasonal influenza
Discussion
The VSD successfully conducted near–real time, prospective surveillance for adverse events following seasonal and H1N1 influenza vaccines. This served as a key component of public health efforts to protect the health of children and adults in the U.S. during the 2009–2010 influenza season. Prospective surveillance did not detect statistical signals for GBS, demyelinating disease, peripheral nervous system disorders, seizures, encephalomyelitis, ataxia, anaphylaxis, allergic reactions, cranial
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2023, VaccineCitation Excerpt :The FDA-CMS near real-time active surveillance program complements other FDA and US Government vaccine safety surveillance systems by rapidly detecting safety concerns that may not have been voluntarily reported to passive surveillance systems such as Vaccine Adverse Event Reporting System. Routinely used by FDA in safety surveillance for annual influenza vaccines in the past decade, this method is designed to be sensitive enough to quickly screen safety signals for further evaluation in robust epidemiologic studies [4,5]. This rapid screening method performs hypothesis testing, sequentially, in a prospective manner as the vaccine data accrue to detect potential safety signals earlier in the course of surveillance, but signals must be further evaluated in more robust studies with confounding adjustment.
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