A review of the smallpox vaccine adverse events active surveillance system.
ABSTRACT In response to concern about smallpox possibly being used as a biological weapon, the President of the United States launched the National Smallpox Pre-Event Vaccination Program on 13 December 2002. Given safety concerns, identifying potentially serious adverse events (SAEs) was an essential tool of the program. To monitor for SAEs, both enhanced passive surveillance and active surveillance systems were used. The enhanced passive system was built, in part, on the existing Vaccine Adverse Event Reporting System; the active system was implemented 24 January 2003. During January 2003-May 2005, the active system detected only 1 SAE in addition to those reported through the enhanced passive system. Furthermore, the active system was not universally used by states. With the enhancements to passive surveillance, the performance of enhanced passive surveillance was comparable to that of active surveillance. However, an active surveillance system may be important when there is no enhanced passive surveillance system available.
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ABSTRACT: An inhalation exposure system was characterized to deliver aerosolized monkeypox virus (MPXV), and a non-human primate (NHP) inhalation monkeypox model was developed in cynomolgus macaques. A head-only aerosol exposure system was characterized, and two sampling methods were evaluated: liquid impingement via an impinger and impaction via a gelatin filter. The aerosol concentrations obtained with the gelatin filter and impinger were virtually identical, indicating that either method is acceptable for sampling aerosols containing MPXV. The mass median aerodynamic diameter (MMAD) for individual aerosol tests in the aerosol system characterization and the NHP study ranged from 1.08 to 1.15 μm, indicating that the aerosol particles were of a sufficient size to reach the alveoli. Six cynomolgus macaques (four male and two female) were used on study. The animals were aerosol exposed with MPXV and received doses between 2.51 × 10(4) to 9.28 × 10(5) plaque forming units (PFUs) inhaled. Four of the six animals died or were euthanized due to their moribund conditions. Both animals that received the lowest exposure doses survived to the end of the observation period. The inhalation LD(50) was determined to be approximately 7.8 × 10(4) pfu inhaled. These data demonstrate that an inhalation MPXV infection model has been developed in the cynomolgus macaque with disease course and lethal dose similar to previously published data.Frontiers in Cellular and Infection Microbiology 01/2012; 2:117. · 2.62 Impact Factor
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ABSTRACT: The following introduction describes the context in which the national smallpox vaccination program was implemented and highlights the significance of the key policy, programmatic, or scientific challenges, observations, and lessons learned that are presented in the articles that follow within this supplement to Clinical Infectious Diseases. Although the execution of this national program posed multiple complex and varied challenges, the focus of this supplement is on vaccine-associated adverse events and vaccine safety.Clinical Infectious Diseases 04/2008; 46 Suppl 3:S153-6. · 9.42 Impact Factor
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ABSTRACT: Variola virus, the cause of smallpox disease, has been deemed a possible bioterrorism agent. Since November 2001, federal, state, and local public health partners implemented activities to prepare for a possible smallpox outbreak. The Centers for Disease Control and Prevention (CDC) produced and delivered training and educational materials for smallpox preparedness in many formats, developed detailed smallpox vaccine information statements about vaccine contraindications and vaccination site care, and established mechanisms to monitor and respond to adverse events after smallpox vaccination. The last included enhancements to the Vaccine Adverse Event Reporting System, a pregnancy registry for inadvertently vaccinated pregnant women, and a Clinician Telephone Information Line to collect reports about adverse events. The civilian responder vaccination program was conducted with rigorous safety procedures, and few historically recognized adverse events were observed. However, myocarditis and/or pericarditis was newly recognized as an adverse event caused by the New York City Board of Health vaccinia vaccine strain. This smallpox preparedness program put into place a number of measures to advance the United States' readiness for a smallpox outbreak that have assisted in preparedness for other threats.Clinical Infectious Diseases 04/2008; 46 Suppl 3:S157-67. · 9.42 Impact Factor