Emergency Use Authority and 2009 H1N1 Influenza

Sherman, Susan E.; Foster, Joseph; Vaid, Sonal

doi:10.1089/bsp.2009.0040

Cited by 7 publications

(11 citation statements)

References 1 publication

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“…Historically, the sole mechanisms for the large-scale use of drugs, devices, and biological products regulated by the Food and Drug Administration (FDA) were traditional FDA approval, clearance, or licensure or, alternatively, an investigational new drug (IND) application or investigational device exemption (IDE). 2 Over the past decade, 2 other legal pathways have emerged to facilitate emergency uses of MCMs: Emergency Use Authorizations (EUAs) and additional emergency use authorities for certain activities involving FDA-approved products. 3 This section explains the current statutory and regulatory framework for the use of MCMs during emergencies (Table 1).…”

Section: Emergency Use Of Mcmsmentioning

confidence: 99%

“…23 The issuance of such an Emergency Use Authorization (EUA) requires a 3-step approach ( Table 3). 2 The first action is a relevant determination, whereby the secretary of the Department of Homeland Security (DHS), DoD, or HHS pronounces the existence of (or significant potential for) a qualifying domestic, military, or public health emergency, respectively. The DHS or DoD determination of a domestic or military emergency, or significant potential thereof, must involve a ''heightened risk'' of attack with a CBRN agent or agents against either the United States or its military forces.…”

Section: Genesis and Modification Of The Eua Authoritymentioning

confidence: 99%

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Dispensing Medical Countermeasures: Emergency Use Authorities and Liability Protections

Kels¹

2015

Health Security

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The Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 (PAHPRA) enhances emergency use authorities with respect to both approved and unapproved medical countermeasures (MCMs). PAHPRA authorities can also be critical to preserving tort liability protections for public health stakeholders, since these protections are often contingent upon appropriate authorizations for the MCMs utilized. This article details the evolution of emergency use authorities and liability protections, analyzes how these separate legal doctrines can intersect in practice, and discusses implications for facilitating preparedness and response activities and for protecting associated personnel.

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Section: Emergency Use Of Mcmsmentioning

confidence: 99%

Section: Genesis and Modification Of The Eua Authoritymentioning

confidence: 99%

Dispensing Medical Countermeasures: Emergency Use Authorities and Liability Protections

Kels¹

2015

Health Security

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“…Los primeros casos ocurrieron a mediados de abril del 2009 al sur de EEUU y en Oxaca México (4)(5)(6)(7) , extendiéndose posteriormente a nivel mundial (8) . Instituciones internacionales (OMS) y nacionales elaboraron medidas frente a la pandemia (9)(10)(11)(12) , como el uso de oseltamivir a los casos confirmados o fuertemente sospechosos con presentación clínica severa o progresiva, y a los grupos de alto riesgo como niños menores de 5 años y adultos mayores.…”

Section: Introductionunclassified

Niños hospitalizados con neumonía por influenza AH1N1/2009 pandémico en un hospital de referencia de Perú

Miranda-Choque

Ramı́rez

Candela-Herrera

et al. 2014

Rev Peru Med Exp Salud Publica

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Objetivos. Determinar las características clínicas y demográficas de la neumonía por el virus de influenza AH1N1/2009 pandémico en un hospital de referencia de Perú. Materiales y métodos. Se realizó un estudio serie de casos en niños hospitalizados por neumonía por influenza AH1N1/2009 pandémico en un hospital de referencia. Revisamos las historias clínicas entre los meses de junio a septiembre 2009. Todos los casos tuvieron confirmación virológica. Resultados. Se encontró 74 casos de neumonía por el virus de Influenza AH1N1/2009 pandémico (NVIp), de los cuales 50 tuvieron el diagnóstico de neumonía adquirida en la comunidad viral (NACv) y 24 con neumonía nosocomial viral (NNv) de los cuales 16 requirieron ventilación mecánica. Fallecieron 12, todos ellos con antecedentes de comorbilidad. Los casos NNv presentaron asociación estadística con mortalidad. En los casos NACv, los menores de 6 años representaron 72 % (36/50). La mediana de tiempo de enfermedad fue de 5 días. Los síntomas más frecuentes fueron fiebre, tos, rinorrea. Recibieron oseltamivir el 82 %. En la radiografía de tórax el 48 % de los casos presentó infiltrado en parches y el 44 % infiltrado intersticial en la radiografía de tórax. La proteína C reactiva (PCR) mayor a 10mg/L tuvo una asociación significativa con insuficiencia respiratoria (p <0,05). Conclusiones. Encontramos casos NNv quienes tuvieron mayor mortalidad, también los que presentaron el PCR elevado y los que presentaron condición preexistente. were community acquire pneumonia viral (NACv) and 24 pneumonia nosocomial viral (NNv), 16 required mechanical ventilation. 12 died, all had preexisting factors. NN cases showed statistical association with mortality. The most frequent factors were malnutrition, respiratory infections, congenital heart disease and neurological deficits In NACv cases the children under 6 years accounted for 72% (36/50). The median disease duration was 5 days. The most frequent symptoms were fever, cough, runny nose. Received oseltamivir 82%. The chest radiograph 48% of cases showed patchy infiltrates and 44% interstitial infiltrate on chest radiograph. Protein c reactive (CRP) more than 10mg / L was significantly associated with respiratory failure (p <0.05). Conclusions. Cases of NN found who had more mortality, even those who had the highest PCR and those with preexisting condition. Palabras clave: Subtipo H1N1 del virus de la influenza A; Virus de la influenza; Neumonía; Niño (fuente: DeCS BIREME). CHILDREN HOSPITALIZED WITH

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“…It could also be used in the context of vaccinomics tests. The Emergency Use Authority given by section 564 of the Food, Drug, and Cosmetic Act would allow vaccines and IVDs (such as vaccinomics tests) to be authorized for use even if they have not yet been approved or cleared by the FDA (Sherman et al, 2009). This process was used in response to the 2009 H1N1 influenza to authorize emergency use of several IVDs, including one that was uncleared and unapproved (Sherman et al, 2009).…”

mentioning

confidence: 99%

“…The Emergency Use Authority given by section 564 of the Food, Drug, and Cosmetic Act would allow vaccines and IVDs (such as vaccinomics tests) to be authorized for use even if they have not yet been approved or cleared by the FDA (Sherman et al, 2009). This process was used in response to the 2009 H1N1 influenza to authorize emergency use of several IVDs, including one that was uncleared and unapproved (Sherman et al, 2009). The Emergency Use Authority is a tool that could prove valuable in situations where, for example, individuals with certain genetic variations could be particularly at risk of infection from a new virus or pathogen that poses a biological threat.…”

mentioning

confidence: 99%

Diagnostic Testing for Vaccinomics: Is the Regulatory Approval Framework Adequate? A Comparison of Canada, the United States, and Europe

Joly

Koutrikas²,

Ramos-Paque³

et al. 2011

OMICS: A Journal of Integrative Biology

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Vaccinomics aims to integrate variability information from multiple levels of the biological hierarchy from genome to proteome to metabolome, and ways in which these biological parts interact with each other and the environment. Vaccinomics holds significant promise as a new public health tool in designing safer and more effective vaccines for both developed and developing countries. Vaccinomics tests that are envisioned to be used in tandem with vaccine-based health interventions could permit an informed forecast of individual and subpopulation variations in immune responses to vaccines, reduce adverse effects, and contribute to a foundation for rational and directed use of vaccines. A proactive, multidisciplinary engagement with vaccinomics is now timely and much needed in order to develop regulations that best ensure the protection of the public and promote the transition of vaccinomics innovations from discovery to real-life public health applications. This article examines and compares the regulatory oversight of vaccinomics tests in Canada, the United States, and Europe. Recent trends in these jurisdictions suggest that regulatory agencies view personalized genomics/omics medicine, such as vaccinomics, as a desirable goal. At the same time, proposals to increase oversight could impact progress in the field and affect the availability of vaccinomics tests in public health practice and the diagnostic test market. The comparative analysis of vaccinomics in three jurisdictions presented in this article highlights both the convergence and divergence of regulatory oversight. In a rapidly emerging field such as vaccinomics that is pivotal for global public health, achieving better harmonization of policies may be an advantageous target, while ensuring that symmetry exists between the goals of public safety and promoting public health innovation. We suggest it is now timely to proactively initiate a constructive dialogue among all stakeholders (publics, policymakers, researchers, private sector, governments) to foster the development of appropriately targeted regulatory policies in this field.

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Emergency Use Authority and 2009 H1N1 Influenza

Cited by 7 publications

References 1 publication

Dispensing Medical Countermeasures: Emergency Use Authorities and Liability Protections

Dispensing Medical Countermeasures: Emergency Use Authorities and Liability Protections

Niños hospitalizados con neumonía por influenza AH1N1/2009 pandémico en un hospital de referencia de Perú

Diagnostic Testing for Vaccinomics: Is the Regulatory Approval Framework Adequate? A Comparison of Canada, the United States, and Europe

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