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WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.

ABSTRACT: Consultations have been held to promote the revision of the WHO guidelines for assuring the quality and nonclinical safety evaluation of DNA vaccines adopted by the Expert Committee on Biological Standardization (ECBS) in 2005. The drivers for this revision are described, including the need for regulatory convergence highlighted by the WHO R&D Blueprint. These consultations have driven the revision to its current form, where a new guideline that includes quality, nonclinical, and clinical evaluation of plasmid DNA vaccines is being prepared for public consultation with a view to present to an upcoming ECBS. Major changes to the guidelines include streamlining the existing quality (part A) and nonclinical (part B) sections to reflect the two decades of experience, with manufacturing and control, nonclinical evaluation, and clinical testing of plasmid DNA vaccines, as a platform technology. The urgency for gaining regulatory convergence on this topic is that development of such a platform technology as DNA vaccines for routine use immunizations will prepare manufacturers and regulators across the globe in dealing with rapid development of medical countermeasures against emerging infectious diseases even in the face of an emergency setting. Two examples are described of Zika candidate vaccines that have rapidly advanced in development based on preexisting nonclinical and clinical data that precluded the need to repeat nonclinical toxicology. This report describes the progress stemming from the most recent consultation on the guidelines, including topics discussed and consensus reached.

SUBMITTER: Sheets R

PROVIDER: S-EPMC7303131 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Though Switzerland has one of the highest life expectancies in the world, this global indicator may mask significant disparities at a local level. The present study used a spatial cluster detection approach based on individual death records to investigate the geographical footprint of life expectancy inequalities in the state of Geneva, Switzerland. Individual-level mortality data (n = 22,751) were obtained from Geneva's official death notices (2009-2016). We measured life expectancy inequalities using the years of potential life lost or gained (YPLLG) metric, defined as the difference between an individual's age at death and their life expectancy at birth. We assessed the spatial dependence of YPLLG across the state of Geneva using spatial autocorrelation statistics (Local Moran's I). To ensure the robustness of the patterns discovered, we ran the analyses for ten random subsets of 10,000 individuals taken from the 22,751 deceased. We also repeated the spatial analysis for YPLLG before and after controlling for individual-level and neighborhood-level covariates. The results showed that YPLLG was not randomly distributed across the state of Geneva. The ten random subsets revealed no significant difference with the geographic footprint of YPLLG and the population characteristics within Local Moran cluster types, suggesting robustness for the observed spatial structure. The proportion of women, the proportion of Swiss, the neighborhood median income, and the neighborhood median age were all significantly lower for populations in low YPLLG clusters when compared to populations in high YPLLG clusters. After controlling for individual-level and neighborhood-level covariates, we observed a reduction of 43% and 39% in the size of low and high YPLLG clusters, respectively. To our knowledge, this is the first study in Switzerland using spatial cluster detection methods to investigate inequalities in life expectancy at a local scale and based on individual data. We identified clear geographic footprints of YPLLG, which may support further investigations and guide future public health interventions at the local level.

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Project description:BackgroundThere are no time trends in prevalence, unawareness, treatment, and control of hypertension in Switzerland. The objective of this study was to analyze these trends and to determine the associated factors.Methods/findingsPopulation-based study conducted in the Canton of Geneva, Switzerland, between 1999 and 2009. Blood pressure was measured thrice using a standard protocol. Hypertension was defined as mean systolic or diastolic blood pressure ? 140/90 mmHg or self-reported hypertension or anti-hypertensive medication. Unawareness, untreated and uncontrolled hypertension was determined by questionnaires/blood pressure measurements. Yearly age-standardized prevalences and adjusted associations for the 1999-2003 and 2004-2009 survey periods were reported. The 10-year survey included 9,215 participants aged 35 to 74 years. Hypertension remained stable (34.4%). Hypertension unawareness decreased from 35.9% to 17.7% (P<0.001). The decrease in hypertension unawareness was not paralleled by a concomitant absolute increase in hypertension treatment, which remained low (38.2%). A larger proportion of all hypertensive participants were aware but not treated in 2004-2009 (43.7%) compared to 1999-2003 (33.1%). Uncontrolled hypertension improved from 62.2% to 40.6% between 1999 and 2009 (P = 0.02). In 1999-2003 period, factors associated with hypertension unawareness were current smoking (OR = 1.27, 95%CI, 1.02-1.59), male gender (OR = 1.56, 1.27-1.92), hypercholesterolemia (OR = 1.31, 1.20-1.44), and older age (OR 65-74 yrs vs 35-49 yrs = 1.56, 1.21-2.02). In 1999-2003 and 2004-2009, obesity and diabetes were negatively associated with hypertension unawareness, high education was associated with untreated hypertension (OR = 1.45, 1.12-1.88 and 1.42, 1.02-1.99, respectively), and male gender with uncontrolled hypertension (OR = 1.49, 1.03-2.17 and 1.65, 1.08-2.50, respectively). Sedentarity was associated with higher risk of hypertension and uncontrolled hypertension in 1999-2003.ConclusionsHypertension prevalence remained stable since 1999 in the canton of Geneva. Although hypertension unawareness substantially decreased, more than half of hypertensive subjects still remained untreated or uncontrolled in 2004-2009. This study identified determinants that should guide interventions aimed at improving hypertension treatment and control.

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WHO informal consultation on the guidelines for evaluation of the quality, safety, and efficacy of DNA vaccines, Geneva, Switzerland, December 2019.

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