Last data update: Mar 21, 2025. (Total: 48935 publications since 2009)
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Query Trace: Gerstein J[original query] |
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Use of Pfizer-BioNTech COVID-19 Vaccine in Persons Aged ≥16 Years: Recommendations of the Advisory Committee on Immunization Practices - United States, September 2021.
Dooling K , Gargano JW , Moulia D , Wallace M , Rosenblum HG , Blain AE , Hadler SC , Plumb ID , Moline H , Gerstein J , Collins JP , Godfrey M , Campos-Outcalt D , Morgan RL , Brooks O , Talbot HK , Lee GM , Daley MF , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (38) 1344-1348 ![]() The Pfizer-BioNTech COVID-19 vaccine (BNT162b2) is a lipid nanoparticle-formulated, nucleoside mRNA vaccine encoding the prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Vaccination with the Pfizer-BioNTech COVID-19 vaccine consists of 2 intramuscular doses (30 μg, 0.3 mL each) administered 3 weeks apart. In December 2020, the vaccine was granted Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA) as well as an interim recommendation for use among persons aged ≥16 years by the Advisory Committee on Immunization Practices (ACIP) (1). In May 2021, the EUA and interim ACIP recommendations for Pfizer-BioNTech COVID-19 vaccine were extended to adolescents aged 12-15 years (2). During December 14, 2020-September 1, 2021, approximately 211 million doses of Pfizer-BioNTech COVID-19 vaccine were administered in the United States.* On August 23, 2021, FDA approved a Biologics License Application for use of the Pfizer-BioNTech COVID-19 vaccine, Comirnaty (Pfizer, Inc.), in persons aged ≥16 years (3). The ACIP COVID-19 Vaccines Work Group's conclusions regarding the evidence for the Pfizer-BioNTech COVID-19 vaccine were presented to ACIP at a public meeting on August 30, 2021. To guide its deliberations regarding the Pfizer-BioNTech COVID-19 vaccine, ACIP used the Evidence to Recommendation (EtR) Framework,(†) and incorporated a Grading of Recommendations, Assessment, Development and Evaluation (GRADE) approach.(§) In addition to initial clinical trial data, ACIP considered new information gathered in the 8 months since issuance of the interim recommendation for Pfizer-BioNTech COVID-19 vaccine, including additional follow-up time in the clinical trial, real-world vaccine effectiveness studies, and postauthorization vaccine safety monitoring. The additional information increased certainty that benefits from prevention of asymptomatic infection, COVID-19, and associated hospitalization and death outweighs vaccine-associated risks. On August 30, 2021, ACIP issued a recommendation(¶) for use of the Pfizer-BioNTech COVID-19 vaccine in persons aged ≥16 years for the prevention of COVID-19. |
Diabetes care editors' expert forum 2018: Managing big data for diabetes research and care
Riddle MC , Blonde L , Gerstein HC , Gregg EW , Holman RR , Lachin JM , Nichols GA , Turchin A , Cefalu WT . Diabetes Care 2019 42 (6) 1136-1146 ![]() Technological progress in the past half century has greatly increased our ability to collect, store, and transmit vast quantities of information, giving rise to the term "big data." This term refers to very large data sets that can be analyzed to identify patterns, trends, and associations. In medicinedincluding diabetes care and researchdbig data come from three main sources: electronic medical records (EMRs), surveys and registries, and randomized controlled trials (RCTs). These systems have evolved in different ways, each with strengths and limitations. EMRs continuously accumulate information about patients and make it readily accessible but are limited by missing data or data that are not quality assured. Because EMRs vary in structure and management, comparisons of data between health systems may be difficult. Registries and surveys provide data that are consistently collected andrepresentativeof broadpopulationsbutare limited in scopeandmaybeupdated only intermittently. RCT databases excel in the specificity, completeness, and accuracy of their data, but rarely include a fully representative sample of the general population. Also, they are costly to build and seldommaintained after a trial's end. To consider these issues, and the challenges andopportunities they present, the editors of Diabetes Care convened a group of experts in management of diabetes related data on 21 June 2018, in conjunction with the American Diabetes Association's 78th Scientific Sessions in Orlando, FL. This article summarizes the discussion and conclusions of that forum, offering a vision of benefits that might be realized from prospectively designed and unified data-management systems to support the collective needs of clinical, surveillance, and research activities related to diabetes. |
Fatal disseminated Cryptococcus gattii infection in New Mexico
Walraven CJ , Gerstein W , Hardison SE , Wormley F , Lockhart SR , Harris JR , Fothergill A , Wickes B , Gober-Wilcox J , Massie L , Ku TS , Firacative C , Meyer W , Lee SA . PLoS One 2011 6 (12) e28625 ![]() We report a case of fatal disseminated infection with Cryptococcus gattii in a patient from New Mexico. The patient had no history of recent travel to known C. gattii-endemic areas. Multilocus sequence typing revealed that the isolate belonged to the major molecular type VGIII. Virulence studies in a mouse pulmonary model of infection demonstrated that the strain was less virulent than other C. gattii strains. This represents the first documented case of C. gattii likely acquired in New Mexico. |
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