Last data update: Apr 18, 2025. (Total: 49119 publications since 2009)
Records 1-8 (of 8 Records) |
Query Trace: Freed J[original query] |
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Characterizing the transport of aluminum-, silicon- and titanium-containing particles and nanoparticles in mainstream tobacco smoke
Fresquez MR , Watson CH , Valentin-Blasini L , Steven Pappas R . J Anal Toxicol 2021 45 (7) 722-729 The most commonly observed forms of aluminum, silicon and titanium in tobacco products are aluminum silicates (e.g., kaolin), silica and titanium(IV) oxide. These compounds are neither water soluble nor volatile at cigarette combustion temperatures. Rather, they are transported in mainstream tobacco smoke as particles after being freed by combustion from the tobacco filler and can induce pulmonary inflammation when inhaled. Aluminum silicate particles are the most frequently observed particles in the pulmonary macrophages of smokers and have become known as 'smokers' inclusions'. A relatively new technique, single particle triple quadrupole inductively coupled plasma-mass spectrometry was used to analyze aluminum-, silicon- and titanium-containing particle deliveries in cigarette and little cigar mainstream tobacco smoke, and to collect information on solid inorganic particles. The mass concentration of aluminum-containing particles transmitted in mainstream smoke was low (0.89-0.56 ng/cigarette), which was not surprising because aluminum silicates are not volatile. Although the collective masses (ng/cigarette) of aluminum-, silicon- and titanium-containing particles under 100 nm diameter transported in mainstream smoke were low, an abundance of 'ultrafine' particles (particles < 100 nm or nanoparticles) was observed. Limitations of the particle background equivalent diameter (the smallest detectable particle size (MassHunter 4.5 Software) due to the environmentally ubiquitous silicon background restricted the determination of silica nanoparticles, but silica particles slightly below 200 nm diameter were consistently detected. Aluminum- and titanium-containing nanoparticles were observed in all cigarette and little cigar samples, with titanium(IV) oxide particle deliveries consistently fewer in number and smaller in diameter than the other two types of particles. The highest concentrations of aluminum-containing particles (as kaolin) were in the nanoparticle range with much lower concentrations extending to the larger particle sizes (>100 nm). The number and range of particle sizes determined in mainstream smoke is consistent with pulmonary deposition of aluminum silicates described by other researchers as contributing to the 'smokers' inclusions' observed in pulmonary macrophages. |
Improvement in the analysis of Vaccine Adverse Event Reporting System database
Zhao L , Lee S , Li R , Ong E , He Y , Freed G . Stat Biopharm Res 2020 12 (3) 303-310 As a national public health surveillance resource, Vaccine Adverse Event Reporting System (VAERS) is a key component in ensuring the safety of vaccines. Numerous methods have been used to conduct safety studies with the VAERS database. These efforts focus on the downstream statistical analysis of the vaccine and adverse event associations. In this article, we primarily focus on processing the raw data in VAERS before the analysis step, which is also an important part of the signal detection process. Due to the semiannual update in the Medical Dictionary for Regulatory Activities (MedDRA) coding system, adverse event terms that describe the same symptom might change in VAERS; therefore, we identify these terms and combine them to increase the signal detection power. We also consider the uncertainty of the vaccine and adverse event pairs that arise from reports with multiple vaccines. Finally, we discuss four commonly used statistics in assessing the vaccine and adverse event associations, and propose to use the statistics that are robust to the reporting bias in VAERS and adjust for potential confounders of the vaccine and adverse event association to increase signal detection accuracy. |
Choose safe places for early care and education: Building state programs
Wendel AM , Somers TS , Freed J , Hall E . J Environ Health 2019 82 (3) 40-42 What would you want to know before your children attend a day care opening in a former industrial building or adjacent to a nail salon? Are children at risk if their new preschool is located on former farmland where lead arsenate pesticide might have been used? What site-related environmental risks are most concerning for children attending early care and education (ECE) facilities? | | States involved with the Agency for Toxic Substances and Disease Registry’s (ATSDR) Choose Safe Places for Early Care and Education (CSPECE) effort are addressing site-related questions like these to help protect children from harmful environmental exposures. |
Progress toward poliomyelitis eradication - Nigeria, January 2018-May 2019
Adamu US , Archer WR , Braka F , Damisa E , Siddique A , Baig S , Higgins J , Sume GE , Banda R , Korir CK , Waziri N , Gidado S , Bammeke P , Edukugo A , Nganda GW , Forbi JC , Burns CC , Liu H , Jorba J , Asekun A , Franka R , Wassilak SGF , Bolu O . MMWR Morb Mortal Wkly Rep 2019 68 (29) 642-646 The number of wild poliovirus (WPV) cases in Nigeria decreased from 1,122 in 2006 to six WPV type 1 (WPV1) in 2014 (1). During August 2014-July 2016, no WPV cases were detected; during August-September 2016, four cases were reported in Borno State. An insurgency in northeastern Nigeria had resulted in 468,800 children aged <5 years deprived of health services in Borno by 2016. Military activities in mid-2016 freed isolated families to travel to camps, where the four WPV1 cases were detected. Oral poliovirus vaccine (OPV) campaigns were intensified during August 2016-December 2017; since October 2016, no WPV has been detected (2). Vaccination activities in insurgent-held areas are conducted by security forces; however, 60,000 unvaccinated children remain in unreached settlements. Since 2018, circulating vaccine-derived poliovirus type 2 (cVDPV2) has emerged and spread from Nigeria to Niger and Cameroon; outbreak responses to date have not interrupted transmission. This report describes progress in Nigeria polio eradication activities during January 2018-May 2019 and updates the previous report (2). Interruption of cVDPV2 transmission in Nigeria will need increased efforts to improve campaign quality and include insurgent-held areas. Progress in surveillance and immunization activities will continue to be reviewed, potentially allowing certification of interruption of WPV transmission in Africa in 2020. |
Failure-to-success ratios, transition probabilities and phase lengths for prophylactic vaccines versus other pharmaceuticals in the development pipeline
Davis MM , Butchart AT , Wheeler JR , Coleman MS , Singer DC , Freed GL . Vaccine 2011 29 (51) 9414-6 Research and development of prophylactic vaccines carries a high risk of failure. In the past, industry experts have asserted that vaccines are riskier to produce than other pharmaceuticals. This assertion has not been critically examined. We assessed outcomes in pharmaceutical research and development from 1995 to 2011, using a global pharmaceutical database to identify prophylactic vaccines versus other pharmaceuticals in preclinical, Phase I, Phase II, or Phase III stages of development. Over 16 years of follow-up for 4367 products (132 prophylactic vaccines; 4325 other pharmaceuticals), we determined the failure-to-success ratios for prophylactic vaccines versus all other products. The overall ratio of failures to successes for prophylactic vaccines for the 1995 cohort over 16 years of follow-up was 8.3 (116/14) versus 7.7 (3650/475) for other pharmaceuticals. The probability of advancing through the development pipeline at each point was not significantly different for prophylactic vaccines than for other pharmaceuticals. Phase length was significantly longer for prophylactic vaccines than other pharmaceuticals for preclinical development (3.70 years vs 2.80 years; p<.0001), but was equivalent for all 3 human clinical trial phases between the two groups. We conclude that failure rates, phase transition probabilities, and most phase lengths for prophylactic vaccines are not significantly different from those of other pharmaceutical products, which may partially explain rapidly growing interest in prophylactic vaccines among major pharmaceutical manufacturers. |
Financing vaccination of children and adolescents: National Vaccine Advisory Committee recommendations
Lindley MC , Birkhead GS , Almquist JR , Clover RD , Dekker C , Feinberg M , Fergie J , Gordon LK , Humiston SG , Jackson LA , Lovell Jr C , Mason JO , McCormick M , Nevin-Woods C , Parnell T , Pavia A , Riley LE , Abramson JS , Coleman MS , Edwards B , Freed GL , Gellin B , Greenbaum E , Haddix AC , Hinman AR , Johnson CB , Kelman J , Klein JO , Orenstein WA , Pauly M , Pisani AA , Rodewald LE , Rosenberg A , Salesa J , Shen AK , Wallace G , Wilson JJ , Wisniewski AC . Pediatrics 2009 124 S558-S562 Increases in the number and cost of vaccines routinely recommended for children and adolescents have raised concerns about the ability of the current systems for vaccine financing and delivery to ensure that all children and adolescents have access to all routinely recommended vaccinations without financial barriers. The National Vaccine Advisory Committee (NVAC) was chartered in 1988 to advise and to make recommendations to the director of the National Vaccine Program and the Assistant Secretary for Health at the US Department of Health and Human Services on matters related to the prevention of infectious diseases through vaccination. In October 2006, NVAC established a Vaccine Financing Working Group to explore approaches for child and adolescent vaccine financing. The Vaccine Financing Working Group was charged with establishing a process for obtaining stakeholder input regarding challenges to creating optimal approaches to vaccine financing in both the public and private sectors. The goal of this process was to develop recommendations to ensure that all children and adolescents have access to all routinely recommended vaccinations without financial barriers. | The NVAC considered several overarching principles in formulating its recommendations. First, vaccine-preventable diseases are not constrained by geographic boundaries, and policies on vaccine financing should be national in scope. Second, vaccine financing solutions should address near-term problems with vaccine financing and should anticipate continued changes in recommended child and adolescent immunization schedules and the health care delivery system. Third, because vaccine financing problems are multifactorial, their solutions also should be multifactorial and all stakeholders will need to participate in implementing the solutions. Finally, because it is difficult to achieve uniform national implementation of policies that require state-based legislative or budgetary action, legislative or policy actions at the federal level, when appropriate, are recommended for achieving vaccine financing goals. |
The expanding vaccine development pipeline, 1995-2008
Davis MM , Butchart AT , Coleman MS , Singer DC , Wheeler JR , Pok A , Freed GL . Vaccine 2009 28 (5) 1353-6 Successful launches of recently licensed vaccines contrast with pharmaceutical industry concerns about unfavorable market conditions, making the status and future of vaccine development uncertain. We assessed trends in private-sector vaccine research and development for the period 1995-2008, using a global pharmaceutical database to identify prophylactic vaccines in preclinical, Phase I, Phase II, or Phase III stages of development. We counted companies that research and/or manufacture vaccines ("vaccine originators") and their vaccine products in each year. The global number of vaccine originators doubled (to 136), as did the number of prophylactic vaccine products in development (to 354); the majority of this growth was in preclinical and early phase clinical research. Because rapid growth in earlier research phases has not yet led to growth in Phase III, it is not yet clear whether recent industry expansion will translate to an increase in the number of available vaccines in the near future. |
Immunization programs for infants, children, adolescents, and adults: clinical practice guidelines by the Infectious Diseases Society of America
Pickering LK , Baker CJ , Freed GL , Gall SA , Grogg SE , Poland GA , Rodewald LE , Schaffner W , Stinchfield P , Tan L , Zimmerman RK , Orenstein WA . Clin Infect Dis 2009 49 (6) 817-40 Evidence-based guidelines for immunization of infants, children, adolescents, and adults have been prepared by an Expert Panel of the Infectious Diseases Society of America (IDSA). These updated guidelines replace the previous immunization guidelines published in 2002. These guidelines are prepared for health care professionals who care for either immunocompetent or immunocompromised people of all ages. Since 2002, the capacity to prevent more infectious diseases has increased markedly for several reasons: new vaccines have been licensed (human papillomavirus vaccine; live, attenuated influenza vaccine; meningococcal conjugate vaccine; rotavirus vaccine; tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis [Tdap] vaccine; and zoster vaccine), new combination vaccines have become available (measles, mumps, rubella and varicella vaccine; tetanus, diphtheria, and pertussis and inactivated polio vaccine; and tetanus, diphtheria, and pertussis and inactivated polio/Haemophilus influenzae type b vaccine), hepatitis A vaccines are now recommended universally for young children, influenza vaccines are recommended annually for all children aged 6 months through 18 years and for adults aged 50 years, and a second dose of varicella vaccine has been added to the routine childhood and adolescent immunization schedule. Many of these changes have resulted in expansion of the adolescent and adult immunization schedules. In addition, increased emphasis has been placed on removing barriers to immunization, eliminating racial/ethnic disparities, addressing vaccine safety issues, financing recommended vaccines, and immunizing specific groups, including health care providers, immunocompromised people, pregnant women, international travelers, and internationally adopted children. This document includes 46 standards that, if followed, should lead to optimal disease prevention through vaccination in multiple population groups while maintaining high levels of safety. |
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