Last data update: Dec 09, 2024. (Total: 48320 publications since 2009)
Records 1-30 (of 34 Records) |
Query Trace: Wharton A[original query] |
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Improving ICD coding in the emergency department: Factors related to use of "unspecified" codes for head and brain injury
Wharton T , Hunt Costello E , Peterson A , Bleser JA , Sarmiento K , Bailey M . J Public Health Manag Pract 2024 CONTEXT: International Classification of Diseases (ICD) codes are used for billing but also for surveillance for injuries such as traumatic brain injuries (TBI). While specificity is possible in the ICD-10-CM scheme, use of the code for unspecified injury of head (SO9.9) remains high. OBJECTIVES: This process evaluation sought to understand medical ICD-10-CM coding behaviors for TBI in emergency department (ED) settings. DESIGN: Semi-structured interviews explored the processes that facilitate or hinder ED physicians from selecting specific ICD codes for TBI and potential points of intervention for increased coding specificity and reducing the use of unspecified codes. SETTING: Video interviews were conducted with a nationwide sample in the United States. PARTICIPANTS: A purposive snowball sampling strategy was used to recruit 26 ED physicians with experience diagnosing TBI. INTERVENTION: Semi-structured interviews identified factors related to the selection of specific ICD codes for head injury. MAIN OUTCOME MEASURE: Thematic analysis of transcribed data. RESULTS: Four main themes emerged from the data: the impact of training and expertise, factors related to diagnosis, unclear connections with medical coders, and actionable recommendations. Interviews underscored the context surrounding "unspecified" codes for TBI, including demands from patient care, time pressures, issues around how a diagnosis may impact patient management decisions, and considerations related to mapping within the electronic medical record (EMR) where options may default to an unspecified code. CONCLUSIONS: Findings from this analysis indicate that ED providers may benefit from more robust training on how documentation can better support ICD-10-CM coding for this type of trauma. Revised EMR structures could support efficient coding specificity and clarity. |
Medical coders' use of the ICD-10-CM "unspecified" codes for head and brain injury in emergency department settings
Wharton T , Bailey M , Peterson A , Sarmiento K , Bleser JA , Costello EH . J Public Health Manag Pract 2024 CONTEXT: In the emergency department (ED) setting, prioritizing triage and patient care may lead to challenges in capturing detailed documentation necessary for specific International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) coding in medical records. Consequently, the prevalent use of the "unspecified head injury" code poses concerns about the precision of ED-based administrative billing claims data when analyzed for public health surveillance of nonfatal traumatic brain injuries (TBIs). Understanding the perspective of medical coders can illuminate coding processes and opportunities to enhance coding accuracy for TBI and other head injuries in the ED. OBJECTIVE: This evaluation explores medical coders' perspectives and challenges when assigning ICD-10-CM codes to head injuries in the ED. DESIGN: This qualitative evaluation utilized a phenomenological approach, which employed semi-structured interviews to understand medical coders' perspectives, processes, and coding determinations for head injuries in the ED. SETTING: Interviews were conducted using a HIPAA-compliant video-based platform between July 2022 and January 2023. PARTICIPANTS: Seventeen medical coders with ED coding experience were interviewed. Their backgrounds were diverse, though most had more than 15 years of experience. MAIN OUTCOMES: Four qualitative themes emerged, which highlighted challenges with lack of detailed documentation, defaulting to unspecified codes, time, and productivity pressure, and additional insights into coders' assumptions and code determination processes. RESULTS: Medical coders expressed challenges assigning ICD-10-CM codes to the highest level of specificity, citing issues including insufficient documentation by ED providers and terminology variations. Workplace time constraints and pressure for expedited claims also led to defaulting to unspecified codes. CONCLUSIONS: This evaluation highlights the need for improved documentation consistency and detail in ED records to facilitate accurate ICD-10-CM coding. Alleviating time pressures, improving algorithms, and offering specialized training opportunities to medical coders could be helpful steps to improve coding specificity and data accuracy for head injuries in the ED. |
Increasing equity in adult immunization through community-level action
Koppaka R , Wharton M , Lindley MC , Kohli J , Morita J . Health Aff Sch 2023 1 (6) qxad071 Inequities in availability and access to adult vaccinations represent significant gaps in the US public health infrastructure. Adults in racial and ethnic minority groups are less likely to receive routinely recommended vaccinations due to systemic barriers, distribution inequities, and lack of trust in vaccines; similar disparities were seen during early COVID-19 vaccination efforts. However, a deliberate focus on reducing disparities can yield progress. National data show narrowing of racial and ethnic adult COVID-19 vaccination coverage disparities over time, highlighting the value of the equity-focused, community-level interventions implemented during the pandemic. This paper describes the Centers for Disease Control and Prevention's efforts during the COVID-19 pandemic to address racial and ethnic disparities in adult immunization, and how lessons learned may be applied post-pandemic. Progress made is likely to be lost without sustained support for adult vaccination at national, state, and community levels. |
COVID-19 Vaccine Safety Technical (VaST) work group: Enhancing vaccine safety monitoring during the pandemic
Markowitz LE , Hopkins RH Jr , Broder KR , Lee GM , Edwards KM , Daley MF , Jackson LA , Nelson JC , Riley LE , McNally VV , Schechter R , Whitley-Williams PN , Cunningham F , Clark M , Ryan M , Farizo KM , Wong HL , Kelman J , Beresnev T , Marshall V , Shay DK , Gee J , Woo J , McNeil MM , Su JR , Shimabukuro TT , Wharton M , Keipp Talbot H . Vaccine 2024 During the COVID-19 pandemic, candidate COVID-19 vaccines were being developed for potential use in the United States on an unprecedented, accelerated schedule. It was anticipated that once available, under U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) or FDA approval, COVID-19 vaccines would be broadly used and potentially administered to millions of individuals in a short period of time. Intensive monitoring in the post-EUA/licensure period would be necessary for timely detection and assessment of potential safety concerns. To address this, the Centers for Disease Control and Prevention (CDC) convened an Advisory Committee on Immunization Practices (ACIP) work group focused solely on COVID-19 vaccine safety, consisting of independent vaccine safety experts and representatives from federal agencies - the ACIP COVID-19 Vaccine Safety Technical Work Group (VaST). This report provides an overview of the organization and activities of VaST, summarizes data reviewed as part of the comprehensive effort to monitor vaccine safety during the COVID-19 pandemic, and highlights selected actions taken by CDC, ACIP, and FDA in response to accumulating post-authorization safety data. VaST convened regular meetings over the course of 29 months, from November 2020 through April 2023; through March 2023 FDA issued EUAs for six COVID-19 vaccines from four different manufacturers and subsequently licensed two of these COVID-19 vaccines. The independent vaccine safety experts collaborated with federal agencies to ensure timely assessment of vaccine safety data during this time. VaST worked closely with the ACIP COVID-19 Vaccines Work Group; that work group used safety data and VaST's assessments for benefit-risk assessments and guidance for COVID-19 vaccination policy. Safety topics reviewed by VaST included those identified in safety monitoring systems and other topics of scientific or public interest. VaST provided guidance to CDC's COVID-19 vaccine safety monitoring efforts, provided a forum for review of data from several U.S. government vaccine safety systems, and assured that a diverse group of scientists and clinicians, external to the federal government, promptly reviewed vaccine safety data. In the event of a future pandemic or other biological public health emergency, the VaST model could be used to strengthen vaccine safety monitoring, enhance public confidence, and increase transparency through incorporation of independent, non-government safety experts into the monitoring process, and through strong collaboration among federal and other partners. |
Development of COVID-19 vaccine policy - United States, 2020-2023
Oliver SE , Wallace M , Twentyman E , Moulia DL , Godfrey M , Link-Gelles R , Meyer S , Fleming-Dutra KE , Hall E , Wolicki J , MacNeil J , Bell BP , Lee GM , Daley MF , Cohn A , Wharton M . Vaccine 2023 COVID-19 vaccines represent a great scientific and public health achievement in the face of overwhelming pressures from a global pandemic, preventing millions of hospitalizations and deaths due to COVID-19 vaccines in the United States. Over 675 million doses of COVID-19 vaccines have been administered in the United States, and over 80% of the U.S. population has had at least 1 dose of a COVID-19 vaccine. Over the course of the COVID-19 pandemic in the United States, over one million people died from COVID-19, and over six million were hospitalized. It has been estimated that COVID-19 vaccines prevented more than 18 million additional hospitalizations and more than 3 million additional deaths due to COVID-19 in the United States. From the beginning of the COVID-19 pandemic in 2020 through June 2023, ACIP had 35 COVID-19 focused meetings and 24 votes for COVID-19 vaccine recommendations. ACIP had the critical task of rapidly and thoroughly reviewing emerging and evolving data on COVID-19 epidemiology and vaccines, as well as making comprehensive population-based recommendations for vaccine policy and considerations for implementation through a transparent and evidence-based framework. Safe and effective COVID-19 vaccines, recommended through transparent policy discussions with ACIP, remain the best tool we have to prevent serious illness, hospitalization and death from COVID-19. |
Rapid Development of Neutralizing and Diagnostic SARS-COV-2 Mouse Monoclonal Antibodies (preprint)
Chapman AP , Tang X , Lee JR , Chida A , Mercer K , Wharton RE , Kainulainen M , Harcourt JL , Martines RB , Schroeder M , Zhao L , Bryksin A , Zhou B , Bergeron E , Bollweg BC , Tamin A , Thornburg N , Wentworth DE , Petway D , Bagarozzi DA Jr , Finn MG , Goldstein JM . bioRxiv 2020 2020.10.13.338095 The need for high-affinity, SARS-CoV-2-specific monoclonal antibodies (mAbs) is critical in the face of the global COVID-19 pandemic, as such reagents can have important diagnostic, research, and therapeutic applications. Of greatest interest is the ~300 amino acid receptor binding domain (RBD) within the S1 subunit of the spike protein because of its key interaction with the human angiotensin converting enzyme 2 (hACE2) receptor present on many cell types, especially lung epithelial cells. We report here the development and functional characterization of 29 nanomolar-affinity mouse SARS-CoV-2 mAbs created by an accelerated immunization and hybridoma screening process. Differing functions, including binding of diverse protein epitopes, viral neutralization, impact on RBD-hACE2 binding, and immunohistochemical staining of infected lung tissue, were correlated with variable gene usage and sequence.Competing Interest StatementThe authors have declared no competing interest. |
High-throughput quantitation of SARS-CoV-2 antibodies in a single-dilution homogeneous assay (preprint)
Kainulainen MH , Bergeron E , Chatterjee P , Chapman AP , Lee J , Chida A , Tang X , Wharton RE , Mercer KB , Petway M , Jenks HM , Flietstra TD , Schuh AJ , Satheshkumar PS , Chaitram JM , Owen SM , Finn MG , Goldstein JM , Montgomery JM , Spiropoulou CF . medRxiv 2020 2020.09.16.20195446 SARS-CoV-2 emerged in late 2019 and has since spread around the world, causing a pandemic of the respiratory disease COVID-19. Detecting antibodies against the virus is an essential tool for tracking infections and developing vaccines. Such tests, primarily utilizing the enzyme-linked immunosorbent assay (ELISA) principle, can be either qualitative (reporting positive/negative results) or quantitative (reporting a value representing the quantity of specific antibodies). Quantitation is vital for determining stability or decline of antibody titers in convalescence, efficacy of different vaccination regimens, and detection of asymptomatic infections. Quantitation typically requires two-step ELISA testing, in which samples are first screened in a qualitative assay and positive samples are subsequently analyzed as a dilution series. To overcome the throughput limitations of this approach, we developed a simpler and faster system that is highly automatable and achieves quantitation in a single-dilution screening format with sensitivity and specificity comparable to those of ELISA.One sentence summary Protein complementation enables mix-and-read SARS-CoV-2 serology that rivals sensitivity and specificity of ELISA but excels in throughput and quantitation.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThis research was funded by the Centers for Disease Control and Prevention.Author DeclarationsI confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.YesThe details of the IRB/oversight body that provided approval or exemption for the research described are given below:Residual specimen materials were used for diagnostics development under a protocol that was reviewed and approved by the CDC Institutional Review Board (See 45 C.F.R. part 46; 21 C.F.R. part 56)All necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived.YesI understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).YesI have followed all appropriate research reporting guidelines and uploaded the relevant EQUATOR Network research reporting checklist(s) and other pertinent material as supplementary files, if applicable.YesNo external data links |
Uninsured and not immune - closing the vaccine-coverage gap for adults
Wallender E , Peacock G , Wharton M , Walensky RP . N Engl J Med 2023 389 (3) 193-195 The U.S. Covid-19 vaccination strategy was simple: get safe and effective vaccines into arms as quickly as possible by making them free and accessible. This strategy worked: more than 670 million Covid-19 vaccine doses had been administered to more than 270 million Americans by the end of the national public health emergency. As we look toward the fall, Covid-19 vaccines — the most effective tool for preventing severe disease — will largely be moving to the commercial market, where access to vaccines is often limited for adults without health insurance. | | In keeping with its pandemic-long goal of promoting equitable access to Covid-19 vaccines, the Biden administration in April 2023 introduced the Health and Human Services Bridge Access Program for Covid-19 Vaccines and Treatments to cover Covid-19 vaccines for uninsured people through 2024. Conceived of as a temporary solution until a more comprehensive vaccine-access plan can be authorized and funded by Congress, the program would utilize more than $1 billion of Covid-19 funds to distribute Covid-19 vaccines to state and local health departments and associated providers, clinics supported by the Health Resources and Services Administration (HRSA), and pharmacies. The fact that this program had to be created from scratch — with funding identified, contracts modified, and timelines and end points designated — speaks to the need for a sustainable, comprehensive vaccine program for uninsured adults, to provide protection against vaccine-preventable diseases for both eligible participants and the general public. |
Measurement of microcystin activity in human plasma using immunocapture and protein phosphatase inhibition assay
Cunningham BR , Wharton RE , Lee C , Mojica MA , Krajewski LC , Gordon SC , Schaefer AM , Johnson RC , Hamelin EI . Toxins (Basel) 2022 14 (11) Microcystins are toxic chemicals generated by certain freshwater cyanobacteria. These chemicals can accumulate to dangerous levels during harmful algal blooms. When exposed to microcystins, humans are at risk of hepatic injury, including liver failure. Here, we describe a method to detect microcystins in human plasma by using immunocapture followed by a protein phosphatase inhibition assay. At least 279 microcystins have been identified, and most of these compounds share a common amino acid, the Adda side chain. We targeted this Adda side chain using a commercial antibody and extracted microcystins from human samples for screening and analysis. To quantitate the extracted microcystins, we fortified plasma with microcystin-LR, one of the most well-studied, commonly detected, and toxic microcystin congeners. The quantitation range for the detection of microcystin in human plasma using this method is 0.030-0.50 ng/mL microcystin-LR equivalents. This method detects unconjugated and conjugated forms (cysteine and glutathione) of microcystins. Quality control sample accuracies varied between 98.9% and 114%, with a precision of 7.18-15.8%. Finally, we evaluated plasma samples from a community health surveillance project of Florida residents living or working near harmful algae blooms. |
Report of the 2nd workshop of the International Collaboration on advanced vaccinology training.
Duclos P , MacDonald NE , Dochez C , Thacker N , Steffen CA , Nohynek H , Lambert PH , Wharton M . Vaccine 2022 40 (47) 6689-6699 At a workshop on 22-24 March 2022, leaders of 33 advanced vaccinology courses were invited to meet with partners to further the aims of the International Collaboration on Advanced Vaccinology Training (ICAVT) initiated in 2018 to assist courses in addressing challenges in priority areas and facilitate interactions and exchange of information. This included: an update to the landscape analysis of advanced vaccinology courses conducted in 2018, sharing experiences and good practices in the implementation of virtual training, reviewing the training needs of target audiences, informing courses of the principles, challenges, and added value of accreditation, discussing course evaluations and measurement of course impact, reviewing principles and support needed for quality cascade training, reviewing COVID-19 impact on training and identifying remaining related training needs, and identifying solutions to facilitate refresher courses and ways to facilitate networking of courses' alumni (particularly for virtual courses). The aims were to identify needs and impediments and implement necessary actions to facilitate sharing of information and resources between courses, to identify need for further developments of the e-Portal of the Collaboration (icavt.org) established to facilitate communication between the different courses and assist future course participants identify the most suitable course for them, and to discuss the formalization of the Collaboration. During the workshop, participants looked at several reports of surveys completed by courses and courses' alumni or partners. The COVID-19 pandemic impacted the delivery of some vaccinology courses leading to postponement, delivery online or hybrid training events. Lack of sustainable funding remained a major constraint for advanced vaccinology training and needs to be addressed. The Collaboration was consolidated with responsibilities and benefits for the members better defined. There was strong support for the Collaboration to continue with the organization of educational sessions at future workshops. The meeting re-enforced the view that there was much enthusiasm and commitment for the Global Collaboration and its core values. |
Use of the Janssen (Johnson & Johnson) COVID-19 Vaccine: Updated Interim Recommendations from the Advisory Committee on Immunization Practices - United States, December 2021.
Oliver SE , Wallace M , See I , Mbaeyi S , Godfrey M , Hadler SC , Jatlaoui TC , Twentyman E , Hughes MM , Rao AK , Fiore A , Su JR , Broder KR , Shimabukuro T , Lale A , Shay DK , Markowitz LE , Wharton M , Bell BP , Brooks O , McNally V , Lee GM , Talbot HK , Daley MF . MMWR Morb Mortal Wkly Rep 2022 71 (3) 90-95 On February 27, 2021, the Food and Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the adenovirus-vectored COVID-19 vaccine (Janssen Biotech, Inc., a Janssen Pharmaceutical company, Johnson & Johnson), and on February 28, 2021, the Advisory Committee on Immunization Practices (ACIP) issued an interim recommendation for its use as a single-dose primary vaccination in persons aged ≥18 years (1,2). On April 13, 2021, CDC and FDA recommended a pause in the use of Janssen COVID-19 vaccine after reports of thrombosis with thrombocytopenia syndrome (TTS), a rare condition characterized by low platelets and thrombosis, including at unusual sites such as the cerebral venous sinus (cerebral venous sinus thrombosis [CVST]), after receipt of the vaccine.* ACIP rapidly convened two emergency meetings to review reported cases of TTS, and 10 days after the pause commenced, ACIP reaffirmed its interim recommendation for use of the Janssen COVID-19 vaccine in persons aged ≥18 years, but included a warning regarding rare clotting events after vaccination, primarily among women aged 18-49 years (3). In July, after review of an updated benefit-risk assessment accounting for risks of Guillain-Barré syndrome (GBS) and TTS, ACIP concluded that benefits of vaccination with Janssen COVID-19 vaccine outweighed risks. Through ongoing safety surveillance and review of reports from the Vaccine Adverse Event Reporting System (VAERS), additional cases of TTS after receipt of Janssen COVID-19 vaccine, including deaths, were identified. On December 16, 2021, ACIP held an emergency meeting to review updated data on TTS and an updated benefit-risk assessment. At that meeting, ACIP made a recommendation for preferential use of mRNA COVID-19 vaccines over the Janssen COVID-19 vaccine, including both primary and booster doses administered to prevent COVID-19, for all persons aged ≥18 years. The Janssen COVID-19 vaccine may be considered in some situations, including for persons with a contraindication to receipt of mRNA COVID-19 vaccines. |
Maintenance of measles elimination status in the United States for 20 years despite increasing challenges
Mathis AD , Clemmons NS , Redd SB , Pham H , Leung J , Wharton AK , Anderson R , McNall RJ , Rausch-Phung E , Rosen JB , Blog D , Zucker JR , Bankamp B , Rota PA , Patel M , Gastañaduy PA . Clin Infect Dis 2021 75 (3) 416-424 BACKGROUND: Measles elimination (interruption of endemic measles virus transmission) in the United States was declared in 2000; however, the number of cases and outbreaks have increased in recent years. We characterized the epidemiology of measles outbreaks and measles transmission patterns post-elimination to identify potential gaps in the U.S. measles control program. METHODS: We analyzed national measles notification data from January 1, 2001-December 31, 2019. We defined measles infection clusters as single cases (isolated cases not linked to additional cases), 2-case clusters, or outbreaks with 3 or more linked cases. We calculated the effective reproduction number (R) to assess changes in transmissibility and reviewed molecular epidemiology data. RESULTS: During 2001-2019, 3,873 measles cases, including 747 international importations, were reported in the United States; 29% of importations were associated with outbreaks. Among 871 clusters, 69% were single cases and 72% had no spread. Larger and longer clusters were reported since 2013, including seven outbreaks with >50 cases lasting >2 months, 5 of which occurred in known underimmunized, close-knit communities. No measles lineage circulated in a single transmission chain for >12 months. Higher estimates of R were noted in recent years, although R remained below the epidemic threshold of 1. CONCLUSIONS: Current epidemiology continues to support the interruption of endemic measles virus transmission in the United States. However, larger and longer outbreaks in recent post-elimination years and emerging trends of increased transmission in underimmunized communities emphasize the need for targeted approaches to close existing immunity gaps and maintain measles elimination. |
Use of COVID-19 Vaccines After Reports of Adverse Events Among Adult Recipients of Janssen (Johnson & Johnson) and mRNA COVID-19 Vaccines (Pfizer-BioNTech and Moderna): Update from the Advisory Committee on Immunization Practices - United States, July 2021.
Rosenblum HG , Hadler SC , Moulia D , Shimabukuro TT , Su JR , Tepper NK , Ess KC , Woo EJ , Mba-Jonas A , Alimchandani M , Nair N , Klein NP , Hanson KE , Markowitz LE , Wharton M , McNally VV , Romero JR , Talbot HK , Lee GM , Daley MF , Mbaeyi SA , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (32) 1094-1099 In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for Pfizer-BioNTech and Moderna COVID-19 vaccines, and in February 2021, FDA issued an EUA for the Janssen (Johnson & Johnson) COVID-19 vaccine. After each EUA, the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for vaccine use; currently Pfizer-BioNTech is authorized and recommended for persons aged ≥12 years and Moderna and Janssen for persons aged ≥18 years (1-3). Both Pfizer-BioNTech and Moderna vaccines, administered as 2-dose series, are mRNA-based COVID-19 vaccines, whereas the Janssen COVID-19 vaccine, administered as a single dose, is a recombinant replication-incompetent adenovirus-vector vaccine. As of July 22, 2021, 187 million persons in the United States had received at least 1 dose of COVID-19 vaccine (4); close monitoring of safety surveillance has demonstrated that serious adverse events after COVID-19 vaccination are rare (5,6). Three medical conditions have been reported in temporal association with receipt of COVID-19 vaccines. Two of these (thrombosis with thrombocytopenia syndrome [TTS], a rare syndrome characterized by venous or arterial thrombosis and thrombocytopenia, and Guillain-Barré syndrome [GBS], a rare autoimmune neurologic disorder characterized by ascending weakness and paralysis) have been reported after Janssen COVID-19 vaccination. One (myocarditis, cardiac inflammation) has been reported after Pfizer-BioNTech COVID-19 vaccination or Moderna COVID-19 vaccination, particularly after the second dose; these were reviewed together and will hereafter be referred to as mRNA COVID-19 vaccination. ACIP has met three times to review the data associated with these reports of serious adverse events and has comprehensively assessed the benefits and risks associated with receipt of these vaccines. During the most recent meeting in July 2021, ACIP determined that, overall, the benefits of COVID-19 vaccination in preventing COVID-19 morbidity and mortality outweigh the risks for these rare serious adverse events in adults aged ≥18 years; this balance of benefits and risks varied by age and sex. ACIP continues to recommend COVID-19 vaccination in all persons aged ≥12 years. CDC and FDA continue to closely monitor reports of serious adverse events and will present any additional data to ACIP for consideration. Information regarding risks and how they vary by age and sex and type of vaccine should be disseminated to providers, vaccine recipients, and the public. |
Subjective cognitive decline higher among sexual and gender minorities in the United States, 2015-2018
Flatt JD , Cicero EC , Lambrou NH , Wharton W , Anderson JG , Bouldin ED , McGuire LC , Taylor CA . Alzheimers Dement (N Y) 2021 7 (1) e12197 INTRODUCTION: Subjective cognitive decline (SCD) represents self-reported problems with memory, a possible early sign of dementia. Little is known about SCD among sexual and gender minority (SGM) adults who identify as lesbian, gay, bisexual, and/or transgender or gender non-binary. METHODS: Data were weighted to represent population estimates from 25 states' 2015-2018 Behavioral Risk Factor Surveillance System to describe SCD in adults ≥45 years by SGM status. Logistic regression tested associations between demographic and health conditions. RESULTS: SCD prevalence was higher in SGM (15.7%; 95% confidence interval [CI]:13.1-18.2) than in non-SGM adults (10.5%; 95% CI:10.1-10.9; P < .0001). SGM adults with SCD were also more likely to report functional limitations due to SCD than non-SGM adults with SCD, 60.8% versus 47.8%, P = .0048. Differences in SCD by SGM status were attenuated after accounting for depression. DISCUSSION: Higher prevalence of SCD in SGM adults highlights the importance of ensuring inclusive screenings, interventions, care services, and resources for SGM adults. |
Use of mRNA COVID-19 Vaccine After Reports of Myocarditis Among Vaccine Recipients: Update from the Advisory Committee on Immunization Practices - United States, June 2021.
Gargano JW , Wallace M , Hadler SC , Langley G , Su JR , Oster ME , Broder KR , Gee J , Weintraub E , Shimabukuro T , Scobie HM , Moulia D , Markowitz LE , Wharton M , McNally VV , Romero JR , Talbot HK , Lee GM , Daley MF , Oliver SE . MMWR Morb Mortal Wkly Rep 2021 70 (27) 977-982 In December 2020, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for the Pfizer-BioNTech COVID-19 (BNT162b2) vaccine and the Moderna COVID-19 (mRNA-1273) vaccine,(†) and the Advisory Committee on Immunization Practices (ACIP) issued interim recommendations for their use in persons aged ≥16 years and ≥18 years, respectively.(§) In May 2021, FDA expanded the EUA for the Pfizer-BioNTech COVID-19 vaccine to include adolescents aged 12-15 years; ACIP recommends that all persons aged ≥12 years receive a COVID-19 vaccine. Both Pfizer-BioNTech and Moderna vaccines are mRNA vaccines encoding the stabilized prefusion spike glycoprotein of SARS-CoV-2, the virus that causes COVID-19. Both mRNA vaccines were authorized and recommended as a 2-dose schedule, with second doses administered 21 days (Pfizer-BioNTech) or 28 days (Moderna) after the first dose. After reports of myocarditis and pericarditis in mRNA vaccine recipients,(¶) which predominantly occurred in young males after the second dose, an ACIP meeting was rapidly convened to review reported cases of myocarditis and pericarditis and discuss the benefits and risks of mRNA COVID-19 vaccination in the United States. Myocarditis is an inflammation of the heart muscle; if it is accompanied by pericarditis, an inflammation of the thin tissue surrounding the heart (the pericardium), it is referred to as myopericarditis. Hereafter, myocarditis is used to refer to myocarditis, pericarditis, or myopericarditis. On June 23, 2021, after reviewing available evidence including that for risks of myocarditis, ACIP determined that the benefits of using mRNA COVID-19 vaccines under the FDA's EUA clearly outweigh the risks in all populations, including adolescents and young adults. The EUA has been modified to include information on myocarditis after receipt of mRNA COVID-19 vaccines. The EUA fact sheets should be provided before vaccination; in addition, CDC has developed patient and provider education materials about the possibility of myocarditis and symptoms of concern, to ensure prompt recognition and management of myocarditis. |
High-throughput quantitation of SARS-CoV-2 antibodies in a single-dilution homogeneous assay.
Kainulainen MH , Bergeron E , Chatterjee P , Chapman AP , Lee J , Chida A , Tang X , Wharton RE , Mercer KB , Petway M , Jenks HM , Flietstra TD , Schuh AJ , Satheshkumar PS , Chaitram JM , Owen SM , McMullan LK , Flint M , Finn MG , Goldstein JM , Montgomery JM , Spiropoulou CF . Sci Rep 2021 11 (1) 12330 SARS-CoV-2 emerged in late 2019 and has since spread around the world, causing a pandemic of the respiratory disease COVID-19. Detecting antibodies against the virus is an essential tool for tracking infections and developing vaccines. Such tests, primarily utilizing the enzyme-linked immunosorbent assay (ELISA) principle, can be either qualitative (reporting positive/negative results) or quantitative (reporting a value representing the quantity of specific antibodies). Quantitation is vital for determining stability or decline of antibody titers in convalescence, efficacy of different vaccination regimens, and detection of asymptomatic infections. Quantitation typically requires two-step ELISA testing, in which samples are first screened in a qualitative assay and positive samples are subsequently analyzed as a dilution series. To overcome the throughput limitations of this approach, we developed a simpler and faster system that is highly automatable and achieves quantitation in a single-dilution screening format with sensitivity and specificity comparable to those of ELISA. |
Vaccine safety issues at the turn of the 21st century
Conklin L , Hviid A , Orenstein WA , Pollard AJ , Wharton M , Zuber P . BMJ Glob Health 2021 6 Global gains in vaccination coverage during the early 21st century have been threatened by the emergence of antivaccination groups that have questioned the effectiveness of vaccines to generate public distrust of vaccines and immunisation programmes. This manuscript summarises six key topics that have been at the centre of global discussions on vaccine safety during the early 21st century: thiomersal in multi-dose non-live vaccines, aluminium adjuvants used with several non-live vaccines, autism and auto-immune conditions as possible consequences of vaccination, a risk of immune overload with increasing numbers of vaccinations, and detrimental non-specific effects (NSEs) of vaccination. For each topic, we describe the hypothesis behind the public concern, the evidence reviewed by the WHO's Global Advisory Committee for Vaccine Safety (GACVS) during 1999-2019, and any significant new data that has emerged since GACVS conclusions were made. Although the scientific evidence on these issues overwhelmingly supports the safety of vaccines, communication messages to caregivers and providers need to condense and convey scientific information in an appropriate way to address concerns contributing to vaccine distrust. In addition, there is need for further studies specifically designed to address both positive and negative NSE of vaccination. The role of GACVS will be increasingly important in evaluating the evidence and engaging the global community in promoting and assuring the safety of vaccines in the decades to come as we move into an era in which we use new vaccination platforms, antigens and formulations. |
Rapid development of neutralizing and diagnostic SARS-COV-2 mouse monoclonal antibodies.
Chapman AP , Tang X , Lee JR , Chida A , Mercer K , Wharton RE , Kainulainen M , Harcourt JL , Martines RB , Schroeder M , Zhao L , Bryksin A , Zhou B , Bergeron E , Bollweg BC , Tamin A , Thornburg N , Wentworth DE , Petway D , Bagarozzi DA Jr , Finn MG , Goldstein JM . Sci Rep 2021 11 (1) 9682 The need for high-affinity, SARS-CoV-2-specific monoclonal antibodies (mAbs) is critical in the face of the global COVID-19 pandemic, as such reagents can have important diagnostic, research, and therapeutic applications. Of greatest interest is the ~ 300 amino acid receptor binding domain (RBD) within the S1 subunit of the spike protein because of its key interaction with the human angiotensin converting enzyme 2 (hACE2) receptor present on many cell types, especially lung epithelial cells. We report here the development and functional characterization of 29 nM-affinity mouse SARS-CoV-2 mAbs created by an accelerated immunization and hybridoma screening process. Differing functions, including binding of diverse protein epitopes, viral neutralization, impact on RBD-hACE2 binding, and immunohistochemical staining of infected lung tissue, were correlated with variable gene usage and sequence. |
Detection of 30 fentanyl analogs by commercial immunoassay kits
Wharton RE , Casbohm J , Hoffmaster R , Brewer BN , Finn MG , Johnson RC . J Anal Toxicol 2021 45 (2) 111-116 Health-care workers, laboratorians and overdose prevention centers rely on commercial immunoassays to detect the presence of fentanyl; however, the cross-reactivity of fentanyl analogs with these kits is largely unknown. To address this, we conducted a pilot study evaluating the detection of 30 fentanyl analogs and metabolites by 19 commercially available kits (9 lateral flow assays, 7 heterogeneous immunoassays and 3 homogenous immunoassays). The analogs selected for analysis were compiled from the Drug Enforcement Administration and National Forensic Laboratory Information System reports from 2015 to 2018. In general, the immunoassays tested were able to detect their intended fentanyl analog and some closely related analogs, but more structurally diverse analogs, including 4-methoxy-butyryl fentanyl and 3-methylfentanyl, were not well detected. Carfentanil was only detected by kits specifically designed for its recognition. In general, analogs with group additions to the piperidine, or bulky rings or long alkyl chain modifications in the N-aryl or alkyl amide regions, were poorly detected compared to other types of modifications. This preliminary information is useful for screening diagnostic, forensic and unknown powder samples for the presence of fentanyl analogs and guiding future testing improvements. |
Detection and Genetic Characterization of Community-Based SARS-CoV-2 Infections - New York City, March 2020.
Greene SK , Keating P , Wahnich A , Weiss D , Pathela P , Harrison C , Rakeman J , Langley G , Tong S , Tao Y , Uehara A , Queen K , Paden CR , Szymczak W , Orner EP , Nori P , Lai PA , Jacobson JL , Singh HK , Calfee DP , Westblade LF , Vasovic LV , Rand JH , Liu D , Singh V , Burns J , Prasad N , Sell J , CDC COVID-19 Surge Laboratory Group , Abernathy Emily , Anderson Raydel , Bankamp Bettina , Bell Melissa , Galloway Renee , Graziano James , Kim Gimin , Kondas Ashley , Lee Christopher , Radford Kay , Rogers Shannon , Smith Peyton , Tiller Rebekah , Weiner Zachary , Wharton Adam , Whitaker Brett . MMWR Morb Mortal Wkly Rep 2020 69 (28) 918-922 To limit introduction of SARS-CoV-2, the virus that causes coronavirus disease 2019 (COVID-19), the United States restricted travel from China on February 2, 2020, and from Europe on March 13. To determine whether local transmission of SARS-CoV-2 could be detected, the New York City (NYC) Department of Health and Mental Hygiene (DOHMH) conducted deidentified sentinel surveillance at six NYC hospital emergency departments (EDs) during March 1-20. On March 8, while testing availability for SARS-CoV-2 was still limited, DOHMH announced sustained community transmission of SARS-CoV-2 (1). At this time, twenty-six NYC residents had confirmed COVID-19, and ED visits for influenza-like illness* increased, despite decreased influenza virus circulation.(†) The following week, on March 15, when only seven of the 56 (13%) patients with known exposure histories had exposure outside of NYC, the level of community SARS-CoV-2 transmission status was elevated from sustained community transmission to widespread community transmission (2). Through sentinel surveillance during March 1-20, DOHMH collected 544 specimens from patients with influenza-like symptoms (ILS)(§) who had negative test results for influenza and, in some instances, other respiratory pathogens.(¶) All 544 specimens were tested for SARS-CoV-2 at CDC; 36 (6.6%) tested positive. Using genetic sequencing, CDC determined that the sequences of most SARS-CoV-2-positive specimens resembled those circulating in Europe, suggesting probable introductions of SARS-CoV-2 from Europe, from other U.S. locations, and local introductions from within New York. These findings demonstrate that partnering with health care facilities and developing the systems needed for rapid implementation of sentinel surveillance, coupled with capacity for genetic sequencing before an outbreak, can help inform timely containment and mitigation strategies. |
Genetic Characterization of Mumps Viruses Associated with the Resurgence of Mumps in the United States: 2015-2017.
McNall RJ , Wharton AK , Anderson R , Clemmons N , Lopareva EN , Gonzalez C , Espinosa A , Probert WS , Hacker JK , Liu G , Garfin J , Strain A , Boxrud D , Bryant PW , George KS , Davis T , Griesser RH , Shult P , Bankamp B , Hickman CJ , Wroblewski K , Rota PA . Virus Res 2020 281 197935 Despite high coverage with measles, mumps, and rubella vaccine in the United States, outbreaks of mumps occur in close contact settings such as schools, colleges, and camps. Starting in late 2015, outbreaks were reported from several universities, and by the end of 2017, greater than 13,800 cases had been reported nation-wide. In 2013, the CDC and the Association of Public Health Laboratories contracted four Vaccine Preventable Diseases Reference Centers (VPD-RCs) to perform real-time reverse transcription PCR (RT-qPCR) to detect mumps RNA in clinical samples and to determine the genotype. Twelve genotypes of mumps virus are currently recognized by the World Health Organization, and the standard protocol for genotyping requires sequencing the entire gene coding for the small hydrophobic (SH) protein. Phylogenetic analysis of the 1862 mumps samples genotyped from 2015 through 2017 showed that the overall diversity of genotypes detected was low. Only 0.8% of the sequences were identified as genotypes C, H, J, or K, and 0.5% were identified as vaccine strains in genotypes A or N, while most sequences (98.7%) were genotype G. The majority of the genotype G sequences could be included into one of two large groups with identical SH sequences. Within genotype G, a small number of phylogenetically significant outlier sequences were associated with epidemiologically distinct chains of transmission. These results demonstrate that molecular and epidemiologic data can be used to track transmission pathways of mumps virus; however, the limited diversity of the SH sequences may be insufficient for resolving transmission in all outbreaks. |
Measurement of microcystin and nodularin activity in human urine by immunocapture-protein phosphatase 2A assay
Wharton RE , Cunningham BR , Schaefer AM , Guldberg SM , Hamelin EI , Johnson RC . Toxins (Basel) 2019 11 (12) Microcystins (MC) and nodularin (NOD) are toxins released by cyanobacteria during harmful algal blooms. They are potent inhibitors of protein phosphatases 1 and 2A (PP1 and PP2A) and cause a variety of adverse symptoms in humans and animals if ingested. More than 250 chemically diverse congeners of MCs have been identified, but certified reference materials are only available for a few. A diagnostic test that does not require each reference material for detection is necessary to identify human exposures. To address this need, our lab has developed a method that uses an antibody to specifically isolate MCs and NOD from urine prior to detection via a commercially available PP2A kit. This assay quantitates the summed inhibitory activity of nearly all MCs and NOD on PP2A relative to a common MC congener, microcystin-LR (MC-LR). The quantitation range for MC-LR using this method is from 0.050-0.500 ng/mL. No background responses were detected in a convenience set of 50 individual urines. Interday and intraday % accuracies ranged from 94%-118% and relative standard deviations were 15% or less, meeting FDA guidelines for receptor binding assays. The assay detected low levels of MCs in urines from three individuals living in close proximity to harmful algal blooms (HABs) in Florida. |
Notes From The Field: Mumps outbreak in a recently vaccinated population - Kosrae, Federated States of Micronesia, August-December, 2017
McKay SL , Kambui A , Taulung LA , Tippins A , Eckert M , Wharton AK , McNall RJ , Hickman C , Hancock WT , Apaisam C , Judicpa P , Patel M , Routh J . MMWR Morb Mortal Wkly Rep 2019 68 (4) 95-96 On August 6, 2017, the Kosrae Department of Health Services (KDHS) in the Federated States of Micronesia identified a confirmed case of mumps in a Kosrae resident who had 2 documented doses of measles-mumps-rubella (MMR) vaccine. The patient aged 18 years had recently traveled to Seattle, Washington, which was experiencing a mumps outbreak among members of its Pacific Islander population. Other Pacific Islands were concurrently experiencing large mumps outbreaks (1,2), in some places exceeding 500 cases, raising concern about the possibility of a similar outbreak in Kosrae. By October 6, KDHS had identified 17 cases (nine laboratory confirmed and eight suspected [clinically diagnosed as parotitis]) on the island (population 6,600) (Figure), with an attack rate of 14 cases per 1,000 residents in the primary affected municipality. At the request of KDHS, CDC deployed a team on October 17 to assist KDHS in investigation and control activities. The KDHS-CDC team conducted active surveillance to assess outbreak magnitude, interviewed mumps patients, collected specimens for laboratory testing, and reviewed patients’ vaccination records. KDHS conducted islandwide awareness campaigns about the outbreak and mumps prevention measures, and highlighted the importance of vaccination. |
Determination of fentanyl analog exposure using dried blood spots with LC-MS-MS
Seymour C , Shaner RL , Feyereisen MC , Wharton RE , Kaplan P , Hamelin EI , Johnson RC . J Anal Toxicol 2018 43 (4) 266-276 Fentanyl, and the numerous drugs derived from it, are contributing to the opioid overdose epidemic currently underway in the USA. To identify human exposure to these growing public health threats, an LC-MS-MS method for 5 muL dried blood spots (DBS) was developed. This method was developed to detect exposure to 3-methylfentanyl, alfentanil, alpha-methylfentanyl, carfentanil, fentanyl, lofentanil, sufentanil, norcarfentanil, norfentanyl, norlofentanil, norsufentanil, and using a separate LC-MS-MS injection, cyclopropylfentanyl, acrylfentanyl, 2-furanylfentanyl, isobutyrylfentanyl, ocfentanil and methoxyacetylfentanyl. Preparation of materials into groups of compounds was used to accommodate an ever increasing need to incorporate newly identified fentanyls. This protocol was validated within a linear range of 1.00-100 ng/mL, with precision </=12% CV and accuracy >/=93%, as reported for the pooled blood QC samples, and limits of detection as low as 0.10 ng/mL. The use of DBS to assess fentanyl analog exposures can facilitate rapid sample collection, transport, and preparation for analysis that could enhance surveillance and response efforts in the ongoing opioid overdose epidemic. |
Quantification of microcystin-LR in human urine by immunocapture liquid chromatography tandem mass spectrometry
Wharton RE , Ojeda-Torres G , Cunningham B , Feyereisen MC , Hill KL , Abbott NL , Seymour C , Hill D , Lang J , Hamelin EI , Johnson RC . Chem Res Toxicol 2018 31 (9) 898-903 Microcystins are toxins produced by many cyanobacteria species, which are often released into waterways during blue-green algal blooms in freshwater and marine habitats. The consumption of microcystin-contaminated water is a public health concern as these toxins are recognized tumor promoters and are hepatotoxic to humans and animals. A method to confirm human exposures to microcystins is needed; therefore, our laboratory has developed an immunocapture liquid chromatography tandem mass spectrometry (LC-MS/MS) method targeting the conserved adda portion of microcystins for the quantitation of a prevalent and highly toxic congener of microcystin, microcystin-LR (MC-LR). An acute exposure method was initially evaluated for accuracy and precision by analyzing calibrators and quality control (QC) samples ranging from 0.500 to 75.0 ng/mL in urine. All calibrators and QC samples characterized were within 15% of theoretical concentrations. An analysis of acutely exposed mouse urine samples using this method identified MC-LR levels from 10.7 to 33.9 ng/mL. Since human exposures are anticipated to result from low-dose or chronic exposures, a high-sensitivity method was validated with 20 calibration curves and QC samples ranging from 0.0100 to 7.50 ng/mL. Relative standard deviations (RSDs) and inaccuracies of these samples were within 15%, meeting United States Food and Drug Administration (FDA) guidelines for analytical methods, and the limit of detection was 0.00455 ng/mL. In conclusion, we have developed a method which can be used to address public health concerns by precisely and accurately measuring MC-LR in urine samples. |
Progress in vaccine-preventable and respiratory infectious diseases - first 10 Years of the CDC National Center for Immunization and Respiratory Diseases, 2006-2015
Schuchat A , Anderson LJ , Rodewald LE , Cox NJ , Hajjeh R , Pallansch MA , Messonnier NE , Jernigan DB , Wharton M . Emerg Infect Dis 2018 24 (7) 1178-1187 The need for closer linkages between scientific and programmatic areas focused on addressing vaccine-preventable and acute respiratory infections led to establishment of the National Center for Immunization and Respiratory Diseases (NCIRD) at the Centers for Disease Control and Prevention. During its first 10 years (2006-2015), NCIRD worked with partners to improve preparedness and response to pandemic influenza and other emergent respiratory infections, provide an evidence base for addition of 7 newly recommended vaccines, and modernize vaccine distribution. Clinical tools were developed for improved conversations with parents, which helped sustain childhood immunization as a social norm. Coverage increased for vaccines to protect adolescents against pertussis, meningococcal meningitis, and human papillomavirus-associated cancers. NCIRD programs supported outbreak response for new respiratory pathogens and oversaw response of the Centers for Disease Control and Prevention to the 2009 influenza A(H1N1) pandemic. Other national public health institutes might also find closer linkages between epidemiology, laboratory, and immunization programs useful. |
Notes from the field: Absence of asymptomatic mumps virus shedding among vaccinated college students during a mumps outbreak - Washington, February-June 2017
Bonwitt J , Kawakami V , Wharton A , Burke RM , Murthy N , Lee A , Dell B , Kay M , Duchin J , Hickman C , McNall RJ , Rota PA , Patel M , Lindquist S , DeBolt C , Routh J . MMWR Morb Mortal Wkly Rep 2017 66 (47) 1307-1308 On February 8, 2017, a suspected case of mumps in a member of a fraternity or sorority at the University of Washington, Seattle campus (UW) was reported to Public Health—Seattle & King County (PHSKC). Additional confirmed and probable mumps cases were subsequently identified among UW students and staff members according to the national case definition.* By July 19, 2017, a total of 42 (16 confirmed and 26 probable) mumps cases were reported among UW students and associated community members, with symptom onset February 6–June 4 (Figure). |
Quantification of saxitoxin in human blood by ELISA
Wharton RE , Feyereisen MC , Gonzalez AL , Abbott NL , Hamelin EI , Johnson RC . Toxicon 2017 133 110-115 Saxitoxin (STX) is a potent marine toxin that causes paralytic shellfish poisoning (PSP) which can result in significant morbidity and mortality in humans. Low lethal doses, rapid onset of PSP symptoms, and brief STX half-life in vivo require sensitive and rapid diagnostic techniques to monitor human exposures. Our laboratory has validated an enzyme-linked immunosorbent assay (ELISA) for quantitative detection of STX from 0.020 to 0.80 ng/mL in human whole blood and from 0.06 to 2.0 ng/mL in dried human blood which is simple, sensitive, rapid, and cost-effective. To our knowledge, this is the first validated method for the quantitation of saxitoxin in whole blood. Microsampling devices were used in sample collection which allows for standardized collection of blood, stable storage, and cost-efficient shipping. Quality control precision and accuracy were evaluated over the course of validation and were within 20% of theoretical concentrations. No detectable background concentrations of STX were found among fifty whole blood and dried blood convenience samples. Additionally, ten spiked individual whole blood and dried blood samples were tested for accuracy and precision and were within 20% of theoretical concentrations. Gonyautoxins 2&3 (GTX2&3) cross-reacted with this ELISA by 21%, but all other structurally related PSP toxins tested cross-reacted less than two percent. While clinical diagnosis or treatment of PSP would be unaffected by GTX2&3 cross-reactivity by ELISA, to accurately quantify individual PSP toxins, these results should be coupled with high performance liquid chromatography mass spectrometry measurements. |
Development and validation of a high-throughput online solid phase extraction - liquid chromatography - tandem mass spectrometry method for the detection of gonyautoxins1&4 and gonyautoxins2&3 in human urine
Coleman R , Lemire SW , Bragg W , Garrett A , Ojeda-Torres G , Wharton R , Hamelin E , Thomas J , Johnson RC . Biomed Chromatogr 2017 31 (9) Paralytic shellfish toxins (PSTs), including gonyautoxins and saxitoxins, are produced by multiple species of microalgae and dinoflagellates, and are bioaccumulated by shellfish and other animals. Human exposure to PSTs typically occurs through ingestion of recreationally-harvested contaminated shellfish and results in non-specific symptomology. Confirmation of exposure to PSTs has often relied on the measurement of saxitoxin, the most toxic congener; however, gonyautoxins (GTXs), the sulfated carbamate derivatives of saxitoxin, may be present in shellfish at higher concentrations. To improve identification of PST exposures, our group has developed an online solid phase extraction hydrophilic interaction liquid chromatography (HILIC) method to identify GTX1-4 in human urine with tandem mass spectrometry. The reportable range varied for each analyte, with all falling within 0.899 and 250 ng/mL in urine with precision <15% and >85% accuracy as determined for all quality control samples. This new online method quantitates GTX1-4 following exposures to PSTs, supporting the work of public health authorities. |
Contributions and challenges for worldwide vaccine safety: The Global Advisory Committee on Vaccine Safety at 15 years
Asturias EJ , Wharton M , Pless R , MacDonald NE , Chen RT , Andrews N , Salisbury D , Dodoo AN , Hartigan-Go K , Zuber PL . Vaccine 2016 34 (29) 3342-9 In 1999, the Global Advisory Committee on Vaccine Safety (GACVS) was established by the World Health Organization (WHO) to provide independent scientific advice on issues relating to the safety of vaccines and immunization. Fifteen years onward, we conducted a multi-faceted review to evaluate the impact, reach and challenges facing GACVS, including the role GACVS plays in informing global, regional and WHO member state vaccine policy. The methods included measures of organizational structure, citation impact, themes approached, and a discussion by previous and current members to evaluate past, present and future challenges. Given the increasing range of data sources and the deployment of many new vaccines, the Committee is facing the complex task of identifying the best available evidence for recommendations on vaccine safety. To help meet the increased demand for public transparency in decision making, GACVS-structured methodology for evidence-based decisions is evolving. GACVS also promotes best practices and capacity building for timely and accurate risk assessment; risk communications; outreach to help countries maintain and, if needed, rebuild public trust in vaccines; and advocacy for bridging the major gaps in vaccine safety capacity globally. |
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