Last data update: May 06, 2024. (Total: 46732 publications since 2009)
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Overview of U.S. COVID-19 vaccine safety surveillance systems
Gee J , Shimabukuro TT , Su JR , Shay D , Ryan M , Basavaraju SV , Broder KR , Clark M , Buddy Creech C , Cunningham F , Goddard K , Guy H , Edwards KM , Forshee R , Hamburger T , Hause AM , Klein NP , Kracalik I , Lamer C , Loran DA , McNeil MM , Montgomery J , Moro P , Myers TR , Olson C , Oster ME , Sharma AJ , Schupbach R , Weintraub E , Whitehead B , Anderson S . Vaccine 2024 The U.S. COVID-19 vaccination program, which commenced in December 2020, has been instrumental in preventing morbidity and mortality from COVID-19 disease. Safety monitoring has been an essential component of the program. The federal government undertook a comprehensive and coordinated approach to implement complementary safety monitoring systems and to communicate findings in a timely and transparent way to healthcare providers, policymakers, and the public. Monitoring involved both well-established and newly developed systems that relied on both spontaneous (passive) and active surveillance methods. Clinical consultation for individual cases of adverse events following vaccination was performed, and monitoring of special populations, such as pregnant persons, was conducted. This report describes the U.S. government's COVID-19 vaccine safety monitoring systems and programs used by the Centers for Disease Control and Prevention, the U.S. Food and Drug Administration, the Department of Defense, the Department of Veterans Affairs, and the Indian Health Service. Using the adverse event of myocarditis following mRNA COVID-19 vaccination as a model, we demonstrate how the multiple, complementary monitoring systems worked to rapidly detect, assess, and verify a vaccine safety signal. In addition, longer-term follow-up was conducted to evaluate the recovery status of myocarditis cases following vaccination. Finally, the process for timely and transparent communication and dissemination of COVID-19 vaccine safety data is described, highlighting the responsiveness and robustness of the U.S. vaccine safety monitoring infrastructure during the national COVID-19 vaccination program. |
Planning for the future of maternal immunization: Building on lessons learned from the COVID-19 pandemic
Meaney-Delman D , Carroll S , Polen K , Jatlaoui TC , Meyer S , Oliver S , Gee J , Shimabukuro T , Razzaghi H , Riley L , Galang RR , Tong V , Gilboa S , Ellington S , Cohn A . Vaccine 2024 As the worldwide COVID-19 pandemic unfolded, the clinical and public health community raced to understand SARS-CoV-2 infection and develop life-saving vaccines. Pregnant persons were disproportionately impacted, experiencing more severe illness and adverse pregnancy outcomes. And yet, when COVID-19 vaccines became available in late 2020, safety and efficacy data were not available to inform their use during pregnancy because pregnant persons were excluded from pre-authorization clinical trials. Concerns about vaccine safety during pregnancy and misinformation linking vaccination and infertility circulated widely, creating a lack of vaccine confidence. Many pregnant people initially chose not to get vaccinated, and while vaccination rates rose after safety and effectiveness data became available, COVID-19 vaccine acceptance was suboptimal and varied across racial and ethnic distribution of the pregnant population. The COVID-19 pandemic experience provided valuable insights that can inform current and future approaches to maternal vaccination against. |
Ethnic and racial differences in self-reported symptoms, health status, activity level, and missed work at 3 and 6 months following SARS-CoV-2 infection
O'Laughlin KN , Klabbers RE , Ebna Mannan I , Gentile NL , Geyer RE , Zheng Z , Yu H , Li SX , Chan KCG , Spatz ES , Wang RC , L'Hommedieu M , Weinstein RA , Plumb ID , Gottlieb M , Huebinger RM , Hagen M , Elmore JG , Hill MJ , Kelly M , McDonald S , Rising KL , Rodriguez RM , Venkatesh A , Idris AH , Santangelo M , Koo K , Saydah S , Nichol G , Stephens KA . Front Public Health 2023 11 1324636 INTRODUCTION: Data on ethnic and racial differences in symptoms and health-related impacts following SARS-CoV-2 infection are limited. We aimed to estimate the ethnic and racial differences in symptoms and health-related impacts 3 and 6 months after the first SARS-CoV-2 infection. METHODS: Participants included adults with SARS-CoV-2 infection enrolled in a prospective multicenter US study between 12/11/2020 and 7/4/2022 as the primary cohort of interest, as well as a SARS-CoV-2-negative cohort to account for non-SARS-CoV-2-infection impacts, who completed enrollment and 3-month surveys (N = 3,161; 2,402 SARS-CoV-2-positive, 759 SARS-CoV-2-negative). Marginal odds ratios were estimated using GEE logistic regression for individual symptoms, health status, activity level, and missed work 3 and 6 months after COVID-19 illness, comparing each ethnicity or race to the referent group (non-Hispanic or white), adjusting for demographic factors, social determinants of health, substance use, pre-existing health conditions, SARS-CoV-2 infection status, COVID-19 vaccination status, and survey time point, with interactions between ethnicity or race and time point, ethnicity or race and SARS-CoV-2 infection status, and SARS-CoV-2 infection status and time point. RESULTS: Following SARS-CoV-2 infection, the majority of symptoms were similar over time between ethnic and racial groups. At 3 months, Hispanic participants were more likely than non-Hispanic participants to report fair/poor health (OR: 1.94; 95%CI: 1.36-2.78) and reduced activity (somewhat less, OR: 1.47; 95%CI: 1.06-2.02; much less, OR: 2.23; 95%CI: 1.38-3.61). At 6 months, differences by ethnicity were not present. At 3 months, Other/Multiple race participants were more likely than white participants to report fair/poor health (OR: 1.90; 95% CI: 1.25-2.88), reduced activity (somewhat less, OR: 1.72; 95%CI: 1.21-2.46; much less, OR: 2.08; 95%CI: 1.18-3.65). At 6 months, Asian participants were more likely than white participants to report fair/poor health (OR: 1.88; 95%CI: 1.13-3.12); Black participants reported more missed work (OR, 2.83; 95%CI: 1.60-5.00); and Other/Multiple race participants reported more fair/poor health (OR: 1.83; 95%CI: 1.10-3.05), reduced activity (somewhat less, OR: 1.60; 95%CI: 1.02-2.51; much less, OR: 2.49; 95%CI: 1.40-4.44), and more missed work (OR: 2.25; 95%CI: 1.27-3.98). DISCUSSION: Awareness of ethnic and racial differences in outcomes following SARS-CoV-2 infection may inform clinical and public health efforts to advance health equity in long-term outcomes. |
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. |
Compare the marginal effects for environmental exposure and biomonitoring data with repeated measurements and values below the limit of detection
Chen IC , Bertke SJ , Estill CF . J Expo Sci Environ Epidemiol 2024 BACKGROUND: Environmental exposure and biomonitoring data with repeated measurements from environmental and occupational studies are commonly right-skewed and in the presence of limits of detection (LOD). However, existing model has not been discussed for small-sample properties and highly skewed data with non-detects and repeated measurements. OBJECTIVE: Marginal modeling provides an alternative to analyzing longitudinal and cluster data, in which the parameter interpretations are with respect to marginal or population-averaged means. METHODS: We outlined the theories of three marginal models, i.e., generalized estimating equations (GEE), quadratic inference functions (QIF), and generalized method of moments (GMM). With these approaches, we proposed to incorporate the fill-in methods, including single and multiple value imputation techniques, such that any measurements less than the limit of detection are assigned values. RESULTS: We demonstrated that the GEE method works well in terms of estimating the regression parameters in small sample sizes, while the QIF and GMM outperform in large-sample settings, as parameter estimates are consistent and have relatively smaller mean squared error. No specific fill-in method can be deemed superior as each has its own merits. IMPACT: Marginal modeling is firstly employed to analyze repeated measures data with non-detects, in which only the mean structure needs to be correctly provided to obtain consistent parameter estimates. After replacing non-detects through substitution methods and utilizing small-sample bias corrections, in a simulation study we found that the estimating approaches used in the marginal models have corresponding advantages under a wide range of sample sizes. We also applied the models to longitudinal and cluster working examples. |
Locally acquired melioidosis linked to environment - Mississippi, 2020-2023
Petras JK , Elrod MG , Ty MC , Dawson P , O'Laughlin K , Gee JE , Hanson J , Boutwell C , Ainsworth G , Beesley CA , Saile E , Tiller R , Gulvik CA , Ware D , Sokol T , Balsamo G , Taylor K , Salzer JS , Bower WA , Weiner ZP , Negrón ME , Hoffmaster AR , Byers P . N Engl J Med 2023 389 (25) 2355-2362 Melioidosis, caused by Burkholderia pseudomallei, is a rare but potentially fatal bacterial disease endemic to tropical and subtropical regions worldwide. It is typically acquired through contact with contaminated soil or fresh water. Before this investigation, B. pseudomallei was not known to have been isolated from the environment in the continental United States. Here, we report on three patients living in the same Mississippi Gulf Coast county who presented with melioidosis within a 3-year period. They were infected by the same Western Hemisphere B. pseudomallei strain that was discovered in three environmental samples collected from the property of one of the patients. These findings indicate local acquisition of melioidosis from the environment in the Mississippi Gulf Coast region. |
Recommendations on the use of quadrivalent human papillomavirus vaccine in males--Advisory Committee on Immunization Practices (ACIP), 2011
Centers for Disease Control and Prevention , Dunne EF , Markowitz LE , Chesson H , Curtis R , Saraiya M , Gee J , Unger ER . MMWR Morb Mortal Wkly Rep 2011 60 (50) 1705-8 On October 25, 2011, the Advisory Committee on Immunization Practices (ACIP) recommended routine use of quadrivalent human papillomavirus (HPV) vaccine (HPV4; Gardasil, Merck & Co. Inc.) in males aged 11 or 12 years. ACIP also recommended vaccination with HPV4 for males aged 13 through 21 years who have not been vaccinated previously or who have not completed the 3-dose series; males aged 22 through 26 years may be vaccinated. These recommendations replace the October 2009 ACIP guidance that HPV4 may be given to males aged 9 through 26 years. For these recommendations, ACIP considered information on vaccine efficacy (including data available since October 2009, on prevention of grade 2 or 3 anal intraepithelial neoplasia [AIN2/3], a precursor of anal cancer), vaccine safety, estimates of disease and cancer resulting from HPV, cost-effectiveness, and programmatic considerations. The evidence for HPV4 vaccination of males was evaluated using Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methods. |
A multi-city study of indoor air quality in green vs non-green low-income housing
Rabito FA , Werthmann DW , Straubing R , Adamkiewicz G , Reponen T , Ashley PJ , Chew GL . Environ Res 2023 240 117576 OBJECTIVES: The condition of the home is a strong predictor of exposure to environmental contaminants, with low-income households being particularly vulnerable. Therefore, improving housing standards is a priority. Housing built to "green" standards, with improved building methods and materials, has been suggested to reduce contaminants. However, evidence is limited as to which contaminants are reduced. The Green Housing Study was conducted to address this issue. The study hypothesis was that housing built using green components has lower concentrations of environmental contaminants compared to conventional housing. METHODS: A repeated-measures, 12-month cohort study was performed in three U.S. cities. Data were collected in the home at three time points throughout a year. The level of contaminants were estimated using air samples for particulate matter and black carbon, dust samples for aeroallergens and pesticides, and resident or study staff reporting evidence of mold. To investigate source(s) of PM(2.5) and black carbon, multivariable models using stepwise variable selection were developed. RESULTS: In adjusted generalized estimating equations (GEE) models, black carbon concentration (μg/m(3)) (β = -0.22, 95% CI = -0.38 to -0.06, p = 0.01), permethrin (OR = 0.28, 95% CI = 0.15-0.49, p < 0.0001), and reported mold (OR = 0.29, 95% CI = 0.13-0.68, p = 0.003) were significantly lower in green homes. Cockroach antigen was also lower in green homes (OR = 0.59, 95% CI = 0.33-1.08, p = 0.09), although not statistically significant. We found that 68% of PM(2.5) was explained by dwelling type and smoking and 42% of black carbon was explained by venting while cooking and use of a gas stove. CONCLUSIONS: This study provides quantitative data suggesting benefits of incorporating green building practices on the level of numerous environmental contaminants known to be associated with health. Occupant behavior, particularly smoking, is an important contributor to indoor air pollution. |
Safety Monitoring of mRNA Vaccines Administered During the Initial 6 Months of the U.S. COVID-19 Vaccination Program: Reports to Vaccine Adverse Events Reporting System (VAERS) and v-safe (preprint)
Rosenblum HG , Gee J , Liu R , Marquez PL , Zhang B , Strid P , Abara WE , McNeil MM , Myers TR , Hause AM , Su JR , Baer B , Menschik D , Markowitz LE , Shimabukuro TT , Shay DK . medRxiv 2021 2021.10.26.21265261 Background In December 2020, two mRNA-based COVID-19 vaccines were authorized for use in the United States. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a passive surveillance system, and v-safe, an active surveillance system.Methods VAERS and v-safe data during December 14, 2020—June 14, 2021 were analyzed. VAERS reports were categorized as non-serious, serious, or death; reporting rates were calculated. Rates of reported deaths were compared to expected mortality rates by age. Proportions of v-safe participants reporting local and systemic reactions or health impacts the week following doses 1 and 2 were determined.Findings During the analytic period, 298,792,852 doses of mRNA vaccines were administered in the United States. VAERS processed 340,522 reports; 92·1% were non-serious; 6·6%, serious, non-death; and 1·3%, death. Over half of 7,914,583 v-safe participants self-reported local and systemic reactogenicity, more frequently after dose 2. Injection-site pain, fatigue, and headache were commonly reported during days 0–7 following vaccination. Reactogenicity was reported most frequently one day after vaccination; most reactions were mild. More reports of being unable to work or do normal activities occurred after dose 2 (32·1%) than dose 1 (11·9%); <1% of participants reported seeking medical care after vaccination. Rates of deaths reported to VAERS were lower than expected background rates by age group.Interpretation Safety data from >298 million doses of mRNA COVID-19 vaccine administered in the first 6 months of the U.S. vaccination program show the majority of reported adverse events were mild and short in duration.Competing Interest StatementDisclosures: Ruiling Liu- Stock or stock options, Johnson &Johnson50 shares of stocks Moderna20 shares of stocks & Spouse works for Ethicon|Johnson & Johnson, on surgery robotics Funding StatementThis study did not receive any funding.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:Both VAERS and v-safe conduct surveillance as a public health function and are exempt from institutional review board review. This analysis was reviewed by the CDC and conducted in accordance with applicable federal law and CDC policy (See: 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. 241(d); 5 U.S.C. 552a; 44 U.S.C. 3501 et seq.). I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.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.YesData produced in the present study are available upon reasonable request to the authors |
Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring (preprint)
Abara WE , Gee J , Delorey M , Ye T , Mu Y , Shay DK , Shimabukuro T . medRxiv 2021 2021.08.31.21262919 Background Knowledge of expected rates of potential adverse events of special interest (AESI) that may occur coincidentally following COVID-19 vaccination is essential for vaccine safety surveillance and assessment. We calculated the expected rates of 21 potential AESI following COVID-19 vaccination among vaccinated persons within 1 day, 7 days, and 42 days of vaccination.Methods We used meta-analytic methods to estimate background rates of 21 medical conditions considered potential AESI and calculated expected rates of each potential AESI within 1 day, 7 days, and 42 days of vaccination.Results Background rates of three commonly monitored AESI, Guillain-Barre syndrome (GBS), myopericarditis, and all-cause deaths were 2.0 GBS cases/100,000 person-years, 1.3 myopericarditis cases/100,000 person-years, and 863.8 all-cause deaths/100,000 person-years, respectively. Based on these background rates, if 10,000,000 persons are vaccinated, we would expect 0.5, 3.7, and 22.5 GBS cases; 0.3, 2.4, and 14.3 myopericarditis cases; and 236.5, 1655.5, and 9932.8 all-cause deaths to occur in coincident temporal association (i.e., as a result of background incidence) within 1 day, 7 days, and 42 days of vaccination, respectively.Conclusion Knowledge of expected rates of potential AESI can help contextualize adverse health events associated temporally with immunization, aid in safety signal detection, guide COVID-19 vaccine public health communication, and inform benefit-risk assessments of COVID-19 vaccines.Competing Interest StatementThe authors have declared no competing interest.Funding StatementThere are no funding sources for this study.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:This analysis was exempt from CDC Institutional Review Board review.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.YesWe conducted a meta-analysis using incidence rate data from eligible published studies cited in this paper. |
Post-authorization safety surveillance of Ad.26.COV2.S vaccine: Reports to the Vaccine Adverse Event Reporting System and v-safe, February 2021-February 2022
Woo EJ , Gee J , Marquez P , Baggs J , Abara WE , McNeil MM , Dimova RB , Su JR . Vaccine 2023 41 (30) 4422-4430 BACKGROUND: On 2/27/2021, FDA authorized Janssen COVID-19 Vaccine (Ad.26.COV2.S) for use in individuals 18 years of age and older. Vaccine safety was monitored using the Vaccine Adverse Event Reporting System (VAERS), a national passive surveillance system, and v-safe, a smartphone-based surveillance system. METHODS: VAERS and v-safe data from 2/27/2021 to 2/28/2022 were analyzed. Descriptive analyses included sex, age, race/ethnicity, seriousness, AEs of special interest (AESIs), and cause of death. For prespecified AESIs, reporting rates were calculated using the total number of doses of Ad26.COV2.S administered. For myopericarditis, observed-to-expected (O/E) analysis was performed based on the number verified cases, vaccine administration data, and published background rates. Proportions of v-safe participants reporting local and systemic reactions, as well as health impacts, were calculated. RESULTS: During the analytic period, 17,018,042 doses of Ad26.COV2.S were administered in the United States, and VAERS received 67,995 reports of AEs after Ad26.COV2.S vaccination. Most AEs (59,750; 87.9 %) were non-serious and were similar to those observed during clinical trials. Serious AEs included COVID-19 disease, coagulopathy (including thrombosis with thrombocytopenia syndrome; TTS), myocardial infarction, Bell's Palsy, and Guillain-Barré syndrome (GBS). Among AESIs, reporting rates per million doses of Ad26.COV2.S administered ranged from 0.06 for multisystem inflammatory syndrome in children to 263.43 for COVID-19 disease. O/E analysis revealed elevated reporting rate ratios (RRs) for myopericarditis; among adults ages 18-64 years, the RR was 3.19 (95 % CI 2.00, 4.83) within 7 days and 1.79 (95 % CI 1.26, 2.46) within 21 days of vaccination. Of 416,384 Ad26.COV2.S recipients enrolled into v-safe, 60.9 % reported local symptoms (e.g. injection site pain) and 75.9 % reported systemic symptoms (e.g., fatigue, headache). One-third of participants (141,334; 33.9 %) reported a health impact, but only 1.4 % sought medical care. CONCLUSION: Our review confirmed previously established safety risks for TTS and GBS and identified a potential safety concern for myocarditis. |
COVID-19 vaccine safety inquiries to the Centers For Disease Control And Prevention Immunization Safety Office
Miller ER , Moro PL , Shimabukuro TT , Carlock G , Davis SN , Freeborn EM , Roberts AL , Gee J , Taylor AW , Gallego R , Suragh T , Su JR . Vaccine 2023 BACKGROUND: Following the authorization and recommendations for use of the U.S. COVID-19 vaccines, the Centers for Disease Control and Prevention (CDC)'s Immunization Safety Office (ISO) responded to inquiries and questions from public health officials, healthcare providers, and the general public on COVID-19 vaccine safety. METHODS: We describe COVID-19 vaccine safety inquiries, by topic, received and addressed by ISO from December 1, 2020-August 31, 2022. RESULTS: Of the 1978 COVID-19 vaccine-related inquiries received, 1655 specifically involved vaccine safety topics. The most frequently asked-about topics included deaths following vaccination, myocarditis, pregnancy, and reproductive health outcomes, understanding or interpreting data from the Vaccine Adverse Event Reporting System (VAERS), and thrombosis with thrombocytopenia syndrome. CONCLUSIONS: Inquiries about vaccine safety generally reflect issues that receive media attention. ISO will continue to monitor vaccine safety inquiries and provide accurate and timely information to healthcare providers, public health officials, and the general public. |
Epidemiology of upper limb complex regional pain syndrome in a retrospective cohort of persons aged 9-30 years, 2002-2017
Naleway AL , Henninger ML , Irving SA , Bianca Salas S , Kauffman TL , Crane B , Mittendorf KF , Harsh S , Elder C , Gee J . Perm J 2023 27 (2) 1-12 Introduction This paper describes the epidemiology and clinical presentation of complex regional pain syndrome (CRPS) in a large, integrated health care delivery system; and CRPS incidence rates (IRs) over a time period spanning human papillomavirus (HPV) vaccine licensure and published case reports of CRPS following HPV vaccination. Methods The authors examined CRPS diagnoses in patients aged 9-30 years between January 2002 and December 2017 using electronic medical records, excluding patients with lower limb diagnoses only. Medical record abstraction and adjudication were conducted to verify diagnoses and describe clinical characteristics. CRPS IRs were calculated for 3 periods: Period 1 (2002-2006: before HPV vaccine licensure), Period 2 (2007-2012: after licensure but before published case reports), and Period 3 (2013-2017: after published case reports). Results A total of 231 individuals received an upper limb or unspecified CRPS diagnosis code during the study period; 113 cases were verified through abstraction and adjudication. Most verified cases (73%) were associated with a clear precipitating event (eg, non-vaccine-related injury, surgical procedure). The authors identified only 1 case in which a practitioner attributed CRPS onset to HPV vaccination. Twenty-five incident cases occurred in Period 1 (IR = 4.35/100,000 person-years (PY), 95% confidence interval (CI) = 2.94-6.44), 42 in Period 2 (IR = 5.94/100,000 PY, 95% CI = 4.39-8.04), and 29 in Period 3 (IR = 4.53/100,000 PY, 95% CI = 3.15-6.52); differences between periods were not statistically significant. Conclusion These data provide a comprehensive assessment of the epidemiology and characteristics of CRPS in children and young adults and provide further reassurance about the safety of HPV vaccination. |
COVID-19 vaccine safety first year findings in adolescents
Hesse EM , Hause A , Myers T , Su JR , Marquez P , Zhang B , Cortese MM , Thames-Allen A , Curtis CR , Maloney SA , Thompson D , Nair N , Alimchandani M , Niu M , Gee J , Shay DK , Shimabukuro TT . Pediatrics 2023 151 (5) BACKGROUND AND OBJECTIVES: The Food and Drug Administration expanded Emergency Use Authorization for use of Pfizer-BioNTech (BNT-162b2) coronavirus disease 2019 vaccine to include people ages 12 years and older on May 10, 2021. We describe adverse events observed during the first full year of the US coronavirus disease 2019 vaccination program for adolescents ages 12 to 17 years. METHODS: We conducted descriptive analyses using data from 2 complementary US vaccine safety monitoring systems: v-safe, a voluntary smartphone-based system that monitors reactions and health impacts, and the Vaccine Adverse Event Reporting System (VAERS), the national spontaneous reporting system. We reviewed reports and calculated adverse event reporting rates using vaccine administration data. RESULTS: Among 172 032 adolescents ages 12 to 17 years enrolled in v-safe, most reported reactions following BNT-162b2 were mild to moderate, most frequently reported on the day after vaccination, and more common after dose 2. VAERS received 20 240 adverse event reports; 91.5% were nonserious. Among adverse events of interest, we verified 40 cases of multisystem inflammation syndrome in children (1.2 cases per million vaccinations), 34 (85%) of which had evidence of prior severe acute respiratory syndrome coronavirus 2 infection; and 570 cases of myocarditis (17.7 cases per million vaccinations), most of whom (77%) reported symptom resolution at the time of report. CONCLUSIONS: During the first year BNT-162b2 was administered to adolescents ages 12 to 17 years, most reported adverse events were mild and appeared self-limited. Rates of myocarditis were lower than earlier reports. No new serious safety concerns were identified. |
Burkholderia thailandensis Isolated from the Environment, United States.
Hall CM , Stone NE , Martz M , Hutton SM , Santana-Propper E , Versluis L , Guidry K , Ortiz M , Busch JD , Maness T , Stewart J , Sidwa T , Gee JE , Elrod MG , Petras JK , Ty MC , Gulvik C , Weiner ZP , Salzer JS , Hoffmaster AR , Rivera-Garcia S , Keim P , Kieffer A , Sahl JW , Soltero F , Wagner DM . Emerg Infect Dis 2023 29 (3) 618-621 Burkholderia thailandensis, an opportunistic pathogen found in the environment, is a bacterium closely related to B. pseudomallei, the cause of melioidosis. Human B. thailandensis infections are uncommon. We isolated B. thailandensis from water in Texas and Puerto Rico and soil in Mississippi in the United States, demonstrating a potential public health risk. |
Pesticide exposure and asthma morbidity in children residing in urban, multi-family housing
Werthmann DW , Rabito FA , Adamkiewicz G , Reponen T , Calafat AM , Ospina M , Chew GL . J Expo Sci Environ Epidemiol 2023 BACKGROUND: Children are potentially more susceptible to the adverse effects of pesticides due to more sensitive organ systems and lower capacity to metabolize and eliminate chemicals compared to adults. The health risks are particularly concerning children with asthma, living in low-income neighborhoods in multi-family housing because of their impaired respiratory health, and factors associated with low-income, multi-family environments. OBJECTIVE: To assess the association between pesticide exposure and asthma morbidity among children 7-12 years residing in low-income, multi-family housing. METHODS: The concentrations of seven urinary pesticide biomarkers: 3,5,6-trichloro-2-pyridinol (TCPy), 2-isopropyl-4-methyl-6-hydroxypyrimidine, para-nitrophenol (PNP), 3-phenoxybenzoic acid (3-PBA), 4-fluoro-3-phenoxybenzoic acid, trans-3-(2,2-dichlorovinyl)-2,2-dimethyl-cyclopropane-1-carboxylic acid, and 2,4-dichlorophenoxyacetic acid (2,4-D) were measured. Children (n = 162) were followed for one year with three measures of pesticides biomarkers. Associations between individual biomarkers and asthma attack, asthma related health care utilization, and fraction of exhaled nitric oxide (FeNO), adjusting for demographic and household factors were examined with Generalized Estimating Equations (GEE). Weighted Quantile Sum (WQS) regression was used to examine the effect of pesticide mixture on asthma attacks and asthma-related health care utilization (HCU). RESULTS: In adjusted GEE models, positive non-significant associations were found between PNP and HCU (adjusted Odds Ratio(aOR):2.05 95% CI:0.76-5.52) and null associations for 3-PBA and HCU (aOR:1.07 95% CI: 0.88-1.29). Higher concentrations of PNP and 2,4-D were associated with significantly lower FeNO levels (PNP: -17.4%; 2,4-D:-19.74%). The mixture was positively associated with HCU in unadjusted (OR: 1.56 97.5% CI: 1.08-2.27) but not significant in adjusted models (aOR: 1.40 97.5% CI: .86-2.29). The non-specific pyrethroid biomarker 3-PBA at baseline contributed the greatest weight to the index (45%). SIGNIFICANCE: There were non-significant associations between pesticide biomarkers and respiratory outcomes in children with asthma. There was a suggestive association between urinary pesticide biomarkers and HCU. Further studies with larger sample sizes could help to confirm these findings. IMPACT STATEMENT: Pesticide exposure among children in the urban environment is ubiquitous and there is a dearth of information on the impact of low-level chronic exposure in vulnerable populations. This study suggested that pesticide exposure at concentrations below the national average may not affect asthma morbidity in children. However, different biomarkers of pesticides showed different effects, but the mixture suggested increasing pesticide exposure results in asthma related HCU. The results may show that children with asthma may be at risk for negative health outcomes due to pesticides and the need to further examine this relationship. |
Melioidosis in cynomolgus macaques ( macaca fascicularis ) imported to the United States from Cambodia
Taetzsch SJ , Swaney EM , Gee JE , Hidalgo PM , Broussard KR , Martines RB , Blaney DD , Galland GG , Gulvik CA , Marston CK , Liu L , Elrod MG , DeLeon-Carnes M , Tyler RD , Bower WA , Bhatnager J , Brown CM , Pieracci EG , Weiner ZP . Comp Med 2022 72 (6) 394-402 Melioidosis, a potentially fatal infectious disease of humans and animals, including nonhuman primates (NHPs), is caused by the high-consequence pathogen Burkholderia pseudomallei. This environmental bacterium is found in the soil and water of tropical regions, such as Southeast Asia, where melioidosis is endemic. The global movement of humans and animals can introduce B. pseudomallei into nonendemic regions of the United States, where environmental conditions could allow establishment of the organism. Approximately 60% of NHPs imported into the United States originate in countries considered endemic for melioidosis. To prevent the introduction of infectious agents to the United States, the Centers for Disease Control and Prevention (CDC) requires newly imported NHPs to be quarantined for at least 31 d, during which time their health is closely monitored. Most diseases of public health concern that are transmissible from imported NHPs have relatively short incubation periods that fall within the 31-d quarantine period. However, animals infected with B. pseudomallei may appear healthy for months to years before showing signs of illness, during which time they can shed the organism into the environment. Melioidosis presents diagnostic challenges because it causes nonspecific clinical signs, serologic screening can produce unreliable results, and culture isolates are often misidentified on rapid commercial testing systems. Here, we present a case of melioidosis in a cynomolgus macaque (Macaca fascicularis) that developed a subcutaneous abscess after importation from Cambodia to the United States. The bacterial isolate from the abscess was initially misidentified on a commercial test. This case emphasizes the possibility of melioidosis in NHPs imported from endemic countries and its associated diagnostic challenges. If melioidosis is suspected, diagnostic samples and culture isolates should be submitted to a laboratory in the CDC Laboratory Response Network for conclusive identification and characterization of the pathogen. |
Reports of Guillain-Barr Syndrome after COVID-19 vaccination in the United States
Abara WE , Gee J , Marquez P , Woo J , Myers TR , DeSantis A , Baumblatt JAG , Woo EJ , Thompson D , Nair N , Su JR , Shimabukuro TT , Shay DK . JAMA Netw Open 2023 6 (2) e2253845 IMPORTANCE: Because of historical associations between vaccines and Guillain-Barré syndrome (GBS), the condition was a prespecified adverse event of special interest for COVID-19 vaccine monitoring. OBJECTIVE: To evaluate GBS reports to the Vaccine Adverse Event Reporting System (VAERS) and compare reporting patterns within 21 and 42 days after vaccination with Ad26.COV2.S (Janssen), BNT162b2 (Pfizer-BioNTech), and mRNA-1273 (Moderna) COVID-19 vaccines. DESIGN, SETTING, AND PARTICIPANTS: This retrospective cohort study was conducted using US VAERS reports submitted during December 2020 to January 2022. GBS case reports verified as meeting the Brighton Collaboration case definition for GBS in US adults after COVID-19 vaccination were included. EXPOSURES: Receipt of the Ad26.COV2.S, BNT162b2, or mRNA-1273 COVID-19 vaccine. MAIN OUTCOMES AND MEASURES: Descriptive analyses of GBS case were conducted. GBS reporting rates within 21 and 42 days after Ad26.COV2.S, BNT162b2, or mRNA-1273 vaccination based on doses administered were calculated. Reporting rate ratios (RRRs) after receipt of Ad26.COV2.S vs BNT162b2 or mRNA-1273 within 21- and 42-day postvaccination intervals were calculated. Observed-to-expected (OE) ratios were estimated using published GBS background rates. RESULTS: Among 4 651 785 COVID-19 vaccine doses, 17 944 515 doses (3.7%) were Ad26.COV2.S, 266 859 784 doses (54.7%) were BNT162b2, and 202 847 486 doses (41.6%) were mRNA-1273. Of 295 verified reports of individuals with GBS identified after COVID-19 vaccination (12 Asian [4.1%], 18 Black [6.1%], and 193 White [65.4%]; 17 Hispanic [5.8%]; 169 males [57.3%]; median [IQR] age, 59.0 [46.0-68.0] years), 275 reports (93.2%) documented hospitalization. There were 209 and 253 reports of GBS that occurred within 21 days and 42 days of vaccination, respectively. Within 21 days of vaccination, GBS reporting rates per 1 000 000 doses were 3.29 for Ad26.COV.2, 0.29 for BNT162b2, and 0.35 for mRNA-1273 administered; within 42 days of vaccination, they were 4.07 for Ad26.COV.2, 0.34 for BNT162b2, and 0.44 for mRNA-1273. GBS was more frequently reported within 21 days after Ad26.COV2.S than after BNT162b2 (RRR = 11.40; 95% CI, 8.11-15.99) or mRNA-1273 (RRR = 9.26; 95% CI, 6.57-13.07) vaccination; similar findings were observed within 42 days after vaccination (BNT162b2: RRR = 12.06; 95% CI, 8.86-16.43; mRNA-1273: RRR = 9.27; 95% CI, 6.80-12.63). OE ratios were 3.79 (95% CI, 2.88-4.88) for 21-day and 2.34 (95% CI, 1.83-2.94) for 42-day intervals after Ad26.COV2.S vaccination and less than 1 (not significant) after BNT162b2 and mRNA-1273 vaccination within both postvaccination periods. CONCLUSIONS AND RELEVANCE: This study found disproportionate reporting and imbalances after Ad26.COV2.S vaccination, suggesting that Ad26.COV2.S vaccination was associated with increased risk for GBS. No associations between mRNA COVID-19 vaccines and risk of GBS were observed. |
The V-safe after vaccination health checker: Active vaccine safety monitoring during CDC's COVID-19 pandemic response
Myers TR , Marquez PL , Gee JM , Hause AM , Panagiotakopoulos L , Zhang B , McCullum I , Licata C , Olson CK , Rahman S , Kennedy SB , Cardozo M , Patel CR , Maxwell L , Kallman JR , Shay DK , Shimabukuro TT . Vaccine 2023 41 (7) 1310-1318 The Centers for Disease Control and Prevention (CDC) developed and implemented the v-safe after vaccination health checker (v-safe) to monitor COVID-19 vaccine safety and as an active surveillance supplement to existing CDC vaccine safety monitoring programs. V-safe allows persons who received COVID-19 vaccines to report on post-vaccination experiences and how symptoms affected their health at daily, weekly, and monthly timepoints after vaccination. Text message reminders are sent linking to Internet-based health check-in surveys. Surveys include questions to identify v-safe participants who may be eligible to enroll in a separate pregnancy registry activity that evaluates maternal and infant outcomes in those pregnant at the time of vaccination or receiving vaccine in the periconception period. We describe the development of and enhancements to v-safe, data management, promotion and communication to vaccination sites and partners, publications, strengths and limitations, and implications for future systems. We also describe enrollment in v-safe over time and demographics of persons participating in v-safe during the first year of operation (December 14, 2020 - December 13, 2021). During this time, 9,342,582 persons submitted 131,543,087 v-safe surveys. The majority of participants were female (62.3 %) and non-Hispanic White (61.2 %); median age was 49.0 years. Most participants reported receiving an mRNA COVID-19 vaccine as their first recorded dose (95.0 %). V-safe contributed to CDC's vaccine safety assessments for FDA-authorized COVID-19 vaccines by enabling near real-time reporting of reactogenicity once the COVID-19 vaccination program began in the community, encouraging reports to the Vaccine Adverse Event Reporting System and facilitating enrollment in a large post-vaccination pregnancy registry. Given that v-safe is an integral component of the most comprehensive safety monitoring program in U.S. history, we believe that this approach has promise as a potential application for future pandemic response activities as well as rollout of novel vaccines in a non-pandemic context. |
Safety monitoring of bivalent COVID-19 mRNA vaccine booster doses among children aged 5-11 years - United States, October 12-January 1, 2023
Hause AM , Marquez P , Zhang B , Su JR , Myers TR , Gee J , Panchanathan SS , Thompson D , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2023 72 (2) 39-43 On October 12, 2022, the Food and Drug Administration (FDA) issued Emergency Use Authorizations (EUAs) for bivalent (mRNA encoding the spike protein from the SARS-CoV-2 ancestral strain and BA.4/BA.5 Omicron variants) formulations of Pfizer-BioNTech and Moderna mRNA COVID-19 vaccines for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination for children aged 5-11 years (Pfizer-BioNTech) and 6-17 years (Moderna); on December 8, 2022, FDA amended the EUAs to include children aged ≥6 months (1,2). The Advisory Committee on Immunization Practices (ACIP) recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose (3). The safety of bivalent mRNA booster doses among persons aged ≥12 years has previously been described (4). To characterize the safety of bivalent mRNA booster doses among children aged 5-11 years after receipt of bivalent Pfizer-BioNTech and Moderna booster doses, CDC reviewed adverse events and health impacts reported to v-safe,* a voluntary, smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and to the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system co-managed by CDC and FDA(†) (5). During October 12-January 1, 2023, a total of 861,251 children aged 5-11 years received a bivalent Pfizer-BioNTech booster, and 92,108 children aged 6-11 years received a bivalent Moderna booster.(§) Among 3,259 children aged 5-11 years registered in v-safe who received a bivalent booster dose, local (68.7%) and systemic reactions (49.5%) were commonly reported in the week after vaccination. Approximately 99.8% of reports to VAERS for children aged 5-11 years after bivalent booster vaccination were nonserious. There were no reports of myocarditis or death after bivalent booster vaccination. Eighty-four percent of VAERS reports were related to vaccination errors, 90.5% of which did not list an adverse health event. Local and systemic reactions reported after receipt of a bivalent booster dose are consistent with those reported after a monovalent booster dose; serious adverse events are rare. Vaccine providers should provide this information when counseling parents or guardians about bivalent booster vaccination. Preliminary safety findings from the first 11 weeks of bivalent booster vaccination among children aged 5-11 years are reassuring. Compared with the low risk of serious health effects after mRNA COVID-19 vaccination, the health effects of SARS-CoV-2 infection include death and serious long-term sequalae (6). ACIP recommends that all persons aged ≥6 months receive an age-appropriate bivalent mRNA booster dose ≥2 months after completion of a COVID-19 primary series or receipt of a monovalent booster dose.(¶). |
Notes from the field: Burkholderia pseudomallei detected in a raccoon carcass linked to a multistate aromatherapy-associated melioidosis outbreak - Texas, 2022
Petras JK , Elrod MG , Ty M , Adams P , Zahner D , Adams A , Calfee MW , Tomlinson C , Serre S , Ryan S , Jakabhazy E , Gee JE , Weiner Z , Bower WA , Negron ME , Hoffmaster AR , Honza H . MMWR Morb Mortal Wkly Rep 2022 71 (50) 1597-1598 Burkholderia pseudomallei, the causative agent of melioidosis, is an environmental gram-negative bacterium endemic in tropical and subtropical regions worldwide. B. pseudomallei can infect humans and a wide range of animals through percutaneous inoculation, inhalation, or ingestion (1). Melioidosis symptoms are nonspecific and vary widely because B. pseudomallei can infect any organ of the body, including the brain. In October 2021, the source of a multistate outbreak of melioidosis that involved four human cases in Georgia, Kansas, Minnesota, and Texas was identified as an aromatherapy room spray imported from India* (2). | | After the discovery of the aromatherapy spray as the outbreak source, the Texas Department of State Health Services (DSHS) learned that a previously healthy pet raccoon, owned by the family of the Texas patient, had broken a bottle of the implicated aromatherapy spray and walked through the liquid. On April 3, 2021, approximately 2 weeks after this exposure, the raccoon displayed acute neurologic symptoms consistent with neurologic melioidosis† and died from an undetermined cause 3 days later. The carcass was wrapped in a cloth robe and buried on the family’s property. The strain found in the aromatherapy bottle (ATS2021) and linked to the outbreak contained a genetic variant, the bimABm allele, which is a virulence factor associated with neurologic melioidosis (3). |
BMI reporting and accuracy of child's weight perception
Gee KA , Thompson HR , Sliwa SA , Madsen KA . Pediatrics 2022 150 (6) OBJECTIVES: To estimate whether school-based body mass index (BMI) reports impacted the accuracy of children's self-reported weight category, for children overall and within subgroups. METHODS: We analyzed existing data from the Fit Study, a randomized controlled trial of a BMI screening and reporting intervention conducted in California from 2014 to 2017. The sample included 4690 children in 27 schools randomized to receive BMI reports and 4975 children in 27 controls schools that received BMI screening only. To estimate how BMI reporting affected accuracy, we fit multinomial logistic regression models to our data. We calculated average marginal effects, which capture the change in probability that children more accurately reported their weight category because of BMI reporting. RESULTS: We detected no impact of BMI reporting on children's self-reported weight accuracy. Exploratory subgroup analyses show that for Black children, exposure to 1 round of BMI reporting was associated with a 10.0 percentage point increase in the probability of accurately reporting their weight category (95% confidence interval [CI]: 2.6 to 17.4). Two rounds of reporting were associated with an increase in the probability of accuracy for Asian children (6.6 percentage points; 95% CI: 0.4 to 12.8), 5th graders (11.1 percentage points; 95% CI: 1.6 to 20.5), and those with BMI <5th percentile (17.1 percentage points; 95% CI: 2.7 to 31.6). CONCLUSIONS: BMI reporting has limited efficacy in increasing children's weight perception accuracy. Although exploratory analyses show that specific subpopulations became more accurate, future prospective studies should be designed to confirm these results. |
Weight status of children participating in the National Spina Bifida Patient Registry
Polfuss M , Liu T , Smith K , Murphy PS , Ward E , Thibadeau J , Dosa NP , Wang Y , Sawin KJ . Pediatrics 2022 150 (6) OBJECTIVES: Describe the distribution of weight status categories and determine factors associated with overweight and obesity (OW/OB) in children and adolescents with spina bifida (SB) using the National Spina Bifida Patient Registry. METHODS: Demographic, anthropometric, and clinical data collected from 2009 through 2018 was used to describe the prevalence of OW/OB. The generalized estimating equation model (GEE) identified factors associated with OW/OB among individuals with SB. RESULTS: Participants (n = 7215) were aged 2 to 19 years (mean = 11.1; standard error, 0.06) and 51.4% female. The majority were non-Hispanic white (57.2%) followed by Hispanic or Latino (25.1%) and non-Hispanic Black (7.5%). The myelomeningocele (MMC) subgroup accounted for 76.3%. Most (60.2%) were community ambulators. The overall percentage of OW/OB was 45.2%, with 49.2% of MMC and 32.0% of nonmyelomeningocele OW/OB. Following the Centers for Disease Control Obesity Severity Classification System, 19.7% of MMC were in class 1, 6.6% in class 2, and 3.5% in class 3. Univariate analysis of MMC participants demonstrated demographic (age, sex, race/ethnicity, and clinic region) and clinical variables (functional level of lesion, ambulation, and number of shunt surgeries) were associated with OW/OB. The GEE model showed that OW/OB was independently, and significantly, associated with age, sex, race/ethnicity, lesion levels, and geographic location of the clinics. CONCLUSIONS: The demographic and clinical factors associated with OW/OB in children and adolescents with SB further our understanding of factors contributing to the higher prevalence of OW/OB in this population and may inform OW/OB prevention and treatment strategies. |
Association between history of SARS-CoV-2 infection and severe systemic adverse events after mRNA COVID-19 vaccination among U.S. adults.
Tompkins LK , Baggs J , Myers TR , Gee JM , Marquez PL , Kennedy SB , Peake D , Dua D , Hause AM , Strid P , Abara W , Rossetti R , Shimabukuro TT , Shay DK . Vaccine 2022 40 (52) 7653-7659 BACKGROUND: Risk of experiencing a systemic adverse event (AE) after mRNA coronavirus disease 2019 (COVID-19) vaccination may be greater among persons with a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection; data on serious events are limited. We assessed if adults reporting systemic AEs resulting in emergency department visits or hospitalizations during days 0-7 after mRNA COVID-19 vaccine dose 1 were more likely to have a history of prior SARS-CoV-2 infection compared with persons who reported no or non-severe systemic AEs. METHODS: We conducted a nested case-control study using v-safe surveillance data. Participants were18years and received dose 1 during December 14, 2020May 9, 2021. Cases reported severe systemic AEs 0-7days after vaccination. Three controls were frequency matched per case by age, vaccination date, and days since vaccination. Follow-up surveys collected SARS-CoV-2 histories. RESULTS: Follow-up survey response rates were 38.6% (potential cases) and 56.8% (potential controls). In multivariable analyses including 3,862 case-patients and 11,586 controls, the odds of experiencing a severe systemic AE were 2.4 (Moderna, mRNA-1273; 95% confidence interval [CI]: 1.89, 3.09) and 1.5 (Pfizer-BioNTech, BNT162b2; 95% CI: 1.17, 2.02) times higher among participants with pre-vaccination SARS-CoV-2 histories compared with those without. Medical attention of any kind for symptoms during days 0-7 following dose 2 was not common among case-patients or controls. CONCLUSIONS: History of SARS-CoV-2 infection was significantly associated with severe systemic AEs following dose 1 of mRNA COVID-19 vaccine; the effect varied by vaccine received. Most participants who experienced severe systemic AEs following dose 1 did not require medical attention of any kind for symptoms following dose 2. Vaccine providers can use these findings to counsel patients who had pre-vaccination SARS-CoV-2 infection histories, experienced severe systemic AEs following dose 1, and are considering not receiving additional mRNA COVID-19 vaccine doses. |
Urinary phenol concentrations and fecundability and early pregnancy loss.
Rosen Vollmar AK , Weinberg CR , Baird DD , Wilcox AJ , Calafat AM , Deziel NC , Johnson CH , Jukic AMZ . Hum Reprod 2022 38 (1) 139-155 STUDY QUESTION: Are urinary phenol concentrations of methylparaben, propylparaben, butylparaben, triclosan, benzophenone-3, 2,4-dichlorophenol or 2,5-dichlorophenol associated with fecundability and early pregnancy loss? SUMMARY ANSWER: 2,5-dichlorophenol concentrations were associated with an increased odds of early pregnancy loss, and higher concentrations of butylparaben and triclosan were associated with an increase in fecundability. WHAT IS KNOWN ALREADY: Phenols are chemicals with endocrine-disrupting potential found in everyday products. Despite plausible mechanisms of phenol reproductive toxicity, there are inconsistent results across few epidemiologic studies examining phenol exposure and reproductive function in non-fertility treatment populations. STUDY DESIGN, SIZE, DURATION: Specimens and data were from the North Carolina Early Pregnancy Study prospective cohort of 221 women attempting to conceive naturally from 1982 to 1986. This analysis includes data from 221 participants across 706 menstrual cycles, with 135 live births, 15 clinical miscarriages and 48 early pregnancy losses (before 42 days after the last menstrual period). PARTICIPANTS/MATERIALS, SETTING, METHODS: Participants collected daily first-morning urine specimens. For each menstrual cycle, aliquots from three daily specimens across the cycle were pooled within individuals and analyzed for phenol concentrations. To assess sample repeatability, we calculated intraclass correlation coefficients (ICCs) for each phenol. We evaluated associations between phenol concentrations from pooled samples and time to pregnancy using discrete-time logistic regression and generalized estimating equations (GEE), and early pregnancy loss using multivariable logistic regression and GEE. MAIN RESULTS AND THE ROLE OF CHANCE: ICCs for within-person variability across menstrual cycles in pooled phenol concentrations ranged from 0.42 to 0.75. There was an increased odds of early pregnancy loss with 2,5-dichlorophenol concentrations although the CIs were wide (5th vs 1st quintile odds ratio (OR): 4.79; 95% CI: 1.06, 21.59). There was an increased per-cycle odds of conception at higher concentrations of butylparaben (OR: 1.62; 95% CI: 1.08, 2.44) and triclosan (OR: 1.49; 95% CI: 0.99, 2.26) compared to non-detectable concentrations. No associations were observed between these endpoints and concentrations of other phenols examined. LIMITATIONS, REASONS FOR CAUTION: Limitations include the absence of phenol measurements for male partners and a limited sample size, especially for the outcome of early pregnancy loss, which reduced our power to detect associations. WIDER IMPLICATIONS OF THE FINDINGS: This study is the first to use repeated pooled measures to summarize phenol exposure and the first to investigate associations with fecundability and early pregnancy loss. Within-person phenol concentration variability underscores the importance of collecting repeated samples for future studies. Exposure misclassification could contribute to differences between the findings of this study and those of other studies, all of which used one urine sample to assess phenol exposure. This study also contributes to the limited literature probing potential associations between environmental exposures and early pregnancy loss, which is a challenging outcome to study as it typically occurs before a pregnancy is clinically recognized. STUDY FUNDING/COMPETING INTEREST(S): This research was supported by the National Institute of Environmental Health Sciences of the National Institutes of Health (award number F31ES030594), the Intramural Research Program of the National Institutes of Health, the National Institute of Environmental Health Sciences (project numbers ES103333 and ES103086) and a doctoral fellowship at the Yale School of Public Health. The authors declare they have no competing interests to disclose. TRIAL REGISTRATION NUMBER: N/A. |
Predictors of Severe Acute Respiratory Syndrome Coronavirus 2 Seropositivity Before Coronavirus Disease 2019 Vaccination Among Children 0-4 Years and Their Household Members in the SEARCh Study.
Garcia Quesada M , Hetrich MK , Zeger S , Sharma J , Na YB , Veguilla V , Karron RA , Dawood FS , Knoll MD . Open Forum Infect Dis 2022 9 (10) ofac507 BACKGROUND: Estimates of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) seroprevalence in young children and risk factors for seropositivity are scarce. Using data from a prospective cohort study of households during the pre-coronavirus disease 2019 (COVID-19) vaccine period, we estimated SARS-CoV-2 seroprevalence by age and evaluated risk factors for SARS-CoV-2 seropositivity. METHODS: The SARS-CoV-2 Epidemiology and Response in Children (SEARCh) study enrolled 175 Maryland households (690 participants) with ≥1 child aged 0-4 years during November 2020-March 2021; individuals vaccinated against COVID-19 were ineligible. At enrollment, participants completed questionnaires about sociodemographic and health status and work, school, and daycare attendance. Participants were tested for SARS-CoV-2 antibodies in sera. Logistic regression models with generalized estimating equations (GEE) to account for correlation within households assessed predictors of individual- and household-level SARS-CoV-2 seropositivity. RESULTS: Of 681 (98.7%) participants with enrollment serology results, 55 (8.1%; 95% confidence interval [CI], 6.3%-10.4%) participants from 21 (12.0%) households were seropositive for SARS-CoV-2. Among seropositive participants, fewer children than adults reported being tested for SARS-CoV-2 infection before enrollment (odds ratio [OR] = 0.23; 95% CI, .06-.73). Seropositivity was similar by age (GEE OR vs 0-4 years: 1.19 for 5-17 years, 1.36 for adults; P = .16) and was significantly higher among adults working outside the home (GEE adjusted OR = 2.2; 95% CI, 1.1-4.4) but not among children attending daycare or school. CONCLUSIONS: Before study enrollment, children and adults in this cohort had similar rates of SARS-CoV-2 infection as measured by serology. An adult household member working outside the home increased a household's odds of SARS-CoV-2 infection, whereas a child attending daycare or school in person did not. |
Reactions following Pfizer-BioNTech COVID-19 mRNA vaccination and related healthcare encounters among 7,077 children aged 5-11 years within an integrated healthcare system.
Malden DE , Gee J , Glenn S , Li Z , Mercado C , Ogun OA , Kim S , Lewin BJ , Ackerson BK , Jazwa A , Weintraub ES , McNeil MM , Tartof SY . Vaccine 2022 41 (2) 315-322 BACKGROUND: Studies combining data from digital surveys and electronic health records (EHR) can be used to conduct comprehensive assessments on COVID-19 vaccine safety. METHODS: We conducted an observational study using data from a digital survey and EHR of children aged 5-11 years vaccinated with Pfizer-BioNTech COVID-19 mRNA vaccine across Kaiser Permanente Southern California during November 4, 2021-February 28, 2022. Parents/guardians who enrolled their children were sent a 14-day survey on reactions. Survey results were combined with EHR, and medical encounters were described for children whose parents or guardians indicated seeking medical care for vaccine-related symptoms. This study describes self-reported reactions (local and systemic) and additional symptoms (chest pain, tachycardia, and pre-syncope). RESULTS: The study recruited 7,077 participants aged 5-11 years who received the Pfizer-BioNTech COVID-19 mRNA vaccine. Of 6,247 participants with survey responses after dose 1, 2,176 (35 %) reported at least one systemic reaction, and 1,076 (32 %) of 3,401 respondents following dose 2 reported at least one systemic reaction. Local reactions were reported less frequently following dose 2 (1,113, 33 %) than dose 1 (3,140, 50 %). The most frequently reported reactions after dose 1 were pain at the injection site (48 %), fatigue (20 %), headache (12 %), myalgia (9 %) and fever (5 %). The most frequently reported symptoms after dose 2 were also pain at the injection site (30 %), fatigue (19 %), headache (13 %), myalgia (10 %) and fever (9 %). Post-vaccination reactions occurred most frequently-one day following vaccination. Chest pain or tachycardia were reported infrequently (1 %). EHR demonstrated that parents rarely sought care for post-vaccination symptoms, and among those seeking care, the most common symptoms documented in EHR were fever and nausea, comprising<0.5 % of children. No encounters were related to myocarditis. CONCLUSION: While post-vaccination reactions to the Pfizer-BioNTech COVID-19 mRNA vaccine were common in children aged 5-11 years, our data showed that in most cases they were transient and did not require medical care. |
Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Persons Aged ≥12 Years - United States, August 31-October 23, 2022.
Hause AM , Marquez P , Zhang B , Myers TR , Gee J , Su JR , Blanc PG , Thomas A , Thompson D , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (44) 1401-1406 On August 31, 2022, the Food and Drug Administration (FDA) authorized bivalent formulations of BNT162b2 (Pfizer-BioNTech) and mRNA-1273 (Moderna) COVID-19 vaccines; these vaccines include mRNA encoding the spike protein from the original (ancestral) strain of SARS-CoV-2 (the virus that causes COVID-19) and from the B.1.1.529 (Omicron) variants BA.4 and BA.5 (BA.4/BA.5). These bivalent mRNA vaccines were authorized for use as a single booster dose ≥2 months after completion of primary series or monovalent booster vaccination; Pfizer-BioNTech bivalent booster was authorized for persons aged ≥12 years and Moderna for adults aged ≥18 years.*(,)(†) On September 1, 2022, the Advisory Committee on Immunization Practices (ACIP) recommended that all persons aged ≥12 years receive an age-appropriate bivalent mRNA booster dose.(§) To characterize the safety of bivalent mRNA booster doses, CDC reviewed adverse events and health impacts reported after receipt of bivalent Pfizer-BioNTech and Moderna booster doses during August 31-October 23, 2022, to v-safe,(¶) a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination, and the Vaccine Adverse Event Reporting System (VAERS),** a U.S. passive vaccine safety surveillance system managed by CDC and FDA (1). During August 31-October 23, 2022, approximately 14.4 million persons aged ≥12 years received a bivalent Pfizer-BioNTech booster dose, and 8.2 million adults aged ≥18 years received a bivalent Moderna booster dose.(††) Among the 211,959 registrants aged ≥12 years who reported receiving a bivalent booster dose to v-safe, injection site and systemic reactions were frequently reported in the week after vaccination (60.8% and 54.8%, respectively); fewer than 1% of v-safe registrants reported receiving medical care. VAERS received 5,542 reports of adverse events after bivalent booster vaccination among persons aged ≥12 years; 95.5% of reports were nonserious and 4.5% were serious events. Health care providers and patients can be reassured that adverse events reported after a bivalent booster dose are consistent with those reported after monovalent doses. Health impacts after COVID-19 vaccination are less frequent and less severe than those associated with COVID-19 illness (2). |
COVID-19 mRNA Vaccine Safety Among Children Aged 6 Months-5 Years - United States, June 18, 2022-August 21, 2022.
Hause AM , Marquez P , Zhang B , Myers TR , Gee J , Su JR , Parker C , Thompson D , Panchanathan SS , Shimabukuro TT , Shay DK . MMWR Morb Mortal Wkly Rep 2022 71 (35) 1115-1120 On June 17, 2022, the Food and Drug Administration (FDA) amended the Emergency Use Authorization (EUA) for mRNA COVID-19 vaccines to include children aged 6 months4 years for receipt of BNT162b2 (Pfizer-BioNTech) (administered as 3 doses, 3 g [0.2 mL] each) and children aged 6 months5 years for receipt of mRNA-1273 (Moderna) (administered as 2 doses, 25 g [0.25 mL] each) (1,2). In preauthorization clinical trials, the Pfizer-BioNTech vaccine was administered to 3,013 children aged 6 months4 years (3) and the Moderna vaccine was administered to 5,011 children aged 6 months5 years (4). Most adverse events reported in these trials were mild to moderate in severity and no serious vaccine-related adverse events were reported. To characterize postauthorization safety of COVID-19 vaccine primary series among young children, CDC reviewed adverse events and health impacts after receipt of Pfizer-BioNTech and Moderna vaccines that were reported to v-safe, a voluntary smartphone-based U.S. safety surveillance system established by CDC to monitor adverse events after COVID-19 vaccination (https://vsafe.cdc.gov/en/), and the Vaccine Adverse Event Reporting System (VAERS), a U.S. passive vaccine safety surveillance system managed by CDC and FDA. During June 18August 21, 2022, approximately 599,457children aged 6 months4 years received the Pfizer-BioNTech vaccine and 440,773 aged 6 months5 years received the Moderna vaccine*; approximately 23,266 children were enrolled in v-safe after mRNA COVID-19 vaccination. The most frequent systemic reactions reported to v-safe after receipt of Pfizer-BioNTech or Moderna vaccines were irritability or crying among approximately one half of children aged 6 months2 years. Among children aged 3 years, systemic reactions after vaccination were less frequently reported; injection site pain was the most frequently reported reaction among these older children. VAERS received a total of 1,017 reports of adverse events after Pfizer-BioNTech or Moderna vaccination among children aged 6 months4 years and children aged 6 months5 years; 998 (98.1%) events were classified as nonserious and 19 (1.9%) as serious. No reports of myocarditis after vaccination were reported. These initial safety findings are similar to those from preauthorization clinical trials (3,4). Health care providers and parents of young children should be aware that local and systemic reactions are expected after vaccination with Pfizer-BioNTech or Moderna vaccine and that serious adverse events are rare. |
Strains Associated with Two 2020 Welder Anthrax Cases in the United States Belong to Separate Lineages within Bacillus cereus sensu lato.
Carroll LM , Marston CK , Kolton CB , Gulvik CA , Gee JE , Weiner ZP , Kovac J . Pathogens 2022 11 (8) Anthrax-causing members of Bacillus cereus sensu lato (s.l.) pose a serious threat to public health. While most anthrax-causing strains resemble B. anthracis phenotypically, rare cases of anthrax-like illness caused by strains resembling "B. cereus" have been reported. Here, whole-genome sequencing was used to characterize three B. cereus s.l. isolates associated with two 2020 welder anthrax cases in the United States, which resembled "B. cereus" phenotypically. Comparison of the three genomes sequenced here to all publicly available, high-quality B. cereus s.l. genomes (n = 2890 total genomes) demonstrated that genomes associated with each case effectively belonged to separate species at the conventional 95% average nucleotide identity prokaryotic species threshold. Two PubMLST sequence type 78 (ST78) genomes affiliated with a case in Louisiana were most closely related to B. tropicus and possessed genes encoding the Bps exopolysaccharide capsule, as well as hemolysin BL (Hbl) and cytotoxin K (CytK). Comparatively, a ST108 genome associated with a case in Texas was most closely related to B. anthracis; however, like other anthrax-causing strains most closely related to B. anthracis, this genome did not possess Bps-, Hbl-, or CytK-encoding genes. Overall, results presented here provide insights into the evolution of anthrax-causing B. cereus s.l. |
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