BACKGROUND: Oral pre-exposure prophylaxis (PrEP) with emtricitabine/tenofovir disoproxil fumarate (F/TDF) has high efficacy against HIV-1 acquisition. Seventy-two prospective studies of daily oral F/TDF PrEP were conducted to evaluate HIV-1 incidence, drug resistance, adherence, and bone and renal safety in diverse settings. METHODS: HIV-1 incidence was calculated from incident HIV-1 diagnoses after PrEP initiation and within 60 days of discontinuation. Tenofovir concentrations in dried blood spots (DBS), drug resistance, and bone/renal safety indicators were evaluated in a subset of studies. RESULTS: Among 17 274 participants, there were 101 cases with new HIV-1 diagnosis (.77 per 100 person-years; 95% confidence interval [CI]: .63-.94). In 78 cases with resistance data, 18 (23%) had M184I or V, 1 (1.3%) had K65R, and 3 (3.8%) had both mutations. In 54 cases with tenofovir concentration data from DBS, 45 (83.3%), 2 (3.7%), 6 (11.1%), and 1 (1.9%) had average adherence of <2, 2-3, 4-6, and ≥7 doses/wk, respectively, and the corresponding incidence was 3.9 (95% CI: 2.9-5.3), .24 (.060-.95), .27 (.12-.60), and .054 (.008-.38) per 100 person-years. Adherence was low in younger participants, Hispanic/Latinx and Black participants, cisgender women, and transgender women. Bone and renal adverse event incidence rates were 0.69 and 11.8 per 100 person-years, respectively, consistent with previous reports. CONCLUSIONS: Leveraging the largest pooled analysis of global PrEP studies to date, we demonstrate that F/TDF is safe and highly effective, even with less than daily dosing, in diverse clinical settings, geographies, populations, and routes of HIV-1 exposure.

The size of airborne particles emitted from infected individuals is crucial in the transmission of respiratory viruses. The use of source control devices is essential for interrupting the transmission of exhaled submicron particles, particularly in healthcare settings with high infection risk. This study evaluated the efficacy of five types of source control devices, commonly used in healthcare settings, in mitigating the transmission of exhaled submicron particles (20–210 nm). Total outward leakage (TOL) of these devices was analyzed across different particle sizes, and the TOL mean diameter (TOLMD) was calculated to characterize particle size distribution. The devices tested included N95 filtering facepiece respirators (N95 FFRs), N95 FFRs with an exhalation valve (N95 FFRV), surgical masks (SMs), elastomeric half-mask respirators (EHMRs), and EHMRs with a SM covering the exhalation valve (EHMRSM). The study also examined the effects of faceseal and flowrate on TOL and particle size characteristics. Results indicated that TOL varied with particle size, increasing from 40 to 90 nm before stabilizing. Aerosols larger than 90 nm had significantly higher TOL compared to smaller aerosols. Higher flow rates increased TOL for EHMR and EHMRSM across all particle sizes. Improved faceseal on N95 FFRs and SMs significantly reduced TOL and decreased TOLMD. The study underscored that using well-fitting devices without exhalation valves is crucial for preventing the transmission of exhaled aerosols potentially carrying viruses, in particular for larger particle sizes. This is especially crucial in the absence of proper indoor ventilation and other control measures. © This work was authored as part of the Contributor’s official duties as an Employee of the United States Government and is therefore a work of the United States Government. In accordance with 17 U.S.C. 105, no copyright protection is available for such works under U.S. Law.

Public health practitioners rely on timely surveillance data for planning and decision-making; however, surveillance data are often subject to delays. Epidemic trend categories, based on time-varying effective reproductive number (R(t)) estimates that use nowcasting methods, can mitigate reporting lags in surveillance data and detect changes in community transmission before reporting is completed. CDC analyzed the performance of epidemic trend categories for COVID-19 during summer 2024 in the United States and at the state level in New Mexico. COVID-19 epidemic trend categories were estimated and released in real time based on preliminary data, then retrospectively compared with final emergency department (ED) visit data to determine their ability to detect or confirm real-time changes in subsequent ED visits. Across the United States and in New Mexico, epidemic trend categories were an early indicator of increases in COVID-19 community transmission, signifying increases in COVID-19 community transmission in May, and a confirmatory indicator that decreasing COVID-19 ED visits reflected actual decreases in COVID-19 community transmission in September, rather than incomplete reporting. Public health decision-makers can use epidemic trend categories, in combination with other surveillance indicators, to understand whether COVID-19 community transmission and subsequent ED visits are increasing, decreasing, or not changing; this information can guide communications decisions.

BACKGROUND: During COVID-19 pandemic, the general public used any face-worn products they could get to overcome the shortage of N95 respirators and surgical masks. These products, often not meeting any standards, raised concerns about their effectiveness in reducing the spread of respiratory viruses. METHODS: This study quantified total outward leakage (TOL) of units from nine face-worn product categories used by members of the general public. A benchtop system was devised to test two units from each category on two different-sized headforms with silicone elastomer skin. Each unit was donned five times per headform. RESULTS: Both face-worn product category and headform size significantly affected TOL (P-Value <0.05). The TOL of tested face-worn products varied from 10% to 58% depending on both model and headform size. Face-worn products donned on the medium headform had a higher mean TOL compared to those donned on the larger headform. CONCLUSIONS: Overall, single-layer cloth masks are the least effective measure for source control due to their highest TOL among the tested face-worn products. Three-layer disposable face masks may be a favorable option for source control among the public. A standard should be developed for face-worn product design and manufacturing to accommodate different facial sizes.

BACKGROUND: In response to the 2022 mpox outbreak in the United States, people with higher potential for exposure to mpox were recommended to receive 2 doses of the JYNNEOS vaccine. Vaccine safety was monitored using 2 complementary systems. METHODS: The Vaccine Adverse Event Reporting System (VAERS) is a passive surveillance system that accepts reports of adverse events after vaccination. VAERS is capable of rapidly identifying rare adverse events and unusual reporting patterns. Medical records were requested and reviewed for adverse events of special interest, including myocarditis. Adverse event reporting rates were calculated as the number of verified adverse event cases divided by the number of JYNNEOS doses administered. V-safe for mpox was a voluntary smartphone-based vaccine safety surveillance system that sent enrolled persons text messages linked to health surveys asking about reactions and health impact events occurring after vaccination. RESULTS: There were 1,207,056 JYNNEOS doses administered in the United States. VAERS received 1927 reports for JYNNEOS. The myocarditis reporting rate per million doses was 2.69 after dose 1 and 8.64 after dose 2. V-safe had 213 participants complete at least one health survey. Rates of injection site and systemic reactions were similar in the first week after dose 1 and dose 2. CONCLUSIONS: JYNNEOS vaccine safety surveillance findings from VAERS and v-safe did not identify any unexpected safety concerns. The VAERS reporting rate for myocarditis was similar to previously published population background rates.

OBJECTIVE: To update state-specific estimates of diabetes-attributable costs in the U.S. and assess changes in spending from 2013 to 2021. RESEARCH DESIGN AND METHODS: We used an attributable fraction approach to estimate direct medical costs of diagnosed diabetes using the 2021 State Health Expenditure Accounts, the 2021 Behavioral Risk Factor Surveillance System, and the Centers for Medicare and Medicaid Services 2018-2019 Minimum Data Set. We estimated diabetes-attributable productivity losses from morbidity and mortality using the 2016-2021 National Health Interview Survey and the 2021 mortality data from the Centers for Disease Control and Prevention. Costs were adjusted to 2021 U.S. dollars. RESULTS: Total diabetes-attributable cost in 2021 was $640 billion ($335 billion in direct medical costs and $305 billion in indirect costs). The median state-level total diabetes-attributable cost was $8.2 billion (range $842 million to $81 billion). The median state-level per-person cost was $21,082, ranging from $17,452 to $37,090. Total diabetes-attributable cost increased by a median of 33% between 2013 and 2021, ranging from 16 to 68% across states. Medical costs increased by 50% overall (range 33-79%) and by 27% (range 15-41%) for per person with diabetes. Costs paid by Medicaid experienced the highest increase between 2013 and 2021 (median 153%; range 41-483%). CONCLUSIONS: State economic costs of diagnosed diabetes are substantial and increased over the last decade. These costs and their growth vary considerably across states. These findings may help state policy makers in developing evidenced-based public health interventions in their respective states to prevent and control the prevalence of diabetes.

Objective: To describe the work experience and respiratory health of women coal miners in the United States using Coal Workers' Health Surveillance Program (CWHSP) data. Methods: Analysis included CWHSP participants with self-reported sex of female between January 1, 1970, and December 31, 2022, and examined radiographic surveillance, demographics, and job history. National Institute for Occupational Safety and Health-certified physicians classified chest radiographs. Results: Among 8,182 women participants, most worked <10 years and a majority reported working in non-dusty jobs. Among 3,392 with ≥1 year of coal mining tenure, 18 (0.5%) had evidence of pneumoconiosis, with no cases of progressive massive fibrosis. Conclusion: Women coal miners participating in the CWSHP had short mining careers and low pneumoconiosis prevalence. Few worked in the most dusty jobs, indicating limited exposure to coal mine dust. This underscores the need to explore women's roles in mining, and for improved gender-specific employment reporting. Such changes can enhance health and work conditions for women in male-dominated industries.

Introduction COVID-19 vaccines may be administered with other vaccines during the same healthcare visit. COVID-19 monovalent (Fall 2021) and bivalent (Fall 2022) vaccine recommendations coincided with annual seasonal influenza vaccination. Data describing the frequency of the co-administration of COVID-19 vaccines with other vaccines are limited. Methods We used V-safe, a voluntary smartphone-based U.S. safety surveillance system established by the CDC, to describe trends in the administration of COVID-19 vaccines with other vaccines reported to V-safe during December 14, 2020 - May 19, 2023. Results Of the 21 million COVID-19 vaccinations reported to V-safe, 2.2% (459,817) were administered with at least 1 other vaccine. Co-administration most frequently occurred during the first week of October 2023 (27,092; 44.1%). Most reports of co-administration included influenza vaccine (393,003; 85.5%). Co-administration was most frequently reported for registrants aged 6 months-6 years (4,872; 4.4%). Conclusion Reports of co-administration to V-safe peaked during October 2023, when influenza vaccination most often occurs, possibly reflecting increased opportunities for multiple vaccinations and greater acceptability of the co-administration of COVID-19 vaccine with other vaccines, especially influenza vaccine.

BACKGROUND: Understanding characteristics of healthcare personnel (HCP) with SARS-CoV-2 infection supports the development and prioritization of interventions to protect this important workforce. We report detailed characteristics of HCP who tested positive for SARS-CoV-2 from April 20, 2020 through December 31, 2021. METHODS: CDC collaborated with Emerging Infections Program sites in 10 states to interview HCP with SARS-CoV-2 infection (case-HCP) about their demographics, underlying medical conditions, healthcare roles, exposures, personal protective equipment (PPE) use, and COVID-19 vaccination status. We grouped case-HCP by healthcare role. To describe residential social vulnerability, we merged geocoded HCP residential addresses with CDC/ATSDR Social Vulnerability Index (SVI) values at the census tract level. We defined highest and lowest SVI quartiles as high and low social vulnerability, respectively. RESULTS: Our analysis included 7,531 case-HCP. Most case-HCP with roles as certified nursing assistant (CNA) (444, 61.3%), medical assistant (252, 65.3%), or home healthcare worker (HHW) (225, 59.5%) reported their race and ethnicity as either non-Hispanic Black or Hispanic. More than one third of HHWs (166, 45.2%), CNAs (283, 41.7%), and medical assistants (138, 37.9%) reported a residential address in the high social vulnerability category. The proportion of case-HCP who reported using recommended PPE at all times when caring for patients with COVID-19 was lowest among HHWs compared with other roles. CONCLUSIONS: To mitigate SARS-CoV-2 infection risk in healthcare settings, infection prevention, and control interventions should be specific to HCP roles and educational backgrounds. Additional interventions are needed to address high social vulnerability among HHWs, CNAs, and medical assistants.

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.

INTRODUCTION: Reaching, enrolling, and retaining participants in lengthy lifestyle change interventions for weight loss is a major challenge. The objective of our meta-analysis was to investigate whether lifestyle interventions addressing nutrition and physical activity lasting 6 months or less are effective for weight loss. METHODS: We searched for peer-reviewed studies on lifestyle change interventions of 6 months or less published from 2012 through 2023. Studies were screened based on inclusion criteria, including randomized controlled trials (RCTs) for adults with overweight or obesity. We used a random-effects model to pool the mean difference in weight loss between intervention and control groups. We also performed subgroup analyses by intervention length and control type. RESULTS: Fourteen RCTs were identified and included in our review. Half had interventions lasting less than 13 weeks, and half lasted from 13 to 26 weeks. Seven were delivered remotely, 4 were delivered in person, and 3 used combined methods. The pooled mean difference in weight change was -2.59 kg (95% CI, -3.47 to -1.72). The pooled mean difference measured at the end of the intervention was -2.70 kg (95% CI, -3.69 to -1.71) among interventions lasting less than 13 weeks and -2.40 kg (95% CI, -4.44 to -0.37) among interventions of 13 to 26 weeks. CONCLUSION: Short-term multicomponent interventions involving physical activity and nutrition can achieve weight loss for adults with overweight or obesity. Offering short-term interventions as alternatives to long-term ones may reach people who otherwise would be unwilling or unable to enroll in or complete longer programs.

OBJECTIVE: Identify characteristics of healthcare personnel (HCP) who did not have timely initiation of the COVID-19 primary series, as well as HCP who did not receive a booster vaccine. METHODS: Characteristics of HCP enrolled in a COVID-19 vaccine effectiveness study between 12/28/2020-12/01/2022 were compared by timing of receipt of 1st mRNA dose, and by receipt of a booster dose. Data for this retrospective cohort analysis came from HCP working at a large healthcare system in Monroe County, New York, and included standardized questionnaires and verified vaccination status. HCP were categorized by whether they received their 1stmRNA COVID-19 vaccine between 12/14/2020-03/30/2021 (earlier) or 04/01/2021-09/28/2021 (later) based on timing of local vaccine eligibility and mandates, and by whether they received a 3rdmRNA booster dose by 12/01/22. Logistic regression models were run to identify characteristics of HCP who had later 1stdose receipt or did not receive a booster. RESULTS: 3,375 HCP were enrolled. Of these, 86.8 % had early initiation of their 1stCOVID-19 vaccine, and 85.0 % received a booster dose. Low education, low household income, younger age (<50), non-White race and public health insurance were all significant predictors of later receipt of 1stdose and lack of uptake of a booster. However, advanced professional role was only found to be a significant predictor of early 1stdose receipt. CONCLUSIONS: Continual monitoring of COVID-19 vaccine uptake among HCP to identify those less likely to receive new booster doses will be crucial to support targeted vaccine campaigns in this important population.

IMPORTANCE: Emtricitabine and tenofovir disoproxil fumarate (F/TDF) for HIV preexposure prophylaxis (PrEP) is highly effective in cisgender men who have sex with men (MSM) when adherence is high (>4 doses/week). Real-world effectiveness and adherence with F/TDF for PrEP in cisgender women is less well characterized. OBJECTIVE: To characterize the effectiveness of F/TDF for PrEP and its relationship with adherence in cisgender women. DESIGN, SETTING, AND PARTICIPANTS: Data were pooled from 11 F/TDF PrEP postapproval studies conducted in 6 countries that included 6296 cisgender women aged 15 to 69 years conducted from 2012 to 2020. HIV incidence was evaluated according to adherence level measured objectively (tenofovir diphosphate concentration in dried blood spots or tenofovir concentration in plasma; n = 288) and subjectively (electronic pill cap monitoring, pill counts, self-report, and study-reported adherence scale; n = 2954) using group-based trajectory modeling. EXPOSURES: F/TDF prescribed orally once a day. HIV incidence was analyzed in subgroups based on adherence trajectory. MAIN OUTCOMES AND MEASURES: HIV incidence. RESULTS: Of the 6296 participants, 46% were from Kenya, 28% were from South Africa, 21% were from India, 2.9% were from Uganda, 1.6% were from Botswana, and 0.8% were from the US. The mean (SD) age at PrEP initiation across all studies was 25 (7) years, with 61% of participants being younger than 25 years. The overall HIV incidence was 0.72 per 100 person-years (95% CI, 0.51-1.01; 32 incident HIV diagnoses among 6296 participants). Four distinct groups of adherence trajectories were identified: consistently daily (7 doses/week), consistently high (4-6 doses/week), high but declining (from a mean of 4-6 doses/week and then declining), and consistently low (less than 2 doses/week). None of the 498 women with consistently daily adherence acquired HIV. Only 1 of the 658 women with consistently high adherence acquired HIV (incidence rate, 0.13/100 person-years [95% CI, 0.02-0.92]). The incidence rate was 0.49 per 100 person-years (95% CI, 0.22-1.08) in the high but declining adherence group (n = 1166) and 1.27 per 100 person-years (95% CI, 0.53-3.04) in the consistently low adherence group (n = 632). CONCLUSIONS AND RELEVANCE: In a pooled analysis of 11 postapproval studies of F/TDF for PrEP among cisgender women, overall HIV incidence was 0.72 per 100 person-years; individuals with consistently daily or consistently high adherence (4-6 doses/week) to PrEP experienced very low HIV incidence.

BACKGROUND: Inhalation injuries due to acute occupational exposures to chemicals are preventable. National surveillance of acute inhalation exposures is limited. This study identified the most common acute inhalation exposure-related incidents by industry sector among US workers. METHODS: To characterize inhalation-related injuries and their exposures during April 2011-March 2022, state and federal records from the Occupational Safety and Health Administration (OSHA) Occupational Safety and Health Information System (OIS) accident database were analyzed. Industry-specific injury, hospitalization, and fatality rates were calculated. RESULTS: The most frequent acute inhalation incidents investigated by OSHA were caused by inorganic gases (52.9%) such as carbon monoxide (CO) or acids, bases, and oxidizing chemical agents (12.9%) such as anhydrous ammonia. The largest number of fatal and nonfatal injuries were reported in the manufacturing (28.6%) and construction (17.2%) sectors. CONCLUSIONS: Workers were affected by acute inhalation exposures in most industries. Using this surveillance, employers can recognize frequently-occurring preventable acute inhalation exposures by industry, such as inorganic gases in the manufacturing sector, and implement prevention measures. Training of workers on exposure characteristics and limits, adverse health effects, and use of protective equipment by exposure agent can prevent inhalation injuries.

The nationwide scale-up of evidence-based and evidence-informed interventions has been widely recognized as a crucial step in ending the HIV epidemic. Although the successful delivery of interventions may involve intensive expert training, technical assistance (TA), and dedicated funding, most organizations attempt to replicate interventions without access to focused expert guidance. Thus, there is a grave need for initiatives that meaningfully address HIV health disparities while addressing these inherent limitations. Here, the Health Resources and Services Administration HIV/AIDS Bureau (HRSA HAB) initiative Using Evidence-Informed Interventions to Improve HIV Health Outcomes among People Living with HIV (E2i) piloted an alternative approach to implementation that de-emphasized expert training to naturalistically simulate the experience of future HIV service organizations with limited access to TA. The E2i approach combined the HAB-adapted Institute for Healthcare Improvement's Breakthrough Series Collaborative Learning Model with HRSA HAB's Implementation Science Framework, to create an innovative multi-tiered system of peer-to-peer learning that was piloted across 11 evidence-informed interventions at 25 Ryan White HIV/AIDS Program sites. Four key types of peer-to-peer learning exchanges (i.e., intervention, site, staff role, and organization specific) took place at biannual peer learning sessions, while quarterly intervention cohort calls and E2i monthly calls with site staff occurred during the action periods between learning sessions. Peer-to-peer learning fostered both experiential learning and community building and allowed site staff to formulate robust site-specific action plans for rapid cycle testing between learning sessions. Strategies that increase the effectiveness of interventions while decreasing TA could provide a blueprint for the rapid uptake and integration of HIV interventions nationwide.

In 2021, the Association for Diagnostics & Laboratory Medicine (ADLM) (formerly the American Association for Clinical Chemistry [AACC]) developed a scientific study that aimed to contribute to the understanding of SARS-CoV-2 immunity during the evolving course of the pandemic. This study was led by a group of expert member volunteers and resulted in survey data from 975 individuals and blood collection from 698 of those participants. This paper describes the formulation and execution of this large-scale scientific study, encompassing best practices and insights gained throughout the endeavor.

BACKGROUND: Bivalent mRNA vaccines were recommended since September 2022. However, coverage with a recent vaccine dose has been limited, and there are few robust estimates of bivalent VE against symptomatic SARS-CoV-2 infection (COVID-19). We estimated VE of a bivalent mRNA vaccine dose against COVID-19 among eligible U.S. healthcare personnel who had previously received monovalent mRNA vaccine doses. METHODS: We conducted a case-control study in 22 U.S. states, and enrolled healthcare personnel with COVID-19 (case-participants) or without COVID-19 (control-participants) during September 2022-May 2023. Participants were considered eligible for a bivalent mRNA dose if they had received 2-4 monovalent (ancestral-strain) mRNA vaccine doses, and were ≥67 days after the most recent vaccine dose. We estimated VE of a bivalent mRNA dose using conditional logistic regression, accounting for matching by region and four-week calendar period. We adjusted estimates for age group, sex, race and ethnicity, educational level, underlying health conditions, community COVID-19 exposure, prior SARS-CoV-2 infection, and days since the last monovalent mRNA dose. RESULTS: Among 3,647 healthcare personnel, 1,528 were included as case-participants and 2,119 as control-participants. Participants received their last monovalent mRNA dose a median of 404 days previously; 1,234 (33.8%) also received a bivalent mRNA dose a median of 93 days previously. Overall, VE of a bivalent dose was 34.1% (95% CI, 22.6%-43.9%) against COVID-19 and was similar by product, days since last monovalent dose, number of prior doses, age group, and presence of underlying health conditions. However, VE declined from 54.8% (95% CI, 40.7%-65.6%) after 7-59 days to 21.6% (95% CI 5.6%-34.9%) after ≥60 days. CONCLUSIONS: Bivalent mRNA COVID-19 vaccines initially conferred approximately 55% protection against COVID-19 among U.S. healthcare personnel. However, protection waned after two months. These findings indicate moderate initial protection against symptomatic SARS-CoV-2 infection by remaining up-to-date with COVID-19 vaccines.

Although malaria was eliminated in the United States in the mid-1950s, approximately 2,000 malaria cases are imported into the United States from regions with endemic disease transmission each year, including approximately 200 in Maryland* (Figure) (1). Anopheles mosquito species that can transmit malaria exist in many areas in the United States (2). Locally acquired mosquito-transmitted (i.e., autochthonous) cases have not been identified since 2003; however, these imported cases represent a potential source of infection. In mid-2023, eight autochthonous malaria cases (Plasmodium vivax) were identified in Florida and Texas (3); in both states, the autochthonous cases occurred in the vicinity of an imported malaria case.

Both respirators and surgical masks (SM) are used as source control devices. During the COVID-19 pandemic, there was much interest in understanding the extent of particle total outward leakage (TOL) from these devices. The objective of this study was to quantify the TOL for five categories of devices: SMs, National Institute for Occupational Safety and Health (NIOSH®) Approved N95(®) filtering facepiece respirators (FFRs) without exhalation valves, NIOSH Approved N95 FFRs with exhalation valves (N95 FFRV), NIOSH Approved elastomeric half-mask respirators (EHMRs) with exhalation valves, and NIOSH Approved EHMRs with an SM covering the exhalation valve (EHMRSM). A benchtop test system was designed to test two models of each device category. Each device was mounted on a headform at three faceseal levels (0% faceseal, 50% faceseal, and 100% faceseal). At each faceseal level, the TOL was assessed at three flowrates of minute ventilations of 17, 28, and 39 L/min. The experimental design was a split-split-plot configuration. Device type, faceseal level, flowrate, and the interaction of device type and faceseal level were found to have a significant effect ( P - Value <0.05) on the TOL.This study found that the N95 FFRs without exhalation valves had the lowest mean TOL. The SMs had about three times higher TOL than the N95 FFRs without exhalation valves. The TOL of the N95 FFRV was comparable to that of the SM at 0% and 50% faceseal on average over all conditions, but the N95 FFRV had a significantly higher TOL than the SM at a 100% faceseal. The EHMRs had the highest TOL because of the exhalation valve. Using an SM to cover the exhalation valve did not improve the EHMRs' efficiency in mitigating the TOL. Caution should be exercised when using N95 FFRVs as a source control measure against respiratory activities with heavy work rates, such as performing CPR. Results of this study showed that reduced faceseal leakage for N95 FFRs and SMs improves source control.

In this case study, we aim to understand how health departments in 5 US jurisdictions addressed health inequities and implemented strategies to reach populations disproportionately affected by COVID-19 during the initial Omicron variant period. We used qualitative methods to examine health department experiences during the initial Omicron surge, from November 2021 to April 2022, assessing successful interventions, barriers, and lessons learned from efforts to promote health equity. Our findings indicate that government leadership supported prioritizing health equity from the beginning of the pandemic, seeing it as a need and vital part of the response framework. All jurisdictions acknowledged the historical trauma and distrust of the government. Health departments found that collaborating and communicating with trusted community leaders helped mitigate public distrust. Having partnerships, resources, and infrastructure in place before the pandemic facilitated the establishment of equity-focused COVID-19 response activities. Finally, misinformation about COVID-19 was a challenge for all jurisdictions. Addressing the needs of diverse populations involves community-informed decisionmaking, diversity of thought, and delivery measures that are tailored to the community. It is imperative to expand efforts to reduce and eliminate health inequities to ensure that individuals and communities recover equitably from the effects of COVID-19.

We are pleased that the World Health Organization (WHO) is developing a pandemic treaty to improve the global response to future pandemics. In their article, De Luca and Ramirez1 rightly argue that a pandemic treaty should be informed by experiences with WHO's existing treaty, the WHO Framework Convention on Tobacco Control (WHO FCTC), which came into force in 2005. However, the authors have mischaracterized the WHO FCTC and made criticisms that could hinder a productive discussion about a treaty for pandemics. | | The authors identify a limited emphasis on “harm reduction” as a key limitation of the WHO FCTC. However, the treaty itself includes “harm reduction strategies” in its definition of tobacco control.2 As the authors indicate, harm reduction encompasses actions “aimed at reducing the negative effects of health behaviors without necessarily extinguishing the problematic health behaviors completely or permanently.”1,3 The WHO FCTC and its guidelines for implementation—which include requiring smoke-free public places; banning tobacco advertising, promotion, and sponsorship; and reducing the attractiveness of tobacco products by limiting flavoring agents—allow the continuation of product use, while reducing t

Approximately 6 months before an unprecedented global mpox outbreak was first identified in the United Kingdom, an adult man was diagnosed with mpox in Maryland, USA [1]. At the time of the investigation, the case was only the eighth monkeypox virus (MPXV) infection diagnosed in a non-African country during the preceding 3 years, all of which were associated with recent travel to Nigeria [2]. One of these 8 imported cases occurred in Texas, USA four months earlier; that case exhibited features clinically consistent with those classically reported in Africa (i.e., large and diffuse lesions, high fever and prodromal symptoms, umbilicated lesions in the same stage of development on specific anatomic surfaces) [3]. In contrast, the Maryland case was milder in severity and had signs that, at the time, were considered unusual for mpox. Several aspects of the Maryland case are noteworthy and in retrospect may offer clues to the origins of the 2022 global mpox outbreak, as well as explain how mpox might have spread undetected before emerging as a global outbreak.

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%); &lt;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 &gt;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 &amp;Johnson50 shares of stocks Moderna20 shares of stocks &amp; Spouse works for Ethicon|Johnson &amp; 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

Short-term probabilistic forecasts of the trajectory of the COVID-19 pandemic in the United States have served as a visible and important communication channel between the scientific modeling community and both the general public and decision-makers. Forecasting models provide specific, quantitative, and evaluable predictions that inform short-term decisions such as healthcare staffing needs, school closures, and allocation of medical supplies. In 2020, the COVID-19 Forecast Hub (https://covid19forecasthub.org/) collected, disseminated, and synthesized hundreds of thousands of specific predictions from more than 50 different academic, industry, and independent research groups. This manuscript systematically evaluates 23 models that regularly submitted forecasts of reported weekly incident COVID-19 mortality counts in the US at the state and national level. One of these models was a multi-model ensemble that combined all available forecasts each week. The performance of individual models showed high variability across time, geospatial units, and forecast horizons. Half of the models evaluated showed better accuracy than a naïve baseline model. In combining the forecasts from all teams, the ensemble showed the best overall probabilistic accuracy of any model. Forecast accuracy degraded as models made predictions farther into the future, with probabilistic accuracy at a 20-week horizon more than 5 times worse than when predicting at a 1-week horizon. This project underscores the role that collaboration and active coordination between governmental public health agencies, academic modeling teams, and industry partners can play in developing modern modeling capabilities to support local, state, and federal response to outbreaks.Competing Interest StatementAV, MC, and APP report grants from Metabiota Inc outside the submitted work.Funding StatementFor teams that reported receiving funding for their work, we report the sources and disclosures below. CMU-TimeSeries: CDC Center of Excellence, gifts from Google and Facebook. CU-select: NSF DMS-2027369 and a gift from the Morris-Singer Foundation. COVIDhub: This work has been supported by the US Centers for Disease Control and Prevention (1U01IP001122) and the National Institutes of General Medical Sciences (R35GM119582). The content is solely the responsibility of the authors and does not necessarily represent the official views of CDC, NIGMS or the National Institutes of Health. Johannes Bracher was supported by the Helmholtz Foundation via the SIMCARD Information&amp; Data Science Pilot Project. Tilmann Gneiting gratefully acknowledges support by the Klaus Tschira Foundation. DDS-NBDS: NSF III-1812699. EPIFORECASTS-ENSEMBLE1: Wellcome Trust (210758/Z/18/Z) GT_CHHS-COVID19: William W. George Endowment, Virginia C. and Joseph C. Mello Endowments, NSF DGE-1650044, NSF MRI 1828187, research cyberinfrastructure resources and services provided by the Partnership for an Advanced Computing Environment (PACE) at Georgia Tech, and the following benefactors at Georgia Tech: Andrea Laliberte, Joseph C. Mello, Richard Rick E. &amp; Charlene Zalesky, and Claudia &amp; Paul Raines GT-DeepCOVID: CDC MInD-Healthcare U01CK000531-Supplement. NSF (Expeditions CCF-1918770, CAREER IIS-2028586, RAPID IIS-2027862, Medium IIS-1955883, NRT DGE-1545362), CDC MInD program, ORNL and funds/computing resources from Georgia Tech and GTRI. IHME: This work was supported by the Bill &amp; Melinda Gates Foundation, as well as funding from the state of Washington and the National Science Foundation (award no. FAIN: 2031096). IowaStateLW-STEM: Iowa State University Plant Sciences Institute Scholars Program, NSF DMS-1916204, NSF CCF-1934884, Laurence H. Baker Center for Bioinformatics and Biological Statistics. JHU_IDD-CovidSP: State of California, US Dept of Health and Human Services, US Dept of Homeland Security, US Office of Foreign Disaster Assistance, Johns Hopkins Health System, Office of the Dean at Johns Hopkins Bloomberg School of Public Health, Johns Hopkins University Modeling and Policy Hub, Centers fo Disease Control and Prevention (5U01CK000538-03), University of Utah Immunology, Inflammation, &amp; Infectious Disease Initiative (26798 Seed Grant). LANL-GrowthRate: LANL LDRD 20200700ER. MOBS-GLEAM_COVID: COVID Supplement CDC-HHS-6U01IP001137-01. NotreDame-mobility and NotreDame-FRED: NSF RAPID DEB 2027718 UA-EpiCovDA: NSF RAPID Grant # 2028401. UCSB-ACTS: NSF RAPID IIS 2029626. UCSD-NEU: Google Faculty Award, DARPA W31P4Q-21-C-0014, COVID Supplement CDC-HHS-6U01IP001137-01. UMass-MechBayes: NIGMS R35GM119582, NSF 1749854. UMich-RidgeTfReg: The University of Michigan Physics Department and the University of Michigan Office of Research.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:UMass-Amherst IRBAll 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.YesAll data and code referred to in the manuscript are publicly available. https://github.com/reichlab/covid19-forecast-hub/ https://github.com/reichlab/covidEnsembles https://zoltardata.com/project/44

Recent studies have provided key information about SARS-CoV-2 vaccines’ efficacy and effectiveness (VE). One important question that remains is whether the protection conferred by vaccines wanes over time. However, estimates over time are subject to bias from differential depletion of susceptibles between vaccinated and unvaccinated groups. Here we examine the extent to which biases occur under different scenarios and assess whether serologic testing has the potential to correct this bias. By identifying non-vaccine antibodies, these tests could identify individuals with prior infection. We find in scenarios with high baseline VE, differential depletion of susceptibles creates minimal bias in VE estimates, suggesting that any observed declines are likely not due to spurious waning alone. However, if baseline VE is lower, the bias for leaky vaccines (that reduce individual probability of infection given contact) is larger and should be corrected by excluding individuals with past infection if the mechanism is known to be leaky. Conducting analyses both unadjusted and adjusted for past infection could give lower and upper bounds for the true VE. Studies of VE should therefore enroll individuals regardless of prior infection history but also collect information, ideally through serologic testing, on this critical variable.Competing Interest StatementDr. Lipsitch reports consulting/honoraria from Bristol Myers Squibb, Sanofi Pasteur, and Merck, as well as a grant through his institution, unrelated to COVID-19, from Pfizer. He has served as an unpaid advisor related to COVID-19 to Pfizer, One Day Sooner, Astra-Zeneca, Janssen, and COVAX (United Biomedical). Dr. Kahn discloses consulting fees from Partners In Health.Funding StatementThis work was supported by the U.S. National Cancer Institute Seronet cooperative agreement U01CA261277. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.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:N/AAll 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.YesCode is available on github. https://github.com/rek160/spurious-waning

Background The E484K and L452R amino acid substitutions on the spike protein of SARS-CoV-2 are associated with reduced neutralization by antibodies from acquired immunity. This study examines the respective association of these mutations with infection in persons who had previously received a COVID-19 vaccine.Methods Genetic sequences from SARS-CoV-2 specimens collected from Maryland residents and reported to Maryland Department of Health were linked to vaccination history. The prevalence of infections in fully vaccinated persons -- defined as being at least two weeks past receiving the final scheduled dose of a COVID-19 vaccine series -- was compared between infections caused by viruses carrying E484K to those not carrying E484K, and between infections caused by viruses carrying L452R to those not carrying L452R, using logistic regression to adjust for confounding.Results Of 9,048 sequenced SARS-CoV-2 specimens examined, 265 (2.9%) were collected from fully vaccinated persons. In adjusted analysis, the E484K substitution was associated with an increase in the odds of the sequenced specimen being collected from a fully vaccinated person (OR 1.96, 95% CI, 1.36 to 2.83). The L452R mutation was not significantly associated with infections in vaccinated persons (OR 1.07, 95% CI, 0.69 to 1.68).Conclusion Though more than 97% of SARS-CoV-2 infections were in persons who were not fully vaccinated, the E484K mutation was associated with increased odds of SARS-CoV-2 infection in vaccinated persons. Linking vaccination and sequencing data can help identify and estimate the impact SARS-CoV-2 mutations may have on vaccine effectiveness.Summary In viruses sequenced for Maryland’s routine SARS-CoV-2 genomic surveillance, the spike protein amino acid substitution E484K was more prevalent in viruses that infected vaccinated people than in viruses that infected people who were not vaccinated.Competing Interest StatementThe authors have declared no competing interest.Funding StatementNo external funding to report.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:Case investigation, data collection, and analysis were conducted for public health purposes. This project was reviewed by the Division of Scientific Education and Professional Development within the Center for Surveillance, Epidemiology, and Laboratory Services at the Centers for Disease Control and Prevention (CDC). The project was determined to meet the requirements of public health surveillance covered by the U.S. Department of Health and Human Services Policy for the Protection of Human Research Subjects as defined in 45 C.F.R. part 46.102(l)(2), 21 C.F.R. part 56; 42 U.S.C. Sec.241(d); 5 U.S.C. Sec.552a; 44 U.S.C. Sec.3501 et seq. In., and the decision was made that this project was nonresearch and did not require ethical review by the CDC Human Research Protection Office. Ethical approval was waived and informed consent was not required.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.YesData are the property of the U.S. state of Maryland and are collected for public health surveillance purposes. They are not available to the ublic.

The Democratic Republic of the Congo (DRC) harbors 11% of global malaria cases, yet little is known about the spatial and genetic structure of the parasite population in that country. We sequenced 2537 Plasmodium falciparum infections, including a nationally representative population sample from DRC and samples from surrounding countries, using molecular inversion probes - a novel high-throughput genotyping tool. We identified an east-west divide in haplotypes known to confer resistance to chloroquine and sulfadoxine-pyrimethamine. Furthermore, we identified highly related parasites over large geographic distances, indicative of gene flow and migration. Our results were consistent with a background of isolation by distance combined with the effects of selection for antimalarial drug resistance. This study provides a high-resolution view of parasite genetic structure across a large country in Africa and provides a baseline to study how implementation programs may impact parasite populations.

Importance: Post-authorization monitoring of vaccines in a large population can detect rare adverse events not identified in clinical trials including Guillain-Barre syndrome (GBS). GBS has a background rate of 1-2 per 100,000 person-years. Objective(s): To 1) describe cases and incidence of GBS following COVID-19 vaccination, and 2) assess the risk of GBS after vaccination for Ad.26.COV2.S (Janssen) and mRNA vaccines. Design(s): Interim analysis of surveillance data from the Vaccine Safety Datalink. Setting(s): Eight participating integrated healthcare systems in the United States. Participant(s): 10,158,003 individuals aged >=12 years. Exposures: Receipt of Ad.26.COV2.S, BNT162b2 (Pfizer-BioNTech), or mRNA-1273 (Moderna) COVID-19 vaccine. Main Outcomes and Measures: GBS with symptom onset in the 1-84 days after vaccination as confirmed by medical record review and adjudication. Descriptive characteristics of confirmed cases, GBS incidence rates during postvaccination risk intervals after each type of vaccine compared to the background rate, rate ratios (RRs) comparing GBS incidence in the 1-21 vs. 22-42 days postvaccination, and RRs directly comparing risk of GBS after Ad.26.COV2.S vs. mRNA vaccination, using Poisson regression adjusted for age, sex, race/ethnicity, site, and calendar day. Result(s): From December 13, 2020 through November 13, 2021, 14,723,318 doses of COVID-19 vaccines were administered, including 467,126 Ad.26.COV2.S, 8,573,823 BNT162b2, and 5,682,369 mRNA-1273 doses. Eleven cases of GBS after Ad.26.COV2.S were confirmed. The unadjusted incidence rate of confirmed cases of GBS per 100,000 person-years in the 1-21 days after Ad.26.COV2.S was 34.6 (95% confidence interval [CI]: 15.8-65.7), significantly higher than the background rate, and the adjusted RR in the 1-21 vs. 22-42 days following Ad.26.COV2.S was 6.03 (95% CI: 0.79-147.79). Thirty-four cases of GBS after mRNA vaccines were confirmed. The unadjusted incidence rate of confirmed cases per 100,000 person-years in the 1-21 days after mRNA vaccines was 1.4 (95% CI: 0.7-2.5) and the adjusted RR in the 1-21 vs. 22-42 days following mRNA vaccines was 0.56 (95% CI: 0.21-1.48). In a head-to-head comparison of Ad.26.COV2.S vs. mRNA vaccines, the adjusted RR was 20.56 (95% CI: 6.94-64.66). Conclusions and Relevance: In this interim analysis of surveillance data of COVID-19 vaccines, the incidence of GBS was elevated after Ad.26.COV2.S. Surveillance is ongoing. Copyright The copyright holder for this preprint is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-NC-ND 4.0 International license.