COVID-19 booster vaccination during pregnancy enhances maternal binding and neutralizing antibody responses and transplacental antibody transfer to the newborn.

The immune response to COVID-19 booster vaccinations during pregnancy for mothers and their newborns and the functional response of vaccine-induced antibodies against Omicron variants are not well characterized. We conducted a prospective, multicenter cohort study of participants vaccinated during pregnancy with primary or booster mRNA COVID-19 vaccines from July 2021 to January 2022 at 9 academic sites. We determined SARS-CoV-2 binding and live virus and pseudovirus neutralizing antibody (nAb) titers pre- and post-vaccination, and at delivery for both maternal and infant participants. Immune responses to ancestral and Omicron BA.1 SARS-CoV-2 strains were compared between primary and booster vaccine recipients in maternal sera at delivery and in cord blood, after adjusting for days since last vaccination. A total of 240 participants received either Pfizer or Moderna mRNA vaccine during pregnancy (primary 2-dose series: 167; booster dose: 73). Booster vaccination resulted in significantly higher binding and nAb titers, including to the Omicron BA.1 variant, in maternal serum at delivery and in cord blood compared to a primary 2-dose series (range 0.44-0.88 log10 higher, p < 0.0001 for all comparisons). Live virus nAb to Omicron BA.1 were present at delivery in 9 % (GMT ID50 12.7) of Pfizer and 22 % (GMT ID50 14.7) of Moderna primary series recipients, and in 73 % (GMT ID50 60.2) of mRNA boosted participants (p < 0.0001), although titers were significantly lower than to the D614G strain. Transplacental antibody transfer was efficient for all regimens with median transfer ratio range: 1.55-1.77 for IgG, 1.00-1.78 for live virus nAb and 1.79-2.36 for pseudovirus nAb. COVID-19 mRNA vaccination during pregnancy elicited robust immune responses in mothers and efficient transplacental antibody transfer to the newborn. A booster dose during pregnancy significantly increased maternal and cord blood binding and neutralizing antibody levels, including against Omicron BA.1. Findings support the use of a booster dose of COVID-19 vaccine during pregnancy.

Time to Extubation among ARDS Subjects with and without COVID-19 Pneumonia.

BACKGROUND: Pneumonia from COVID-19 that results in ARDS may require invasive mechanical ventilation. This retrospective study assessed the characteristics and outcomes of subjects with COVID-19-associated ARDS versus ARDS (non-COVID) during the first 6 months of the COVID-19 pandemic in 2020. The primary objective was to determine whether mechanical ventilation duration differed between these cohorts and identify other potential contributory factors. METHODS: We retrospectively identified 73 subjects admitted between March 1 and August 12, 2020, with either COVID-19-associated ARDS (37) or ARDS (36) who were managed with the lung protective ventilator protocol and required > 48 h of mechanical ventilation. Exclusion criteria were the following: <18 years old or the patient required tracheostomy or interfacility transfer. Demographic and baseline clinical data were collected at ARDS onset (ARDS day 0), with subsequent data collected on ARDS days 1-3, 5, 7, 10, 14, and 21. Comparisons were made by using the Wilcoxon rank-sum test (continuous variables) and chi-square test (categorical variables) stratified by COVID-19 status. A Cox proportional hazards model assessed the cause-specific hazard ratio for extubation. RESULTS: The median (interquartile range) mechanical ventilation duration among the subjects who survived to extubation was longer in those with COVID-19-ARDS versus the subjects with non-COVID ARDS: 10 (6-20) d versus 4 (2-8) d; P < .001. Hospital mortality was not different between the two groups (22% vs 39%; P = .11). The competing risks Cox proportional hazard analysis (fit among the total sample, including non-survivors) revealed that improved compliance of the respiratory system and oxygenation were associated with the probability of extubation. Oxygenation improved at a lower rate in the subjects with COVID-19-associated ARDS than in the subjects with non-COVID ARDS. CONCLUSIONS: Mechanical ventilation duration was longer in subjects with COVID-19-associated ARDS compared with the subjects with non-COVID ARDS, which may be explained by a lower rate of improvement in oxygenation status.

Association Between the Community Prevalence of COVID-19 and Daily Unscheduled Absences of Anesthesiologists, Nurse Anesthetists, and Residents in an Academic Anesthesia Department.

Introduction An "unscheduled absence" refers to an occurrence when an employee does not appear for work and the absence was not approved in advance by an authorized supervisor. Daily unscheduled absences need to be forecasted when doing staff scheduling to maintain an acceptable risk of being unable to run all anesthetizing locations and operating rooms planned. The number of extra personnel to be scheduled needs to be at least twice as large as the mean number absent. In an earlier historical cohort study, we found that our department's modeled risks of being unavailable unexpectedly differed among types of anesthesia practitioners (e.g., anesthesiologists and nurse anesthetists) and among weekdays (i.e., Mondays, Fridays, and workdays adjacent to holidays versus other weekdays). In the current study, with two extra years of data, we examined the effect of the coronavirus COVID-19 pandemic on the frequency of unscheduled absences. Methods There were 50 four-week periods studied at a large teaching hospital in the United States, from August 30, 2018 to June 29, 2022. The sample size of 120,687 person-assignment days (i.e., a person assigned to work on a given day) included 322 anesthesia practitioners (86 anesthesiologists, 88 certified registered nurse anesthetists, 99 resident and fellow physicians, and 49 student nurse anesthetists). The community prevalence of COVID­19 was estimated using the percentage positive among asymptomatic patients tested before surgery and other interventional procedures at the hospital. Results Each 1% increase in the prevalence of COVID-19 among asymptomatic patients was associated with a 1.131 increase in the odds of unscheduled absence (P < 0.0001, 99% confidence interval 1.086 to 1.178). Using an alternative model with prevalence categories, unscheduled absences were substantively more common when the COVID-19 prevalence exceeded 2.50%, P [Formula: see text] 0.0002. For example, there was a 1% unscheduled absence rate among anesthesiologists working Mondays and Fridays early in the pandemic when the prevalence of COVID-19 among asymptomatic patients was 1.3%. At a 1% unscheduled absence rate, 67 would be the minimum scheduled to maintain a <5.0% risk for being unable to run all 65 anesthetizing locations. In contrast, there was a 3% unscheduled absence rate among nurse anesthetists working Mondays and Fridays during the Omicron variant surge when the prevalence was 4.5%. At a 3% unscheduled absence rate, 70 would be the minimum scheduled to maintain the same risk of not being able to run 65 rooms. Conclusions Increases in the prevalence of COVID-19 asymptomatic tests were associated with more unscheduled absences, with no detected threshold. This quantitative understanding of the impact of communicable diseases on the workforce potentially has broad generalizability to other fields and infectious diseases.

Targets and cross-reactivity of human T cell recognition of common cold coronaviruses.

The coronavirus (CoV) family includes several viruses infecting humans, highlighting the importance of exploring pan-CoV vaccine strategies to provide broad adaptive immune protection. We analyze T cell reactivity against representative Alpha (NL63) and Beta (OC43) common cold CoVs (CCCs) in pre-pandemic samples. S, N, M, and nsp3 antigens are immunodominant, as shown for severe acute respiratory syndrome 2 (SARS2), while nsp2 and nsp12 are Alpha or Beta specific. We further identify 78 OC43- and 87 NL63-specific epitopes, and, for a subset of those, we assess the T cell capability to cross-recognize sequences from representative viruses belonging to AlphaCoV, sarbecoCoV, and Beta-non-sarbecoCoV groups. We find T cell cross-reactivity within the Alpha and Beta groups, in 89% of the instances associated with sequence conservation >67%. However, despite conservation, limited cross-reactivity is observed for sarbecoCoV, indicating that previous CoV exposure is a contributing factor in determining cross-reactivity. Overall, these results provide critical insights in developing future pan-CoV vaccines.

A Novel Approach to the Room of Errors (ROE): A Three-Dimensional Virtual Tour Activity to Spotlight Patient Safety Threats.

BACKGROUND: Live simulation-based activities are effective tools in teaching situational awareness to improve patient safety training in healthcare settings. The coronavirus disease 2019 (COVID-19) pandemic forced the discontinuation of these in-person sessions. We describe our solution to this challenge: an online interactive activity titled the "Virtual Room of Errors." The aim of this activity is to create an accessible and feasible method of educating healthcare providers about situational awareness in the hospital.  Materials and Methods: We applied existing three-dimensional virtual tour technology used in the real estate sector to a hospital patient room with a standardized patient and 46 intentionally placed hazards. Healthcare providers and students from our institution accessed the room online through a link where they independently navigate, and document observed safety hazards.  Results: In 2021 and 2022, a total of 510 learners completed the virtual Room of Errors (ROE). The virtual ROE increased annual participation in the activity, as compared to the in-person Room, and demonstrated learner satisfaction.  Conclusions: The virtual ROE is an accessible, feasible, and cost-effective method of educating healthcare workers on situational awareness of preventable hazards. Furthermore, the activity is a sustainable way to reach a larger number of learners from multiple disciplines, even as in-person activities resume.

Pain Management in Older Adults before and during the First Year of Covid-19 Pandemic: Prevalence, Trends, and Correlates.

BACKGROUND: There is limited knowledge on whether and how healthcare access restrictions imposed by the Covid-19 pandemic have affected utilization of both opioid and non-pharmacological treatments among US older adults living with chronic pain. METHODS: We compared prevalence of chronic pain and high impact chronic pain (HICP; i.e., chronic pain limiting life or work activities on most days or every day in the past 6 months) between 2019 (pre-pandemic) and 2020 (first year of pandemic) and utilization of opioids and non-pharmacological pain treatments among adults aged ≥65 years enrolled in the National Health Interview Survey (NHIS), a nationally representative sample of non-institutionalized civilian US adults. RESULTS: Of 12,027 survey participants aged ≥65 (representing 32.6 million non-institutionalized older adults nationally), the prevalence of chronic pain was not significantly different from 2019 (30.8%; 95% confidence interval [CI], 29.7-32.0%) to 2020 (32.1%; 95% CI, 31.0-33.3%; p=0.06). Among older adults with chronic pain, the prevalence of HICP was also unchanged (38.3%; 95% CI, 36.1-40.6% in 2019 versus 37.8%; 95% CI, 34.9-40.8% in 2020; p=0.79). Use of any non-pharmacological interventions for pain management decreased significantly from 61.2% (95 CI, 58.8-63.5%) in 2019 to 42.1% (95% CI, 40.5-43.8%) in 2020 (p<0.001) among those with chronic pain, as did opioid use in the past 12 months from 20.2% (95% CI, 18.9-21.6%) in 2019 to 17.9% (95% CI, 16.7-19.1%) in 2020 (p=0.006). Predictors of treatment utilization were similar in both chronic pain and HICP. CONCLUSION: Use of pain treatments among older adults with chronic pain declined in the first year of Covid-19 pandemic. Future research is needed to assess long-term effects of Covid-19 pandemic on pain management in older adults.

Virtual Care and Emergency Department Use During the COVID-19 Pandemic Among Patients of Family Physicians in Ontario, Canada.

Importance: The COVID-19 pandemic has played a role in increased use of virtual care in primary care. However, few studies have examined the association between virtual primary care visits and other health care use. Objective: To evaluate the association between the percentage of virtual visits in primary care and the rate of emergency department (ED) visits. Design, Setting, and Participants: This cross-sectional study used routinely collected administrative data and was conducted in Ontario, Canada. The sample comprised family physicians with at least 1 primary care visit claim between February 1 and October 31, 2021, and permanent Ontario residents who were alive as of March 31, 2021. All residents were assigned to physicians according to enrollment and billing data. Exposure: Family physicians' virtual visit rate was the exposure. Physicians were stratified by the percentage of total visits that they delivered virtually (via telephone or video) during the study period (0% [100% in person], >0%-20%, >20%-40%, >40%-60%, >60%-80%, >80% to <100%, or 100%). Main Outcomes and Measures: Population-level ED visit rate was calculated for each stratum of virtual care use. Multivariable regression models were used to understand the relative rate of patient ED use after adjusting for rurality of practice, patient characteristics, and 2019 ED visit rates. Results: Data were analyzed for a total of 13 820 family physicians (7114 males [51.5%]; mean [SD] age, 50 [13.1] years) with 12 951 063 patients (6 714 150 females [51.8%]; mean [SD] age, 42.6 [22.9] years) who were attached to these physicians. Most physicians provided between 40% and 80% of care virtually. A higher percentage of the physicians who provided more than 80% of care virtually were 65 years or older, female individuals, and practiced in big cities. Patient comorbidity and morbidity were similar across strata of virtual care use. The mean (SD) number of ED visits was highest among patients whose physicians provided only in-person care (470.3 [1918.8] per 1000 patients) and was lowest among patients of physicians who provided more than 80% to less than 100% of care virtually (242.0 [800.3] per 1000 patients). After adjustment for patient characteristics, patients of physicians with more than 20% of visits delivered virtually had lower rates of ED visits compared with patients of physicians who provided more than 0% to 20% of care virtually (eg, >80% to <100% vs >0%-20% virtual visits in big cities: relative rate, 0.77%; 95% CI, 0.74%-0.81%). This pattern was unchanged across all rurality of practice strata and after adjustment for 2019 ED visit rates. In urban areas, there was a gradient whereby patients of physicians providing the highest level of virtual care had the lowest ED visit rates. Conclusions and Relevance: Findings of this study show that patients of physicians who provided a higher percentage of virtual care did not have higher ED visit rates compared with patients of physicians who provided the lowest levels of virtual care. The findings refute the hypothesis that family physicians providing more care virtually during the pandemic resulted in higher ED use.

What is the role of primary care in the COVID-19 vaccine roll-out and the barriers and facilitators to an equitable vaccine roll-out? A rapid scoping review of nine jurisdictions.

OBJECTIVES: This study aimed to: (1) examine the experience of nine global jurisdictions that engaged primary care providers (PCPs) to administer COVID-19 vaccines during the pandemic; (2) describe how vaccine hesitancy and principles of equity were incorporated in the COVID-19 vaccine roll-out strategies and (3) identify the barriers and facilitators to the vaccine roll-out. DESIGN: Rapid scoping review. DATA SOURCES: Searches took place in MEDLINE, CINAHL, Embase, the Cochrane Library, SCOPUS and PsycINFO, Google, and the websites of national health departments. Searches and analyses took place from May 2021 to July 2021. RESULTS: Sixty-two documents met the inclusion criteria (35=grey literature; 56% and 27=peer reviewed; 44%). This review found that the vaccine distribution approach started at hospitals in almost all jurisdictions. In some jurisdictions, PCPs were engaged at the beginning, and the majority included PCPs over time. In many jurisdictions, equity was considered in the prioritisation policies for various marginalised communities. However, vaccine hesitancy was not explicitly considered in the design of vaccine distribution approaches. The barriers to the roll-out of vaccines included personal, organisational and contextual factors. The vaccine roll-out strategy was facilitated by establishing policies and processes for pandemic preparedness, well-established and coordinated information systems, primary care interventions, adequate supply of providers, education and training of providers, and effective communications strategy. CONCLUSIONS: Empirical evidence is lacking on the impact of a primary care-led vaccine distribution approach on vaccine hesitancy, adoption and equity. Future vaccine distribution approaches need to be informed by further research evaluating vaccine distribution approaches and their impact on patient and population outcomes.

Reintubation in COVID-19 patients: a multicenter observational study in Japan (J-RECOVER study)

Background Reintubation is not an uncommon occurrence following extubation and discontinuation of mechanical ventilation. In COVID-19 patients, the proportion of reintubation may be higher than that of non-COVID-19 patients. Furthermore, COVID-19 patients may have a higher risk for developing laryngotracheal stenosis, along with a higher proportion of reintubation than in non-COVID-19 patients. Our understanding of the proportion of reintubation in COVID-19 patients is limited in Japan. Additionally, the reasons for reintubation have not been adequately examined in previous studies outside of Japan. Thus, the present study aimed to describe the proportion and causes of reintubation among COVID-19 patients in Japan. Methods This was a multicenter observational study that included 64 participating centers across Japan. This study included mechanically ventilated COVID-19 patients who were discharged between April 1, 2020 and September 30, 2020. The outcomes examined were the proportion and causes of reintubation. Results A total of 373 patients were eligible for inclusion in the current analysis. The median age of patients was 64 years and 80.4% were male. Reintubation was required for 35 patients (9.4%) and the most common causes for reintubation were respiratory failure (71.4%;n = 25) and laryngotracheal stenosis (8.6%;n = 3). Conclusions The proportion of reintubation among COVID-19 patients in Japan was relatively low. Respiratory failure was the most common cause for reintubation. Reintubation due to laryngotracheal stenosis accounted for only a small fraction of all reintubated COVID-19 patients in Japan.

Impact of SARS-CoV-2 variants on the total CD4+ and CD8+ T cell reactivity in infected or vaccinated individuals.

The emergence of SARS-CoV-2 variants with evidence of antibody escape highlight the importance of addressing whether the total CD4+ and CD8+ T cell recognition is also affected. Here, we compare SARS-CoV-2-specific CD4+ and CD8+ T cells against the B.1.1.7, B.1.351, P.1, and CAL.20C lineages in COVID-19 convalescents and in recipients of the Moderna (mRNA-1273) or Pfizer/BioNTech (BNT162b2) COVID-19 vaccines. The total reactivity against SARS-CoV-2 variants is similar in terms of magnitude and frequency of response, with decreases in the 10%-22% range observed in some assay/VOC combinations. A total of 7% and 3% of previously identified CD4+ and CD8+ T cell epitopes, respectively, are affected by mutations in the various VOCs. Thus, the SARS-CoV-2 variants analyzed here do not significantly disrupt the total SARS-CoV-2 T cell reactivity; however, the decreases observed highlight the importance for active monitoring of T cell reactivity in the context of SARS-CoV-2 evolution.

Postpartum Glucose Tolerance Testing Among Patients With Gestational Diabetes During the Coronavirus Disease 2019 Pandemic.

Introduction The impact of the coronavirus disease (COVID-19) COVID-19 pandemic on the care of pregnant patients with gestational diabetes (GDM) is largely unreported. The objective of this study was to compare the completion of postpartum oral glucose tolerance testing (GTT) prior to and during the COVID-19 pandemic among patients with GDM. Methods This was a retrospective review of patients diagnosed with GDM between April 2019 and March 2021. Medical records of patients diagnosed with GDM prior to and during the pandemic were compared. The primary outcome was the difference in the completion of postpartum GTT prior to and during the COVID-19 pandemic. Completion was defined as testing between four weeks to six months postpartum. Secondary objectives were: 1) to compare maternal and neonatal outcomes prior to and during the pandemic among patients with GDM, and 2) to compare pregnancy characteristics and outcomes by compliance with postpartum GTT. Results There were 185 patients included in the study, of whom 83 (44.9%) delivered prior to the pandemic and 102 (55.1%) delivered during the pandemic. There was no difference in completion of postpartum diabetes testing prior, compared to during the pandemic (27.7% vs 33.3%, p=0.47). Postpartum diagnosis of pre-diabetes and type two diabetes mellitus (T2DM) did not differ between groups (p=0.36 and p=1.00, respectively). Patients who completed postpartum testing were less likely to have preeclampsia with severe features compared to patients who did not (OR 0.08, 95% CI 0.01-0.96, p=0.02). Conclusion Completion of postpartum testing for T2DM remained poor prior to and during the COVID-19 pandemic. These findings underscore the need for the adoption of more accessible methods of postpartum testing for T2DM among patients with GDM.

The Ethics of Implementing Emergency Resource Allocation Protocols.

AbstractWe explore the various ethical challenges that arise during the practical implementation of an emergency resource allocation protocol. We argue that to implement an allocation plan in a crisis, a hospital system must complete five tasks: (1) formulate a set of general principles for allocation, (2) apply those principles to the disease at hand to create a concrete protocol, (3) collect the data required to apply the protocol, (4) construct a system to implement triage decisions with those data, and (5) create a system for managing the consequences of implementing the protocol, including the effects on those who must carry out the plan, the medical staff, and the general public. Here we illustrate the complexities of each task and provide tentative solutions, by describing the experiences of the Coronavirus Ethics Response Group, an interdisciplinary team formed to address the ethical issues in pandemic resource planning at the University of Rochester Medical Center. While the plan was never put into operation, the process of preparing for emergency implementation exposed ethical issues that require attention.

Breath-by-breath P0.1 measured on quasi-occlusion via Hamilton C6 may result in underestimation of respiratory drive and inspiratory effort.

We aimed to identify the threshold for P0.1 in a breath-by-breath manner measured by the Hamilton C6 on quasi-occlusion for high respiratory drive and inspiratory effort. In this prospective observational study, we analyzed the relationships between airway P0.1 on quasi-occlusion and esophageal pressure (esophageal P0.1 and esophageal pressure swing). We also conducted a linear regression analysis and derived the threshold of airway P0.1 on quasi-occlusion for high respiratory drive and inspiratory effort. We found that airway P0.1 measured on quasi-occlusion had a strong positive correlation with esophageal P0.1 measured on quasi-occlusion and esophageal pressure swing, respectively. Additionally, the P0.1 threshold for high respiratory drive and inspiratory effort were calculated at approximately 1.0 cmH2O from the regression equations. Our calculations suggest a lower threshold of airway P0.1 measured by the Hamilton C6 on quasi-occlusion than that which has been previously reported.

Reintubation in COVID-19 patients: a multicenter observational study in Japan (J-RECOVER study).

BACKGROUND: Reintubation is not an uncommon occurrence following extubation and discontinuation of mechanical ventilation. In COVID-19 patients, the proportion of reintubation may be higher than that of non-COVID-19 patients. Furthermore, COVID-19 patients may have a higher risk for developing laryngotracheal stenosis, along with a higher proportion of reintubation than in non-COVID-19 patients. Our understanding of the proportion of reintubation in COVID-19 patients is limited in Japan. Additionally, the reasons for reintubation have not been adequately examined in previous studies outside of Japan. Thus, the present study aimed to describe the proportion and causes of reintubation among COVID-19 patients in Japan. METHODS: This was a multicenter observational study that included 64 participating centers across Japan. This study included mechanically ventilated COVID-19 patients who were discharged between April 1, 2020 and September 30, 2020. The outcomes examined were the proportion and causes of reintubation. RESULTS: A total of 373 patients were eligible for inclusion in the current analysis. The median age of patients was 64 years and 80.4% were male. Reintubation was required for 35 patients (9.4%) and the most common causes for reintubation were respiratory failure (71.4%; n = 25) and laryngotracheal stenosis (8.6%; n = 3). CONCLUSIONS: The proportion of reintubation among COVID-19 patients in Japan was relatively low. Respiratory failure was the most common cause for reintubation. Reintubation due to laryngotracheal stenosis accounted for only a small fraction of all reintubated COVID-19 patients in Japan.

Characteristics and Health Care Use of Patients Attending Virtual Walk-in Clinics in Ontario, Canada: Cross-sectional Analysis.

BACKGROUND: Funding changes in response to the COVID-19 pandemic supported the growth of direct-to-consumer virtual walk-in clinics in several countries. Little is known about patients who attend virtual walk-in clinics or how these clinics contribute to care continuity and subsequent health care use. OBJECTIVE: The objective of the present study was to describe the characteristics and measure the health care use of patients who attended virtual walk-in clinics compared to the general population and a subset that received any virtual family physician visit. METHODS: This was a retrospective, cross-sectional study in Ontario, Canada. Patients who had received a family physician visit at 1 of 13 selected virtual walk-in clinics from April 1 to December 31, 2020, were compared to Ontario residents who had any virtual family physician visit. The main outcome was postvisit health care use. RESULTS: Virtual walk-in patients (n=132,168) had fewer comorbidities and lower previous health care use than Ontarians with any virtual family physician visit. Virtual walk-in patients were also less likely to have a subsequent in-person visit with the same physician (309/132,168, 0.2% vs 704,759/6,412,304, 11%; standardized mean difference [SMD] 0.48), more likely to have a subsequent virtual visit (40,030/132,168, 30.3% vs 1,403,778/6,412,304, 21.9%; SMD 0.19), and twice as likely to have an emergency department visit within 30 days (11,003/132,168, 8.3% vs 262,509/6,412,304, 4.1%; SMD 0.18), an effect that persisted after adjustment and across urban/rural resident groups. CONCLUSIONS: Compared to Ontarians attending any family physician virtual visit, virtual walk-in patients were less likely to have a subsequent in-person physician visit and were more likely to visit the emergency department. These findings will inform policy makers aiming to ensure the integration of virtual visits with longitudinal primary care.

Assessing the Fit of N95 Filtering Facepiece Respirators Fitted with an Ear Loop Strap System: A Pilot Study.

Throughout the COVID-19 pandemic, hundreds of millions of people worldwide have become new users of respiratory protective devices. Facemasks and KN95 respirators utilizing an ear loop straps system (ELSS) have recently become popular among occupational and non-occupational populations. Part of this popularity is due to the ease of wearability as compared with traditional devices utilizing two headbands, one worn over the head and the other behind the neck-a universal strap system used in NIOSH-certified N95 filtering facepiece respirators (FFRs). Some users convert the two-strap configuration to an adjustable ELSS. The first objective of this pilot study was to quantitatively characterize how such a conversion impacts the respirator fit. Additionally, a novel faceseal (NFS) technology, which has been previously demonstrated to enhance the fit of N95 FFRs, was deployed to modify the ELSS-converted N95 FFRs. The second objective of this study was to quantify the fit improvement that results from adding the NFS to the ELSS. The study was conducted by performing the Occupational Safety and Health Administration (OSHA)-approved quantitative fit testing (QNFT) on 16 human subjects featuring different facial shapes and dimensions. Three models of cup-shaped N95 FFRs were tested in three versions: the standard version with manufacturer's strap system, the ELSS-converted, and the ELSS-converted version modified by adding the NFS. QNFT demonstrated that the fit of an N95 FFR featuring the traditional/standard headbands strap system is negatively impacted when this system is converted to an ELSS. The fit of an ELSS-converted respirator can be significantly improved by the addition of the NFS. We found that the FFR model and the strap system version are significant factors affecting the QNFT-determined respirator fit factor (FF), as well as the OSHA QNFT pass rate (FF ≥100). The findings suggest that the current NFS, if further improved, has a potential for developing a 'universally fitting' ELSS-equipped N95 FFR that can be used by the general public, the vast majority of whom do not have access to OSHA fit requirements.

Establishing Genomic SARS-CoV-2 Surveillance at the National Level: Germany, 2021

Background. The COVID-19 pandemic has demonstrated the importance of pathogen genomic surveillance. At RKI, the German National Institute of Public Health, we established the Integrated Molecular Surveillance for SARS-CoV-2 (IMS-SC2) network to perform SARS-CoV-2 genomic surveillance. Methods. SARS-CoV-2 positive samples from laboratories distributed across Germany regularly undergo whole-genome sequencing at RKI. This surveillance instrument enables (i) almost-real-time monitoring of SARS-CoV-2 genomic diversity and evolution, (ii) in vitro assessment of vaccine coverage against emerging variants and (iii) genome-based estimates of SARS-CoV-2-incidences. Results. We report the results of our analyses of 3623 SARS-CoV-2 genomes collected between 12/1/2020 and 12/31/2021. All variants of concern were identified, at ratios equivalent to those in the 100-fold larger German GISAID sequence dataset from the same time period. Lineage distributions fluctuated over time, covering the rise of the Alpha and Delta, as well as the emergence of Omicron. Phylogenetic analysis confirmed variant assignments. Multiple mutations of concern emerged during the observation period. To model vaccine effectiveness in vitro, we employed authentic-virus neutralization assays, confirming that both the Beta and Zeta variants are capable of immune evasion. The IMS-SC2 sequence dataset facilitated an estimate of the SARS-CoV-2 incidence based on genetic evolution rates. Together with modelled vaccine efficacies, Delta-specific incidence estimation indicated that the German vaccination campaign contributed substantially to a deceleration of the nascent German Delta wave. Conclusion. This example illustrates that pathogen genomics enables a proactive approach to controlling a pandemic as the virus evolves. Molecular and genomic SARS-CoV-2 surveillance will be crucial during the post-pandemic future, informing public health policies including vaccination strategies. Of note, the IMS-SC2 infrastructure can be adapted to many other pathogens, serving as a blueprint for future efforts to increase genomic pathogen surveillance.