Developing a SARS-CoV-2 Vaccine at Warp Speed O’Callaghan, Kevin P; Blatz, Allison M; Offit, Paul A
JAMA : the journal of the American Medical Association,
08/2020, Volume:
324, Issue:
5
Journal Article
Peer reviewed
Open access
The development of a vaccine against the SARS-CoV-2 virus, which causes COVID-19, in the United States is discussed. The efforts have opened new pathways of vaccine development that will persist long ...after the pandemic.
The World Health Organization has named vaccine hesitancy as one of the top ten threats to global health in 2019. The reasons why people choose not to vaccinate are complex, but lack of confidence in ...vaccine safety, driven by concerns about adverse events, has been identified as one of the key factors. Healthcare workers, especially those in primary care, remain key influencers on vaccine decisions. It is important, therefore, that they be supported by having easy access to trusted, evidence-based information on vaccines. Although parents and patients have a number of concerns about vaccine safety, among the most common are fears that adjuvants like aluminum, preservatives like mercury, inactivating agents like formaldehyde, manufacturing residuals like human or animal DNA fragments, and simply the sheer number of vaccines might be overwhelming, weakening or perturbing the immune system. As a consequence, some fear that vaccines are causing autism, diabetes, developmental delays, hyperactivity, and attention-deficit disorders, amongst others. In this review we will address several of these topics and highlight the robust body of scientific evidence that refutes common concerns about vaccine safety.
To describe syphilis treatment status and prenatal care among people with syphilis during pregnancy to identify missed opportunities for preventing congenital syphilis.
Six jurisdictions that ...participated in SET-NET (Surveillance for Emerging Threats to Pregnant People and Infants Network) conducted enhanced surveillance among people with syphilis during pregnancy based on case investigations, medical records, and linkage of laboratory data with vital records. Unadjusted risk ratios (RRs) were used to compare demographic and clinical characteristics by syphilis stage (primary, secondary, or early latent vs late latent or unknown) and treatment status during pregnancy (adequate per the Centers for Disease Control and Prevention's "Sexually Transmitted Infections Treatment Guidelines, 2021" vs inadequate or not treated) and by prenatal care (timely: at least 30 days before pregnancy outcome; nontimely: less than 30 days before pregnancy outcome; and no prenatal care).
As of September 15, 2023, of 1,476 people with syphilis during pregnancy, 855 (57.9%) were adequately treated and 621 (42.1%) were inadequately treated or not treated. Eighty-two percent of the cohort received timely prenatal care. Although those with nontimely or no prenatal care were more likely to receive inadequate or no treatment (RR 2.50, 95% CI, 2.17-2.88 and RR 2.73, 95% CI, 2.47-3.02, respectively), 32.1% of those with timely prenatal care were inadequately or not treated. Those with reported substance use or a history of homelessness were nearly twice as likely to receive inadequate or no treatment (RR 2.04, 95% CI, 1.82-2.28 and RR 1.83, 95% CI, 1.58-2.13, respectively).
In this surveillance cohort, people without timely prenatal care had the highest risk for syphilis treatment inadequacy; however, almost a third of people who received timely prenatal care were not adequately treated. These findings underscore gaps in syphilis screening and treatment for pregnant people, especially those experiencing substance use and homelessness, and the need for systems-based interventions, such as treatment outside of traditional prenatal care settings.
Congenital syphilis (CS) rates have risen in the United States since 2013. Prevention of CS requires testing and treatment of pregnant and pregnancy-capable persons at high risk for syphilis. We ...developed a CS Prevention Cascade to assess how effectively testing and treatment interventions reached pregnant persons with a CS outcome.
is a globally important zoonotic pathogen largely found in cattle hosts and is typically transmitted to humans through contaminated dairy products or contact with diseased animals. Despite the long, ...shared history of cattle and humans, little is known about how trade in cattle has spread this pathogen throughout the world. Whole genome sequencing provides unparalleled resolution to investigate the global evolutionary history of a bacterium such as
by providing phylogenetic resolution that has been unobtainable using other methods. We report on large-scale genome sequencing and analysis of
collected globally from cattle and 16 other hosts from 52 countries. We used single nucleotide polymorphisms (SNPs) to identify genetic variation in 1,074
genomes and using maximum parsimony generated a phylogeny that identified four major clades. Two of these clades, clade A (median date 972 CE; 95% HPD, 781-1142 CE) and clade B (median date 150 BCE; 95% HPD, 515 BCE-164 CE), were exceptionally diverse for this species and are exclusively of African origin where provenance is known. The third clade, clade C (median date 949 CE; 95% HPD, 766-1102 CE), had most isolates coming from a broad swath of the Middle East, Europe, and Asia, also had relatively high diversity. Finally, the fourth major clade, clade D (median date 1467 CE; 95% HPD, 1367-1553 CE) comprises the large majority of genomes in a dominant but relatively monomorphic group that predominantly infects cattle in Europe and the Americas. These data are consistent with an African origin for
and a subsequent spread to the Middle East, Europe, and Asia, probably through the movement of infected cattle. We hypothesize that European arrival to the Americas starting in the 15th century introduced
from Western Europe through the introduction of a few common cattle breeds infected with strains from clade D. These data provide the foundation of a comprehensive global phylogeny of this important zoonotic pathogen that should be an important resource in human and veterinary epidemiology.
Despite universal prenatal syphilis screening recommendations and availability of effective antibiotic treatment, syphilis prevalence during pregnancy and the incidence of congenital syphilis have ...continued to increase in the United States (1,2). Concurrent increases in methamphetamine, injection drug, and heroin use have been described in women with syphilis (3). CDC used data on births that occurred during January 1, 2018-December 31, 2021, from two states (Arizona and Georgia) that participate in the Surveillance for Emerging Threats to Pregnant People and Infants Network (SET-NET) to describe the prevalence of substance use among pregnant persons with syphilis by congenital syphilis pregnancy outcome (defined as delivery of a stillborn or live-born infant meeting the surveillance case definition for probable or confirmed congenital syphilis). The prevalence of substance use (e.g., tobacco, alcohol, cannabis, illicit use of opioids, and other illicit, nonprescription substances) in persons with a congenital syphilis pregnancy outcome (48.1%) was nearly double that among those with a noncongenital syphilis pregnancy outcome (24.6%). Persons with a congenital syphilis pregnancy outcome were six times as likely to report illicit use of opioids and four times as likely to report using other illicit, nonprescription substances during pregnancy than were persons with a noncongenital syphilis pregnancy outcome. Approximately one half of persons who used substances during pregnancy and had a congenital syphilis pregnancy outcome had late or no prenatal care. Tailored interventions should address barriers and facilitators to accessing screening and treatment for syphilis among persons who use substances. The need for syphilis screening and treatment should be addressed at any health care encounter during pregnancy, especially among persons who use substances.
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DOBA, IZUM, KILJ, NUK, ODKLJ, OILJ, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK, VSZLJ
INTRODUCTION: Neonatal herpes simplex virus (nHSV) infection is rare but can cause serious morbidity and mortality. This study assessed the incidence, mortality, and costs of nHSV infections in the ...United States in 2019. METHODS: Inpatient records of neonates aged 28 days or less at admission were examined using the 2019 Healthcare Cost and Utilization Project Kids' Inpatient Database, a nationally representative sample of U.S. pediatric discharges. Neonatal herpes simplex virus cases were defined as those with ICD-10-CM codes for herpes simplex virus (B00.xx, A60.xx, or P35.2), and hospital stays greater than 5 days or resulting in death. Cases involving readmission or transfer from another hospital were excluded. Incidence, mortality, and costs were estimated by sociodemographic factors including race, U.S. region, primary payer, and median household income. RESULTS: In 2019, there were an estimated 561 nHSV cases in the United States (15.7 per 100,000 births), with a 4.6% mortality rate. Incidence rates were highest in neonates of Black race (27.3), in the South (21.3), with public insurance coverage (25.2), and born into a household with a median income less than $48,000 (24.5). The incidence rate of nHSV in preterm (41.8) was three times that of term neonates (13.0). The median hospital stay was 15 days with a median cost of $109,562. CONCLUSION: We found disparities in nHSV incidence, with infants in the South and born to Black birthing parents disproportionately affected. Higher incidence rates were also found in infants with public insurance coverage and lower household income. Prevention efforts and early detection are crucial to mitigate these disparities.
Abstract
Background
Congenital syphilis (CS) rates have increased in the United States since 2013. Management of infants exposed to syphilis during pregnancy entails a detailed clinical evaluation, ...followed by stratified work-up and treatment.
Methods
During 2016─2021, 9,827 surveillance cases of CS were notified to the National Notifiable Diseases Surveillance System. Using the clinical framework described in the 2015 CDC Sexually Transmitted Diseases Treatment Guidelines, we assigned a clinical scenario (Proven or Highly Probable CS, Possible CS, CS Less Likely, and CS Unlikely) to 8,280 liveborn cases which had sufficient data for case classification (Figure 1). Based on data documented in the case report, we described the elements of evaluation and therapy provided to neonates, assessing whether they met, were in excess of, or were less extensive than recommendations, and stratified these findings by race, ethnicity, and geography.
Results
Of the 8,280 surveillance cases which were assigned a clinical scenario, the majority (80.9%) were classified as Possible CS, of whom 60.7% received an appropriate evaluation, while 68.4% received appropriate treatment. Of those assigned to Proven or Highly Probable CS, 46.0% received an appropriate evaluation, while 82.3% received appropriate treatment.
By U.S. census region, infants born in the Northeast were most likely to receive evaluation (75.7%) and treatment (87.3%) at or above recommendations for their case scenario, while infants born in the South were least likely to receive at or above recommended evaluation (49.5%) and treatment (59.3%). Infants born to a birth parent reporting non-Hispanic Native Hawaiian/Pacific Islander race were most likely to report less than recommended evaluation (36.7%), while infants of a non-Hispanic Black birth parent were most likely to experience less than recommended treatment (32.2%).
Conclusion
This analysis of CS clinical scenarios underscores disparities in evaluation and therapy across geographic, racial, and ethnic lines. Further research is needed to understand factors involved in the evaluation and treatment of infants affected by CS, particularly for those born in the South and to birthing parents reporting minority racial and ethnic backgrounds.
Disclosures
All Authors: No reported disclosures
Abstract
Background
Global spread of SARS-CoV-2 led to an urgent need for data on national and regional prevalence to inform public health policy. Healthcare systems were also in need of data to ...develop best practices around defining patient risk. We describe a data analytics tool developed at our institution which uses public data sources to track county-level prevalence of COVID-19 so as to delineate risk for individual patients.
Methods
We investigated a number of data sources tracking COVID-19 case counts, assessing for (1) frequency of updates, (2) granularity of geographic detail (optimally to zip-code or county) and (3) completeness of the data. We chose the Johns Hopkins University CSSE COVID-19 data set. This contains counts of new diagnoses per day by county using Federal Information Processing System (FIPS) codes. The dataset is updated daily with adjustments made for backdated corrections.
We developed a data analytics tool which allowed for direct comparison of county period prevalence. We developed a metric of 10-day rolling period prevalence calculated as a total case count from the preceding 10 days, divided by county population from 2018 American Community Survey (ACS) estimates.
Results
Benchmarking against local (peak of 3.12 cases per 1,000 persons) and regional prevalence, we set 6 cases/1,000 persons as the threshold for a Geographic Region with Widespread Community Transmission (GReWCoT). Counties have to reach this threshold for at least 4 out of 7 days within the period 3 to 10 days prior to the evaluation, to adjust for bulking of test results and delayed reporting.
We used the analytics tool to support a semimonthly review of geographic regions, and made specific recommendations for patients from qualifying regions including use of modified enhanced precautions (including surgical mask and eye protection), as well as restricted visitation of caregivers.
Figure 1. Epidemic curves for 10-day rolling period prevalence of COVID-19 in the Mid-Atlantic Region: Philadelphia County, PA
Figure 2. Epidemic curves for 10-day rolling period prevalence of COVID-19 in the Mid-Atlantic Region: Westchester County, NY
Figure 3. Epidemic curves for 10-day rolling period prevalence of COVID-19 in the Mid-Atlantic Region: Bergen County, NJ
Conclusion
This approach allowed for a nuanced investigation of COVID-19 prevalence in real-time, and provided support for risk stratification of patients throughout our large catchment area. The dashboard was shared on an inward-facing site to support staff messaging about regions of increased risk. Next steps include leveraging international data to inform a similar approach to international travel for our patients and staff.
Disclosures
All Authors: No reported disclosures
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