REACTOGENICITY AMONG PEOPLE LIVING WITH HIV AFTER mRNA-1273 VACCINE IN UBUNTU STUDY

Background: The tolerability of mRNA COVID-19 vaccines among people living with HIV (PLWH) has been understudied in vaccine trials. CoVPN 3008 (Ubuntu) is the largest multicenter Phase 3 efficacy trial of mRNA vaccines in sub-Saharan Africa. Method(s): We enrolled adults age >=18 years living with HIV or another comorbidity associated with severe COVID-19. Previously vaccinated individuals were excluded. Baseline testing included HIV, CD4 count and HIV viral load (VL) (if HIV+), anti-SARS-CoV-2 antibodies, and nasal swab SARS-CoV-2 nucleic acid amplification test (NAAT). All participants receive vaccinations at months 0 and 6, and SARS-CoV-2 seronegative individuals also receive vaccination at month 1. This analysis includes mRNA-1273 vaccinations at months 0 and 1. Reactogenicity (solicited adverse events [AEs]) was assessed among a representative subset of participants (Safety Subset, SS) for 7 days post-vaccination. Baseline characteristics associated with moderate/severe reactogenicity events were assessed by univariate and multivariate logistic regression. Result(s): 14002 participants were enrolled in the trial (1510 into the SS) at 46 sites from 2 Dec 2021 to 9 Sep 2022. At baseline in the SS, 71% (1065) were female, median age 38 years (IQR 32-46), and median BMI 25.0 (IQR 20.7-30.2). 73% (1108) were SARS-CoV-2 seropositive, and 8.7% (131) had a positive nasal NAAT swab. 16% (197) had a history of tuberculosis. 84% (1267) were PLWH, with median CD4 count of 614 cells/muL (IQR 414-861);7.8% had CD4 count < 200. 21% (238) had detectable HIV VL (>=50 copies/mL), with median VL 1660 (IQR 182-23932). 14% (172/1262) and 12% (64/542) of PLWH reported moderate/severe reactogenicity after the 1st and 2nd vaccination (Figure), with no hospitalizations. Female PLWH and CD4 count >500 had 35% (p=0.03) and 44% (p=0.04) increased odds of moderate/severe reactogenicity, respectively. Other baseline characteristics were not associated with the odds of reporting moderate/severe reactogenicity among PLWH after 1st vaccination. Similar trends were seen after the 2nd vaccination, but none reached statistical significance. In multivariate models, female sex remained associated with increased odds of moderate/severe reactogenicity after the 2nd vaccination. Conclusion(s): Similar to observations in HIV-negative populations, mRNA-1273 was well tolerated by PLWH with more reactogenicity in females. Impaired inflammatory responses among participants with CD4 counts < 500 cell/muL may explain less moderate/severe reactions.

The Taxability of Third-Party Food Delivery Services: Certified Public Accountant

[...]party food delivery companies-such as Uber Eats, Grub Hub, and DoorDash-have allowed restaurants to deliver prepared meals to their customers. A marketplace facilitator is a company or person who facilitates the sale of tangible personal property by a marketplace seller by providing a forum where the sale takes place and collects the receipts from customers for the tangible personal property. [...]New York offered guidance that a marketplace provider is not required to collect sales tax on transactions that are not considered the sale of tangible personal property, such as sales of restaurant food [New York Technical Memorandum TSB-M-19(2.1)S, 10/17/2019]. Under California law, when an online ordering service provider acts as an agent of the restaurant, the restaurant is considered the retailer of the meals sold through the online ordering service and is liable for the tax, measured by the full selling price of those sales, without any deduction of the commission retained by the service provider.

SAFETY and EFFECTIVENESS of the Ad26.COV2.S VACCINE in SOUTH AFRICA

Background: The Sisonke Phase IIIB open-label implementation study vaccinated health care workers (HCWs) with the single dose Ad26.COV2.S vaccine during two phases of the South African Covid-19 epidemic, dominated first by the Beta followed by the Delta variant of concern. Methods: HCWs were vaccinated over 3 months (17 February-17 May 2021). Safety was monitored by self-reporting, facility reporting and linkage to national databases. Vaccine effectiveness (VE) against Covid-19 related hospitalisation, hospitalisation requiring critical or intensive care and death, ascertained 28 days or more post vaccination was assessed up until 17 July 2021. Nested sub-cohorts (A and B) from two national medical schemes were evaluated to assess VE using a matched retrospective cohort design. Results: Over the 3-month period, 477234 HCWs were vaccinated in 122 vaccination sites across South Africa. VE derived from the sub-cohorts comprising 215 813 HCWs was 83% (95% CI 75-89) to prevent Covid-19 deaths, 75% (95% CI 69-82) to prevent hospital admissions requiring critical or intensive care and 67% (95% CI 62-71) to prevent Covid-19 related hospitalisations. The VE was maintained in older HCWs and those with comorbidities including HIV infection. VE remained consistent throughout the Beta and Delta dominant phases of the study. 10279 adverse events were reported and 139 (1.4%) were serious, including two cases of thrombosis with thrombocytopenia syndrome and four cases of Guillain-Barré syndrome who recovered. Conclusion: The single dose Ad26.COV2.S was safe and effective against severe Covid-19 disease and death post-vaccination, and against both Beta and Delta variants providing real-world evidence for its use globally.

SYMPTOM DURATION in COVID-19 CONVALESCENT PATIENTS: REGIONAL & CLINICAL ASSOCIATIONS

Background: Post-Acute Sequelae of SARS-CoV-2 (PASC) is characterized by persistent symptoms negatively impacting quality of life several weeks after SARS-CoV-2 diagnosis. Proposed risk factors include older age, female sex, comorbidities, and severe COVID-19, including hospitalization and oxygen requirement. Yet, associations of these factors with prolonged symptoms remain poorly understood globally. Methods: The global, observational cohort study HVTN 405/HPTN 1901 characterizes the clinical and immunologic course in the first year after SARS-CoV-2 infection among adults. The cohort was categorized by infection severity (asymptomatic;symptomatic with no oxygen requirement [NOR];non-invasive oxygen requirement [NIOR];or invasive oxygen requirement [IOR]). A regression model was applied to estimate geometric mean ratios (GMR) for duration and odds ratios (OR) for persistence of symptoms. Results: 759 participants from Peru (25.2%), USA (26.0%), Republic of South Africa (RSA, 37.7%), and non-RSA Sub-Saharan Africa (11.2%) were enrolled a median of 51 (IQR 35-66) days post-diagnosis, from May 2020 to Mar 2021. 53.8% were female, 69.8% were <55yo (median 44yo, IQR 33-58) and identified as non-Hispanic Black (42.7%), Hispanic (27.9%) or non-Hispanic White (15.8%). Comorbidities included obesity (42.8%), hypertension (24%), diabetes (14%), HIV infection (11.6%) and lung disease (7.5%). 76.2% were symptomatic (NOR 47.4%;NIOR 22.9%;and IOR 5.8%). Among symptomatic participants, median acute COVID-19 duration was 20 days (IQR 11-35);43.3% had ≥1 persistent symptom after COVID-19 resolution (39.8% NOR;49.1 % NIOR+IOR;p=0.037);16.8% reported ≥1 symptom >42 days (14.0% NOR;21.6% NIOR+IOR;p=0.025). Symptom duration was not associated with age or sex assigned at birth but was associated with disease severity (GMR 2.09;95%CI 1.5-2.91, p<0.001 for NIOR vs NOR;not significant for IOR vs NIOR), lung disease (GMR 2.43;95%CI 1.42-4.16, p=0.001), and global region (p<0.05, see Figure 1). Prolonged viral shedding was associated with persistent diarrhea (OR 6.59;95%CI 1.65-26.86;p=0.008). Conclusion: A recovery course consistent with PASC was significantly associated with infection severity, lung disease, and region. Regional differences in symptom profiles and duration may be influenced by viral diversity, genetic, or cultural factors and likely reflect disparities in healthcare access and interventions. Better understanding PASC associations may improve clinical assessment and management globally.

Asymptomatic Infection and Duration of Viral Shedding in Symptomatic Breakthrough Infections in a Phase 3 Study of AZD1222 (ChAdOx1 nCoV-19)

Background. SARS-CoV-2 vaccine efficacy (VE) against asymptomatic infection and impact on viral shedding during breakthrough infections have critical implications for pandemic control. AZD1222 (ChAdOx1 nCoV-19;2 doses, 4 weeks apart) demonstrated VE of 74.0% (95% CI 65.3, 80.5) against the primary endpoint of symptomatic RT-PCR-confirmed COVID-19 and safety in a Phase 3, 2:1 randomized, placebo-controlled study in the US, Chile and Peru (n=32,451). Here we present exploratory analyses on asymptomatic infections determined by nucleocapsid (N) seroconversion and time to viral clearance in participants with symptomatic infections determined by N seroconversion (primary data cut, March 5, 2021). Methods. N seroconversion was assessed at all scheduled and illness visits in the fully vaccinated analysis set (Table). In this analysis, symptomatic infections are defined as N seroconversion ≥ 15 days post second dose in participants who attended an illness visit with ≥ 1 qualifying COVID-19 symptom and had ≥ 1 positive RT-PCR result for SARS-CoV-2. Asymptomatic infections are defined as N seroconversion ≥ 15 days post second dose in participants who did not meet the criteria for symptomatic infections. In participants with symptomatic infections, viral shedding in saliva was assessed for 28 days and cumulative incidence of viral clearance was determined. Table. AZD1222 VE against symptomatic and potentially asymptomatic SARS-CoV-2 infections as determined by N seroconversion Results. Overall, 358 participants had SARS-CoV-2 infections as determined by N seroconversion (Table). Incidences per 1000 person-years of symptomatic infections were 25.62 for AZD1222 vs 103.42 for placebo (VE 75.23%;95% CI 65.33, 82.31) and of asymptomatic infections were 51.24 vs 111.95 (VE 54.24%;95% CI 39.99, 65.10) (Table). Sensitivity analyses for N seroconversion using the primary endpoint and CDC criteria for defining symptomatic/asymptomatic status were supportive. Median time to viral clearance in saliva in participants with symptomatic infections was 11 days (AZD1222, n=52) vs 16 days (placebo, n=92) (Figure). Conclusion. AZD1222 resulted in lower yet meaningful VE against asymptomatic compared to symptomatic infections, as determined by N seroconversion, and shortened viral shedding in symptomatic SARS-CoV-2 breakthrough infections vs placebo, highlighting its potential contribution to reducing viral transmission.

Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial

[Figure: see text].

Social psychology and COVID-19: What the field can tell us about behavior in a pandemic.

The COVID-19 pandemic has wreaked havoc in the lives of people around the world. Pandemics are powerful situations that can be examined from a social psychological lens. In this special section, four articles present data collected before and during the pandemic, providing a type of quasi-experimental design that helped examine the impact of the pandemic on social behavior. A number of findings emerged: the pandemic potentially increased instances of cyberbullying; the pandemic may have increased reports that Black-White intergroup interactions are more competitive and discriminatory; the pandemic may have reduced negative attitudes and bias in domestic versus international students in the U.S; and the pandemic may have allowed feelings of helplessness to provide a fear-reducing mechanism. We expand upon these findings by discussing how social psychology can help us understand and modify behaviors related to health and social relations during major threats like a pandemic.

SARS-CoV-2 neutralizing-antibody responses in convalescent individuals in US and Peru

Background: SARS-CoV-2 has claimed over a million lives and remains a global threat. Understanding immune responses to infection and developing validated laboratory assays to measure them is critical to the rapid development, assessment and implementation of effective interventions. Our development of a validated pseudovirus neutralization assay and characterization of neutralizing antibody (nAb) profiles in a diverse post-SARS-CoV-2 cohort can inform preventative and therapeutic efforts, including vaccine and monoclonal antibody development and deployment. Methods:This analysis comprises an observational cohort of n=330 adults in the US (n=168) and Peru (n=162), convalescing from SARS-CoV-2 infection and stratified by age, asymptomatic or symptomatic infection, and hospitalization. NAb titers are measured in serum by SARS-CoV-2.D614G Spike-pseudotyped virus infection of 293T/ACE2 cells. Multiple linear regression is applied to define associations between nAb titers and demographic variables, disease severity and duration, and co-morbidities within and across US and Peruvian cohorts over time. Results: The mean age is 48 years;49% were assigned female sex at birth, 51% male;54% are Latinx;50% identified as Other race, 34% White, 11% Black, 4%Asian. The mean days from SARS-CoV-2 diagnosis to enrollment was 52. NAb titers were higher in participants with a history of severe illness (p<0.001) and peaked 28-42 days post-diagnosis. ID50 (ID80) nAb titers >20 were detected at enrollment in 66% (46%) of asymptomatic, 86% (74%) of symptomatic and 95% (92%) of hospitalized individuals. Median ID50 (ID80) titers at enrollment among asymptomatic, symptomatic and hospitalized individuals were 107 (10), 482 (59) and 1,953 (366), respectively. Two months post-enrollment, median ID50 (ID80) titers among asymptomatic, symptomatic and hospitalized individuals declined to 30 (10), 130 (16) and 564 (103), respectively. Diabetes (p=0.011), age >55yo (p<0.001), male sex (p=0.003) and BMI ≥30 (p=0.021) were associated with higher ID80 titers. Hypertension was associated with lower ID50 titers (p=0.005). Conclusion: NAb titers after SARS-CoV-2 infection correlate with illness severity and underlying co-morbidities, and peak approximately one month postdiagnosis. Large, diverse, well-characterized cohorts of convalescent individuals facilitate development of standardized laboratory methods and reagents to measure immune responses and provide standardized values to benchmark SARS-CoV-2 vaccine-elicited responses.

The Exodus from New York due to COVID-19: Income Tax Residency Considerations: Certified Public Accountant

[...]while these rules can be confusing, there are two foundational residency concepts-domicile and statutory residency - that must be addressed to determine whether an individual is a New York resident for income tax purposes. An Overview of New York States Rules Generally, New York residents are subject to New York personal income tax on all of their income -including earned income (e.g., wages) and unearned income (e.g., dividends, interest, capital gains). [...]it is extremely important to understand the basic rules that New York State (and City) apply in determining residency status. [...]an auditor will examine how and where an individual spends his time during each day of the year.

CURE in a Box: an Online CURE for Introductory Biology Majors That Incorporates Vision and Change.

Course-based undergraduate research experiences (CUREs) help fulfill the recommendation of Vision and Change for biology curricula to focus on key concepts and skills to better prepare students for careers in the sciences. However, the COVID-19 pandemic has forced many schools to move instruction online, highlighting the dearth of resources available for offering a CURE for introductory biology outside of the traditional laboratory-based setting. Here, we present a revision of our first-semester General Biology laboratory for a synchronous online setting where students perform a research-based wet lab component at home using an affordable preassembled kit while still meeting the CURE learning objectives. This template can be utilized by other colleges and universities that are looking to offer a safe, reliable, and affordable CURE in their introductory biology courses whether in a virtual or face-to-face environment.

COVID-19 and the 'Great Lockdown': Certified Public Accountant

The City of Philadelphia, for example, has issued a notice stating that it will temporarily waive nexus and grant apportionment relief for purposes of the Business Income and Receipts Tax (BIRT) as well as the Net Profits Tax (NPT) for taxpayers affected by COVID-19 ["Business Income & Receipts Tax (BIRT), Net Profits Tax (NPT) nexus and apportionment policies due to the COVID19 pandemic," Apr. 22, 2020, https:// bit.ly/2CWmfnN.]. Sales Tax Considerations Under the landmark 2018 Wayfair decision, the U.S. Supreme Court abrogated the physical presence requirement and ushered in economic nexus for sales tax purposes [South Dakota v. Wayfair, 138 S. Ct. 2080 (2018)]. [...]many remote sellers of taxable goods and services are now subject to each state's recently enacted Wayfair provisions, which include small seller threshold exceptions. [...]the seller might find itself subject to sales tax collection obligations in the new state on the first dollar of sales (after the start of the COVID-19 pandemic), without the protections of the Wayfair small-seller thresholds.