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2.
Journal of Adolescent Health ; 70(4):S79-S80, 2022.
Article in English | EMBASE | ID: covidwho-1936633

ABSTRACT

Purpose: Despite decades of safety and effectiveness data, human papillomavirus (HPV) vaccination rates remain low, and one-third of adolescents fail to initiate the series by age 13, the age at which it should be completed. While there is extensive research on factors related to uptake, there is less known about the times that eligible adolescents do not get vaccinated (missed opportunities [MOs]). This study sought to quantify the extent of MOs among adolescents ages 11 to 13 during both preventive and acute care visits. Methods: Medical claims data from years 2010 to 2017 from a large midwestern insurance provider were used to calculate total numbers of MOs between ages 11 and 13. Adolescents included had continuous health insurance enrollment born between 2001 and 2004 in Iowa for the three-year period between ages 11 and 13 (n=14,505). The creation of the MO definition was informed by input from primary care and pediatric providers to ensure that all visits that could be potential vaccination opportunities were included. MOs were divided into several categories: total, among non-initiators, occurring prior to initiation, occurring after the first dose, and occurring between the first and last dose. Two subgroup comparisons for all categories (urban vs. rural;male vs. female) were explored using t-tests. Results: Overall, less than one-third of adolescents in the sample initiated the series by age 13. Females experienced significantly fewer MOs;5.98 (SD=5.49) for females compared to 6.18 (SD=6.04) for males. For initiators, the majority of MOs occurred prior to initiation of the series, which on average, occurred at age 12;again females experienced significantly fewer MOs compared to males;means for males and females were 3.62 and 4.07, respectively. In sub-group comparisons, rural adolescents tended to have fewer MOs than their urban counterparts and females tended to have fewer MOs than males. For example, urban females had significantly more MOs overall (M=6.08) compared to rural females (M=5.85). Conclusions: Results from this study highlight not only the extent of MOs, but also the utility of medical claims data in understanding patterns of adolescent health care utilization. Claims data provides a comprehensive view and level of granularity not available in other immunization data source. Future research could focus on better understanding the issue of MOs in other geographic areas or among populations with public insurance. Overall, in this sample of privately insured adolescents, it is clear that a lack of opportunity was not a barrier to HPV vaccination, as there were many opportunities in this critical age range, particularly among males and urban adolescents. Additionally, low rates of HPV vaccination have been compounded by the COVID-19 pandemic with many adolescents missing preventive care visits during the pandemic. Moving forward, it will be critical for providers to take advantage of any opportunities to vaccinate, both acute and preventive care visits, to ensure adolescents receive the vaccines they need and reduce these MOs going forward. Sources of Support: Cooperative Agreement 3 U48 DP005021-01S4 from the Centers for Disease Control and Prevention and the National Cancer Institute.

3.
Alcoholism: Clinical and Experimental Research ; 46:120A, 2022.
Article in English | EMBASE | ID: covidwho-1937888

ABSTRACT

Purpose: Social support is critically important to recovery from alcohol use disorder (AUD). During the COVID-19 pandemic, community and government social restrictions and mandates reduced inperson contact and increased social isolation, heightening the risk of relapse for many persons in recovery. A key question concerns what forms and sources of social connection and support were important for maintaining recovery during the pandemic. Methods: This study used a large, pre-existing, national cohort, Knowledge Panel, to recruit participants with resolved AUD for an online survey. The sample consisted of 1,492 adults, 71% of whom had been in recovery more than 5 years. In addition to close-ended questions on COVID-19 stressors and coping responses, an open-ended question asked participants what was most helpful in sustaining their recovery during the pandemic. A qualitative codebook was created, and iterative coding was conducted by multiple analysts using Dedoose, followed by preliminary analysis of themes from codes on COVID-19 restrictions and sources of social connection and support. Results: Participants commonly referenced talking to, staying in touch with, and/or spending time with family members, including children (latter mentioned more commonly by women) as helpful in maintaining recovery. Participants also highlighted support and encouragement from family. Communication and interaction with friends were also integral to recovery maintenance. Support, care, and contact from and towards others in their networks, including those in recovery, were also cited. Many participants continued to attend Alcoholics Anonymous (AA) meetings and other mutual support groups throughout the pandemic. When in-person gatherings were not possible, participants sustained social connections through various forms of telecommunication. Unexpectedly, some participants characterized the lack of social interactions during COVID-19 as beneficial to their continued recovery, as it removed opportunities and temptations to drink with others. Conclusions: Despite profound disruption to social routines during the pandemic, many individuals in recovery experienced helpful social connections and support that were important to maintaining recovery. For some, social restrictions were perceived as beneficial and limiting opportunities for relapse. These findings underscore the importance of social support and networks in long-term recovery, warranting further investigation into the dynamics of support systems conducive to recovery maintenance.

4.
Alcoholism-Clinical and Experimental Research ; 46:120A-120A, 2022.
Article in English | Web of Science | ID: covidwho-1893971
5.
Topics in Antiviral Medicine ; 30(1 SUPPL):5, 2022.
Article in English | EMBASE | ID: covidwho-1880272

ABSTRACT

Vaccines are approved by regulatory agencies based on randomized, placebo-controlled vaccine efficacy (VE) trials that demonstrate vaccination is safe and reduces the risk of acquisition of an infectious disease clinical endpoint. The resource intensity of VE trials makes it difficult to base vaccine approval on this gold-standard approach for every indication of interest (defined by host population, virus strain population, and/or the specific vaccine regimen). Therefore, an important objective in vaccinology is to develop 'immune marker surrogate endpoints' that can be used as primary endpoints in smaller and faster studies for provisional or traditional approval of vaccines. After summarizing why immune correlates are needed, the talk summarizes approaches to the evaluation of the quality of an immune marker as a surrogate endpoint for a clinical endpoint based on VE trials and on other evidence sources (lab development of immunoassays/biomarkers, natural history studies, post-approval epidemiological studies, vaccine mechanism studies, meta-analysis of multiple VE trials). In VE trials, data analysis evaluates 'correlates of risk' (CoRs) and 'correlates of protection' (CoPs) as distinct objectives. CoR analysis assesses the association of an immune marker with the acquisition of the clinical endpoint in vaccine recipients. CoR analysis estimates association parameters and is limited in that it does not assess a causal effect of vaccination, such that an immune marker may be a CoR but fail to be a CoP. CoP analysis, on the other hand, studies how immune markers predict, cause, or mediate VE, with goal to generate evidence of whether and how an immune marker can be used to reliably predict VE against the clinical endpoint. An immune marker with established robust evidence for providing this reliable prediction can be designated a 'non-validated surrogate endpoint' or 'validated surrogate endpoint' (depending on evidence level) and thus be used for provisional or traditional vaccine approval, respectively. The talk summarizes statistical approaches for evaluating CoRs and CoPs in VE trials, illustrated by the Moderna COVID-19 VE trial. Approaches to evaluating CoPs include controlled direct effect analysis that assesses the causal effect of the marker on reducing risk and mediation analysis that assesses how much of the vaccine's overall efficacy is mediated through the marker. Meta-analysis quantifies how well VE can be predicted by an immune marker.

6.
Public Anthropologist ; 4(1):51-77, 2022.
Article in English | Scopus | ID: covidwho-1832809

ABSTRACT

This article examines the role played by philanthrocapitalist foundations in impact investing for international development, focusing on the covid-19 Vaccines Global Access Initiative (covax) as a response to the current pandemic. Philanthrocapitalists and development institutions are increasingly turning to "blended finance" and "social bonds" to address the gaps in funding required to meet global development agendas, particularly in the arena of global health. These impact investing mechanisms deploy public or philanthropic money to leverage for-profit investment in development, by "de-risking" (providing guarantees for) interventions that might otherwise put private capital at risk. Via covax, the Bill and Melinda Gates Foundation has platformed a pandemic response centred on this approach, resisting alternative responses - such as the proposal for a temporary waiver to pharmaceutical patent rights - that seek to challenge the prevailing trade architecture. The global policy response to covid-19 thus accelerates the "financialization" of development and cements the role of philanthropy in "de-risking" for-profit impact investment. © 2022 Brill. All rights reserved.

7.
Journal of Victorian Culture ; : 10, 2022.
Article in English | Web of Science | ID: covidwho-1816156

ABSTRACT

Epidemics are times of negotiation between the individual and the collective. The British realist novel, with its emphasis on possessive individualism, turns in the mid-nineteenth century to engage a larger population brought into view, in large part, by the emergence of statistical models of public health. Dickens is critically engaged in this process in Bleak House, which shows the difficulties of negotiating between the plot of individual agency and representing collective suffering and responsibility. Moreover, it highlights one of the major problems of defining such a collective. At a moment when Britons were beginning to understand themselves as part of a worldwide system, specifically in the light of pandemics such as cholera, what is the definition of the society to which one belongs and has responsibility? Dickens reaches for inclusion in his insistence on the linkage between events and bodies in England, but does so in part by implying that other, racialized, bodies - in Borrioboola-gha for example - are beyond that collective and its concerns. In so doing, he appeals to the notion of an ethnically coherent nation-state that was gaining ground in the period. Now we, supposedly beyond the nation-state model, find that we must think about global community within the terms of COVID-19 (and climate change) - precisely when regressive fantasies of the self-enclosed, homogenous nation are being peddled by some of the most politically reactionary governments the West has seen in many decades. This essay uses Dickens to think about the problems and opportunities of representing our global interdependence.

8.
PubMed; 2020.
Preprint in English | PubMed | ID: ppcovidwho-333640

ABSTRACT

BACKGROUND: Several candidate vaccines to prevent COVID-19 disease have entered large-scale phase 3 placebo-controlled randomized clinical trials and some have demonstrated substantial short-term efficacy. Efficacious vaccines should, at some point, be offered to placebo participants, which will occur before long-term efficacy and safety are known. METHODS: Following vaccination of the placebo group, we show that placebo-controlled vaccine efficacy can be derived by assuming the benefit of vaccination over time has the same profile for the original vaccine recipients and the placebo crossovers. This reconstruction allows estimation of both vaccine durability and potential vaccine-associated enhanced disease. RESULTS: Post-crossover estimates of vaccine efficacy can provide insights about durability, identify waning efficacy, and identify late enhancement of disease, but are less reliable estimates than those obtained by a standard trial where the placebo cohort is maintained. As vaccine efficacy estimates for post-crossover periods depend on prior vaccine efficacy estimates, longer pre-crossover periods with higher case counts provide better estimates of late vaccine efficacy. Further, open-label crossover may lead to riskier behavior in the immediate crossover period for the unblinded vaccine arm, confounding vaccine efficacy estimates for all post-crossover periods. CONCLUSIONS: We advocate blinded crossover and continued follow-up of trial participants to best assess vaccine durability and potential delayed enhancement of disease. This approach allows placebo recipients timely access to the vaccine when it would no longer be proper to maintain participants on placebo, yet still allows important insights about immunological and clinical effectiveness over time.

9.
PubMed; 2022.
Preprint in English | PubMed | ID: ppcovidwho-329492

ABSTRACT

Extensive mutations in the Omicron spike protein appear to accelerate the transmission of SARS-CoV-2, and rapid infections increase the odds that additional mutants will emerge. To build an investigative framework, we have applied an unsupervised machine learning approach to 4296 Omicron viral genomes collected and deposited to GISAID as of December 14, 2021, and have identified a core haplotype of 28 polymutants (A67V, T95I, G339D, R346K, S371L, S373P, S375F, K417N, N440K, G446S, S477N, T478K, E484A, Q493R, G496S, Q498R, N501Y, Y505H, T547K, D614G, H655Y, N679K, P681H, N764K, K796Y, N856K, Q954H, N69K, L981F) in the spike protein and a separate core haplotype of 17 polymutants in non-spike genes: (K38, A1892) in nsp3, T492 in nsp4, (P132, V247, T280, S284) in 3C-like proteinase, I189 in nsp6, P323 in RNA-dependent RNA polymerase, I42 in Exonuclease, T9 in envelope protein, (D3, Q19, A63) in membrane glycoprotein, and (P13, R203, G204) in nucleocapsid phosphoprotein. Using these core haplotypes as reference, we have identified four newly emerging polymutants (R346, A701, I1081, N1192) in the spike protein (p-value=9.37*10 -4 , 1.0*10 -15 , 4.76*10 -7 and 1.56*10 -4 , respectively), and five additional polymutants in non-spike genes (D343G in nucleocapsid phosphoprotein, V1069I in nsp3, V94A in nsp4, F694Y in the RNA-dependent RNA polymerase and L106L/F of ORF3a) that exhibit significant increasing trajectories (all p-values < 1.0*10 -15 ). In the absence of relevant clinical data for these newly emerging mutations, it is important to monitor them closely. Two emerging mutations may be of particular concern: the N1192S mutation in spike protein locates in an extremely highly conserved region of all human coronaviruses that is integral to the viral fusion process, and the F694Y mutation in the RNA polymerase may induce conformational changes that could impact Remdesivir binding.

10.
PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-296801

ABSTRACT

Although interim results from several large placebo-controlled phase 3 trials demonstrated high vaccine efficacy (VE) against symptomatic COVID-19, it is unknown how effective the vaccines are in preventing people from becoming asymptomatically infected and potentially spreading the virus unwittingly. It is more difficult to evaluate VE against SARS-CoV-2 infection than against symptomatic COVID-19 because infection is not observed directly but rather is known to occur between two antibody or RT-PCR tests. Additional challenges arise as community transmission changes over time and as participants are vaccinated on different dates because of staggered enrollment or crossover before the end of the study. Here, we provide valid and efficient statistical methods for estimating potentially waning VE against SARS-CoV-2 infection with blood or nasal samples under time-varying community transmission, staggered enrollment, and blinded or unblinded crossover. We demonstrate the usefulness of the proposed methods through numerical studies mimicking the BNT162b2 phase 3 trial and the Prevent COVID U study. In addition, we assess how crossover and the frequency of diagnostic tests affect the precision of VE estimates. Summary: We show how to estimate potentially waning efficacy of COVID-19 vaccines against SARS-CoV-2 infection using blood or nasal samples collected periodically from clinical trials with staggered enrollment of participants and crossover of placebo recipients.

11.
PUBMED; 2021.
Preprint in English | PUBMED | ID: ppcovidwho-293297

ABSTRACT

BACKGROUND: In the Coronavirus Efficacy (COVE) trial, estimated mRNA-1273 vaccine efficacy against coronavirus disease-19 (COVID-19) was 94%. SARS-CoV-2 antibody measurements were assessed as correlates of COVID-19 risk and as correlates of protection. METHODS: Through case-cohort sampling, participants were selected for measurement of four serum antibody markers at Day 1 (first dose), Day 29 (second dose), and Day 57: IgG binding antibodies (bAbs) to Spike, bAbs to Spike receptor-binding domain (RBD), and 50% and 80% inhibitory dilution pseudovirus neutralizing antibody titers calibrated to the WHO International Standard (cID50 and cID80). Participants with no evidence of previous SARS-CoV-2 infection were included. Cox regression assessed in vaccine recipients the association of each Day 29 or 57 serologic marker with COVID-19 through 126 or 100 days of follow-up, respectively, adjusting for risk factors. RESULTS: Day 57 Spike IgG, RBD IgG, cID50, and cID80 neutralization levels were each inversely correlated with risk of COVID-19: hazard ratios 0.66 (95% CI 0.50, 0.88;p=0.005);0.57 (0.40, 0.82;p=0.002);0.42 (0.27, 0.65;p<0.001);0.35 (0.20, 0.61;p<0.001) per 10-fold increase in marker level, respectively, multiplicity adjusted P-values 0.003-0.010. Results were similar for Day 29 markers (multiplicity adjusted P-values <0.001-0.003). For vaccine recipients with Day 57 reciprocal cID50 neutralization titers that were undetectable (<2.42), 100, or 1000, respectively, cumulative incidence of COVID-19 through 100 days post Day 57 was 0.030 (0.010, 0.093), 0.0056 (0.0039, 0.0080), and 0.0023 (0.0013, 0.0036). For vaccine recipients at these titer levels, respectively, vaccine efficacy was 50.8% (-51.2, 83.0%), 90.7% (86.7, 93.6%), and 96.1% (94.0, 97.8%). Causal mediation analysis estimated that the proportion of vaccine efficacy mediated through Day 29 cID50 titer was 68.5% (58.5, 78.4%). CONCLUSIONS: Binding and neutralizing antibodies correlated with COVID-19 risk and vaccine efficacy and likely have utility in predicting mRNA-1273 vaccine efficacy against COVID-19. TRIAL REGISTRATION NUMBER: COVE ClinicalTrials.gov number, NCT04470427.

12.
PUBMED; 2021.
Preprint in English | PUBMED | ID: ppcovidwho-293015

ABSTRACT

Large-scale deployment of safe and durably effective vaccines can curtail the COVID-19 pandemic. 1-3 However, the high vaccine efficacy (VE) reported by ongoing phase 3 placebo-controlled clinical trials is based on a median follow-up time of only about two months 4-5 and thus does not pertain to long-term efficacy. To evaluate the duration of protection while allowing trial participants timely access to efficacious vaccine, investigators can sequentially cross participants over from the placebo arm to the vaccine arm according to priority groups. Here, we show how to estimate potentially time-varying placebo-controlled VE in this type of staggered vaccination of participants. In addition, we compare the performance of blinded and unblinded crossover designs in estimating long-term VE. Authors' Information: Dan-Yu Lin, Ph.D., is Dennis Gillings Distinguished Professor of Biostatistics, and Donglin Zeng, Ph.D., is Professor of Biostatistics, Gillings School of Global Public Health, University of North Carolina, Chapel Hill, NC 27599-7420, USA. Peter B. Gilbert, Ph.D., is Member, Vaccine and Infectious Disease Division, Fred Hutch, Seattle, WA 98109-1024, USA. Summary: We show how to estimate the potentially waning long-term efficacy of COVID-19 vaccines using data from randomized, placebo-controlled clinical trials with staggered enrollment of participants and sequential crossover of placebo recipients.

14.
PubMed; 2021.
Preprint in English | PubMed | ID: ppcovidwho-290553

ABSTRACT

Vaccine-induced neutralizing antibodies (nAbs) are key biomarkers considered to be associated with vaccine efficacy. In United States Government-sponsored phase 3 efficacy trials of COVID-19 vaccines, nAbs are measured by two different validated pseudovirus-based SARS-CoV-2 neutralization assays, with each trial using one of the two assays. Here we describe and compare the nAb titers obtained in the two assays. We observe that one assay consistently yielded higher nAb titers than the other when both assays were performed on the World Health Organizationa TMs anti-SARS-CoV-2 immunoglobulin International Standard, COVID-19 convalescent sera, and mRNA-1273 vaccinee sera. To overcome the challenge this difference in readout poses in comparing/combining data from the two assays, we evaluate three calibration approaches and show that readouts from the two assays can be calibrated to a common scale. These results may aid decision-making based on data from these assays for the evaluation and licensure of new or adapted COVID-19 vaccines.

15.
Climate Policy ; 2020.
Article in English | Web of Science | ID: covidwho-922353

ABSTRACT

Limiting warming to well below 2 degrees C requires rapid and complete decarbonisation of energy systems. We compare economy-wide modelling of 1.5 degrees C and 2 degrees C scenarios with sector-focused analyses of four critical sectors that are difficult to decarbonise: aviation, shipping, road freight transport, and industry. We develop and apply a novel framework to analyse and track mitigation progress in these sectors. We find that emission reductions in the 1.5 degrees C and 2 degrees C scenarios of the IMAGE model come from deep cuts in CO2 intensities and lower energy intensities, with minimal demand reductions in these sectors' activity. We identify a range of additional measures and policy levers that are not explicitly captured in modelled scenarios but could contribute significant emission reductions. These are demand reduction options, and include less air travel (aviation), reduced transportation of fossil fuels (shipping), more locally produced goods combined with high load factors (road freight), and a shift to a circular economy (industry). We discuss the challenges of reducing demand both for economy-wide modelling and for policy. Based on our sectoral analysis framework, we suggest modelling improvements and policy recommendations, calling on the relevant UN agencies to start tracking mitigation progress through monitoring key elements of the framework (CO2 intensity, energy efficiency, and demand for sectoral activity, as well as the underlying drivers), as a matter of urgency. Key policy insights Four critical sectors (aviation, shipping, road freight, and industry) cannot cut their CO2 emissions to zero rapidly with technological supply-side options alone. Without large-scale negative emissions, significant demand reductions for those sectors' activities are needed to meet the 1.5-2 degrees C goal. Policy priorities include affordable alternatives to frequent air travel;smooth connectivity between low-carbon travel modes;speed reductions in shipping and reduced demand for transporting fossil fuels;distributed manufacturing and local storage;and tightening standards for material use and product longevity. The COVID-19 crisis presents a unique opportunity to enact lasting CO2 emissions reductions, through switching from frequent air travel to other transport modes and online interactions. Policies driving significant demand reductions for the critical sectors' activities would reduce reliance on carbon removal technologies that are unavailable at scale.

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