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Science |
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Origins |
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The genetic structure of SARS‐CoV‐2 does not rule out a laboratory origin Authors: Rossana Segreto and Yuri Deigin Publication date: 17 November 2020 Journal: BioEssays DOI: 10.1002/bies.202000240 Severe acute respiratory syndrome‐coronavirus (SARS‐CoV)‐2′s origin is still controversial. Genomic analyses show SARS‐CoV‐2 likely to be chimeric, most of its sequence closest to bat CoV RaTG13, whereas its receptor binding domain (RBD) is almost identical to that of a pangolin CoV. Chimeric viruses can arise via natural recombination or human intervention. The furin cleavage site in the spike protein of SARS‐CoV‐2 confers to the virus the ability to cross species and tissue barriers, but was previously unseen in other SARS‐like CoVs. Might genetic manipulations have been performed in order to evaluate pangolins as possible intermediate hosts for bat‐derived CoVs that were originally unable to bind to human receptors? Both cleavage site and specific RBD could result from site‐directed mutagenesis, a procedure that does not leave a trace. Considering the devastating impact of SARS‐CoV‐2 and importance of preventing future pandemics, researchers have a responsibility to carry out a thorough analysis of all possible SARS‐CoV‐2 origins. Unexpected detection of SARS-CoV-2 antibodies in the prepandemic period in Italy Authors: Apolone G et al Publication date: 11 November 2020 Journal: Tumori Journal DOI: 10.1177/0300891620974755 There are no robust data on the real onset of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and spread in the prepandemic period worldwide. We investigated the presence of SARS-CoV-2 receptor-binding domain (RBD)–specific antibodies in blood samples of 959 asymptomatic individuals enrolled in a prospective lung cancer screening trial between September 2019 and March 2020 to track the date of onset, frequency, and temporal and geographic variations across the Italian regions. SARS-CoV-2 RBD-specific antibodies were detected in 111 of 959 (11.6%) individuals, starting from September 2019 (14%), with a cluster of positive cases (>30%) in the second week of February 2020 and the highest number (53.2%) in Lombardy. This study shows an unexpected very early circulation of SARS-CoV-2 among asymptomatic individuals in Italy several months before the first patient was identified, and clarifies the onset and spread of the coronavirus disease 2019 (COVID-19) pandemic. Finding SARS-CoV-2 antibodies in asymptomatic people before the COVID-19 outbreak in Italy may reshape the history of pandemic. |
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Mutations |
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SARS-CoV-2 D614G variant exhibits efficient replication ex vivo and transmission in vivo Authors: Hou YJ et al Publication date: 12 November 2020 Journal: Science DOI: 10.1126/science.abe8499 The spike D614G substitution is prevalent in global SARS-CoV-2 strains, but its effects on viral pathogenesis and transmissibility remain unclear. We engineered a SARS-CoV-2 variant containing this substitution. The variant exhibits more efficient infection, replication, and competitive fitness in primary human airway epithelial cells, but maintains similar morphology and in vitro neutralization properties, compared with the ancestral wild-type virus. Infection of human angiotensin-converting enzyme 2 (ACE2) transgenic mice and Syrian hamsters with both viruses resulted in similar viral titers in respiratory tissues and pulmonary disease. However, the D614G variant transmits significantly faster and displayed increased competitive fitness than the wild-type virus in hamsters. These data show that the D614G substitution enhances SARS-CoV-2 infectivity, competitive fitness, and transmission in primary human cells and animal models. |
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Transmission |
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Hospital-Acquired SARS-CoV-2 Infection. Lessons for Public Health Authors: Richterman A et al Publication date: 13 November 2020 Journal: JAMA DOI: 10.1001/jama.2020.21399 From the outset of the coronavirus disease 2019 (COVID-19) pandemic, it was clear that hospitals were an important setting for viral transmission. A review of 2 early case series in China estimated that 44% of 179 severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections were hospital acquired.1 An illustrative example of the devastating potential for health care transmission of SARS-CoV-2 came from St Augustine’s Hospital in Durban, South Africa, a facility with 469 beds, including 18 wards, 6 intensive care units, and 735 clinical staff.2 Through a detailed epidemiologic study supplemented by phylogenetic analyses, investigators documented how a single unsuspected case of SARS-CoV-2 led to 6 major clusters involving 5 hospital wards and an outside nursing home and dialysis unit, with infection ultimately confirmed among 80 staff members and 39 patients, 15 of whom died.2 Patients and health care workers around the world became concerned about the risk of providing routine care for patients with COVID-19, especially given the uncertainties about routes of transmission of SARS-CoV-2. Many settings intentionally limited or decreased elective visits and procedures during surging cases to reduce health care load and potential exposure. In addition, there have been substantial reductions in presentations for urgent or emergency illnesses, including myocardial infarction, tuberculosis, stroke, and hyperglycemic episodes. The consequences of these reductions are likely to contribute to excess mortality associated with the COVID-19 pandemic, considering that these conditions result in hundreds of thousands of deaths each year in the US. Authors: Riley S et al Publication date: 12 November 2020 Source: Imperial College London Background: England is now in the midst of its second wave of the COVID-19 pandemic. Multiple regions of the country are at high infection prevalence and all areas experienced rapid recent growth of the epidemic during October 2020. Methods: REACT-1 is a series of community surveys of SARS-CoV-2 RT-PCR swab-positivity in England designed to monitor the spread of the epidemic and thus increase situational awareness. Round 6 of REACT-1 commenced swab-collection on 16th October. A prior interim report included data from 16th to 25th October for 85,971 participants. Here, we report data for the entire round on 160,175 participants with swab results obtained up to 2nd November 2020. Results: Overall weighted prevalence of infection in the community in England was 1.3% or 130 people per 10,000 infected, up from 60 people per 10,000 in the round 5 report (18th September to 5th October 2020), doubling every 24 days on average since the prior round. The corresponding R number was estimated to be 1.2. Prevalence of infection was highest in North West (2.4%, up from 1.2% ), followed by Yorkshire and The Humber (2.3% up from 0.84%), West Midlands (1.6% up from 0.60%), North East (1.5% up from 1.1%), East Midlands (1.3% up from 0.56%), London (0.97%, up from 0.54%), South West (0.80% up from 0.33%), South East (0.69% up from 0.29%), and East of England (0.69% up from 0.30%). Rapid growth in the South observed in the first half of round 6 was no longer apparent in the second half of round 6. We also observed a decline in prevalence in Yorkshire and The Humber during this period. Comparing the first and second halves of round 6, there was a suggestion of decline in weighted prevalence in participants aged 5 to 12 years and in those aged 25 to 44 years. While prevalence remained high, in the second half of round 6 there was suggestion of a slight fall then rise that was seen nationally and also separately in both the North and the South. Conclusion: The impact of the second national lockdown in England is not yet known. We provide here a detailed description of swab-positivity patterns at national, regional and local scales for the period immediately preceding lockdown, against which future trends in prevalence can be evaluated. Recent endemic coronavirus infection is associated with less severe COVID-19 Authors: Sagar M et al Publication date: 30 September 2020 Journal: The Journal of Clinical Investigation DOI: 10.1172/JCI143380 Four different endemic coronaviruses (eCoVs) are etiologic agents for the seasonal “common cold,” and these eCoVs share extensive sequence homology with human severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2). Here, we show that individuals with as compared to without a relatively recent documented eCoV were tested at greater frequency for respiratory infections but had similar rate of SARS-CoV-2 acquisition. Importantly, the patients with a previously detected eCoV had less severe coronavirus disease-2019 (COVID-19) illness. Our observations suggest that pre-existing immune responses against endemic human coronaviruses can mitigate disease manifestations from SARS-CoV-2 infection. Coronaviruses hijack lysosomes to exit cells Publication date: 10 November 2020 Source: National Institutes of Health COVID-19 cases are surging worldwide. With U.S. deaths nearing 225,000, scientists are working to better understand how the virus that causes the disease infects cells and spreads through the body. SARS-CoV-2, like most viruses, enters and infects cells, and then uses the cell’s protein-making machinery to make multiple copies of itself. It must then escape the cell. While researchers have learned a great deal about how the virus infects cells, they have only a limited understanding of how it exits them. Most viruses—including hepatitis C, Dengue, and West Nile—exit through the “biosynthetic secretory” pathway. That’s the central pathway that cells use to transport hormones, growth factors, and other materials to their surrounding environment. |
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Covid-19 patients |
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Authors: Hendren NS et al Publication date: 17 November 2020 Journal: Circulation DOI: 10.1161/CIRCULATIONAHA.120.051936 Conclusions: Obese patients are more likely to be hospitalized with COVID-19, and are at higher risk of in-hospital death or mechanical ventilation in particular, if young (age <50 years). Obese patients are also at higher risk for venous thromboembolism and dialysis. These observations support clear public health messaging and rigorous adherence to COVID-19 prevention strategies in all obese individuals regardless of age. Authors: Sheshah E et al Publication date: 13 November 2020 Journal: Diabetes Research and Clinical Practice DOI: 10.1016/j.diabres.2020.108538 This retrospective study aimed to characterize comorbidities and associated with mortality among hospitalized adults with Covid-19 managed as per the Saudi Ministry of Health protocol in a specialized tertiary hospital in Riyadh, Saudi Arabia. Medical records of 300 adult patients with PCR-confirmed SARS-CoV2 infection and admitted in King Salman Hospital (KSH) from May 1 to July 31 2020 were included. Medical history, management and outcomes were noted. Males significantly outnumber females (259 versus 41). South Asians comprise 41% of all admitted patients. Mortality rate was 10% and highest among Saudi males (28.9%). Type 2 diabetes mellitus (T2DM) was the most common comorbidity (45.7%). Almost all patients (99%) had pneumonia. Patients >50 years were three times more likely to die (confidence interval, CI 1.3-6.9; p=0.01) from Covid-19. Congestive heart failure (odds ratio OR 19.4, CI-1.5-260.0; p=0.02) and acute kidney injury (OR 11.7, CI-4.7-28.6; p<0.001) were significantly associated with higher mortality. Dexamethasone use significantly improved the final outcome based on net reclassification improvement (NRI) and integrated discrimination improvement (IDI) (p<0.05). In this single-center study, T2DM was very common among hospitalized Covid-19 patients. Patients >50 years, those with congestive heart failure and acute kidney injury are at higher risk for worse Covid-19 outcome. UK report on 14,945 patients critically ill with COVID-19 Institution: Intensive Care National Audit & Research Centre (ICNARC) Publication date: 13 November 2020 Read more... Authors: Mudd PA et al Publication date: 13 November 2020 Journal: Science Advances DOI: 10.1126/sciadv.abe3024 We pursued a study of immune responses in COVID-19 and influenza cohorts. Compared to influenza patients, COVID-19 patients exhibited largely equivalent lymphocyte counts, fewer monocytes, and lower surface HLA-class II expression on select monocyte populations. Furthermore, decreased HLA-DR on intermediate monocytes was a significant predictor of COVID-19 disease severity. In contrast to prevailing assumptions about COVID-19 disease immunopathology, very few (7 of 168) COVID-19 patients exhibited cytokine profiles indicative of Cytokine Storm Syndrome. After controlling for key confounding factors such as age and sample time point, COVID-19 patients exhibited lower cytokine levels than influenza patients. Up-regulation of IL-6, GCSF, IL-1RA, and MCP1 predicted death from acute respiratory failure among COVID-19 patients but were not statistically higher than influenza patients. Single-cell transcriptional profiling was concordant with profound suppression in interferon signaling among COVID-19 patients. When considered across the spectrum of peripheral immune profiles, COVID-19 patients are less inflamed than influenza patients. |
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Covid-19 and children |
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Children and COVID-19: State-Level Data Report Publication date: 12 November 2020 Source: American Academy of Pediatrics State-level reports are the best publicly available data on child COVID-19 cases in the United States. The American Academy of Pediatrics and the Children’s Hospital Association are collaborating to collect and share all publicly available data from states on child COVID-19 cases (definition of “child” case is based on varying age ranges reported across states; see report Appendix for details and links to all data sources). As of November 12th, over 1 million children have tested positive for COVID-19 since the onset of the pandemic. The age distribution of reported COVID-19 cases was provided on the health department websites of 49 states, New York City, the District of Columbia, Puerto Rico, and Guam. Children represented 11.5% of all cases in states reporting cases by age. A smaller subset of states reported on hospitalizations and mortality by age; the available data indicated that COVID-19-associated hospitalization and death is uncommon in children. The number of new child COVID-19 cases reported this week, nearly 112,000, is by far the highest weekly increase since the pandemic began. At this time, it appears that severe illness due to COVID-19 is rare among children. However, there is an urgent need to collect more data on longer-term impacts on children, including ways the virus may harm the long-term physical health of infected children, as well as its emotional and mental health effects. Immune responses to SARS-CoV-2 in three children of parents with symptomatic COVID-19 Authors: Tosif S et al Publication date: 11 November 2020 Journal: Nature Communications DOI: 10.1038/s41467-020-19545-8 Compared to adults, children with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have predominantly mild or asymptomatic infections, but the underlying immunological differences remain unclear. Here, we describe clinical features, virology, longitudinal cellular, and cytokine immune profile, SARS-CoV-2-specific serology and salivary antibody responses in a family of two parents with PCR-confirmed symptomatic SARS-CoV-2 infection and their three children, who tested repeatedly SARS-CoV-2 PCR negative. Cellular immune profiles and cytokine responses of all children are similar to their parents at all timepoints. All family members have salivary anti-SARS-CoV-2 antibodies detected, predominantly IgA, that coincide with symptom resolution in 3 of 4 symptomatic members. Plasma from both parents and one child have IgG antibody against the S1 protein and virus-neutralizing activity detected. Using a systems serology approach, we demonstrate higher levels of SARS-CoV-2-specific antibody features of these family members compared to healthy controls. These data indicate that children can mount an immune response to SARS-CoV-2 without virological confirmation of infection, raising the possibility that immunity in children can prevent the establishment of SARS-CoV-2 infection. Relying on routine virological and serological testing may not identify exposed children, with implications for epidemiological and clinical studies across the life-span. |
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Therapeutics |
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Authors: Walk J et al Publication date: 09 November 2020 Journal: medRxiv preprint DOI: 10.1101/2020.11.07.20227512 SARS-CoV-2 causes remarkably variable disease from asymptomatic individuals to respiratory insufficiency and coagulopathy. Vitamin K deficiency was recently found to associate with clinical outcome in a cohort of COVID-19 patients. Vitamin D has been hypothesized to reduce disease susceptibility by modulating inflammation, yet little is known about its role in disease severity. Considering the critical interaction between vitamin K and vitamin D in calcium and elastic fiber metabolism, we determined vitamin D status in the same cohort of 135 hospitalized COVID-19 patients by measuring blood 25(OH)D levels. We found no difference in vitamin D status between those with good and poor outcome (defined as intubation and/or death). Instead, we found vitamin D sufficient persons (25(OH)D >50 nmol/L) had accelerated elastic fiber degradation compared to those with mild deficiency (25(OH)D 25-50 nmol/L). Based on these findings, we hypothesize that vitamin D might have both favorable anti-inflammatory and unfavorable pro-calcification effects during COVID-19 and that vitamin K might compensate for the latter. |
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Immunity |
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Immunological memory to SARS-CoV-2 assessed for greater than six months after infection Authors: Dan JM et al Publication date: 16 November 2020 Journal: bioRxiv preprint DOI: 10.1101/2020.11.15.383323 Understanding immune memory to SARS-CoV-2 is critical for improving diagnostics and vaccines, and for assessing the likely future course of the pandemic. We analyzed multiple compartments of circulating immune memory to SARS-CoV-2 in 185 COVID-19 cases, including 41 cases at ≥6 months post-infection. Spike IgG was relatively stable over 6+ months. Spike-specific memory B cells were more abundant at 6 months than at 1 month. SARS-CoV-2-specific CD4+ T cells and CD8+ T cells declined with a half-life of 3-5 months. By studying antibody, memory B cell, CD4+ T cell, and CD8+ T cell memory to SARS-CoV-2 in an integrated manner, we observed that each component of SARS-CoV-2 immune memory exhibited distinct kinetics. Characterization of pre-existing and induced SARS-CoV-2-specific CD8+ T cells Authors: Schulien I et al Publication date: 12 November 2020 Journal: Nature Medicine DOI: 10.1038/s41591-020-01143-2 New paper on t cell immunity and covid "merging data indicate that SARS-CoV-2-specific CD8+ T cells targeting different viral proteins are detectable in up to 70% of convalescent individuals1,2,3,4,5. However, very little information is currently available about the abundance, phenotype, functional capacity and fate of pre-existing and induced SARS-CoV-2-specific CD8+ T cell responses during the natural course of SARS-CoV-2 infection. Here, we define a set of optimal and dominant SARS-CoV-2-specific CD8+ T cell epitopes. We also perform a high-resolution ex vivo analysis of pre-existing and induced SARS-CoV-2-specific CD8+ T cells, applying peptide-loaded major histocompatibility complex class I (pMHCI) tetramer technology. We observe rapid induction, prolonged contraction and emergence of heterogeneous and functionally competent cross-reactive and induced memory CD8+ T cell responses in cross-sectionally analyzed individuals with mild disease following SARS-CoV-2 infection and three individuals longitudinally assessed for their T cells pre- and post-SARS-CoV-2 infection. SARS-CoV-2-specific memory CD8+ T cells exhibited functional characteristics comparable to influenza-specific CD8+ T cells and were detectable in SARS-CoV-2 convalescent individuals who were seronegative for anti-SARS-CoV-2 antibodies targeting spike (S) and nucleoprotein. These results define cross-reactive and induced SARS-CoV-2-specific CD8+ T cell responses as potentially important determinants of immune protection in mild SARS-CoV-2 infection. Herd immunity thresholds for SARS-CoV-2 estimated from unfolding epidemics Authors: Aguas R et al Publication date: 16 November 2020 Journal: medRxiv preprint DOI: 10.1101/2020.07.23.20160762 As severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spreads, the susceptible subpopulation declines causing the rate at which new infections occur to slow down. Variation in individual susceptibility or exposure to infection exacerbates this effect. Individuals that are more susceptible or more exposed tend to be infected and removed from the susceptible subpopulation earlier. This selective depletion of susceptibles intensifies the deceleration in incidence. Eventually, susceptible numbers become low enough to prevent epidemic growth or, in other words, the herd immunity threshold is reached. Here we fit epidemiological models with inbuilt distributions of susceptibility or exposure to SARS-CoV-2 outbreaks to estimate basic reproduction numbers (R_0) alongside coefficients of individual variation (CV) and the effects of containment strategies. Herd immunity thresholds are then calculated as 1-(1⁄R_0 )^(1⁄((1+〖CV〗^2 ) )) or 1-(1⁄R_0 )^(1⁄((1+〖2CV〗^2 ) )), depending on whether variation is on susceptibility or exposure. Our inferences result in herd immunity thresholds around 10-20%, considerably lower than the minimum coverage needed to interrupt transmission by random vaccination, which for R_0 higher than 2.5 is estimated above 60%. We emphasize that the classical formula, 1-1⁄R_0 , remains applicable to describe herd immunity thresholds for random vaccination, but not for immunity induced by infection which is naturally selective. These findings have profound consequences for the governance of the current pandemic given that some populations may be close to achieving herd immunity despite being under more or less strict social distancing measures. Challenges in creating herd immunity to SARS-CoV-2 infection by mass vaccination Authors: Anderson RM et al Publication date: 04 November 2020 Journal: The Lancet DOI: 10.1016/S0140-6736(20)32318-7 Vaccines to protect against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) have risen up the agenda of most policy makers and individuals as the second wave of COVID-19 in northern hemisphere countries grows and there is increasing pressure on health-care systems. For any licensed vaccine, efficacy and duration of protection are key issues. Vaccine efficacies to protect against infection above 80% are desirable,1 but duration of protection will remain uncertain for a number of years post licensure of COVID-19 vaccines. Preliminary evidence suggests waning antibody titres in those who have recovered from SARS-CoV-2 infection,2 but antibodies are only one part of the human immune response and acquired immunity to reinfection or the prevention of disease when reinfected.3, 4, 5 Data on immunity to other coronaviruses suggest that immunity to SARS-CoV-2 might be short lived, perhaps 12–18 months in duration.6 Whether past infection will prevent severe COVID-19 on re-exposure to SARS-CoV-2 is not known at present. Authors: Wyse C et al Publication date: 27 October 2020 Journal: medRxiv preprint DOI: 10.1101/2020.10.23.20218305 Background: Seasonal disease outbreaks are perennial features of human infectious disease but the factors generating these patterns are unclear. In animal studies, seasonal and circadian (daily) rhythms in immune function generate periodicity in vulnerability to disease, although it is not known whether the same applies to humans. Making use of extensive data from the UK Biobank cohort, we investigate seasonal and daytime variability in multiple immune parameters (inflammatory markers, white blood cell counts and antibody titres), and test for associations with a wide range of environmental and lifestyle factors. Methods and Findings: Markers of inflammation (CRP), and white blood cell counts were measured between 8am and 7pm over a 4-year time period in 329,261 participants in UK Biobank. Individual-level data were linked to other factors that vary over seasonal and daily cycles, including changes in day length, outdoor temperature and vitamin D at the time the blood sample was collected. Analyses were further adjusted for potentially confounding lifestyle factors. Seasonal patterns were evident in lymphocyte and neutrophil counts, and CRP, but not monocytes, and these were independent of lifestyle, demographic and environmental factors. All the immune parameters assessed demonstrated significant daytime variation that was independent of confounding factors. Conclusions: At a population level, human immune parameters vary across season and across time of day, independent of multiple confounding factors. Both season and time of day are fundamental dimensions of immune function that should be considered in all studies of immuno-prophylaxis and disease transmission. Strategic alignment of human activities to seasons and times of the day when we are less susceptible to infection could be an important additional tool for limiting population-level impacts of infectious diseases. |
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Testing |
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Mass testing for covid-19 in the UK Author: Mike Gill Publication date: 16 November 2020 Journal: The BMJ DOI: 10.1136/bmj.m4436 An unevaluated, underdesigned, and costly mess Quick turnaround testing for covid-19 is to be made available to everybody, initially to those without symptoms, across England at a cost of £100bn (€110bn; $130bn).1 This follows a still uncompleted “pilot” in Liverpool, which started on 6 November at the invitation of Liverpool City Council in October, after incidence had peaked. The objective is “to demonstrate that massive asymptomatic testing can help identify far more cases and break the chain of transmission of coronavirus.”2 Participation in this pilot is voluntary. There is no call or recall. All participants receive two tests, the standard PCR test and the rapid turnaround (within 1 hour) lateral flow Innova test. Those with a positive result in either test are asked to self-isolate and are registered with the national track and trace programme, which initiates contact tracing. Key workers, health and social care staff, school staff, and children aged 11 and over are being targeted, but anyone can get tested, preferably at least twice within two weeks. This is a screening programme, not opportunistic case finding: people are invited to have a test they would not otherwise have had, or asked for. If judged against the criteria drawn up by the UK’s National Screening Committee for appraisal of a programme’s viability, effectiveness, and appropriateness,3 it does not do well and has been already roundly criticised. Comparison of seven commercial SARS-CoV-2 rapid Point-of-Care Antigen tests Authors: Corman VM et al Publication date: 13 November 2020 Journal: medRxiv preprint DOI: 10.1101/2020.11.12.20230292 Background: Antigen point of care tests (AgPOCT) can accelerate SARS-CoV-2 testing. As first AgPOCT are becoming available, there is a growing interest in their utility and performance. Methods: Here we compare AgPOCT products by seven suppliers: the Abbott Panbio COVID-19 Ag Rapid Test; the RapiGEN BIOCREDIT COVID-19 Ag; the Healgen Coronavirus Ag Rapid Test Cassette (Swab); the Coris Bioconcept Covid.19 Ag Respi-Strip; the R-Biopharm RIDA QUICK SARS-CoV-2 Antigen; the NAL von minden NADAL COVID19-Ag Test; and the Roche/SD Biosensor SARS-CoV Rapid Antigen Test. Tests were evaluated on recombinant nucleoprotein, cultured endemic and emerging coronaviruses, stored clinical samples with known SARS-CoV-2 viral loads (n=138), stored samples from patients with respiratory agents other than SARS-CoV-2 (n=100), as well as self-sampled swabs from healthy volunteers (n=35). Findings :Limits of detection in six of seven tested products ranged between 2.08 X 106 and 2.88 X 107 copies per swab, the outlier at 1.58 X 1010 copies per swab. Specificities ranged between 98.53% and 100% in five products, with two outliers at 94.85% and 88.24%. False positive results were not associated with any specific respiratory agent. As some of the tested AgPOCT were early production lots, the observed issues with specificity are unlikely to persist. Interpretation: The sensitivity range of most AgPOCT overlaps with viral load figures typically observed during the first week of symptoms, which marks the infectious period in the majority patients. AgPOCTs with a limit of detection that approximates the virus concentration above which patients are infectious may enable shortcuts in decision-making in various areas of healthcare and public health. Authors: Kharlamova N et al Publication date: 13 November 2020 Journal: medRxiv preprint DOI: 10.1101/2020.11.13.20231076 Objectives: Patients with chronic inflammatory diseases are often treated with immunosuppressants and therefore are of particular concern during the SARS-CoV-2 pandemic. Serological tests will improve our understanding of the infection and immunity in this population, unless the tests give false positive results. The aim of this study was to evaluate the specificity of SARS-Cov-2 serological assays with samples from patients with chronic inflammatory diseases collected before April 2019, thus defined as negative. Methods: Samples from patients with multiple sclerosis (MS, n=10), rheumatoid arthritis (RA, n=47) with or without rheumatoid factor (RF) and/or anti-cyclic citrullinated peptide antibodies (anti-CCP2) and RF +/- systemic lupus erythematosus (SLE, n=10), were tested with 17 commercially available lateral flow assays (LFA), two ELISA kits and one in-house developed multiplex bead-based assay. Results: Six LFA and the in-house IgG assay gave the correct negative results for all samples. However, the majority of assays (n=13), gave false positive signal with samples from patients with RA and SLE. This was most notable in RF positive RA samples. MS samples did not give any false positive in any of the assays. Conclusion: The majority of the verified serological assays were sensitive to interfering antibodies in samples from patients with chronic inflammatory diseases and therefore may have poor specificity in this context. For these patients, the risk of false positivity should be considered when interpreting results of the SARS-CoV-2 serological assays. Challenges in Testing for SARS-CoV-2 Among Patients Who Recovered From COVID-19 Author: Mitchell H Katz Publication date: 12 November 2020 Journal: JAMA Internal Medicine DOI: 10.1001/jamainternmed.2020.7575 Among patients who have recovered from COVID-19, repeated testing for SARS-CoV-2 may be done weeks or months after infection either as part of routine screening (eg, screening nursing home personnel on a weekly basis to prevent transmission of infections to patients) or because of the development of symptoms that are worrisome for reinfection. Unfortunately, the interpretation of positive test results in patients who have previously recovered from COVID-19 is fraught. The best widely available test, a real-time polymerase chain reaction (RT-PCR), is very sensitive for fragments of viral RNA and can be positive because of nonviable remnants of the virus. Currently, there is not a widely available test for determining whether the virus can reproduce and transmit infection. In this issue of JAMA Internal Medicine, Liotti et al1 describe the results of retesting 176 patients who had recovered from COVID-19 with 2 negative RT-PCR test results 24 hours apart. At a mean of 48.6 days from their date of diagnosis, 32 patients (18.2%) had a positive PCR test result for SARS-CoV-2 RNA. Using a specialized assay, only 1 of these 32 patients (3.1%) had evidence of RNA capable of replication. Although this study cannot solve the challenge of interpreting positive PCR results in recovered patients, the data help us to better understand the scope of the problem. |
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Vaccines |
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Authors: Ramasamy MN et al Publication date: 18 November 2020 Journal: The Lancet DOI: 10.1016/S0140-6736(20)32466-1 Background: Older adults (aged ≥70 years) are at increased risk of severe disease and death if they develop COVID-19 and are therefore a priority for immunisation should an efficacious vaccine be developed. Immunogenicity of vaccines is often worse in older adults as a result of immunosenescence. We have reported the immunogenicity of a novel chimpanzee adenovirus-vectored vaccine, ChAdOx1 nCoV-19, in young adults, and now describe the safety and immunogenicity of this vaccine in a wider range of participants, including adults aged 70 years and older. Methods: In this report of the phase 2 component of a single-blind, randomised, controlled, phase 2/3 trial (COV002), healthy adults aged 18 years and older were enrolled at two UK clinical research facilities, in an age-escalation manner, into 18–55 years, 56–69 years, and 70 years and older immunogenicity subgroups. Participants were eligible if they did not have severe or uncontrolled medical comorbidities or a high frailty score (if aged ≥65 years). First, participants were recruited to a low-dose cohort, and within each age group, participants were randomly assigned to receive either intramuscular ChAdOx1 nCoV-19 (2·2 × 1010 virus particles) or a control vaccine, MenACWY, using block randomisation and stratified by age and dose group and study site, using the following ratios: in the 18–55 years group, 1:1 to either two doses of ChAdOx1 nCoV-19 or two doses of MenACWY; in the 56–69 years group, 3:1:3:1 to one dose of ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY; and in the 70 years and older, 5:1:5:1 to one dose of ChAdOx1 nCoV-19, one dose of MenACWY, two doses of ChAdOx1 nCoV-19, or two doses of MenACWY. Prime-booster regimens were given 28 days apart. Participants were then recruited to the standard-dose cohort (3·5–6·5 × 1010 virus particles of ChAdOx1 nCoV-19) and the same randomisation procedures were followed, except the 18–55 years group was assigned in a 5:1 ratio to two doses of ChAdOx1 nCoV-19 or two doses of MenACWY. Participants and investigators, but not staff administering the vaccine, were masked to vaccine allocation. The specific objectives of this report were to assess the safety and humoral and cellular immunogenicity of a single-dose and two-dose schedule in adults older than 55 years. Humoral responses at baseline and after each vaccination until 1 year after the booster were assessed using an in-house standardised ELISA, a multiplex immunoassay, and a live severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) microneutralisation assay (MNA80). Cellular responses were assessed using an ex-vivo IFN-γ enzyme-linked immunospot assay. The coprimary outcomes of the trial were efficacy, as measured by the number of cases of symptomatic, virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were by group allocation in participants who received the vaccine. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. This study is ongoing and is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137. Findings: Between May 30 and Aug 8, 2020, 560 participants were enrolled: 160 aged 18–55 years (100 assigned to ChAdOx1 nCoV-19, 60 assigned to MenACWY), 160 aged 56–69 years (120 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY), and 240 aged 70 years and older (200 assigned to ChAdOx1 nCoV-19: 40 assigned to MenACWY). Seven participants did not receive the boost dose of their assigned two-dose regimen, one participant received the incorrect vaccine, and three were excluded from immunogenicity analyses due to incorrectly labelled samples. 280 (50%) of 552 analysable participants were female. Local and systemic reactions were more common in participants given ChAdOx1 nCoV-19 than in those given the control vaccine, and similar in nature to those previously reported (injection-site pain, feeling feverish, muscle ache, headache), but were less common in older adults (aged ≥56 years) than younger adults. In those receiving two standard doses of ChAdOx1 nCoV-19, after the prime vaccination local reactions were reported in 43 (88%) of 49 participants in the 18–55 years group, 22 (73%) of 30 in the 56–69 years group, and 30 (61%) of 49 in the 70 years and older group, and systemic reactions in 42 (86%) participants in the 18–55 years group, 23 (77%) in the 56–69 years group, and 32 (65%) in the 70 years and older group. As of Oct 26, 2020, 13 serious adverse events occurred during the study period, none of which were considered to be related to either study vaccine. In participants who received two doses of vaccine, median anti-spike SARS-CoV-2 IgG responses 28 days after the boost dose were similar across the three age cohorts (standard-dose groups: 18–55 years, 20 713 arbitrary units [AU]/mL [IQR 13 898–33 550], n=39; 56–69 years, 16 170 AU/mL [10 233–40 353], n=26; and ≥70 years 17 561 AU/mL [9705–37 796], n=47; p=0·68). Neutralising antibody titres after a boost dose were similar across all age groups (median MNA80 at day 42 in the standard-dose groups: 18–55 years, 193 [IQR 113–238], n=39; 56–69 years, 144 [119–347], n=20; and ≥70 years, 161 [73–323], n=47; p=0·40). By 14 days after the boost dose, 208 (>99%) of 209 boosted participants had neutralising antibody responses. T-cell responses peaked at day 14 after a single standard dose of ChAdOx1 nCoV-19 (18–55 years: median 1187 spot-forming cells [SFCs] per million peripheral blood mononuclear cells [IQR 841–2428], n=24; 56–69 years: 797 SFCs [383–1817], n=29; and ≥70 years: 977 SFCs [458–1914], n=48). Interpretation: ChAdOx1 nCoV-19 appears to be better tolerated in older adults than in younger adults and has similar immunogenicity across all age groups after a boost dose. Further assessment of the efficacy of this vaccine is warranted in all age groups and individuals with comorbidities. Rapid Response: Covid-19 vaccine candidate is unimpressive: NNTV is around 256 Author: Alan Cunningham Publication date: 09 November 2020 Journal: The BMJ DOI: 10.1136/bmj.m4347 Pfizer’s vaccine “may be more than 90% effective.” (Mahase, BMJ 2020;371:m4347, November 9) Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000. This yields a Covid-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a “vaccine effectiveness” of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039). The Number Needed To Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just 1 Covid-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them……We’ve already heard that an early effect of the vaccine is “like a hangover or the flu.” Will vaccinees who are later exposed to coronaviruses have more severe illness as a result of antibody-dependent enhancement of infection (ADEI), a known hazard of coronavirus vaccines? Is there squalene in the Pfizer vaccine? If so, will vaccinees be subject to autoimmune diseases, like Gulf War Syndrome and narcolepsy that have been associated with the adjuvant? |
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Non-pharmaceutical interventions |
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Authors: Bungaard H et al Publication date: 18 November 2020 Journal: Annals of Internal Medicine DOI: 10.7326/M20-6817 Background: Observational evidence suggests that mask wearing mitigates transmission of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). It is uncertain if this observed association arises through protection of uninfected wearers (protective effect), via reduced transmission from infected mask wearers (source control), or both. Objective: To assess whether recommending surgical mask use outside the home reduces wearers' risk for SARS-CoV-2 infection in a setting where masks were uncommon and not among recommended public health measures. Intervention: Encouragement to follow social distancing measures for coronavirus disease 2019, plus either no mask recommendation or a recommendation to wear a mask when outside the home among other persons together with a supply of 50 surgical masks and instructions for proper use. Measurements: The primary outcome was SARS-CoV-2 infection in the mask wearer at 1 month by antibody testing, polymerase chain reaction (PCR), or hospital diagnosis. The secondary outcome was PCR positivity for other respiratory viruses. Results: A total of 3030 participants were randomly assigned to the recommendation to wear masks, and 2994 were assigned to control; 4862 completed the study. Infection with SARS-CoV-2 occurred in 42 participants recommended masks (1.8%) and 53 control participants (2.1%). The between-group difference was −0.3 percentage point (95% CI, −1.2 to 0.4 percentage point; P = 0.38) (odds ratio, 0.82 [CI, 0.54 to 1.23]; P = 0.33). Multiple imputation accounting for loss to follow-up yielded similar results. Although the difference observed was not statistically significant, the 95% CIs are compatible with a 46% reduction to a 23% increase in infection. Limitation: Inconclusive results, missing data, variable adherence, patient-reported findings on home tests, no blinding, and no assessment of whether masks could decrease disease transmission from mask wearers to others. Conclusion: The recommendation to wear surgical masks to supplement other public health measures did not reduce the SARS-CoV-2 infection rate among wearers by more than 50% in a community with modest infection rates, some degree of social distancing, and uncommon general mask use. The data were compatible with lesser degrees of self-protection. Association of social distancing and masking with risk of COVID-19 Authors: Kwon S et al Publication date: 13 November 2020 Journal: medRxiv preprint DOI: 10.1101/2020.11.11.20229500 Given the continued burden of severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) disease (COVID-19) across the U.S., there is a high unmet need for data to inform decision-making regarding social distancing and universal masking. We examined the association of community-level social distancing measures and individual masking with risk of predicted COVID-19 in a large prospective U.S. cohort study of 198,077 participants. Individuals living in communities with the greatest social distancing had a 31% lower risk of predicted COVID-19 compared with those living in communities with poor social distancing. Self-reported masking was associated with a 63% reduced risk of predicted COVID-19 even among individuals living in a community with poor social distancing. These findings provide support for the efficacy of mask-wearing even in settings of poor social distancing in reducing COVID-19 transmission. In the current environment of relaxed social distancing mandates and practices, universal masking may be particularly important in mitigating risk of infection. Authors: Huang S et al Publication date: 13 November 2020 Journal: medRxiv preprint DOI: 10.1101/2020.11.11.20228692 Stringent nonpharmaceutical interventions (NPIs) such as lockdowns and border closures are not currently recommended for pandemic influenza control. New Zealand used these NPIs to eliminate coronavirus disease 2019 during its first wave. Using multiple surveillance systems, we observed a parallel and unprecedented reduction of influenza and other respiratory viral infections in 2020. This finding supports the use of these NPIs for controlling pandemic influenza and other severe respiratory viral threats. |
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Social impacts |
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Loneliness, Mental Health, and Substance Use among US Young Adults during COVID-19 Authors: Horigian VE et al Publication date: 28 October 2020 Journal: Journal of Psychoactive Drugs DOI: 10.1080/02791072.2020.1836435 As COVID-19 converges with loneliness and addiction epidemics in the US, both public health and mental health experts forecast dramatic increases in substance use and mental health conditions. This cross-sectional study evaluated relationships of loneliness with depression, anxiety, alcohol use, and drug use during COVID-19, and assessed perceived increases in these symptoms in young adults. Between April 22 and May 11, 2020, 1,008 participants ages 18–35 were recruited through social media to a one-time, online anonymous survey. Symptomatology was assessed using six scales. Perceived changes since COVID-19 were evaluated using 5-point Likert scales. Forty-nine percent of respondents reported loneliness scores above 50; 80% reported significant depressive symptoms; 61% reported moderate to severe anxiety; 30% disclosed harmful levels of drinking. While only 22% of the population reported using drugs, 38% reported severe drug use. Loneliness was associated with higher levels of mental health symptomatology. Participants reported significant increases across mental health and substance use symptoms since COVID-19. While direct impacts of COVID-19 could only be calculated with pre-pandemic assessments of these symptoms, estimates indicate elevated psychosocial symptomatology and suggest that symptoms could have worsened since the pandemic. Findings underscore the importance of prevention and intervention to address these public health problems. |
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Government and Health Authorities |
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Testing |
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Publication date: 08 November 2020 Source: Oxford University Executive summary
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Immunity |
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Evaluating detection of SARS-CoV-2 antibodies Publication date: 22 Setpember 2020 (updated 16 November 2020) Source: Public Health England In many studies evaluating how well LFTs work, samples from people who have had COVID-19 (evidenced by symptoms and positive PCR tests, a group known to have high levels of antibodies against SARS-CoV-2) are compared with samples from people who haven't had disease- typically from before the pandemic. We show this kind of evaluation overestimates how well LFTs work. This is because most people who are infected don't have the high levels of antibodies used in the LFT comparisons. Additionally, using the device we studied we were able to show that it worked much less well at lower antibody concentrations. |
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Infection rates |
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Coronavirus (COVID-19) Infection Survey, UK: 13 November 2020 Publication date: 13 November 2020 Source: Office for National Statistics Positivity rates in England have increased in recent weeks, but the rate of increase is slower than previous weeks; during the most recent week (31 October to 6 November 2020), we estimate 654,000 people (95% credible interval: 619,400 to 689,800) within the community population in England had the coronavirus (COVID-19), equating to around 1 in 85 people (95% credible interval: 1 in 90 to 1 in 80). |
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Vaccines |
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Promising Interim Results from Clinical Trial of NIH-Moderna COVID-19 Vaccine Publication date: 16 November 2020 Source: National Institute of Health An independent data and safety monitoring board (DSMB) overseeing the Phase 3 trial of the investigational COVID-19 vaccine known as mRNA-1273 reviewed trial data and shared its interim analysis with the trial oversight group on Nov. 15, 2020. This interim review of the data suggests that the vaccine is safe and effective at preventing symptomatic COVID-19 in adults. The interim analysis comprised 95 cases of symptomatic COVID-19 among volunteers. The DSMB reported that the candidate was safe and well-tolerated and noted a vaccine efficacy rate of 94.5%. The findings are statistically significant, meaning they are likely not due to chance. 90 of the cases occurred in the placebo group and 5 occurred in the vaccinated group. There were 11 cases of severe COVID-19 out of the 95 total, all of which occurred in the placebo group. The mRNA-1273 vaccine candidate was co-developed by the Cambridge, Massachusetts-based biotechnology company Moderna, Inc., and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. It combines Moderna’s mRNA (messenger RNA) delivery platform with the stabilized SARS-CoV-2 spike immunogen (S-2P) developed by NIAID scientists. |
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Media – Science related |
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Origins |
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EcoHealth Alliance orchestrated key scientists’ statement on “natural origin” of SARS-CoV-2 Author: Sainath Sryanarayanan Publication date: 18 November 2020 Source: US Right to Know Emails obtained by U.S. Right to Know show that a statement in The Lancet authored by 27 prominent public health scientists condemning “conspiracy theories suggesting that COVID-19 does not have a natural origin” was organized by employees of EcoHealth Alliance, a non-profit group that has received millions of dollars of U.S. taxpayer funding to genetically manipulate coronaviruses with scientists at the Wuhan Institute of Virology. The emails obtained via public records requests show that EcoHealth Alliance President Peter Daszak drafted the Lancet statement, and that he intended it to “not be identifiable as coming from any one organization or person” but rather to be seen as “simply a letter from leading scientists”. Daszak wrote that he wanted “to avoid the appearance of a political statement”. The scientists’ letter appeared in The Lancet on February 18, just one week after the World Health Organization announced that the disease caused by the novel coronavirus would be named COVID-19. The 27 authors “strongly condemn[ed] conspiracy theories suggesting that COVID-19 does not have a natural origin,” and reported that scientists from multiple countries “overwhelmingly conclude that this coronavirus originated in wildlife.” The letter included no scientific references to refute a lab-origin theory of the virus. One scientist, Linda Saif, asked via email whether it would be useful “to add just one or 2 statements in support of why nCOV is not a lab generated virus and is naturally occuring? Seems critical to scientifically refute such claims!” Daszak responded, “I think we should probably stick to a broad statement.” Validity of key studies on origin of coronavirus in doubt; science journals investigating Author: Carey Gillam Publication date: 09 November 2020 Source: US Right to Know Since the outbreak of COVID-19 in the Chinese city of Wuhan in December 2019, scientists have searched for clues about what led to the emergence of its causative agent, the novel coronavirus SARS-CoV-2. Uncovering the source of SARS-CoV-2 could be crucial for preventing future outbreaks. A series of four high profile studies published earlier this year provided scientific credence to the hypothesis that SARS-CoV-2 originated in bats and then jumped to humans through a type of anteater called a pangolin — among the world’s most trafficked wild animals. While that specific theory involving pangolins has been largely discounted, the four studies known as the “pangolin papers” continue to provide support for the notion that coronaviruses closely related to SARS-CoV-2 circulate in the wild, meaning the SARS-CoV-2 that caused COVID-19 probably comes from a wild animal source. The focus on a wild animal source, the “zoonotic” theory, has become a critical element in global discussion about the virus, directing public attention away from the possibility that the virus may have originated inside a Chinese governmental laboratory – the Wuhan Institute of Virology. |
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Non-pharmaceutical interventions |
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Does Science Really Demand that Bars and Restaurants Close? Author: Micha Gartz Publication date: 17 November 2020 Source: American Institute for Economic Research It’s Now Up to Governors to Slow the Spread,” says a Wall Street Journal article — written by board members of pharmaceutical companies Pfizer and Illumina, Johnson and Johnson and Cigna. It encourages states and governors to band together and implement restrictions “focus[ed] on known sources of spread, such as bars and nightclubs.” Drs. Gottlieb and McClellan’s plea sounds reasonable. After all, ‘the science’ tells us that Covid spreads in confined spaces. Basing policy advice on ‘the science’ would be the sensible thing to do. These spaces — the restaurants, bars and cafes we enjoy — must be closed for our protection. But there’s just one small problem: ‘the science’ isn’t really there. In fact, the only evidence we have is circumstantial: all we have are data simulations (in other words, predictions), case studies followed up with contact tracing, and… that’s it. Given that Covid has become a worldwide attention magnet for 8 months one would expect a lot more substantial evidence than is available. |
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Lockdowns |
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New health group calls for Nphet to be disbanded Author: Ali Bracken Publication date: 15 November 2020 Source: Independent.ie A group of GPs and other medical professionals who are calling for an end to lockdown and questioning Nphet's health advice are demanding an urgent meeting with the Government. A group consisting of mainly GPs - including former Fianna Fáil minister Jim McDaid and the Mater Hospital's infectious disease expert Professor Jack Lambert - has signed a "white paper" questioning what it calls Ireland's "outdated" public health strategies in response to Covid-19. Many of the signatories are part of a newly formed group, named Covid Recovery - A Scientific Approach, that includes 67 doctors and 100 scientists. Cavan-based GP Michael McConville is a member of the group and was involved in the development of its white paper. His daughter, who lost her job during Covid-19, has set up a GoFundMe page for the group. It has raised over €9,000, which is to be used for her employment within the organisation. Angela Merkel faces rebellion from regional leaders over Covid rules Author: Justin Huggler Publication date: 16 November 2020 Source: The Telegraph Angela Merkel faced a coronavirus rebellion on Monday as German regional leaders rejected her proposals for new lockdown restrictions. The German chancellor wanted to impose tough new measures, including reducing school hours and making face masks compulsory for children of all ages. Germans would have been limited to social contact with one other designated household, while outside, school children would only be allowed to meet with one designated friend. But her proposals were torn up by the heads of Germany’s 16 states in fiery video conference talks that overran by more than three hours. A Second National Lockdown is Dangerous and Reckless Author: Ethan Young Publication date: 13 November 2020 Source: American Institute for Economic Research On Wednesday, November 11, CNBC reported that Dr. Michael Osterholm, a member of Joe Biden’s Covid-19 task force, suggested that the United States should enact a 4-6 week lockdown, stricter than any imposed before. CNBC writes “Shutting down businesses and paying people for lost wages for four to six weeks could help keep the coronavirus pandemic in check and get the economy on track until a vaccine is approved and distributed, said Dr. Michael Osterholm, a coronavirus advisor to President-elect Joe Biden.” This idea was pitched in response to expected spikes in Covid-19 cases in the coming months. Osterholm’s reasoning included: Biden COVID-19 adviser suggests potential lockdown lasting over a month Author: Michael Ruiz Publication date: 11 November 2020 Source: Fox Business One of President-elect Joe Biden’s coronavirus advisers floated the idea of a nationwide coronavirus lockdown in an effort to rein in the illness and rejuvenate the economy as new cases climb once again. Michael Osterholm, a University of Minnesota expert on infectious diseases, said in an interview with Yahoo! Finance that a four- to six-week lockdown could both control the virus’ spread and benefit the economy. “We could pay for a package right now to cover all of the wages, lost wages, for individual workers,” he told the outlet, noting low interest rates. He added that federal borrowing could bail out small- and medium-sized companies, cities, states and county governments. “If we did that, then we could lock down for four to six weeks, and if we did that, we could drive the numbers down,” he said. “Like they’ve done in Asia. Like they did in New Zealand and Australia.” |
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Vaccines |
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Publication date: 16 November 2020 Source: Moderna First interim analysis included 95 participants with confirmed cases of COVID-19 Phase 3 study met statistical criteria with a vaccine efficacy of 94.5% (p <0.0001) Moderna intends to submit for an Emergency Use Authorization (EUA) with U.S. FDA in the coming weeks and expects the EUA to be based on the final analysis of 151 cases and a median follow-up of more than 2 months CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 16, 2020-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the independent, NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3 study of mRNA-1273, its vaccine candidate against COVID-19, has informed Moderna that the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%. This study, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001). Authors: Loomba et al Publication date: 26 October 2020 Journal: medRxiv preprint DOI: 10.1101/2020.10.22.20217513 The successful development and widespread acceptance of a SARS-CoV-2 vaccine will be a major step in fighting the pandemic, yet obtaining high uptake will be a challenging task, worsened by online misinformation. To help inform successful COVID-19 vaccination campaigns in the UK and US, we conducted a survey to quantify how online misinformation impacts COVID-19 vaccine uptake intent and identify socio-economic groups that are most at-risk of non-vaccination and most susceptible to online misinformation. Here, we report findings from nationally representative surveys in the UK and the US conducted in September 2020. We show that recent misinformation around a COVID-19 vaccine induces a fall in vaccination intent among those who would otherwise “definitely” vaccinate by 6.4 (3.8, 9.0) percentages points in the UK and 2.4 (0.1, 5.0) in the US, with larger decreases found in intent to vaccinate to protect others. We find evidence that socio-econo-demographic, political, and trust factors are associated with low intent to vaccinate and susceptibility to misinformation: notably, older age groups in the US are more susceptible to misinformation. We find evidence that scientific-sounding misinformation relating to COVID-19 and vaccines COVID-19 vaccine misinformation lowers vaccination intent, while corresponding factual information does not. These findings reveal how recent COVID-19 misinformation can impact vaccination rates and suggest pathways to robust messaging campaigns. The Covid-19 vaccine will need to have a flawless PR strategy Author: Amit Katwala Publication date: 13 November 2020 Source: Wired Producing and distributing the vaccine is only the first step. The real challenge? Convincing people to have the jab. There is, as you probably know by now, a very long list of things that need to happen before a coronavirus vaccine can be rolled out across the country: raw materials need to be sourced, a sub-zero, Brexit-proof distribution system needs to be designed and implemented, and difficult decisions about who should get the first, scarce doses need to be made. But so far, one of the most important aspects has been largely overlooked. The British government has been under fire over the last week for its lavish spending on PR and communications. Kate Bingham, the head of the vaccine task force, was criticised for spending £670,000 of public money on a “boutique PR” firm, whose services included a bespoke podcast. And at Prime Minister’s Questions this week, Labour leader Keir Starmer hammered Boris Johnson, alleging that £130 million had been spent on public relations by the government since the start of the pandemic. “It was to raise awareness,” Johnson mumbled – as if the news of Pfizer’s mRNA vaccine and its apparent 90 per cent efficacy would have passed under the radar otherwise. |
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Social impacts |
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The State of the Nation: A 50-state covd-19 survey report #23: depression among young adults Authors: Perlis RH et al Publication date: November 2020 Source: www.covidstates.org Alongside the direct health impact of COVID-19 itself, there has been increasing recognition of the consequences of the pandemic for mental health. Initial attention focused on the front line health workers impacted by the first surge, but Americans have felt the impact of the pandemic and the strategies required to contain it far more broadly. Prior to COVID-19, the mental health of young adults in the United States had already been recognized as a major concern, with suicide representing the 2nd-leading cause of death among individuals age 10-34 (unintentional injury is the leading cause of death in this age group). With the advent of the pandemic, many in this group have experienced disruption in college or graduate school plans, family life, or employment -- particularly as they tend to have jobs with less flexibility or capacity for remote work. |
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Media – Reporting |
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Covid-19 science |
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A Lack of Transparency Is Undermining Pandemic Policy Author: Roxanne Khamsi Publication date: 16 November 2020 Source: Wired NEW YORKERS ARE still puzzling over a new, state-wide rule that bars, restaurants, and gyms must close at 10 pm to stop the spread of Covid. Was this based on some brand-new evidence that the virus mutates like a gremlin, getting worse at night? You wouldn’t know it from Governor Andrew Cuomo’s announcement, which did not cite any research whatsoever that might justify this policy. The announcement did claim, however, that New York uses “more science than any state in the nation.” I’ve seen this happen again and again since the start of the pandemic: a new, “science-based” Covid-19 measure is prescribed, but the science in support of it is either vague or missing altogether. Just last week, for example, I was working on a story about the latest research into quarantine procedures. The best data to this point suggests that an eight-day stretch of quarantine, combined with a Covid test, provides the same level of protection as the traditional 14-day quarantine. But then I saw New York state’s new policy: Some people who arrived from out of state are allowed to quarantine for just four days. I asked New York’s Department of Health how they’d come to this decision, and they sent me another statement from Cuomo, in which he said only that he’d “worked with global health experts” on the plan. A formal guidance from the state health department gave no research citations, either, but it did find space to boast about New York’s record of “strict adherence to data-driven, evidence-based protocols.” Read more... |
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Government controls |
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Germany reforms coronavirus laws: What you need to know Publication date: 18 November 2020 Source: The Local de On Wednesday, Germany’s federal government cleared the way for changes in the Infection Protection Act planned by the grand coalition of Chancellor Angela Merkel’s Christian Democrats (CDU) and Social Democrats (SPD). In the parliament (Bundestag) 415 delegates voted on Wednesday in favour of the reform, which aims to give coronavirus measures a stronger legal footing. A full 236 voted against it, while eight abstained in the roll-call vote. During parallel protests, several thousand participants rallied against the change in the law as well as current coronavirus measures on Wednesday. There were clashes with police and more than 100 arrests. Britain's government is exploiting fear to suit its actions, whether on Covid or terrorism Author: Simon Jenkins Publication date: 06 November 2020 Source: The Guardian The home secretary told me this week that I faced a terrorist threat that was “severe” and an incident that was “highly likely”. I should be “alert”, she said. What is the difference between likely and highly likely? Should I fear to leave home? Should I run for my life if I see a man with a backpack? Priti Patel also tells me to be “not alarmed”. So why does she try to scare me? Is she on the terrorists’ side? If I were able to ask the recent murderers in France and Austria what they hoped to gain, I know what they would say. They would want their blood-curdling killings to spread fear among the French and Austrians, to instil antipathy towards Muslims and inspire more acts of terror. Above all they would want their deeds publicised and politicised, to seem heroic to their kind. President Macron duly obliged. Now Patel has given them a bonus. She has offered to make Britons equally afraid. |
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Covid-19 perceptions |
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TCW poll reveals ignorance and exaggerated fear about Covid Publication date: 14 November 2020 Source: The Conservative Woman A NEW Conservative Woman/Savanta ComRes poll reveals a series of profound public misconceptions about the risk of dying from Covid-19, many encouraged by the Government, which may call into question the basis on which repeated opinion polls have registered high levels of support for the latest lockdown restrictions. These misconceptions extend to exaggerated public fears about the age at which people have died with it, the mortality rates of Covid compared to other causes of death and the incidence of ‘long Covid’. The polling also paints a bleak picture of the negative impact of Covid-19 on mental health and access to non-Covid NHS treatment, particularly among women, the disabled and young people. Kathy Gyngell, editor of The Conservative Woman, said of the findings: ‘It is horrifying to think that the British public have been persuaded to support the Government’s extended and restrictive lockdown policy on the basis of such deep misconception of the risk, especially when it has come at such catastrophic cost to their own well-being and that of wider society. |
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Therapeutics |
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Covid: UK government requests guidance on vitamin D use Author: Mattha Busby Publication date: 24 November 2020 Source: The Guardian Vitamin D has moved a step closer to being used as a potential way to prevent and treat coronavirus after Matt Hancock asked government health advisers to produce new guidelines on its use. The health secretary told the National Institute for Health and Care Excellence (Nice) and Public Health England to create guidelines for the use of the “sunshine” nutrient two weeks ago, before it was reported that the government was planning to give four months worth of vitamin D supplements to more than 2 million vulnerable and elderly people, following the lead of Scotland. In a statement, a spokesperson for Nice, which sets NHS clinical guidelines, told the Guardian: “Nice and PHE received a formal request to produce recommendations on vitamin D for prevention and treatment of Covid from the secretary of state for health and social care, Matt Hancock, on October 29.” Nutrition, the digestive system and immunity in COVID-19 infection Authors: Bold JS et al Publication date: 20 September 2020 Journal: Gastroenterology and Hepatology from Bed to Bench DOI: 10.22037/ghfbb.v13i4.2094 The current review aimed to synthesize the literature on the complex relationship between food consumption and nutritional status as well as the digestive system in order to examine the relationship between immunity and potential responses to COVID-19 infection. The goal is to help inform the many healthcare professionals working with COVID-19 patients. A literature search was performed on PubMed, Scopus, and EMBASE databases. Hand searches were also undertaken using Google and reference lists to identify recent evidence. Studies were critically appraised, and the findings were analyzed by narrative synthesis. Nutritional status can impact immunity in several ways, including affecting susceptibility to infection, severity of disease, and recovery time, and is therefore a significant consideration in the management of COVID-19. COVID-19 can also impact digestive function, which can further impact nutritional status. The role of Vitamin D deficiency in vulnerability to severe respiratory infections, including COVID-19, has been recognized, and it may have a role in treatment where deficiency is indicated. Healthcare professionals should be aware that obesity may be accompanied by micronutrient malnutrition including vitamin D deficiency and alterations in the microbiome and inflammatory responses, which can further impact immunity and disease severity. Multidisciplinary team-work is recommended in the management of patients with COVID-19, and approaches should include a consideration of nutritional status (both macronutrients and micronutrients), body weight, and gastrointestinal signs and symptom. |
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Lockdowns |
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A ban on exercise, crazy fines and only 22 Covid cases – welcome to Australia's latest lockdown Author: Robert Fenwick Elliott Publication date: 18 November 2020 Source: The Telegraph This is the response to the latest “surge” in the disease, a cluster of 22 Covid-19 cases in Adelaide. Two new cases – just two – were diagnosed in the State today. There are no reports that either have any symptoms, or are actually ill. In addition, another two people are in hospital having tested positive recently. Just two. Neither is in intensive care. But hey mate, hospital is hospital! No one has died recently, but in total since January, four people in South Australia have lost their lives to Covid. In an average year, this State registers about 13,500 deaths. Yesterday, 9,659 people were tested. They had dutifully queued for many hours. So there will presumably be more cases being reported in coming days, if only due to inevitable false positives. Quite a big slug of the revenue obtained by the South Australian government is from tax on pokies, as gambling machines are known here. They also make quite a bit of money from fining people. Most of this is derived from people driving on the roads at a sensible speed, which is more than the speed limits. Switzerland dubbed 'the new Sweden' as government resists lockdown despite soaring caseload Author: Alexandra Williams Publication date: 17 November 2020 Source: The Telegraph Business is brisk in the shops of the Alpine town of Davos. Apart from the ubiquitous sight of masks - available crystal-encrusted in this luxury Swiss ski resort – there are almost no signs of a global pandemic. In Vögele Shoes store, biotech executive Aled Williams, 50, is busy buying his daughter a pair of snow boots. “Everyone is very respectful here,” he said. “Distances are maintained, hand sanitizers are everywhere and businesses are open. It’s a great vibe.” This landlocked country is home to the five European regions hit hardest by the coronavirus, according to the World Health Organization, but Switzerland has chosen not to implement a second national lockdown, so for many, life goes on more or less as normal. Switzerland’s light-touch approach has been likened to that of Sweden, which refused to enter lockdown earlier this year alongside most other European nations and became one of the worst-affected areas in Europe. 'We have passed the Covid-19 peak' says France's health minister Publication date: 16 November 2020 Source: The Local fr Two weeks into France's second lockdown, the country's health minister believes the "peak" of new Covid-19 cases has passed and the situation is slowly starting to improve. Speaking in an interview on Sunday to a group of French regional newspapers, Health Minister Olivier Véran said: "There is every indication that we have passed the peak of the epidemic [in the second wave]". However, he cautioned that "we haven't yet defeated the virus. Clearly, it is too early to claim victory and relax our efforts." He was speaking as both the number of new cases reported and the percentage of positive tests showed a slow but steady fall, although death rates remain high. How Finland and Norway Proved Sweden’s Approach to COVID-19 Works Author: Jon Miltimore Publication date: 13 November 2020 Source: Foundation for Economic Education The coronavirus is back in force. Many nations around the world are seeing alarming rises in cases and deaths, totals that in many instances exceed the highs reached in March, April, and May. From the beginning of the pandemic, governments around the world have tried to tame the virus. All have failed, to varying degrees. Whether governments implement draconian lockdowns, modest lockdowns, or no lockdowns at all, the virus has spread. Some countries with harsh lockdowns have fared better; many have fared worse. As some have pointed out, the virus doesn’t seem to care what policies you put in place. |
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Immunity |
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Immunity to the Coronavirus May Last Years, New Data Hint Author: Apoorva Mandavilli Publication date: 17 November 2020 Source: NY Times How long might immunity to the coronavirus last? Years, maybe even decades, according to a new study — the most hopeful answer yet to a question that has shadowed plans for widespread vaccination. Eight months after infection, most people who have recovered still have enough immune cells to fend off the virus and prevent illness, the new data show. A slow rate of decline in the short term suggests, happily, that these cells may persist in the body for a very, very long time to come. The research, published online, has not been peer-reviewed nor published in a scientific journal. But it is the most comprehensive and long-ranging study of immune memory to the coronavirus to date. “That amount of memory would likely prevent the vast majority of people from getting hospitalized disease, severe disease, for many years,” said Shane Crotty, a virologist at the La Jolla Institute of Immunology who co-led the new study. Our immune systems can cope with Covid-19 – it's our politicians who can't Author: Angela Rasmussen Publication date: 15 November 2020 Source: The Guardian A great deal of conflicting information has emerged about the immune response that develops in patients who have recovered from Covid-19. A recent study in the UK showed declining antibodies in more than 350,000 people, leading to headlines that immunity wanes rapidly just months after infection. The next day, another study concluded the opposite: in more than 30,000 patients in New York City, the majority showed high levels of IgG antibodies, which are the type of antibodies that typically neutralise Sars-Cov-2, the virus that causes Covid-19. Naturally this is very confusing. Is Sars-Cov-2 a superpowered virus that can subvert the immune systems that protect us so effectively against many other pathogens? Can people who have recovered from Covid-19 expect to have long-lasting protective immunity or not? The good news is that we are unlikely to be reinfected with Sars-Cov-2 repeatedly until it eventually wipes us all out. Most of the evidence in both Covid-19 patients and animal models shows that the immune response to this is quite typical for an acute viral infection. Initially, the body ramps up high levels of IgG antibodies, but after the infection is cleared, those antibodies drop to a baseline level, which may be below the limit of detection of some serological tests. |
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Vaccines |
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Bill Gates worries about a ‘dysfunctional’ approach to Covid-19 vaccine distribution Author: Elizabeth Cooney Publication date: 17 November 2020 Source: STAT Bill Gates fears a “dysfunctional” approach to distributing Covid-19 vaccines, he said Tuesday, despite an inspiring effort by biopharmaceutical companies to produce promising candidates with high measures of protection. Developing apparently effective vaccines so quickly — especially exploiting a novel approach that uses mRNA to instruct cells to make viral proteins and trigger an immune response — has been “fantastic,” Gates said in conversation with Rick Berke, STAT’s co-founder and executive editor, during the 2020 STAT Summit. Despite worries about the speed with which companies moved to get there under perceived political pressure, he said “no corners were cut” by companies backed by Operation Warp Speed or by Pfizer, which developed a vaccine with a German partner without U.S. government funding. Author: Nicholas McElroy Publication date: 13 November 2020 Source: abcNews Australia's national vaccination policy has been endorsed by the National Cabinet. It outlines that there'll be a national system to monitor immunisation levels and individual vaccination status. Prime Minister Scott Morrison says Australia needs to be ready for when vaccines have been approved by the Therapeutic Goods Administration (TGA). And with forecasts that a vaccine could be available in Australia from early 2021, it's likely going to happen sooner rather than later. Here's what we know so far about how a successful COVID-19 vaccine would be rolled out in Australia. Fewer people say they would take a COVID-19 vaccine now than 3 months ago Author: Gayle Markovitz Publication date: 05 November 2020 Source: World Economic Forum
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Covid-19 patients |
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Dame Sally Davies: obesity scourge led to 50,000 Covid death toll Authors Tom Newton, Andrew Gregory Publication date: 15 November 2020 Source: The Sunday Times Thousands of coronavirus deaths could have been avoided if ministers had tackled the obesity crisis, England’s former chief medical officer says today. Professor Dame Sally Davies blames the country’s high death toll on “a structural environment” that enabled junk food makers to encourage consumption. The UK has one of the highest rates of obesity in the world and the second highest in Europe, with nearly one in three adults obese. Obesity, defined as a body mass index greater than 30, raises the risk of dying of Covid-19 by 48%. Over 3.5 million people aged over 50 had hospital treatment cancelled between February and May Authors: Carol Propper, Isabel Stockton and George Stoye Publication date: 06 November 2020 Source: Institute for Fiscal Studies During the early stages of the pandemic, delivery of routine healthcare was changed dramatically in order to prioritise COVID patients’ care and minimise the risk of COVID infection in healthcare settings. As a second national lockdown begins in England, a new report produced by researchers at the Institute for Fiscal Studies, funded by the Economic and Social Research Council (ESRC) as part of UK Research and Innovation’s rapid response to COVID-19, shows that access to health care services for the over 50s was hugely disrupted during the early stage of the pandemic. Drawing on new data from the English Longitudinal Study of Ageing (ELSA) Covid-19 study, a survey of adults in their 50s and over in Summer 2020, researchers find that those in poor health initially and those in more deprived areas were most likely to lose access to treatment they needed. |
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Education |
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We cannot allow the pandemic to reverse a generation of progress in education Author: Daniel Hannan Publication date: 15 November 2020 Source: The Telegraph Ten months of restrictions have undone ten years of progress for children from low-income households. Our last real GCSE results – those of 2019 – showed that we were well on the way to realising Michael Gove’s ambition of bringing state schools up to the standard of private schools. Then came the lockdown. While it was unpleasant for everyone, it was especially hard on young people. Yanked out of school with no goodbyes or exams, their opportunities narrowed, a lifetime of paying off the debts we have run up – and all because of a disease that poses next to no risk to them. The effects are also socio-economically asymmetric. We think of natural disasters and epidemics as levellers; but, as a study by the Sutton Trust showed, the impact of the school closures was far more severe for underprivileged kids. |
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Social Impacts |
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Lockdown plus autumn sends loneliness soaring Author: Sean Coughlan Publication date: 17 November 2020 Source: BBC News The week after the clocks went back saw Britain's highest levels of loneliness since the pandemic began, according to Office for National Statistics figures. The start of November, with darker evenings, had 4.2 million adults always or often lonely, compared with 2.6 million before the pandemic. This was the peak in levels of acute loneliness since the lockdown in March. Loneliness Minister Baroness Barran says the next few months will be "incredibly challenging". Japan suicide rates soar as economy suffers from coronavirus pandemic Author: Danielle Demetriou Publication date: 11 November 2020 Source: The Telegraph Suicide rates in Japan have soared to the highest level in five years, as the coronavirus pandemic takes its toll on the world’s third largest economy. A total of 2,153 people killed themselves during October, a monthly increase of more than 300, according to preliminary police data. Suicide rates across Japan have been climbing since July, but the October figures mark the highest monthly tally since 2015. The surge in people taking their own lives has been widely attributed to the economic impact of the pandemic, which resulted in 870,000 job losses in Japan in the first seven months of the year, according to government figures. Women have been hit hardest by the redundancies, with female workers more likely to be in temporary employment in the retail or services industries, which have been heavily impacted by the pandemic. |
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Misinformation |
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Covid-19: Stop anti-vaccination fake news online with new law says Labour Publication date: 14 November 2020 Source: BBC News Emergency laws to "stamp out dangerous" anti-vaccine content online should be introduced, Labour has said. The party is calling for financial and criminal penalties for social media firms that do not remove false scare stories about vaccines. It follows news of progress on the first effective coronavirus vaccine. The government said it took the issue "extremely seriously" with "a major commitment" from Facebook, Twitter and Google to tackle anti-vaccine content. Many social media platforms label false content as misleading or disputed - and all remove posts that contravene terms of service. But Labour said a commitment by platforms to remove content flagged by the government was not enough. EU Commission backs Spain’s protocol against disinformation campaigns Author: Bernardo de Miguel Publication date: 10 November 2020 Source: El Paīs The European Commission on Monday backed Spain’s protocol against disinformation campaigns, which attracted criticism from the opposition when it was published as part of a ministerial order last Thursday. “The goal of the ministerial order is to guarantee Spain’s participation in the European Union’s Action Plan Against Disinformation,” said European Commission spokesperson Johannes Bahrke, alluding to an initiative that builds on the European Council’s call in 2018 for measures to “protect the Union’s democratic systems and combat disinformation.” The European executive’s nod to the Spanish system to prevent, detect and respond to disinformation campaigns comes after some opposition parties in Spain had accused the government of creating a “Ministry of Truth” that would allegedly make decisions on content and provide media outlets with guidelines to follow. |
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