>>> Find related articles, information and videos in our Covid Zone
|
Science |
|
Origins |
|
Authors: Yan Li-Meng, Kang Shu, Guan Jie, Hu Shanchang Publication date: 14 September 2020 Journal: Zenodo The COVID-19 pandemic caused by the novel coronavirus SARS-CoV-2 has led to over 910,000 deaths worldwide and unprecedented decimation of the global economy. Despite its tremendous impact, the origin of SARS-CoV-2 has remained mysterious and controversial. The natural origin theory, although widely accepted, lacks substantial support. The alternative theory that the virus may have come from a research laboratory is, however, strictly censored on peer-reviewed scientific journals. Nonetheless, SARS-CoV-2 shows biological characteristics that are inconsistent with a naturally occurring, zoonotic virus. In this report, we describe the genomic, structural, medical, and literature evidence, which, when considered together, strongly contradicts the natural origin theory. The evidence shows that SARS-CoV-2 should be a laboratory product created by using bat coronaviruses ZC45 and/or ZXC21 as a template and/or backbone. Building upon the evidence, we further postulate a synthetic route for SARS-CoV-2, demonstrating that the laboratory-creation of this coronavirus is convenient and can be accomplished in approximately six months. Our work emphasizes the need for an independent investigation into the relevant research laboratories. It also argues for a critical look into certain recently published data, which, albeit problematic, was used to support and claim a natural origin of SARS-CoV-2. From a public health perspective, these actions are necessary as knowledge of the origin of SARS-CoV-2 and of how the virus entered the human population are of pivotal importance in the fundamental control of the COVID-19 pandemic as well as in preventing similar, future pandemics. The emergence of SARS-CoV-2 in Europe and North America Authors: Worobey M et al Publication date: 10 September 2020 Journal: Science DOI: 10.1126/science.abc8169 Accurate understanding of the global spread of emerging viruses is critically important for public health responses and for anticipating and preventing future outbreaks. Here, we elucidate when, where and how the earliest sustained SARS-CoV-2 transmission networks became established in Europe and North America. Our results suggest that rapid early interventions successfully prevented early introductions of the virus into Germany and the US from taking hold. Other, later introductions of the virus from China to both Italy and to Washington State founded the earliest sustained European and North America transmission networks. Our analyses demonstrate the effectiveness of public health measures in preventing onward transmission and show that intensive testing and contact tracing could have prevented SARS-CoV-2 from becoming established. |
|
Transmission |
|
Measurement of SARS-CoV-2 RNA in wastewater tracks community infection dynamics Authors: Peccia J et al Publication date: 18 September 2020 Journal: Nature Biotechnology DOI: 10.1038/s41587-020-0684-z We measured severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA concentrations in primary sewage sludge in the New Haven, Connecticut, USA, metropolitan area during the Coronavirus Disease 2019 (COVID-19) outbreak in Spring 2020. SARS-CoV-2 RNA was detected throughout the more than 10-week study and, when adjusted for time lags, tracked the rise and fall of cases seen in SARS-CoV-2 clinical test results and local COVID-19 hospital admissions. Relative to these indicators, SARS-CoV-2 RNA concentrations in sludge were 0–2 d ahead of SARS-CoV-2 positive test results by date of specimen collection, 0–2 d ahead of the percentage of positive tests by date of specimen collection, 1–4 d ahead of local hospital admissions and 6–8 d ahead of SARS-CoV-2 positive test results by reporting date. Our data show the utility of viral RNA monitoring in municipal wastewater for SARS-CoV-2 infection surveillance at a population-wide level. In communities facing a delay between specimen collection and the reporting of test results, immediate wastewater results can provide considerable advance notice of infection dynamics. Transmission of SARS-CoV-2: A Review of Viral, Host, and Environmental Factors Authors: Eric A. Meyerowitz, Aaron Richterman, Rajesh T. Gandhi, Paul E. Sax Publication date: 17 September 2020 Journal: Annals of Internal Medicine DOI: 10.7326/M20-5008 Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the etiologic agent of coronavirus disease 2019 (COVID-19), has spread globally in a few short months. Substantial evidence now supports preliminary conclusions about transmission that can inform rational, evidence-based policies and reduce misinformation on this critical topic. This article presents a comprehensive review of the evidence on transmission of this virus. Although several experimental studies have cultured live virus from aerosols and surfaces hours after inoculation, the real-world studies that detect viral RNA in the environment report very low levels, and few have isolated viable virus. Strong evidence from case and cluster reports indicates that respiratory transmission is dominant, with proximity and ventilation being key determinants of transmission risk. In the few cases where direct contact or fomite transmission is presumed, respiratory transmission has not been completely excluded. Infectiousness peaks around a day before symptom onset and declines within a week of symptom onset, and no late linked transmissions (after a patient has had symptoms for about a week) have been documented. The virus has heterogeneous transmission dynamics: Most persons do not transmit virus, whereas some cause many secondary cases in transmission clusters called “superspreading events.” Evidence-based policies and practices should incorporate the accumulating knowledge about transmission of SARS-CoV-2 to help educate the public and slow the spread of this virus. Cryptic transmission of SARS-CoV-2 in Washington state Authors: Bedford T et al Publication date: 10 September 2020 Journal: Science DOI: 10.1126/science.abc0523 Following its emergence in Wuhan, China, in late November or early December 2019, the SARS-CoV-2 virus has rapidly spread globally. Genome sequencing of SARS-CoV-2 allows reconstruction of its transmission history, although this is contingent on sampling. We have analyzed 453 SARS-CoV-2 genomes collected between 20 February and 15 March 2020 from infected patients in Washington State, USA. We find that most SARS-CoV-2 infections sampled during this time derive from a single introduction in late January or early February 2020 which subsequently spread locally before active community surveillance was implemented. |
|
Mortality |
|
Years of life lost associated with COVID-19 deaths in the United States Authors: Troy Quast, Ross Andel, Sean Gregory and Eric A Storch Publication date: 07 September 2020 Journal: Journal of Public Health DOI: 10.1093/pubmed/fdaa159 Background: The mortality effects of COVID-19 are a critical aspect of the disease’s impact. Years of life lost (YLLs) can provide greater insight than the number of deaths by conveying the shortfall in life expectancy and thus the age profile of the decedents. Methods: We employed data regarding COVID-19 deaths in the USA by jurisdiction, gender and age group for the period 1 February 2020 through 11 July 2020. We used actuarial life expectancy tables by gender and age to estimate YLLs. Results: We estimated roughly 1.2 million YLLs due to COVID-19 deaths. The YLLs for the top six jurisdictions exceeded those for the remaining 43. On a per-capita basis, female YLLs were generally higher than male YLLs throughout the country. Conclusions: Our estimates offer new insight into the effects of COVID-19. Our findings of heterogenous rates of YLLs by geography and gender highlight variation in the magnitude of the pandemic’s effects that may inform effective policy responses. Public Health Lessons Learned From Biases in Coronavirus Mortality Overestimation Author: Ronald B Brown Publication date: 12 August 2020 Journal: Disaster Medicine and Public Health Preparedness DOI: 10.1017/dmp.2020.298 In testimony before US Congress on March 11, 2020, members of the House Oversight and Reform Committee were informed that estimated mortality for the novel coronavirus was 10-times higher than for seasonal influenza. Additional evidence, however, suggests the validity of this estimation could benefit from vetting for biases and miscalculations. The main objective of this article is to critically appraise the coronavirus mortality estimation presented to Congress. Informational texts from the World Health Organization and the Centers for Disease Control and Prevention are compared with coronavirus mortality calculations in Congressional testimony. Results of this critical appraisal reveal information bias and selection bias in coronavirus mortality overestimation, most likely caused by misclassifying an influenza infection fatality rate as a case fatality rate. Public health lessons learned for future infectious disease pandemics include: safeguarding against research biases that may underestimate or overestimate an associated risk of disease and mortality; reassessing the ethics of fear-based public health campaigns; and providing full public disclosure of adverse effects from severe mitigation measures to contain viral transmission. |
|
Covid-19 patients |
|
Immune responses to SARS-CoV-2 infection in hospitalized pediatric and adult patients Authors: Pierce CA et al Publication date: 21 September 2020 Journal: Science Translational Medicine DOI: 10.1126/scitranslmed.abd5487 Children and youth infected with SARS-CoV-2 have milder disease than do adults and, even among those with the recently described multi-system inflammatory syndrome (MIS-C), mortality is rare. The reasons for the differences in clinical manifestations are unknown, but suggest that age-dependent factors may modulate the anti-viral immune response. We compared cytokine, humoral, and cellular immune responses in pediatric (children and youth, age < 24 years) (n=65) and adult (n=60) patients with COVID-19 at a metropolitan hospital system in New York City. The pediatric patients had a shorter length of stay, decreased requirement for mechanical ventilation and lower mortality compared to adults. The serum concentrations of IL-17A and IFN-γ, but not TNF-α or IL-6, were inversely related to age. Adults mounted a more robust T cell response to the viral spike protein compared to pediatric patients as evidenced by increased expression of CD25+ on CD4+ T cells and the frequency of IFN-γ+CD4+ T cells. Moreover, serum neutralizing antibody titers and antibody-dependent cellular phagocytosis were higher in adults compared to pediatric COVID-19 patients. The neutralizing antibody titer correlated positively with age and negatively with IL-17A and IFN-γ serum concentrations. There were no differences in anti-spike protein antibody titers to other human coronaviruses. Together these findings demonstrate that the poor outcome in hospitalized adults with COVID-19 compared to children may not be attributable to a failure to generate adaptive immune responses. Authors: Mancuso P et al Publication date: 02 September 2020 Journal: The BMJ DOI: 10.1136/bmjopen-2020-040380 Objectives: To determine the timing of viral clearance (first negative RT-PCR on nasopharyngeal swab) and the probability of viral clearance confirmation (two consecutive negative swabs) in COVID-19 patients and to identify related determinants. Participants: All 1162 subjects testing positive to RT-PCR on nasopharyngeal swabs and diagnosed with COVID-19 in the Reggio Emilia province with at least 30 days of follow-up by 22 April 2020. Main outcome measures: Median times from diagnosis and from symptom onset to viral clearance with IQR assessed using the Kaplan–Meier estimator, stratified by included characteristics. The probability of viral clearance confirmation, stratified by time from diagnosis and putative determinants assessed using a multivariate logistic regression model. Results: Viral clearance was achieved by 60.6% (704/1162) of patients, with a median time of 30 days from diagnosis (IQR 23–40) and 36 days from symptom onset (IQR 28–45). Of those negative and retested, 78.7% (436/554) had viral clearance confirmation, suggesting one in five false negative tests. The time from symptom onset to viral clearance slightly increased with age, from 35 (IQR 26–44) days under age 50 to 38 (IQR 28–44) in over age 80, and with disease severity, from 33 (IQR 25–41) days in non-hospitalised subjects to 38 (IQR 30–47) days in hospitalised patients. The probability of confirmed viral clearance reached 86.8% after 34 days from symptom onset and increased with time, even when adjusting for age and sex (OR 1.16 95% CI 1.06 to 1.26 per day from diagnosis). Conclusions: Postponing follow-up testing of clinically recovered COVID-19 patients could increase the efficiency and performance of testing protocols. Understanding viral shedding duration also has implications for containment measures of paucisymptomatic subjects. |
|
Covid-19 controls |
|
Facial Masking for Covid-19 — Potential for “Variolation” as We Await a Vaccine Authors: Monica Gandhi and George W Rutherford Publication date: 08 September 2020 Journal: New England Journal of Medicine DOI: 10.1056/NEJMp2026913 As SARS-CoV-2 continues its global spread, it’s possible that one of the pillars of Covid-19 pandemic control — universal facial masking — might help reduce the severity of disease and ensure that a greater proportion of new infections are asymptomatic. If this hypothesis is borne out, universal masking could become a form of “variolation” that would generate immunity and thereby slow the spread of the virus in the United States and elsewhere, as we await a vaccine. One important reason for population-wide facial masking became apparent in March, when reports started to circulate describing the high rates of SARS-CoV-2 viral shedding from the noses and mouths of patients who were presymptomatic or asymptomatic — shedding rates equivalent to those among symptomatic patients.1 Universal facial masking seemed to be a possible way to prevent transmission from asymptomatic infected people. The Centers for Disease Control and Prevention (CDC) therefore recommended on April 3 that the public wear cloth face coverings in areas with high rates of community transmission — a recommendation that has been unevenly followed across the United States. |
|
Therapeutics |
|
Expert panel endorses protocol for COVID-19 herbal medicine clinical trials Publication date: 19 September 2020 Source: World Health Organization regional office for Africa The Regional Expert Committee on Traditional Medicine for COVID-19 formed by the World Health Organization (WHO), the Africa Centre for Disease Control and Prevention and the African Union Commission for Social Affairs has endorsed a protocol for phase III clinical trials of herbal medicine for COVID-19 as well as a charter and terms of reference for the establishment of a data and safety monitoring board for herbal medicine clinical trials. “Just like other areas of medicine, sound science is the sole basis for safe and effective traditional medicine therapies,” said Dr Prosper Tumusiime, Director of Universal Health Coverage and Life Course Cluster at WHO Regional Office for Africa. “The onset of COVID-19, like the Ebola outbreak in West Africa, has highlighted the need for strengthened health systems and accelerated research and development programmes, including on traditional medicines,” said Dr Tumusiime. The endorsed technical documents are aimed at empowering and developing a critical mass of technical capacity of scientists in Africa to conduct proper clinical trials to ensure quality, safety and efficacy of traditional medicines in line with international standards. Phase III clinical trials are pivotal in fully assessing the safety and efficacy of a new medical product. The data safety and monitoring board will ensure that the accumulated studies data are reviewed periodically against participants’ safety. It will also make recommendations on the continuation, modification or termination of a trial based on evaluation of data at predetermined periods during the study. |
|
Testing |
|
Operation Moonshot proposals are scientifically unsound Authors: Jonathan J Deeks, Anthony J Brookes and Allyson M Pollock Publication date: 22 September 2020 Journal: The BMJ DOI: 10.1136/bmj.m3699 They could do more harm than good to people, populations, and the economy The polymerase chain reaction (PCR) swab test is useful (but not perfect) for detecting SARS-CoV-2 virus RNA in symptomatic patients.1 However, problems arise using the test for purposes that disregard symptoms or time of infection—namely, case finding, mass screening, and disease surveillance. This is because PCR is not a test of infectiousness. Rather, the test detects trace amounts of viral genome sequence, which may be either live transmissible virus or irrelevant RNA fragments from previous infection.2 When people with symptoms or who have been recently exposed receive a positive PCR result they will probably be infectious. But a positive result in someone without symptoms or known recent exposure may be from live or dead virus, and so does not determine whether the person is infectious and able to transmit the virus to others.3 The PCR “cycle threshold” (Ct) value provides an estimate of the quantity of target RNA in the swab sample. It correlates with symptoms,4 and people with low Ct values (indicating more viral material) are those most likely to be infectious.5 Using a low maximum Ct value (around 3056) has been suggested to reduce problematic detection of dead virus,6 but it will also miss early infection and rising infectiousness in both presymptomatic and symptomatic people. The measurement error of Ct values is non-trivial, and measurements vary between manufacturers and laboratories.7 Thus it is impossible to define a universally optimal Ct value for reliable identification of those who are infectious. Read more... Authors: Gibani MM et al Publication date: 17 September 2020 Journal: The Lancet Microbe DOI: 10.1016/S2666-5247(20)30121-X Background: Access to rapid diagnosis is key to the control and management of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Laboratory RT-PCR testing is the current standard of care but usually requires a centralised laboratory and significant infrastructure. We describe our diagnostic accuracy assessment of a novel, rapid point-of-care real time RT-PCR CovidNudge test, which requires no laboratory handling or sample pre-processing. Methods: Between April and May, 2020, we obtained two nasopharyngeal swab samples from individuals in three hospitals in London and Oxford (UK). Samples were collected from three groups: self-referred health-care workers with suspected COVID-19; patients attending emergency departments with suspected COVID-19; and hospital inpatient admissions with or without suspected COVID-19. For the CovidNudge test, nasopharyngeal swabs were inserted directly into a cartridge which contains all reagents and components required for RT-PCR reactions, including multiple technical replicates of seven SARS-CoV-2 gene targets (rdrp1, rdrp2, e-gene, n-gene, n1, n2 and n3) and human ribonuclease P (RNaseP) as sample adequacy control. Swab samples were tested in parallel using the CovidNudge platform, and with standard laboratory RT-PCR using swabs in viral transport medium for processing in a central laboratory. The primary analysis was to compare the sensitivity and specificity of the point-of-care CovidNudge test with laboratory-based testing. Findings: We obtained 386 paired samples: 280 (73%) from self-referred health-care workers, 15 (4%) from patients in the emergency department, and 91 (23%) hospital inpatient admissions. Of the 386 paired samples, 67 tested positive on the CovidNudge point-of-care platform and 71 with standard laboratory RT-PCR. The overall sensitivity of the point-of-care test compared with laboratory-based testing was 94% (95% CI 86–98) with an overall specificity of 100% (99–100). The sensitivity of the test varied by group (self-referred healthcare workers 93% [95% CI 84–98]; patients in the emergency department 100% [48–100]; and hospital inpatient admissions 100% [29–100]). Specificity was consistent between groups (self-referred health-care workers 100% [95% CI 98–100%]; patients in the emergency department 100% [69–100]; and hospital inpatient admissions 100% [96–100]). Point of care testing performance was similar during a period of high background prevalence of laboratory positive tests (25% [95% 20–31] in April, 2020) and low prevalence (3% [95% 1–9] in inpatient screening). Amplification of viral nucleocapsid (n1, n2, and n3) and envelope protein gene (e-gene) were most sensitive for detection of spiked SARS-CoV-2 RNA. Interpretation: The CovidNudge platform was a sensitive, specific, and rapid point of care test for the presence of SARS-CoV-2 without laboratory handling or sample pre-processing. The device, which has been implemented in UK hospitals since May, 2020, could enable rapid decisions for clinical care and testing programmes. Universal screening for SARS‐CoV‐2 infection: a rapid review Author: Viswanathan M et al Publication date: 15 September 2020 Journal: Cochrane Library DOI: 10.1002/14651858.CD013718 Background: Coronavirus disease 2019 (COVID‐19) is caused by the novel betacoronavirus, severe acute respiratory syndrome coronavirus‐2 (SARS‐CoV‐2). Most people infected with SARS‐CoV‐2 have mild disease with unspecific symptoms, but about 5% become critically ill with respiratory failure, septic shock and multiple organ failure. An unknown proportion of infected individuals never experience COVID‐19 symptoms although they are infectious, that is, they remain asymptomatic. Those who develop the disease, go through a presymptomatic period during which they are infectious. Universal screening for SARS‐CoV‐2 infections to detect individuals who are infected before they present clinically, could therefore be an important measure to contain the spread of the disease. Objectives: We conducted a rapid review to assess (1) the effectiveness of universal screening for SARS‐CoV‐2 infection compared with no screening and (2) the accuracy of universal screening in people who have not presented to clinical care for symptoms of COVID‐19. Resurgence of SARS-CoV-2 in England: detection by community antigen surveillance Authors: Riley S et al Publication date: 13 September 2020 Journal: medRxiv preprint DOI: 10.1101/2020.09.11.20192492 Background: Based on cases and deaths, transmission of SARS-CoV-2 in England peaked in late March and early April 2020 and then declined until the end of June. Since the start of July, cases have increased, while deaths have continued to decrease. Methods: We report results from 594,000 swabs tested for SARS-CoV-2 virus obtained from a representative sample of people in England over four rounds collected regardless of symptoms, starting in May 2020 and finishing at the beginning of September 2020. Swabs for the most recent two rounds were taken between 24th July and 11th August and for round 4 between 22nd August and 7th September. We estimate weighted overall prevalence, doubling times between and within rounds and associated reproduction numbers. We obtained unweighted prevalence estimates by sub-groups: age, sex, region, ethnicity, key worker status, household size, for which we also estimated odds of infection. We identified clusters of swab-positive participants who were closer, on average, to other swab-positive participants than would be expected. Findings: Over all four rounds of the study, we found that 72% (67%, 76%) of swab-positive individuals were asymptomatic at the time of swab and in the week prior. The epidemic declined between rounds 1 and 2, and rounds 2 and 3. However, the epidemic was increasing between rounds 3 and 4, with a doubling time of 17 (13, 23) days corresponding to an R value of 1.3 (1.2, 1.4). When analysing round 3 alone, we found that the epidemic had started to grow again with 93% probability. Using only the most recent round 4 data, we estimated a doubling time of 7.7 (5.5, 12.7) days, corresponding to an R value of 1.7 (1.4, 2.0). Cycle threshold values were lower (viral loads were higher) for rounds 1 and 4 than they were for rounds 2 and 3. In round 4, we observed the highest prevalence in participants aged 18 to 24 years at 0.25% (0.16%, 0.41%), increasing from 0.08% (0.04%, 0.18%) in round 3. We observed the lowest prevalence in those aged 65 and older at 0.04% (0.02%, 0.06%) which was stable compared with round 3. Participants of Asian ethnicity had elevated odds of infection. We identified clusters in and around London, transient clusters in the Midlands, and an expanding area of clustering in the North West and more recently in Yorkshire and the Humber. Interpretation: Although low levels of transmission persisted in England through to mid-summer 2020, the prevalence of SARS-CoV-2 is now increasing. We found evidence of accelerating transmission at the end of August and beginning of September. Representative community antigen sampling can increase situational awareness and help improve public health decision making even at low prevalence. |
|
Immunity |
|
Authors: Hibino S et al Publication date: 21 September 2020 Journal: medRxiv preprint DOI: 10.1101/2020.09.21.20198796 Importance: Fatality rates related to COVID-19 in Japan have been low compared to Western Countries and have decreased despite the absence of lockdown. Serological tests monitored across the course of the second wave can provide insights into the population-level prevalence and dynamic patterns of COVID-19 infection. Objective: To assess changes in COVID-19 seroprevalence among asymptomatic employees working in Tokyo during the second wave. Design: We conducted an observational cohort study. Healthy volunteers working for a Japanese company in Tokyo were enrolled from disparate locations to determine seropositivity against COVID19 from May 26 to August 25, 2020. COVID-19 IgM and IgG antibodies were determined by a rapid COVID19 IgM/IgG test kit using fingertip blood. Across the company, tests were performed and acquired weekly. For each participant, serology tests were offered twice, separated by approximately a month, to provide self-reference of test results and to assess for seroconversion and seroreversion. Participants: Healthy volunteers from 1877 employees of a large Japanese company were recruited to the study from 11 disparate locations across Tokyo. Participants having fever, cough, or shortness of breath at the time of testing were excluded. medRxiv preprint doi: https://doi.org/10.1101/2020.09.21.20198796.this version posted September 23, 2020. The copyright holder for this preprint (which was not certified by peer review) is the author/funder, who has granted medRxiv a license to display the preprint in perpetuity. It is made available under a CC-BY-ND 4.0 International license . Main Outcome(s) and Measure(s): Seropositivity rate (SPR) was calculated by pooled data from each two-weeks window across the cohort. Either IgM or IgG positivity was defined as seropositive. Changes in immunological status against SARS-CoV-2 were determined by comparing results between two tests obtained from the same individual. Results: Six hundred fifteen healthy volunteers (mean + SD 40.8 + 10.0; range 19 - 69; 45.7 % female) received at least one test. Seroprevalence increased from 5.8 % to 46.8 % over the course of the summer. The most dramatic increase in SPR occurred in late June and early July, paralleling the rise in daily confirmed cases within Tokyo, which peaked on August 4. Out of the 350 individuals (mean + SD 42.5 + 10.0; range 19 - 69; 46.0 % female) who completed both offered tests, 21.4 % of those individuals who tested seronegative became seropositive and seroreversion was found in 12.2 % of initially seropositive participants. 81.1% of IgM positive cases at first testing became IgM negative in approximately one month. Conclusions and Relevance: COVID-19 infection may have spread widely across the general population of Tokyo despite the very low fatality rate. Given the temporal correlation between the rise in seropositivity and the decrease in reported COVID-19 cases that occurred without a shut-down, herd immunity may be implicated. Sequential testing for serological response against COVID-19 is useful for understanding the dynamics of COVID-19 infection at the population-level. Authors: Carrat F et al Publication date: 18 September 2020 Journal: medRxiv preprint DOI: 10.1101/2020.09.16.20195693 Aim: To estimate the seroprevalence of SARS-CoV-2 infection in May-June 2020 after the lockdown in adults living in three regions in France and to identify the associated risk factors. Methods: Participants in a survey on COVID-19 from an existing consortium of three general adult population cohorts living in the Ile-de-France (IDF) or Grand Est (GE), two regions with high rate of COVID-19, or in the Nouvelle-Aquitaine (NA), with a low rate, were asked to take a dried-blood spot (DBS) for anti-SARS-CoV-2 antibodies assessment. The primary outcome was a positive anti-SARS-CoV-2 ELISA IgG result against the spike protein of the virus (ELISA-S). The secondary outcomes were a positive ELISA IgG against the nucleocapsid protein (ELISA-NP), anti-SARS-CoV-2 neutralizing antibodies titers >=40 (SN), and predicted positivity obtained from a multiple imputation model (MI). Prevalence estimates were adjusted using sampling weights and post-stratification methods. Findings: Between May 4, 2020 and June 23, 2020, 16,000 participants were asked to provide DBS, and 14,628 were included in the analysis, 983 with a positive ELISA-S, 511 with a positive ELISA-NP, 424 with SN>=40 and 941 (Standard Deviation=31) with a positive MI. Adjusted estimates of seroprevalence (positive ELISA-S) were 10.0% (95%CI 9.1%;10.9%) in IDF, 9.0% (95%CI 7.7%; 10.2%) in GE and 3.1% (95%CI 2.4%; 3.7%), in NA. The adjusted prevalence of positive ELISA-NP, SN and MI were 5.7%, 5.0% and 10.0% in IDF, 6.0%, 4.3% and 8.6% in GE, and 0.6%, 1.3% and 2.5% in NA, respectively. A higher seroprevalence was observed in younger participants and when at least one child or adolescent lived in the same household. A lower seroprevalence was observed in smokers compared to non-smokers. Interpretation: At the end of the lockdown the prevalence of anti-SARS-CoV-2 IgG or neutralizing antibodies remained low in the French adult population, even in regions with high reported rates of COVID-19. Change in Antibodies to SARS-CoV-2 Over 60 Days Among Health Care Personnel in Nashville, Tennessee Authors: Manish M Patel, Natalie J Thornburg and William B Stubblefield Publication date: 17 September 2020 Journal: JAMA DOI: 10.1001/jama.2020.18796 Declines in immunoglobulin antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) among patients with symptomatic or asymptomatic infections have been documented.1,2 We assessed the duration of antibody response to SARS-CoV-2 infection in health care personnel, who may be at particular risk if antibody levels decline. Discussion Anti–SARS-CoV-2 antibodies to the spike protein, which have correlated with neutralizing antibodies,5 decreased over 60 days in health care personnel, with 58% of seropositive individuals becoming seronegative. The consistency in decline in the signal-to-threshold ratio regardless of the baseline ratio and a higher proportion of asymptomatic participants becoming seronegative support the interpretation as a true decline over a 2-month period rather than an artifact of assay performance. If replicated, these results suggest that cross-sectional seroprevalence studies to evaluate population immunity may underestimate rates of prior infections because antibodies may only be transiently detectable following infection. The window after recovering from SARS-CoV-2 infection when people could donate serum that has sufficiently high antibody levels may be limited. Implications for health care personnel with antibodies assigned to care for infected patients depend on whether decline in these antibodies increases risk of reinfection and disease, which remains unknown, especially given the lack of data on memory B-cell and T-cell responses.6 Limitations of this study include its single-center setting, small sample size, convenience sampling, and lack of information on timing of infection to evaluate antibody kinetics. Covid-19: Do many people have pre-existing immunity? Author: Peter Doshi Publication date: 17 September 2020 Journal: The BMJ DOI: 10.1136/bmj.m3563 Covid-19: Do many people have pre-existing immunity? It seemed a truth universally acknowledged that the human population had no pre-existing immunity to SARS-CoV-2, but is that actually the case? Peter Doshi explores the emerging research on immunological responses Even in local areas that have experienced some of the greatest rises in excess deaths during the covid-19 pandemic, serological surveys since the peak indicate that at most only around a fifth of people have antibodies to SARS-CoV-2: 23% in New York, 18% in London, 11% in Madrid.123 Among the general population the numbers are substantially lower, with many national surveys reporting in single digits. With public health responses around the world predicated on the assumption that the virus entered the human population with no pre-existing immunity before the pandemic,4 serosurvey data are leading many to conclude that the virus has, as Mike Ryan, WHO’s head of emergencies, put it, “a long way to burn.” Yet a stream of studies that have documented SARS-CoV-2 reactive T cells in people without exposure to the virus are raising questions about just how new the pandemic virus really is, with many implications. Authors: Moderbacher CR et al Publication date: 11 September 2020 Journal: Cell DOI: 1016/j.cell.2020.09.038 Limited knowledge is available on the relationship between antigen-specific immune responses and COVID-19 disease severity. We completed a combined examination of all three branches of adaptive immunity at the level of SARS-CoV-2-specific CD4+ and CD8+ T cell and neutralizing antibody responses in acute and convalescent subjects. SARS-CoV-2-specific CD4+ and CD8+ T cells were each associated with milder disease. Coordinated SARS-CoV-2-specific adaptive immune responses were associated with milder disease, suggesting roles for both CD4+ and CD8+ T cells in protective immunity in COVID-19. Notably, coordination of SARS-CoV-2 antigen-specific responses was disrupted in individuals > 65 years old. Scarcity of naive T cells was also associated with ageing and poor disease outcomes. A parsimonious explanation is that coordinated CD4+ T cell, CD8+ T cell, and antibody responses are protective, but uncoordinated responses frequently fail to control disease, with a connection between ageing and impaired adaptive immune responses to SARS-CoV-2. |
|
Vaccines |
|
Unwavering Regulatory Safeguards for COVID-19 Vaccines Authors: Anand Shah, Peter W Marks and Stephen M Hahn Publication date: 07 August 2020 Journal: JAMA DOI: 10.1001/jama.2020.15725 The coronavirus disease 2019 (COVID-19) pandemic has disrupted normal life and had significant consequences for human health, with more than 4.6 million cases and more than 150 000 deaths in the US alone as of early August 2020. Preventive public health measures such as mask usage, physical distancing, and enhanced sanitation procedures are necessary to alleviate strain on the health system and reduce community transmission, while advances in therapeutic development have potentially improved clinical outcomes for patients with severe illness. However, minimizing the risk of resurgence and enabling a safe return to normal life will require a majority of the population to develop immunity against SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2, the virus that causes COVID-19). Acceptably achieving this level of herd immunity quickly will likely require the development of safe and effective vaccines. Yet even under normal circumstances, vaccine development is a challenging endeavor that carries significant financial risk due to the high rate of failure at each stage of the development process. To expedite the development of a COVID-19 vaccine, the US government launched Operation Warp Speed in May 2020.1,2 This endeavor is committed to compressing what can sometimes be a decade-long development process into a matter of months through up-front financial commitments that focus resources and lower the risk of innovation. The completion of phase 1 trials for several vaccine candidates in July 2020 and enrollment for forthcoming phase 3 trials are important milestones for this process. |
|
Social Impacts |
|
Authors: Domingues CPF et al Publication date: 16 September 2020 Journal: mSphere DOI: 10.1128/mSphere.00716-20 Hygienic measures imposed to control the spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and contain COVID-19 have proven effective in controlling the pandemic. In this article, we argue that these measures could impact the human microbiome in two different and disparate ways, acting as a double-edged sword in human health. New lines of research have shown that the diversity of human intestinal and oropharyngeal microbiomes can shape pulmonary viral infection progression. Here, we suggest that the disruption in microbial sharing, as it is associated with dysbiosis (loss of bacterial diversity associated with an imbalance of the microbiota with deleterious consequences for the host), may worsen the prognosis of COVID-19 disease. In addition, social detachment can also decrease the rate of transmission of antibiotic-resistant bacteria. Therefore, it seems crucial to perform new studies combining the pandemic control of COVID-19 with the diversity of the human microbiome. Authors: Mohite OT et al Publication date: 13 September 2020 Journal: medRxiv preprint DOI: 10.1101/2020.09.12.20193078 This work details the study of critical containment zones in Maharashtra within a time (April 9 2020 - July 31 2020) in the context of COVID-19. The effects of lockdown implementation, community isolation, environmental factors, demographic aspects, behavioural factors, diet etc. have been investigated. The effect of the aforementioned factors on the infected cases, cumulative infected cases, recoveries, cumulative recoveries, active cases, deaths and cumulative deaths are analyzed. The integrated effects of the aforementioned factors on COVID- 19 outcomes are further amplified due to adequate and inadequate health facilities. The study will be helpful to scientists, researchers, pharmacists and biotechnologists in new vaccine design & to accommodate above factors for the betterment of susceptible & infected people of Maharashtra and similar demographies across the globe. Further, it pinpoints the need for more awareness and control strategies among the people to reduce the havoc, stress, fear, anxiety, pathogenicity and thereby reducing mortality. |
|
Legal |
|
Legal Challenges |
|
Source: Good Law Project Operation Moonshot’ is the Government’s latest plan to increase the national coronavirus testing programme. The need for increased testing couldn’t be clearer. Yet leaked documents have revealed Operation Moonshot is based on technology that doesn’t even exist yet - and will cost over £100 billion. This is a staggering sum of money - a generational-sized millstone of debt. Yet we know nothing about who has made the decision to spend it, or with what safeguards, or with whom, or why with these counterparties. What we do know is that experts from SAGE, the Royal Statistical Society, the National Screening Committee, and the World Health Organisation have grave concerns about whether it is the right thing to do. We have outlined their concerns in our Pre-Action Protocol letter here. We cannot afford more incompetence and wasted money when the stakes are this high. We need honest and open answers from this Government about ‘Operation Moonshot’. But the Government is not forthcoming - it has ignored letters from our lawyers - which is why, along with EveryDoctor, we are taking legal action to get answers. Good Law Project and EveryDoctor have instructed Bindmans and Maya Lester QC from Brick Court Chambers and Joseph Barrett from 11KBW. The legal challenge is being crowdfunded. If you are in a position to do so, you can make a donation here. COVID-19 & Public Health Totalitarianism: Untoward Effects on Individuals, Institutions and Society Author: Peter R Breggin Publication date: 30 August 2020 Source: Breggin.com Public health experts and policymakers believe that they can estimate what is scientifically required to fight a pandemic and that their personally determined requirements override most or all other considerations. But as a physician, psychiatrist, and researcher who has spent more than fifty years writing and evaluating research studies, I can explain why public health experts and officials are vastly more limited in their scientific knowledge than they admit. As other experts will confirm in this report,5 there is no historical precedent and no scientific basis to the ever-changing pronouncements by public health officials that have driven this nation into a state of fearful lockdown. Nearly every policy and practice—from closing of schools and the stay-at-home orders to the use of various medications and respirators—is subject to varied and conflicting scientific opinion, and to an overall lack of sound data. |
|
Media – Science related |
|
Covid-19 pandemic |
|
The dangers of a Covid ‘elimination’ policy Author: Dr John Lee Publication date: 22 September 2020 Source: The Spectator It’s understandable that, in a crisis, politicians reach for wartime metaphors – but they don’t always fit. There was the 'war on terror'. Now we have politicians talking about the need to vanquish Covid-19. This is about more than language. There’s a big difference between a Covid-19 eradication strategy and one that seeks to find a way to live with this virus, in the way we learned to live with Swine Flu (or, as it’s now called, flu.) The Prime Minister is leading by example. Addressing a committee of conservative MPs on Thursday, he said: 'We have to make sure that we defeat the disease by the means we have set out.' Later he said: 'We must, must defeat this disease.' And last week, the Leader of the Opposition, Sir Keir Starmer, told the PM that, among other things, he should 'Get on with defeating this virus.' Are they aiming for elimination? If so, it’s a new strategy – and a worrying sign of mission creep. Back in March, we were all requested to 'buy time' for the NHS to stop hospitals being overwhelmed by a sudden surge in cases. The idea back then, in so far as it could be divined, seemed to be that we would temporarily 'protect the NHS', then get used to living with the virus once the acute danger had passed. But over the last few months, while the science has become clearer, the politics has changed. Preventing a surge of deaths seems to have morphed into minimising the number of cases in all age groups, which is a completely different proposition. Author: Andrew Mahon Publication date: 22 September 2020 Source: Medium Apparently, there’s a second wave. Cases are soaring and more quarantine restrictions are needed. More self-isolation, more lockdowns, more social distancing, more masks, more fear. Really? Can we pause the hysteria for a moment? Because the truth is being obscured by a few simple misunderstandings. The most glaring of these is that most people seem unaware of the difference between coronavirus, SARS-CoV-2 and CoViD-19. These terms are used almost interchangeably by citizens, politicians and journalists alike. Source: World Economic Forum THE CONTEXT The Covid-19 crisis, and the political, economic and social disruptions it has caused, is fundamentally changing the traditional context for decision-making. The inconsistencies, inadequacies and contradictions of multiple systems –from health and financial to energy and education – are more exposed than ever amidst a global context of concern for lives, livelihoods and the planet. Leaders find themselves at a historic crossroads, managing short-term pressures against medium- and long-term uncertainties. THE OPPORTUNITY As we enter a unique window of opportunity to shape the recovery, this initiative will offer insights to help inform all those determining the future state of global relations, the direction of national economies, the priorities of societies, the nature of business models and the management of a global commons. Drawing from the vision and vast expertise of the leaders engaged across the Forum’s communities, the Great Reset initiative has a set of dimensions to build a new social contract that honours the dignity of every human being. 7 expert perspectives on what COVID-19 means for the planet Author: Douglas Broom Publication date: 15 September 2020 Source: World Economic Forum
The way we live may have changed, perhaps for ever, but what about the impact on our planet? Here are 7 perspectives on what’s happening – and what we can do about it. |
|
Covid-19 science |
|
Author: Ralph Lopez Publication date: 22 September 2020 Source: Hub Pages In a stunning development, a former Chief Science Officer for the pharmaceutical giant Pfizer says "there is no science to suggest a second wave should happen." The "Big Pharma" insider asserts that false positive results from inherently unreliable COVID tests are being used to manufacture a "second wave" based on "new cases." Dr. Mike Yeadon, a former Vice President and Chief Science Officer for Pfizer for 16 years, says that half or even "almost all" of tests for COVID are false positives. Dr. Yeadon also argues that the threshold for herd immunity may be much lower than previously thought, and may have been reached in many countries already. In an interview last week Dr. Yeadon was asked: "we are basing a government policy, an economic policy, a civil liberties policy, in terms of limiting people to six people in a meeting...all based on, what may well be, completely fake data on this coronavirus?" Dr. Yeadon answered with a simple "yes." Dr. Yeadon said in the interview that, given the "shape" of all important indicators in a worldwide pandemic, such as hospitalizations, ICU utilization, and deaths, "the pandemic is fundamentally over." Publication date: 05 September 2020 Source: Docs4OpenDebate We, Belgian doctors and health professionals, wish to express our serious concern about the evolution of the situation in the recent months surrounding the outbreak of the SARS-CoV-2 virus. We call on politicians to be independently and critically informed in the decision-making process and in the compulsory implementation of corona-measures. We ask for an open debate, where all experts are represented without any form of censorship. After the initial panic surrounding covid-19, the objective facts now show a completely different picture – there is no medical justification for any emergency policy anymore. The current crisis management has become totally disproportionate and causes more damage than it does any good. We call for an end to all measures and ask for an immediate restoration of our normal democratic governance and legal structures and of all our civil liberties. |
|
Covid-19 patients |
|
How COVID-19 can damage the brain Author: Michael Marshall Publication date: 15 September 2020 Source: Nature The woman had seen lions and monkeys in her house. She was becoming disoriented and aggressive towards others, and was convinced that her husband was an impostor. She was in her mid-50s — decades older than the age at which psychosis typically develops — and had no psychiatric history. What she did have, however, was COVID-19. Hers was one of the first known cases of someone developing psychosis after contracting the disease1. In the early months of the COVID-19 pandemic, doctors struggled to keep patients breathing, and focused mainly on treating damage to the lungs and circulatory system. But even then, evidence for neurological effects was accumulating. Some people hospitalized with COVID-19 were experiencing delirium: they were confused, disorientated and agitated2. In April, a group in Japan published3 the first report of someone with COVID-19 who had swelling and inflammation in brain tissues. Another report4 described a patient with deterioration of myelin, a fatty coating that protects neurons and is irreversibly damaged in neurodegenerative diseases such as multiple sclerosis. |
|
Therapeutics |
|
Antibody-Based Drug May Reduce COVID-19 Hospitalizations: Study Author: Lisa Winter Publication date: 17 September 2020 Source: The Scientist The results are in from the first monoclonal antibody drug for COVID-19 tested in humans. The small Phase 2 clinical trial involving 452 participants shows the drug can reduce the need for hospitalization in patients with mild-to-moderate COVID-19 symptoms compared to control patients. The drug’s manufacturer, Eli Lilly, released a statement announcing the trial results, and the raw data have not yet been peer-reviewed or published. Convalescent plasma treatments, which work by giving a patient a myriad of antibodies from recovered COVID-19 patients, have received emergency use authorization from the US government, but their benefits are uncertain. Lilly’s LY-CoV555 is monoclonal and provides a singular, targeted antibody treatment that can be scaled up and provide consistent dosing. The medicine binds to the spike protein on the SARS-CoV-2 virus, preventing it from infecting cells. Other antibodies bind to the virus as well but can’t always block infection. |
|
Immunity |
|
Let's stop the continued self-destruction and test for Covid immunity Authors: Michael Levitt, Udi Qimron, Eyal Shahar, Uri Gavish and Ifat Abadi-Korek Publication date: 17 September 2020 Source: The Telegraph Back in January, not long after the Covid-19 outbreak in Wuhan, the number of deaths ceased to follow the exponential growth scare. It took the virus longer and longer to find people to infect, which was unexpected since Wuhan (with an urban population of 9 million) is not a small village and the virus should not have found it difficult to meet and infect new hosts. Non-exponential growth of the epidemic curve was the first clue that preexisting immunity to SARS-CoV-2 may be ubiquitous. Hundreds of outbreak graphs later, it turned out that the pandemic never behaved as if the virus was foreign to most people. China, a country of almost a billion and half people, eventually registered less than 5,000 deaths, and South Korea (51 million people) – about 300. The obvious explanation for those negligible mortality rates - highly prevalent preexisting immunity - was widely ignored. The world chose to believe that the tough lockdown in Wuhan, along with restrictions in other parts of China, somehow eradicated the virus. The Immune Hallmarks of Severe COVID-19 Author: Katarina Zimmer Publication date: 16 September 2020 Source: The Scientist One of the most striking features of SARS-CoV-2, the virus that causes COVID-19, is the exceptional breadth of symptoms it causes in people. Of the nearly 30 million recorded infections to date, the vast majority of people experienced mild or moderate disease—which itself can range from no symptoms at all to pneumonia or long-term, debilitating neurological symptoms. A minority ended up with severe respiratory symptoms but eventually recovered. And some—nearly 940,000 worldwide, of which 196,000 are in the US—took a turn for the worse and died. Why some people die while others recover is thought to depend in large part on the human immune response, which spirals out of control in severe disease. Over the past few months, researchers have developed a better understanding of this dysfunctional immune response. By comparing patients with varying degrees of disease severity, they’ve catalogued a number of dramatic changes across the human immune arsenal that are often apparent when patients first come into the hospital—from signaling cytokine proteins and first-responder cells of the innate immune system, to the B cells and T cells that confer pathogen-specific adaptive immunity. |
|
Vaccines |
|
Moderna and Pfizer Reveal Secret Blueprints for Coronavirus Vaccine Trials Authors: Denise Grady and Katie Thomas Publication date: 17 September 2020 Source: The New York Times Two drug companies that are leading the race to develop coronavirus vaccines bowed to public pressure on Thursday, abandoning their traditional secrecy and releasing comprehensive road maps of how they are evaluating their vaccines. The companies, Moderna and Pfizer, revealed details about how participants are being selected and monitored, the conditions under which the trials could be stopped early if there were problems, and the evidence researchers will use to determine whether people who got the vaccines were protected from Covid-19. Moderna’s study will involve 30,000 participants, and Pfizer’s 44,000. Companies typically share these documents after their studies are complete. The disclosures while the trials are still underway, a rare move, are aimed at addressing growing suspicion among Americans that President Trump’s drive to produce a vaccine before the election on Nov. 3 could result in a product that was unsafe. Great expectations for vaccines threaten more hard times: the vaccine swindle – part 2 Author: Barry Norris Publication date: 16 September 2020 Source: Argonautica There is a widespread and dangerous assumption that a return to normality will only be possible with - and will immediately follow - the approval of a SARS-2/COVID vaccine. Economic destruction from needless lockdowns was a direct consequence of the initial misdiagnosis of COVID as a second “Spanish Flu”. Now in the absence of a credible escape route from their COVID infection suppression policy, the same blundering governments - led by the wrong scientific advisors - look to a vaccine as an alluring overnight solution. This is at best naïve, probably preposterous, and in the hands of policy makers - deep in a lockdown hole of their own making - invites further disaster. In short, these great expectations for vaccines threaten more hard times ahead. COVID has always been uniquely unsuited to a vaccine solution: it is relatively harmless for most of the population (hence the dubious necessity for mass vaccination) but poses a statistically significant mortality risk for a small cohort of the population with impaired immune systems, evidenced not only be the median age of death (82 years) but more significantly, the presence of comorbidities (90%+ cases)1. Vaccines are designed to elicit a specific antibody response from the immune system: it is widely recognised that their efficacy is significantly diminished in the old and sick2. A COVID vaccine has therefore always been most likely to boost the immunity of the population who were only ever at risk of an asymptomatic infection, with the additional risk for previously healthy adults and children of unknown potentially severe vaccine side-effects, particularly antibody dependent enhancement (ADE)3. Although I do not consider myself an “anti-vaxxer”, I will be content to be at the back of the queue for any SARS-2/COVID vaccine. Researchers highlight ‘questionable’ data in Russian coronavirus vaccine trial results Author: Alison Abbott Publication date: 15 September 2020 Source: Nature A group of researchers have expressed concern about repetitive patterns of data in a paper describing early-phase clinical trials of Russia’s coronavirus vaccine — the first jab worldwide to be approved for widespread use. In an open letter to the study authors, who published the trial results1 this month in The Lancet, the researchers highlight values that seem to be duplicated, and warn that the paper presents its results only as box plots without providing a detailed breakdown of the data on which they are based. “While the research described in this study is potentially significant, the presentation of the data raises several concerns which require access to the original data to fully investigate”, the letter says. It has so far been signed by almost 40 scientists. Scientists relieved as coronavirus vaccine trial restarts — but question lack of transparency Authors: David Cyranoski and Smriti Mallapaty Publication date: 14 September 2020 Source: Nature The UK trial of a leading coronavirus vaccine, which was abruptly halted because of safety concerns, restarted on Saturday after the university conducting the trial said an independent committee found that it was safe to do so. The University of Oxford and pharmaceutical company AstraZeneca paused enrolment in the global trials of their vaccine candidate on 6 September, after a person participating in the UK trial experienced an adverse reaction. Scientists say that a pause is not uncommon in large trials, and that a speedy resumption of testing was to be expected. The episode shows that care is being taken with the trial, they say. “Like anybody else who knows the importance of vaccines, I am very happy that the trial will continue,” says Klaus Stöhr, a retired influenza researcher who headed the World Health Organization’s research and epidemiology division for severe acute respiratory syndrome. But some scientists have criticized the trial sponsors for not releasing more information about the reason for the pause and their decision-making. A Bad COVID Vaccine Would Spawn More Conspiracy Theories Author: Alex Berezow PhD Publication date: 10 September 2020 Source: American Council on Science and Health It is difficult to overstate the potential damage that a rushed coronavirus vaccine could inflict on confidence in the biomedical community. Previously, we listed some of the best (worst?) conspiracy theories involving coronavirus and the disease it causes, COVID-19. A bad vaccine would cause them to multiply like rabbits on Viagra. Much of the public already views “Big Pharma” as a malevolent, money-grubbing industry that puts profits over patients. Others view “Big Government” with equal skepticism, believing that it is inept at best and corrupt at worst. Under America’s Operation Warp Speed, Big Pharma and Big Government are working hand-in-hand, surely a sinister partnership in the eyes of many. Conspiracy theories already abound. Perhaps the weirdest is the belief that Bill Gates wishes to use the coronavirus vaccine to inject people with location tracking microchips. Obviously, nobody believes such preposterous nonsense, right? Wrong. Overall, one poll found that 28% of Americans believe in this conspiracy, with another 32% who are “not sure.” As with everything else, belief in the conspiracy breaks down along partisan lines. BIOPHARMA LEADERS UNITE TO STAND WITH SCIENCE Publication date: 08 September 2020 Source: Pfizer All nine CEOs signed the following pledge: We, the undersigned biopharmaceutical companies, want to make clear our on-going commitment to developing and testing potential vaccines for COVID-19 in accordance with high ethical standards and sound scientific principles. The safety and efficacy of vaccines, including any potential vaccine for COVID-19, is reviewed and determined by expert regulatory agencies around the world, such as the United States Food and Drug Administration (FDA). FDA has established clear guidance for the development of COVID-19 vaccines and clear criteria for their potential authorization or approval in the US. FDA’s guidance and criteria are based on the scientific and medical principles necessary to clearly demonstrate the safety and efficacy of potential COVID-19 vaccines. More specifically, the agency requires that scientific evidence for regulatory approval must come from large, high quality clinical trials that are randomized and observer-blinded, with an expectation of appropriately designed studies with significant numbers of participants across diverse populations. Following guidance from expert regulatory authorities such as FDA regarding the development of COVID-19 vaccines, consistent with existing standards and practices, and in the interest of public health, we pledge to: Always make the safety and well-being of vaccinated individuals our top priority. Continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes. Only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase 3 clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA. Work to ensure a sufficient supply and range of vaccine options, including those suitable for global access. |
|
Testing |
|
Lies, Damned Lies and Health Statistics – the Deadly Danger of False Positives Author: Dr Mike Yeadon Publication date: 20 September 2020 Source: Lockdown Sceptics I never expected to be writing something like this. I am an ordinary person, recently semi-retired from a career in the pharmaceutical industry and biotech, where I spent over 30 years trying to solve problems of disease understanding and seek new treatments for allergic and inflammatory disorders of lung and skin. I’ve always been interested in problem solving, so when anything biological comes along, my attention is drawn to it. Come 2020, came SARS-CoV-2. I’ve written about the pandemic as objectively as I could. The scientific method never leaves a person who trained and worked as a professional scientist. Please do read that piece. My co-authors & I will submit it to the normal rigours of peer review, but that process is slow and many pieces of new science this year have come to attention through pre-print servers and other less conventional outlets. While paying close attention to data, we all initially focused on the sad matter of deaths. I found it remarkable that, in discussing the COVID-19 related deaths, most people I spoke to had no idea of large numbers. Asked approximately how many people a year die in the UK in the ordinary course of events, each a personal tragedy, They usually didn’t know. I had to inform them it is around 620,000, sometimes less if we had a mild winter, sometimes quite a bit higher if we had a severe ’flu season. I mention this number because we know that around 42,000 people have died with or of COVID-19. While it’s a huge number of people, its ‘only’ 0.06% of the UK population. Its not a coincidence that this is almost the same proportion who have died with or of COVID-19 in each of the heavily infected European countries – for example, Sweden. The annual all-causes mortality of 620,000 amounts to 1,700 per day, lower in summer and higher in winter. That has always been the lot of humans in the temperate zones. So for context, 42,000 is about ~24 days worth of normal mortality. Please know I am not minimising it, just trying to get some perspective on it. Deaths of this magnitude are not uncommon, and can occur in the more severe flu seasons. Flu vaccines help a little, but on only three occasions in the last decade did vaccination reach 50% effectiveness. They’re good, but they’ve never been magic bullets for respiratory viruses. Instead, we have learned to live with such viruses, ranging from numerous common colds all the way to pneumonias which can kill. Medicines and human caring do their best. Matt Hancock: Obstinate or Innumerate? Author: Dr Mike Yeadon Publication date: 19 September 2020 Source: Lockdown Sceptics Lockdown Sceptics contributor Mike Yeadon, formerly head of R&D at Pfizer, told Julia Hartley-Brewer on Wednesday that she should ask Matt Hancock what the false positive rate is next time he’s on her show. Well, Hancock appeared on her show yesterday morning and she put the question to him. His answer was “less than one percent”. As Julia pointed out on Twitter, that wasn’t as reassuring as he hoped. Fast coronavirus tests: what they can and can’t do Author: Giorgia Guglielmi Publication date: 16 September 2020 Source: Nature Rapid antigen tests are designed to tell in a few minutes whether someone is infectious. Will they be game changers? The United States leads the world in COVID-19 deaths but lags behind many countries — both large and small — in testing capacity. That could soon change. At the end of August, the US Food and Drug Administration (FDA) granted emergency-use approval to a new credit-card-sized testing device for the coronavirus that costs US$5, gives results in 15 minutes and doesn’t require a laboratory or a machine for processing. The United States is spending $760 million on 150 million of these tests from health-care company Abbott Laboratories, headquartered in Abbott Park, Illinois, which plans to ramp up production to 50 million per month in October. The tests detect specific proteins — known as antigens — on the surface of the virus, and can identify people who are at the peak of infection, when virus levels in the body are likely to be high. Proponents argue that this could be a game changer. Antigen tests could help to keep the pandemic at bay, because they can be rolled out in vast numbers and can spot those who are at greatest risk of spreading the disease. These tests are also a key element in the testing strategies of other countries, such as India and Italy. |
|
Media – Reporting |
|
Covid-19 pandemic |
|
Covid: Is it time we learned to live with the virus? Author: Nick Triggle Publication date: 21 September 2020 Source: BBC News The constant mantra is the virus must be suppressed and contained. But how do you do this when people can be infectious without knowing they have it? Where it can be passed on silently because people do not develop symptoms? The nation has been brought to a standstill once at immense cost to the economy, education and health more generally. And now with cases rising there is the threat of new national restrictions, while large parts of the country have already found themselves back in partial lockdown. But are we fighting a losing battle? Do we instead need to learn to live with the virus? It's 'utter chaos' now Prof Carl Heneghan, the head of the Centre for Evidence Based Medicine at Oxford University, says the current situation is "utter chaos" with a constant stream of new restrictions and schools sending whole year groups home when just one person tests positive. All this at a time when the level of infection is still very low. This, Prof Heneghan says, is the consequence of trying to suppress the virus. Instead, he argues we should accept it is here to stay and try to minimise the risks, while balancing that against the consequences of the actions we take. In particular, he's concerned the Covid test is actually so sensitive it's picking up what is effectively dead virus as it spots traces of it months after the person has stopped being infectious. Authors: Carl Heneghan and Tom Jefferson Publication date: 19 September 2020 Source: Mail Online Over the centuries, the course of respiratory illnesses have been so erratic that in the Middle Ages they were attributed to the influence of planets. They were known as ‘Influenza degli astri’ in Italian – hence the term influenza. Today, our bewildered Prime Minister and his platoon of inept advisers might as well be using the planets to guide us through this pandemic, so catastrophic and wildly over-the-top are their decisions. Now we look set to repeat the pattern of what happened six months ago when they first panicked the country into shutting down, except that this time it has been given a fancy title – operation ‘circuit break’. Whatever the name, it may be a grave error with terrible consequences for the health of the British people and for the health of the country. How can we possibly be making the same mistake – again? Bill Gates slams ‘shocking’ U.S. response to Covid-19 pandemic Author: Helen Branswell Publication date: 14 September 2020 Source: STAT Philanthropist Bill Gates, who has long warned of the need to prepare for pandemics, is dumbfounded by how poorly the United States has responded to Covid-19. In an interview with STAT, Gates sounded exasperated at times as he described the badly bungled launch of Covid-19 testing, the enlisting of a neuroradiologist — rather than an epidemiologist or infectious diseases specialist — to help guide the White House’s response decisions, and the recent move to discourage testing of people who have been in contact with a known case but who aren’t yet showing symptoms. “You know, this has been a mismanaged situation every step of the way,” Gates said in the wide-ranging interview. “It’s shocking. It’s unbelievable — the fact that we would be among the worst in the world.” |
|
Transmission |
|
'Anyone with healthcare experience knows the return to schools leads to a rise in the common cold' Authors: Carl Heneghan and Tom Jefferson Publication date: 20 September 2020 Source: The Telegraph Cases of Covid are rising, and hospital admissions are creeping up; demand for testing has outstripped capacity ‘three to four times’, admitted Dido Harding, the head of the newly formed National Institute for Health Protection. She said the ‘sizeable’ rise in demand for tests had been unexpected. Testing capacity was based on modelling from the SAGE advisory group who didn’t anticipate the increase in infections. As a consequence, the testing system is falling over - only a third of people at walk-in centres get their test results within 24 hours, and the tracing system cannot function appropriately. Confusion reigns, and we are talking ourselves into a second national lockdown as the government is further panicked by its advisors and their fortune-tellers. Underpinning the chaos is a fundamental misunderstanding of the effects of seasonal viral pathogens. We are not surprised that Dido Harding doesn’t know that infections rise at this time of year as she has no previous healthcare experience. The oversight of the government advisors in not understanding the seasonal effect, is, however, deeply troubling. |
|
Vaccines |
|
Coronavirus vaccine: why it’s important to know what’s in the placebo Author: Jeremy Howick Publication date: 21 September 2020 Source: The Conversation Some researchers conducting clinical trials on a COVID-19 vaccine have not revealed to the public what the placebo contains, but they should. This is because the placebo ingredients influence how effective or harmful the active treatment, with which the placebo is compared, appears. Our new guideline published in PLOS Medicine remedies this problem by providing a template for reporting what’s in placebo controls. In some COVID-19 vaccine trials, participants in the control group (the group receiving a placebo) are injected with a saline solution. In other trials, they receive an actual treatment. For example, in the COVID-19 vaccine developed by the University of Oxford, the control group receives a meningitis and septicaemia vaccine as a placebo. Engagement with anti-vaccine Facebook posts trebles in one month Authors: Niamh McIntyre and Ben Quinn Publication date: 19 September 2020 Source: The Guardian Engagement with anti-vaccine posts on a sample of UK Facebook pages trebled between July and August, analysis by the Guardian has found, triggering calls for a major new push to tackle conspiracy theories. Interactions on posts expressing scepticism or hostility towards vaccines on six UK Facebook pages increased from 12,000 in July to 42,000 in August, according to the analysis, conducted using the Facebook-owned social media analytics tool CrowdTangle. The pages were selected by running keyword searches on terms associated with the anti-vaccine movement, creating a list of pages that frequently shared disinformation and conspiracy theories. A Facebook page for an alternative medicine business that has 1.9m likes shared about 50 posts expressing scepticism about vaccines during the last three months. These included posts containing conspiracy theories about Bill Gates and false claims that vaccines are a form of population control. U.S. Public Now Divided Over Whether To Get COVID-19 Vaccine Authors: Alex Tyson, Courtney Johnson and Cary Funk Publication date: 17 September 2020 Source: Pew Research Centre As efforts to develop and test a COVID-19 vaccine spur debate around the timing and release of a federally approved vaccine, the share of Americans who say they would get vaccinated for the coronavirus has declined sharply since earlier this year. About half of U.S. adults (51%) now say they would definitely or probably get a vaccine to prevent COVID-19 if it were available today; nearly as many (49%) say they definitely or probably would not get vaccinated at this time. Intent to get a COVID-19 vaccine has fallen from 72% in May, a 21 percentage point drop. The share who would definitely get a coronavirus vaccine now stands at just 21% – half the share that said this four months ago. |
|
Lockdowns |
|
We can beat Covid without lockdowns, says top German virologist Author: Ambrose Evans-Pritchard Publication date: 21 September 2020 Source: The Telegraph Germany’s most celebrated virologist has some trenchant advice for countries contemplating a second national lockdown: hold your nerve, and don’t succumb to the pervasive mood of mass hysteria. “It is time to stop all this alarmism. We can outsmart the virus using all our knowledge,” said Professor Hendrik Streeck, director of Germany's Institute of Virology at Bonn University. “We have to realise that Covid-19 is going to be with us for a long time and we must learn to live with it. We can’t keep shutting down our daily lives and paralysing everything,” he said. Prof Streeck supported the first lockdown in Germany. At that point the early case data from Italy was shocking and scientists were only just starting to grapple with Covid-19. The precautionary principle demanded draconian action. Revealed: Local authority calls on care home providers to accept covid-positive hospital patients Author: Ciaran Jenkins Publication date: 17 September 2020 Source: Channel 4 News The contract, from Trafford Council in Greater Manchester, outlines how eligible care homes will receive COVID-positive patients within just 2 hours of the patient being identified by the hospital as ready for discharge. It also sets out terms for the “Rapid Discharge” of patients from hospital, and states that “some of these patients may have COVID-19, whether symptomatic or asymptomatic.” A leading clinician warned it could become “commonplace” for hospital patients carrying COVID-19 to be discharged into care homes in England this winter, despite the controversy it caused in the early months of the pandemic. |
|
Censorship |
|
Facebook will stop recommending health groups Author: Adi Robertson Publication date: 17 September 2020 Source: The Verge Facebook is adding new rules intended to slow the spread of misinformation and other harmful content on its Groups feature. From now on, if a group is removed for violating Facebook’s policies, its members and administrators will be temporarily unable to create any new groups. If a group has no administrators, it will be archived. And Facebook won’t include any health-related groups in its recommendations. Facebook groups have been blamed for spreading misinformation and conspiracies, particularly when Facebook’s recommendation algorithm promotes them. And the company’s new rules expand on existing efforts to police them. Admins were already barred from creating a new group similar to a banned one, for instance. Some of the new policies encourage more active administration of groups. If administrators step down, they can invite members to take their place; if nobody does, Facebook will apparently “suggest” admin roles to members, then archive the group if that fails. Also, if group members accrue a community standards violation, moderators will have to approve all their posts for 30 days. If the moderators repeatedly approve posts that violate Facebook’s guidelines, the group could be removed. Doctor resigns from hospital group after comments on ‘draconian’ Covid-19 curbs Author: Paul Cullen Publication date: 16 September 2020 Source: The Irish Times A senior Health Service Executive (HSE) doctor has resigned just days after criticising “draconian” anti-Covid-19 restrictions. Dr Martin Feeley’s views that coronavirus is “much less severe” than the flu for most people and that restrictions were no longer justified caused a furore after they were reported in The Irish Times last weekend. The HSE actively dissociated itself from his remarks and rejected his suggestion that young people should be allowed to get the virus to develop herd immunity. Dr Feeley (70) stepped down from his post as clinical director of Dublin Midlands Hospital Group on Tuesday with immediate effect. After his public comments, he came under heavy pressure from HSE management, who told him his position was untenable. A doctor for more than 45 years and an employee of the health service for 30 years, Dr Feeley says he stands by his comments, but decided to resign so management in his hospital group would not be penalised. |
|
Covid-19 controls |
|
CDC Director: Face Masks Offer More Protection Than a Vaccine Author: Tim Dickinson Publication date: 16 September 2020 Source: Rolling Stone Donald Trump — who has returned to holding indoor political rallies with poor social distancing and even worse mask-wearing compliance — continues to cast doubt on the effectiveness of wearing face masks to control the spread of coronavirus, which has killed nearly 200,000 Americans. At a town hall hosted by ABC Tuesday night, Trump rambled, unscientifically, about why “a lot of people think the masks are not good,” citing his recent interaction with a waiter. Uncommitted voter asks Pres. Trump in a special @ABC2020 event: "Why don’t you support a mandate for national mask wearing? And why don’t you wear a mask more often?" https://t.co/m2cgtZUcIY pic.twitter.com/zSZmyjEWNS — ABC News (@ABC) September 16, 2020 On Wednesday, in Senate testimony, CDC director Dr. Robert Redfield directly contradicted the president. When asked about the effectiveness of masks by Sen. Jack Reed (D-RI), Redfield insisted that face masks are our “best defense” against the spread of Covid-19. “We have clear scientific evidence,” he said. “They work.” |
|
Social Impacts |
|
Senior Tories plot backlash against PM's emergency curbs on freedoms during pandemic Author: Christopher Hope Publication date: 19 September 2020 Source: The Telegraph Senior Tories are planning to stop Prime Minister Boris Johnson imposing limits on people's freedoms without scrutiny by forcing Parliament to have the final say on new lockdown measures, The Telegraph can reveal. MPs vote next week on "the renewal of temporary provisions" of lockdown measures under the Coronavirus Act 2020 to reauthorise the Government's use of the powers. Sir Graham Brady, the chairman of the 1922 committee of backbench Conservative MPs, is planning to use this opportunity to amend this legislation to require ministers to put all new measures to a vote of MPs first. The move will effectively impose a “Parliamentary lock” on any future restrictions, amid widespread fury among senior MPs and peers that restrictions have been imposed on Britons without a vote. |
|
Covid collection |
|
Source: Lockdown Sceptics A collection of covid related science and articles. |
Comments
your voice counts
There are currently no comments on this post.
Your voice counts
We welcome your comments and are very interested in your point of view, but we ask that you keep them relevant to the article, that they be civil and without commercial links. All comments are moderated prior to being published. We reserve the right to edit or not publish comments that we consider abusive or offensive.
There is extra content here from a third party provider. You will be unable to see this content unless you agree to allow Content Cookies. Cookie Preferences