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Science

Origins

Lancet COVID-19 Commission Statement on the occasion of the 75th session of the UN General Assembly

Authors: The Lancet COVID-19 Commissioners, Task Force Chairs and Commission Secretariat

Publication date: 14 September 2020

Journal: The Lance

DOI: 10.1016/S0140-6736(20)31927-9

Executive summary

The Lancet COVID-19 Commission was launched on July 9, 2020, to assist governments, civil society, and UN institutions in responding effectively to the COVID-19 pandemic. The Commission aims to offer practical solutions to the four main global challenges posed by the pandemic: suppressing the pandemic by means of pharmaceutical and non-pharmaceutical interventions; overcoming humanitarian emergencies, including poverty, hunger, and mental distress, caused by the pandemic; restructuring public and private finances in the wake of the pandemic; and rebuilding the world economy in an inclusive, resilient, and sustainable way that is aligned with the Sustainable Development Goals (SDGs) and the Paris Climate Agreement. Many creative solutions are already being implemented, and a key aim of the Commission is to accelerate their adoption worldwide.

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Epidemiology

Epidemiology and transmission dynamics of COVID-19 in two Indian states

Authors: Laxminarayan R et al

Publication date: 30 September 2020

Journal: Science

DOI: 10.1126/science.abd7672

Although most COVID-19 cases have occurred in low-resource countries, little is known about the epidemiology of the disease in such contexts. Data from the Indian states of Tamil Nadu and Andhra Pradesh provide a detailed view into SARS-CoV-2 transmission pathways and mortality in a high-incidence setting. Reported cases and deaths have been concentrated in younger cohorts than expected from observations in higher-income countries, even after accounting for demographic differences across settings. Among 575,071 individuals exposed to 84,965 confirmed cases, infection probabilities ranged from 4.7-10.7% for low-risk and high-risk contact types. Same-age contacts were associated with the greatest infection risk. Case-fatality ratios spanned 0.05% at ages 5-17 years to 16.6% at ages ≥85 years. Primary data are urgently needed from low-resource countries to guide control measures.

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Covid-19 patients

Comparing biomarkers for COVID-19 disease with commonly associated preexisting conditions and complications

Author: Jesse Huang

Publication date: 05 October 2020

Journal: medRxvi preprint

DOI: 10.1101/2020.10.02.20205609

Severe coronavirus disease 2019 (COVID-19) has been associated with certain preexisting health conditions and can cause respiratory failure along with other multi-organ injuries. However, the mechanism of these relationships is unclear, and prognostic biomarkers for the disease and its systemic complications are lacking. This study aims to examine the plasma protein profile of COVID-19 patients and evaluate overlapping protein modules with biomarkers of common comorbidities. Blood samples were collected from COVID-19 cases (n=307) and negative controls (n=78) among patients with acute respiratory distress. Proteins were measured by proximity extension assay utilizing next-generation sequencing technology. Its associations to COVID-19 disease characteristics were compared to that of preexisting conditions and established biomarkers for myocardial infarction (MI), stroke, hypertension, diabetes, smoking, and chronic kidney disease. Several proteins were differentially expressed in COVID-19, including multiple pro-inflammatory cytokines such as IFN-gamma, CXCL10, and CCL7/MCP-3. Elevated IL-6 was associated with increased severity, while baseline IL1RL1/ST2 levels were associated with a worse prognosis. Network analysis identified several protein modules associated with COVID-19 disease characteristics overlapping with processes of preexisting hypertension and impaired kidney function. BNP and NTpro-BNP, markers for MI and stroke, increased with disease progression and were positively associated with severity. MMP12 was similarly elevated and has been previously linked to smoking and inflammation in emphysema, along with increased cardiovascular disease risk. In conclusion, this study provides an overview of the systemic effects of COVID-19 and candidate biomarkers for clinical assessment of disease progression and the risk of systemic complications.

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UK report on 11,404 patients critically ill with COVID-19

Institution: Intensive Care National Audit & Research Centre (ICNARC)

Publication date: 02 October 2010

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S Protein-Reactive IgG and Memory B Cell Production after Human SARS-CoV-2 Infection Includes Broad Reactivity to the S2 Subunit

Authors: Nguyen-Contant P et al

Publication date: 25 September 2020

Journal: MBIO

DOI: 10.1128/mBio.01991-20

The high susceptibility of humans to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, the cause of coronavirus disease 2019 (COVID-19), reflects the novelty of the virus and limited preexisting B cell immunity. IgG against the SARS-CoV-2 spike (S) protein, which carries the novel receptor binding domain (RBD), is absent or at low levels in unexposed individuals. To better understand the B cell response to SARS-CoV-2 infection, we asked whether virus-reactive memory B cells (MBCs) were present in unexposed subjects and whether MBC generation accompanied virus-specific IgG production in infected subjects. We analyzed sera and peripheral blood mononuclear cells (PBMCs) from non-SARS-CoV-2-exposed healthy donors and COVID-19 convalescent subjects. Serum IgG levels specific for SARS-CoV-2 proteins (S, including the RBD and S2 subunit, and nucleocapsid [N]) and non-SARS-CoV-2 proteins were related to measurements of circulating IgG MBC levels. Anti-RBD IgG was absent in unexposed subjects. Most unexposed subjects had anti-S2 IgG, and a minority had anti-N IgG, but IgG MBCs with these specificities were not detected, perhaps reflecting low frequencies. Convalescent subjects had high levels of IgG against the RBD, S2, and N, together with large populations of RBD- and S2-reactive IgG MBCs. Notably, IgG titers against the S protein of the human coronavirus OC43 were higher in convalescent subjects than in unexposed subjects and correlated strongly with anti-S2 titers. Our findings indicate cross-reactive B cell responses against the S2 subunit that might enhance broad coronavirus protection. Importantly, our demonstration of MBC induction by SARS-CoV-2 infection suggests that a durable form of B cell immunity is maintained even if circulating antibody levels wane.

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Pathological features of COVID-19-associated myocardial injury: a multicentre cardiovascular pathology study

Authors: Basso C et al

Publication date: 24 September 2020

Journal: European Heart Journal

DOI: 10.1093/eurheartj/ehaa664

Aims

Coronavirus disease 2019 (COVID-19) due to severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) has been associated with cardiovascular features of myocardial involvement including elevated serum troponin levels and acute heart failure with reduced ejection fraction. The cardiac pathological changes in these patients with COVID-19 have yet to be well described.

Methods and results

In an international multicentre study, cardiac tissue from the autopsies of 21 consecutive COVID-19 patients was assessed by cardiovascular pathologists. The presence of myocarditis, as defined by the presence of multiple foci of inflammation with associated myocyte injury, was determined, and the inflammatory cell composition analysed by immunohistochemistry. Other forms of acute myocyte injury and inflammation were also described, as well as coronary artery, endocardium, and pericardium involvement. Lymphocytic myocarditis was present in 3 (14%) of the cases. In two of these cases, the T lymphocytes were CD4 predominant and in one case the T lymphocytes were CD8 predominant. Increased interstitial macrophage infiltration was present in 18 (86%) of the cases. A mild pericarditis was present in four cases. Acute myocyte injury in the right ventricle, most probably due to strain/overload, was present in four cases. There was a non-significant trend toward higher serum troponin levels in the patients with myocarditis compared with those without myocarditis. Disrupted coronary artery plaques, coronary artery aneurysms, and large pulmonary emboli were not identified.

Conclusions

In SARS-CoV-2 there are increased interstitial macrophages in a majority of the cases and multifocal lymphocytic myocarditis in a small fraction of the cases. Other forms of myocardial injury are also present in these patients. The macrophage infiltration may reflect underlying diseases rather than COVID-19.

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Immunity

To achieve “zero covid” we need to include the controlled, careful acquisition of population (herd) immunity

Author: Prof Raj S Bhopal

Publication date: 09 September 2020

Journal: The BMJ

DOI: 10.1136/bmj.m3487

Torjesen asks whether the UK should aim for zero covid.1 Of course it should, but how? My suggested strategy includes herd immunity, which I rename population immunity given the antipathy to the word herd, evoking animals.2

On 7 April 2020 Martin McKee wrote to the covid-19 global researchers email group “seeking sensible thoughts about coming out of lockdown.” I responded with an eight point plan, the last point being that in the absence of a vaccine we should allow young people under 30, particularly women, to get the infection voluntarily, preferably in controlled circumstances. This kind of approach has been conceptualised and modelled by others.345 McKee replied that it was good to think out of the box. But this is already happening in unplanned and haphazard ways.6 Letting the pandemic unfold uncontrolled is not public health strategy.2

I suggest population immunity as part of a comprehensive response.2 I estimate that about 40-50% population immunity would be sufficient to suppress an infection with a reproduction number of about 1 or slightly more, which requires continuing, reasonable control measures. Others consider this proportion to be much lower.7 Allowing infection in people at low risk is justifiable if we make it safer for them than allowing it to occur uncontrolled.2

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Therapeutics

Mitigation of the replication of SARS-CoV-2 by nitric oxide in vitro

Authors: Akaberi D et al

Publication date: October 2020

Journal: Redox Biology

DOI: 10.1016/j.redox.2020.101734

The ongoing SARS-CoV-2 pandemic is a global public health emergency posing a high burden on nations’ health care systems and economies. Despite the great effort put in the development of vaccines and specific treatments, no prophylaxis or effective therapeutics are currently available. Nitric oxide (NO) is a broad-spectrum antimicrobial and a potent vasodilator that has proved to be effective in reducing SARS-CoV replication and hypoxia in patients with severe acute respiratory syndrome. Given the potential of NO as treatment for SARS-CoV-2 infection, we have evaluated the in vitro antiviral effect of NO on SARS-CoV-2 replication. The NO-donor S-nitroso-N-acetylpenicillamine (SNAP) had a dose dependent inhibitory effect on SARS-CoV-2 replication, while the non S-nitrosated NAP was not active, as expected. Although the viral replication was not completely abolished (at 200 μM and 400 μM), SNAP delayed or completely prevented the development of viral cytopathic effect in treated cells, and the observed protective effect correlated with the level of inhibition of the viral replication. The capacity of the NO released from SNAP to covalently bind and inhibit SARS-CoV-2 3CL recombinant protease in vitro was also tested. The observed reduction in SARS-CoV-2 protease activity was consistent with S-nitrosation of the enzyme active site cysteine.

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Mortality

Effect of school closures on mortality from coronavirus disease 2019: old and new predictions

Authors: Ken Rice, Ben Wynne, Victoria Martin and Graeme J Ackland

Publication date: 07 October 2020

Journal: The BMJ

DOI: 10.1136/bmj.m3588

Objective: To replicate and analyse the information available to UK policymakers when the lockdown decision was taken in March 2020 in the United Kingdom.

Design: Independent calculations using the CovidSim code, which implements Imperial College London’s individual based model, with data available in March 2020 applied to the coronavirus disease 2019 (covid-19) epidemic.

Main outcome measures: Replication of summary data on the covid-19 epidemic reported to the UK government Scientific Advisory Group for Emergencies (SAGE), and a detailed study of unpublished results, especially the effect of school closures.

Results: The CovidSim model would have produced a good forecast of the subsequent data if initialised with a reproduction number of about 3.5 for covid-19. The model predicted that school closures and isolation of younger people would increase the total number of deaths, albeit postponed to a second and subsequent waves. The findings of this study suggest that prompt interventions were shown to be highly effective at reducing peak demand for intensive care unit (ICU) beds but also prolong the epidemic, in some cases resulting in more deaths long term. This happens because covid-19 related mortality is highly skewed towards older age groups. In the absence of an effective vaccination programme, none of the proposed mitigation strategies in the UK would reduce the predicted total number of deaths below 200 000.

Conclusions: It was predicted in March 2020 that in response to covid-19 a broad lockdown, as opposed to a focus on shielding the most vulnerable members of society, would reduce immediate demand for ICU beds at the cost of more deaths long term. The optimal strategy for saving lives in a covid-19 epidemic is different from that anticipated for an influenza epidemic with a different mortality age profile.​

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Testing

Cerebrospinal Fluid Leak After Nasal Swab Testing for Coronavirus Disease 2019

Authors: Blake Sullivan C et al

Publication date: 01 October 2020

Journal: JAMA

DOI: 10.1001/jamaoto.2020.3579

In March 2020, coronavirus disease 2019 (COVID-19) emerged as a global pandemic. Testing for presence of active severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection is 1 pillar of the global response.1 In particular, nasopharyngeal, anterior nasal, and midturbinate swabs are 3 of the 5 methods for initial diagnostic specimen collection recommended by the US Centers for Disease Control and Prevention (CDC).2 However, complications associated with nasal swab testing are not well characterized. We describe the first case of a cerebrospinal fluid (CSF) leak after nasal testing for COVID-19, to our knowledge.

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False-positive COVID-19 results: hidden problems and costs

Authors: Elena Surkova, Vladyslav Nikolayevskyy and Francis Drobniewski

Publication date: 29 September 2020

Journal: The Lancet

DOI: 10.1016/S2213-2600(20)30453-7

RT-PCR tests to detect severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA are the operational gold standard for detecting COVID-19 disease in clinical practice. RT-PCR assays in the UK have analytical sensitivity and specificity of greater than 95%, but no single gold standard assay exists.1,  2 New assays are verified across panels of material, confirmed as COVID-19 by multiple testing with other assays, together with a consistent clinical and radiological picture. These new assays are often tested under idealised conditions with hospital samples containing higher viral loads than those from asymptomatic individuals living in the community. As such, diagnostic or operational performance of swab tests in the real world might differ substantially from the analytical sensitivity and specificity.

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Vaccines

Many challenges remain despite progress on SARS-CoV-2 vaccines

Publication date: 01 October 2020

Source: The Royal Society

Vaccines have the potential to end the COVID-19 pandemic but it may be some time before they can make a major difference according to Data Evaluation and Learning for Viral Epidemics (DELVE), a multi-disciplinary group convened by the Royal Society.

Huge progress has been made through international collaboration with 200 vaccines in development and a number in trials that look promising.  However the report, SARS-CoV-2 vaccine development & implementation; scenarios, options, key decisions highlights the challenges involved, including that the initial vaccines might be only partially effective, might not be effective for some groups, might provide only short lived immunity, and have many problems to be solved around rapid scale-up in manufacture, distribution and acceptability.

Dr Fiona Culley of the National Heart and Lung Institute at Imperial College London and one of the lead authors of the report said: “Vaccines are held up as our best chance of getting our lives back to some sense of normality, but we have to be realistic.  The path to successful vaccines is filled with potential problems in finding vaccines that will work effectively in the ways we need and in being able to roll them out.  Planning now for the different scenarios that might play out will give us the best chance of taking rapid advantage of any vaccines that are proven to be safe and effective.”

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Ensuring Uptake of Vaccines against SARS-CoV-2

Authors: Mello MM et al

Publication date: 01 October 2020

DOI: 10.1056/NEJMp2020926

As Covid-19 continues to exact a heavy toll, development of a vaccine appears the most promising means of restoring normalcy to civil life. Perhaps no scientific breakthrough is more eagerly anticipated. But bringing a vaccine to market is only half the challenge; also critical is ensuring a high enough vaccination rate to achieve herd immunity. Concerningly, a recent poll found that only 49% of Americans planned to get vaccinated against SARS-CoV-2.1

One option for increasing vaccine uptake is to require it. Mandatory vaccination has proven effective in ensuring high childhood immunization rates in many high-income countries. However, except for influenza vaccination of health care workers, mandates have not been widely used for adults.

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Social Impacts

Changes in Adult Alcohol Use and Consequences During the COVID-19 Pandemic in the US

Authors: Michael S Pollard PhD, Joan S Tucker PhD and Harold D Green Jr PhD

Publication date: 29 September 2020

Journal: JAMA Network Open

DOI: 10.1001/jamanetworkopen.2020.22942

As stay-at-home orders began in some US states as a mitigation strategy for coronavirus disease 2019 (COVID-19) transmission, Nielsen reported a 54% increase in national sales of alcohol for the week ending March 21, 2020, compared with 1 year before; online sales increased 262% from 2019.1 Three weeks later, the World Health Organization warned that alcohol use during the pandemic may potentially exacerbate health concerns and risk-taking behaviors.2 This study examines individual-level changes in alcohol use and consequences associated with alcohol use in US adults, as well as demographic disparities, from before to during the COVID-19 pandemic.

Discussion

These data provide evidence of changes in alcohol use and associated consequences during the COVID-19 pandemic. In addition to a range of negative physical health associations, excessive alcohol use may lead to or worsen existing mental health problems, such as anxiety or depression,6 which may themselves be increasing during COVID-19. The population level changes for women, younger, and non-Hispanic White individuals highlight that health systems may need to educate consumers through print or online media about increased alcohol use during the pandemic and identify factors associated with susceptibility and resilience to the impacts of COVID-19.

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Government and Health Authorities

Vaccines

FDA In Brief: FDA Issues Guidance on Emergency Use Authorization for COVID-19 Vaccines

Publication date: 06 October 2020

Source: US Food & Drug Administration (FDA)

  • Today, the U.S. Food and Drug Administration issued guidance with recommendations for vaccine sponsors regarding the scientific data and information that would support the issuance of an emergency use authorization (EUA) for an investigational vaccine intended to prevent COVID-19.
  • The recommendations in the guidance describe key information and data that would support issuance of an EUA, including chemistry, manufacturing and controls information, nonclinical and clinical data, and regulatory and administrative information.
  • This guidance provides further information on the EUA process for investigational vaccines and provides additional context to the information provided in the agency’s June guidance regarding the development and licensure of COVID-19 vaccines.

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Human-Challenge Trials – Should we deliberately infect volunteers with Covid-19 to test a vaccine?

Author: Dr Martin Broadstock

Publication date: 05 October 2020

Source: Medical Research Council

The UK has been a world-leader in vaccine research ever since Edward Jenner first introduced the term vaccine. What may surprise you is that Jenner’s iconic experiment performed in 1796 of deliberately infecting a boy with cowpox, and then subsequently infecting him with smallpox could be considered one of the first human-challenge trials. Today, deliberately infecting human volunteers in a controlled clinical setting is used to develop new vaccines for a range of different diseases, including malaria, influenza and typhoid to name just a few. Indeed, MRC has supported human-challenge trials for over 70 years, the earliest being at our Common Cold unit, where coronaviruses were identified as a cause of the common cold.

Recent reports of the potential use of human-challenge trials to tackle Covid-19 have brought this approach to vaccine development into the spotlight. Young, healthy volunteers could be injected with an experimental vaccine and then deliberately infected with SARS-CoV-2, the type of coronavirus which causes Covid-19. So, what are the arguments for and against this approach?

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Covid-19

How COVID-19 Spreads

Publication date: 05 October 2020

Source: Centers for Disease Control and Prevention

COVID-19 is thought to spread mainly through close contact from person to person, including between people who are physically near each other (within about 6 feet). People who are infected but do not show symptoms can also spread the virus to others. We are still learning about how the virus spreads and the severity of illness it causes.

COVID-19 spreads very easily from person to person

How easily a virus spreads from person to person can vary. The virus that causes COVID-19 appears to spread more efficiently than influenza but not as efficiently as measles, which is among the most contagious viruses known to affect people.

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Twelve things we know about Covid-19, thanks to health data research

Publication date: 29 September 2020

Source: UK Research and Innovation

‘Twelve things we know about Covid-19, so far’, published by Health Data Research UK (HDRUK) demonstrates the absolute necessity for timely, secure access to health data across all aspects of the Covid-19, including the effects of the pandemic on care for other conditions such as cancer and heart disease.

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Wider health impacts

Wider Impacts of COVID-19 on Health (WICH) monitoring tool

Source: Public Health England

The Wider Impacts of COVID-19 on Health (WICH) monitoring tool is designed to allow users to explore the indirect effects of the COVID-19 pandemic on the population's health and wellbeing. This tool presents a range of health and wellbeing metrics in interactive plots that can be broken down to show differences between groups - for example, you can explore grocery purchasing habits by Region or Social Class.

This resource will be updated weekly with:

New time point data for existing metrics where available and appropriate.

New metrics covering relevant themes where data become available.

A companion summary document has been published alongside this tool and is available to read here.

Measures

Public Health England (PHE) Health Intelligence teams have collated a range of metrics and grouped them into seven categories.

Below is a table of metrics - click the rows to expand groups and subgroups and click the Link column to view the relevant section of the tool. You can search through indicators using the search bar on the right.

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Media – Science related

Covid-19 pandemic

Coronavirus: Is the cure worse than the disease? The most divisive question of 2020

Author: Danny Dorling

Publication date: 06 October 2020

Source: The Conversation

In 1968, at the height of the last great influenza pandemic, at least a million people worldwide died, including 100,000 Americans. That year A.M.M. Payne, a professor of epidemiology at Yale University, wrote:

In the conquest of Mount Everest anything less than 100% success is failure, but in most communicable diseases we are not faced with the attainment of such absolute goals, but rather with trying to reduce the problem to tolerable levels, as quickly as possible, within the limits of available resources… 

That message is worth repeating because the schism between those seeking “absolute goals” versus those seeking “tolerable levels” is very much evident in the current pandemic. On September 21, the BMJ reported that opinion among UK scientists is divided as to whether it is better to focus on protecting those most at risk of severe COVID, or imposing lockdown for all. 

One group of 40 scientists wrote a letter to the chief medical officers of the UK suggesting that they should aim to “suppress the virus across the entire population”. 

In another letter, a group of 28 scientists suggested that “the large variation in risk by age and health status suggests that the harm caused by uniform policies (that apply to all persons) will outweigh the benefits”. Instead, they called for a “targeted and evidence-based approach to the COVID-19 policy response”. 

A week later, science writer Stephen Buranyi wrote a piece for the Guardian arguing that the positions in the letter with 28 authors represent those of a small minority of scientists. “The overwhelming scientific consensus still lies with a general lockdown,” he claimed.

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Why are coronavirus rates rising in some areas of England and not others?

Authors: Danny Dorling, Anthony Brookes and George Davey Smith

Publication date: 01 Octoboer 2020

Source: The Conversation

Growing alarm has been expressed over the rising number of people who are testing positive for COVID-19 in the UK. More tests have been made available and more people have been taking those tests, but that alone does not explain the increases in the numbers of those who have tested positive, nor why there is such variation across different parts of the nation.

We can explore a number of theories as the basis for this increase. For example, children returned to schools in Scotland on August 11, and eight days later cases in Scotland peaked at 141 before dipping and then rising further again. A similar pattern was seen in England. It’s also likely that people returning from holidays with the infection contributed to these rises.

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Covid: The Big Picture in 7 Charts

Publication date: 01 October 2020

Source: Swiss Policy Research

1) Gobal covid “cases” and deaths vs. all-cause deaths

Chart number one shows global covid deaths by September in blue (about 1 million) versus global all-cause deaths in purple (about 40 million). The chart also shows the cumulative number of global covid “cases” (i.e. positive PCR tests) – the so-called “casedemic” on top of the pandemic.

In contrast, the UN expects that the political reaction to the pandemic may put the livelihood of up to 1.6 billion people at immediate risk and may, by the end of 2020, push an additional 130 million people “to the brink of starvation” and an additional 150 million children into poverty.

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Covid-19 science

The Great Barrington Declaration

Publication date: October 2020

Source: Great Barrington Declaration

As infectious disease epidemiologists and public health scientists we have grave concerns about the damaging physical and mental health impacts of the prevailing COVID-19 policies, and recommend an approach we call Focused Protection.

Coming from both the left and right, and around the world, we have devoted our careers to protecting people. Current lockdown policies are producing devastating effects on short and long-term public health. The results (to name a few) include lower childhood vaccination rates, worsening cardiovascular disease outcomes, fewer cancer screenings and deteriorating mental health – leading to greater excess mortality in years to come, with the working class and younger members of society carrying the heaviest burden. Keeping students out of school is a grave injustice.

Keeping these measures in place until a vaccine is available will cause irreparable damage, with the underprivileged disproportionately harmed.

Fortunately, our understanding of the virus is growing. We know that vulnerability to death from COVID-19 is more than a thousand-fold higher in the old and infirm than the young. Indeed, for children, COVID-19 is less dangerous than many other harms, including influenza.

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Vaccines

INOVIO Reports FDA Partial Clinical Hold for Planned Phase 2 / 3 Trial of COVID-19 Vaccine Candidate INO-4800

Publication date: 28 September 2020

Source: Inovio

INOVIO (NASDAQ:INO), a biotechnology company focused on bringing to market precisely designed DNA medicines to treat and protect people from infectious diseases and cancer, announced that the U.S. Food and Drug Administration (FDA) has notified the company it has additional questions about the company's planned Phase 2/3 trial of its COVID-19 vaccine candidate INO-4800, including its CELLECTRA® 2000 delivery device to be used in the trial. Until the FDA's questions have been satisfactorily addressed, INOVIO's Investigational New Drug Application (IND) for the Phase 2/3 trial is on partial clinical hold. The company is actively working to address the FDA's questions and plans to respond in October, after which the FDA will have up to 30 days to notify INOVIO of its decision as to whether the trial may proceed.

This partial clinical hold is not due to the occurrence of any adverse events related to INOVIO's ongoing expanded Phase 1 study of INO-4800, the conduct of which may continue and is not impacted by the FDA's notification. In addition, this partial clinical hold does not impact the advancement of INOVIO's other product candidates in development. INOVIO and its partners are continuing to prepare for a planned Phase 2/3 trial of INO-4800, following resolution of the FDA's partial clinical hold and subject to the receipt of external funding to conduct the trial.

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Loss of freedoms

Democracy under Lockdown

Authors: Sarah Repucci and Amy Slipowitz

Publication date: 01 October 2020

Source: Freedom House

The COVID-19 pandemic has fueled a crisis for democracy around the world. Since the coronavirus outbreak began, the condition of democracy and human rights has grown worse in 80 countries. Governments have responded by engaging in abuses of power, silencing their critics, and weakening or shuttering important institutions, often undermining the very systems of accountability needed to protect public health.

This is the conclusion of new Freedom House research on the impact of COVID-19 on democracy and human rights, produced in partnership with the survey firm GQR. Based on a survey of 398 journalists, civil society workers, activists, and other experts as well as research on 192 countries by Freedom House’s global network of analysts, this report is the first of its kind and the most in-depth effort to date to examine the condition of democracy during the pandemic (see full methodology).

The research strongly supports the hypothesis that the COVID-19 pandemic is exacerbating the 14 years of consecutive decline in freedom. Not only has democracy weakened in 80 countries, but the problem is particularly acute in struggling democracies and highly repressive states—in other words, settings that already had weak safeguards against abuse of power are suffering the most. The findings illustrate the breadth and depth of the assault on democracy. As one respondent on Cambodia put it, “The government [took] coronavirus as the opportunity to demolish democratic space.”

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Media – Reporting

Mortality

Removal of Form 5 Cremation Certificate for deaths relating to Covid-19 under the Coronavirus Act

Author: Vanessa Beeley

Publication date: 05 October 2020

Source: The Wall Will Fall

The following is from an investigation by Lisa Jane Waters:

Licence for murder?

As we head in to winter watch death statistic manipulation go into overdrive, check out this “Medical Practitioners” guidance on death provisions.

Did you know that the UK Government have removed Form 5 of the Cremation Certificate for deaths relating to Covid-19 under the Coronavirus Act which is the form that the relative who registers the death must be given as it enables them to see and query the death certificate before cremation.

So basically if your loved one dies of or with Covid19 they can have their death certified and cremation certified by the same medical practitioner and sent for cremation within hours and the government have removed your right to see or query that decision before the cremation takes place which in turn removes your right to request a coroners report or second opinion. 

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Vaccines

Coronavirus shock: Millions of Britons to miss out on COVID-19 vaccine - UK chief admits

Author: Luke Hawker

Publication date: 05 October 2020

Source: Express

Kate Bingham, chair of the UK Vaccine Taskforce, has said a vaccine for everyone living in the UK is “not going to happen” and insisted the overall aim of the Government is to vaccinate 30 million out of the 67 million population. Ms Bingham added: “We just need to vaccinate everyone at risk.” The health chief has added any future treatment would be for people aged over 50-years-old with health workers and the vulnerable given top priority.

Speaking to the Financial Times, she said: “People keep talking about ‘time to vaccinate the whole population’, but that is misguided.

“There’s going to be no vaccination of people under 18.

“It’s an adult-only vaccine, for people over 50, focusing on health workers and care home workers and the vulnerable.”

Britain is currently leading the way for a cure for the deadly virus which has killed more than one million people around the world, including more than 40,000 people in the UK.

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Coronavirus vaccine trial participants report day-long exhaustion, fever and headaches — but say it’s worth it

Authors: Christina Farr and Berkeley Lovelace Jr

Publication date: 01 October 2020

Source: CNBC

High fever, body aches, headaches and exhaustion are some of the symptoms participants in Moderna and Pfizer’s coronavirus vaccine trials say they felt after receiving the shots.

While the symptoms were uncomfortable, and at times intense, they often went away after a day, sometimes less.

The phase three trials are a critical last step needed to get the vaccines cleared for distribution.

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Lockdowns

Relationship between Government and Nphet 'changed forever' as ministers 'blindsided' by health experts' meeting

Authors: Philip Ryan, Cormac McQuinn and Tom Brady

Publication date: 06 October 2020

Source: Independent.ie

Trust between the Government and the National Public Health Emergency Team (Nphet) hit an all-time low as the Taoiseach faced down a shock demand to push the country into the highest level of lockdown.

During a tense meeting in Government Buildings, returning chief medical officer Dr Tony Holohan faced a barrage of criticism from senior ministers.

One well-placed source told the Irish Independent that the relationship between the Government and Nphet had "changed forever".

Dr Holohan had stunned the Cabinet late on Sunday with a recommendation to impose Level 5 restrictions on the entire country.

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Apathy towards Covid-19 growing across Europe, warns WHO

Author: Jordan Kelly-Linden

Publication date: 06 October 2020

Source: The Telegraph

“Pandemic fatigue” is on the rise across Europe and with it comes the risk of further disease spread, the World Health Organization has warned

WHO defines pandemic fatigue as a “demotivation to follow recommended protective behaviours”, such as hand washing or sticking to social distancing rules.

And a report last month showed that has reached more than 60 per cent of the population in some places.

Dr Hans Kluge, director of the World Health Organization's European region, said citizens “had made huge sacrifices” since the emergence of the virus. “It has come at an extraordinary cost, which has exhausted all of us regardless of where we live, or what we do. In such circumstances it is easy and natural to feel apathetic and demotivated and to experience fatigue,” he said.

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Therapeutics

Since the Covid-19 epidemic started multiple studies have repeatedly shown a link to Vitamin D deficiency yet when Matt Hancock was asked about it he WRONGLY said a British study had found the opposite. Is he ignorant or incompetent?

Author: Connor Boyd

Publication date: 01 October 2020

Source: Mail Online

Health Secretary Matt Hancock was told to 'get his facts straight' today after shooting down vitamin D as a potential coronavirus treatment despite a growing body of evidence from around the world suggesting it works.

Experts have for months been calling for officials to look into the immune system-boosting nutrient's effect on Covid-19 patients after a mountain of research showed a link to vitamin D deficiency.

Mr Hancock told the House of Commons last week he had green-lit a Government-funded 'trial' investigating vitamin D and that it did not 'appear to have any impact'.

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Social Impacts

Matt Hancock warns cancer patients will only be guaranteed treatment if Covid-19 stays 'under control' - as he is savaged for 'having no idea how many infected people are walking around' after testing shambles saw 16,000 cases MISSED

Author: Luke Andrews

Publication date: 07 October 2020

Source: Mail Online

Cancer patients may only be guaranteed treatment if Covid-19 stays 'under control', Matt Hancock claimed today as he faced a roasting from MPs over an Excel spreadsheet blunder that has potentially led to tens of thousands of Britons being unaware they are infected with the virus.

The Health Secretary claimed that it was 'critical for everybody to understand the best way to keep cancer services running is to suppress the disease', suggesting that hundreds of thousands of patients may face delays to planned surgery and chemotherapy, if the outbreak continues to spiral.

Vital operations were cancelled and patients missed out on potentially life-saving therapy in the spring because tackling Covid-19 became the sole focus of the health service, instead of cancer and other cruel diseases.

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Army sees sharp increase in suicides during coronavirus pandemic

Authors: Barbara Starr and Paul LeBlanc

Publication date: 01 October 2020

Source: CNN

The US Army has seen a worrisome increase in soldier deaths by suicide since March, raising questions about whether troops feeling isolated due to the coronavirus pandemic may be a contributing factor.

CNN has learned that the monthly number of suicides in the active duty Army since March, when the impact of the pandemic began to be felt, was above the five-year average of the monthly totals for the force. As of August 31, the active duty force has had 114 suicides compared to 88 in the same time period during 2019. One-hundred and fourteen deaths is the highest number in the first eight months of any year since 2012.

The total rate of suicides is especially troubling to the Army because for active duty soldiers alone it was 36 per 100,000 so far in 2020 compared to 30.6 the year before.

For the total Army forces, including guard and reserve forces, there were 200 suicides by August 31 of this year compared to 166 for the same period in 2019. The highest number of suicides occurred in July with 35 cases, or more than one suicide every day.

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Health passports

Airlines hope Covid-19 health pass will have passengers flying again

Author: Philip Georgiadis

Publication date: 07 October 2020

Source: Financial Times

The first trials of a digital health pass that certifies airline passengers are Covid-free will begin this week in a push to reopen international travel fully after nearly nine months of disruption.

The World Economic Forum-backed CommonPass project aims to create the first globally recognised proof that a passenger has tested negative for the virus before a flight, using a digital certificate downloaded to a mobile phone.

CommonPass will not conduct tests. Instead it aims to establish standard certifications for Covid-19 test results and, eventually, proof that a passenger has been vaccinated against the virus.

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Health visas and 'mask aware' cameras: How Covid is transforming airports

Author: Hazel Plush

Publication date: 01 October 2020

Source: The Telegraph

The pandemic has changed the airport experience forever, sparking ground-breaking innovation in security and biometrics, says the president of the world's leading specialist in air transport technology.

In an exclusive interview with Telegraph Travel, Sergio Colella, the Europe boss of tech giant SITA – whose clients include airports, airlines and ground operations all over the world – revealed how Covid-19 has forced airports to rethink the passenger journey entirely, and required an overhaul of security controls at a rate “not seen since 9/11”.

“Right now, you see that countries are putting in quarantines, restricting travel – but we can’t afford to keep doing this,” says Colella. “If you shut everything down again, we might be in good health, but the economy will be dead. Instead, what we need is more safety protocols in the airport experience, more touch-free technology for passengers, and an integrated approach to border checks – such as a ‘health visa’, which would permit you to travel when the necessary PCR tests or vaccines have been completed.”

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