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Biosafety Level Guidance for COVID-19 Research – Consolidated Sterilizer Systems

A Biological Safety Level (BSL 1, 2, 3, or 4) is assigned to a biological lab as a safeguard to protect laboratory personnel, as well as the surrounding environment and community.

With research into potential treatments, therapies and vaccines for the SARS-CoV-2 virus (known widely as the COVID-19 Coronavirus) exploding across the globe, many institutions and laboratories are wondering whether their equipment and lab are considered safe to contain samples of the virus. As discussed in our previous blog on biosafety levels, airborne transmissible diseases like COVID-19 are typically categorized as Biosafety Level 3 (BSL-3).  BSL-3 laboratories are almost always purpose-constructed containment laboratories, outfitted with specialized equipment and HVAC systems designed to ensure no airborne particles can exit the contained space.

https://consteril.com/biosafety-level-guidance-covid-19-research/

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Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products – FDA

Published August 2015

Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products The Center for Biologics Evaluation and Research (CBER)/Office of Cellular, Tissue, and Gene Therapies (OCTGT) is issuing this guidance to provide you, sponsors of virus or bacteria-based gene therapy products (VBGT products)1 and oncolytic viruses or bacteria (oncolytic products)2 with recommendations on how to conduct shedding studies during preclinical and clinical development. For purposes of this guidance, the term “shedding” means release of VBGT or oncolytic products from the patient through one or all of the following ways: excreta (feces); secreta (urine, saliva, nasopharyngeal fluids etc.); or through the skin (pustules, sores, wounds). Shedding is distinct from biodistribution because the latter describes how a product is spread within the patient’s body from the site of administration while the former describes how it is excreted or released from the patient’s body. Shedding raises the possibility of transmission of VBGT or oncolytic products3 from treated to untreated individuals (e.g., close contacts and health care professionals). This guidance represents FDA’s current thinking on how and when shedding data should be collected for VBGT and oncolytic products during preclinical and clinical development and how shedding data can be used to assess the potential for transmission to untreated individuals. This guidance finalizes the draft guidance of the same title dated July 2014.

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Pfizer-BioNTech vaccine recipients have lower antibody levels targeting the Delta variant first discovered in India – The Francis Crick Institute

Levels of antibodies in the blood of vaccinated people that are able to recognise and fight the new SARS-CoV-2 Delta variant first discovered in India (B.1.617.2) are on average lower than those against previously circulating variants in the UK, according to new laboratory data from the Francis Crick Institute and the National Institute for Health Research (NIHR) UCLH Biomedical Research Centre, published today (Thursday) as a Research letter in The Lancet.

The results also show that levels of these antibodies are lower with increasing age and that levels decline over time, providing additional evidence in support of plans to deliver a vaccination boost to vulnerable people in the Autumn. 

https://www.crick.ac.uk/news/2021-06-03_pfizer-biontech-vaccine-recipients-have-lower-antibody-levels-targeting-the-delta-variant-first-discovered-in-india

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Neutralising antibody activity against SARS-CoV-2 VOCs B.1.617.2 and B.1.351 by BNT162b2 vaccination – The Lancet

In the case of single-dose recipients, our data show that NAbTs are significantly lower against B.1.617.2 and B.1.351 VOCs relative to B.1.1.7, implying that although a single dose might still afford considerably more protection than no vaccination, single-dose recipients are likely to be less protected against these SARS-CoV-2 variants. These data therefore suggest that the benefits of delaying the second dose, in terms of wider population coverage and increased individual NAbTs after the second dose,7 must now be weighed against decreased efficacy in the short-term, in the context of the spread of B.1.617.2. Worldwide, our data highlight the ongoing need to increase vaccine supply to allow all countries to extend second-dose protection as quickly as possible.

In the longer term, we note that both increased age and time since the second dose of BNT162b2 significantly correlate with decreased NAb activity against B.1.617.2 and B.1.351—both of which are also characteristic of the population in the UK at highest risk of severe COVID-19 (ie, older and vaccinated earlier), independent of other existing factors such as compromised immune status or comorbidity, or geographic-specific responses to vaccination.

https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)01290-3/fulltext

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Had COVID? You’ll probably make antibodies for a lifetime – Nature

People who recover from mild COVID-19 have bone-marrow cells that can churn out antibodies for decades, although viral variants could dampen some of the protection they offer.

Many people who have been infected with SARS-CoV-2 will probably make antibodies against the virus for most of their lives. So suggest researchers who have identified long-lived antibody-producing cells in the bone marrow of people who have recovered from COVID-19.

https://www.nature.com/articles/d41586-021-01442-9

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Risk in Vaccine Research and Development Quantified – PLOS ONE

Published in 20th March 2013

A database was actively compiled to include all vaccine projects in development from 1998 to 2009 in the pre-clinical development phase, clinical trials phase I, II and III up to Market Registration. The average vaccine, taken from the preclinical phase, requires a development timeline of 10.71 years and has a market entry probability of 6%. Stratification by disease area reveals pandemic influenza vaccine targets as lucrative.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0057755

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The four phases of clinical trials – Pfizer

The process of learning about and developing an investigational medicine is divided into four phases. At first, very few people receive the medicine being studied. The number of people participating in clinical studies grows along with our understanding of the investigational medicine, and the research continues as long as the potential benefits outweigh the risks.

https://www.pfizer.com/science/clinical-trials/guide-to-clinical-trials/phases

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Human Augmentation – The Dawn of a New Paradigm – GOV.UK

The Development, Concepts and Doctrine Centre (DCDC) has worked in partnership with the German Bundeswehr Office for Defence Planning to understand the future implications of human augmentation (HA), setting the foundation for more detailed Defence research and development.

The project incorporates research from German, Swedish, Finnish and UK Defence specialists to understand how emerging technologies such as genetic engineering, bioinformatics and the possibility of brain-computer interfaces could affect the future of society, security and Defence. The ethical, moral and legal challenges are complex and must be thoroughly considered, but HA could signal the coming of a new era of strategic advantage with possible implications across the force development spectrum.

HA technologies provides a broad sense of opportunities for today and in the future. There are mature technologies that could be integrated today with manageable policy considerations, such as personalised nutrition, wearables and exoskeletons. There are other technologies in the future with promises of bigger potential such as genetic engineering and brain-computer interfaces. The ethical, moral and legal implications of HA are hard to foresee but early and regular engagement with these issues lie at the heart of success.

Original: https://www.gov.uk/government/publications/human-augmentation-the-dawn-of-a-new-paradigm

Archive: http://archive.today/2021.09.12-013335/https://www.gov.uk/government/publications/human-augmentation-the-dawn-of-a-new-paradigm

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Vaccinating children against SARS-CoV-2 – BMJ

Hard to justify right now for most children in most countries

Following widespread vaccination against SARS-CoV-2 of older adults and other highly vulnerable groups, some high income countries are now considering vaccinating children; just days ago, the US Food and Drug Administration authorized the use of the Pfizer/BioNTech vaccine in children 12-15 years of age. Young people have been largely spared from severe covid-19 so far, and the value of childhood vaccination against respiratory viruses in general remains an open question for three reasons: the limited benefits of protection in age groups that experience only mild disease; the limited effects on transmission because of the range of antigenic types and waning vaccine induced immunity; and the possibility of unintended consequences related to differences in vaccine induced and infection induced immunity. We discuss each in turn.

https://www.bmj.com/content/373/bmj.n1197

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Skeptical of medical science reports? – NCBI

“It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as editor of The New England Journal of Medicine”.

More recently, Richard Horton, editor of The Lancet, wrote that “The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness”.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4572812/

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COVID-19 vaccine refusal is higher among health and social care workers who feel pressured by their employers – London School of Hygiene and Tropical Medicine

Health and social care workers who felt under greater pressure from their employers to receive COVID-19 vaccination were more likely to decline it, according to preliminary new research highlighting factors influencing uptake.

https://www.lshtm.ac.uk/newsevents/news/2021/covid-19-vaccine-refusal-higher-among-health-and-social-care-workers-who-feel

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Social bonds in response to the Covid-19 crisis: when financial markets save lives

Social bonds are an attractive investment for worldwide institutional and individual investors looking for a socially responsible investment with a clear, unambiguous purpose and a portfolio diversification opportunity with attractive risk-adjusted returns. Although the social bond market has been growing fast, it has so far remained a niche sector.

…Over the last few weeks, several social Covid-19 bonds have already been issued by a number of multilateral institutions and public agencies and are already generating significant investor interest, paving the way for more issuances. The stage is now set for social bonds to move from a niche solution to a mainstream one.

http://archive.today/2021.09.06-173555/https://www.ecmi.eu/sites/default/files/when_financial_markets_save_lives_ecmi_commentary.pdf

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Coronavirus and depression in adults, Great Britain: January to March 2021 – ONS

1.Main points
Around 1 in 5 (21%) adults experienced some form of depression in early 2021 (27 January to 7 March); this is an increase since November 2020 (19%) and more than double that observed before the coronavirus (COVID-19) pandemic (10%).
Around 1 in 3 (35%) adults who reported being unable to afford an unexpected expense of £850 experienced depressive symptoms in early 2021, compared with 1 in 5 (21%) adults before the pandemic; for adults who were able to afford this expense, rates increased from 5% to 13%. Over the period 27 January to 7 March 2021:

Younger adults and women were more likely to experience some form of depression, with over 4 in 10 (43%) women aged 16 to 29 years experiencing depressive symptoms, compared with 26% of men of the same age.
Disabled (39%) and clinically extremely vulnerable (CEV) adults (31%) were more likely to experience some form of depression than non-disabled (13%) and non-CEV adults (20%).
A higher proportion of adults renting their home experienced some form of depression (31%) when compared with adults who own their home outright (13%).
Almost 3 in 10 (28%) adults living in the most deprived areas of England experienced depressive symptoms; this compares with just under 2 in 10 (17%) adults in the least deprived areas of England.

https://www.ons.gov.uk/peoplepopulationandcommunity/wellbeing/articles/coronavirusanddepressioninadultsgreatbritain/januarytomarch2021

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Interim Laboratory Biosafety Guidelines for Handling and Processing Specimens Associated with Coronavirus Disease 2019 (COVID-19) – CDC

This guidance is intended for clinical laboratory and support staff who handle or process specimens associated with COVID-19. Guidance for Point-Of-Care Testing can be found here.

All laboratories should perform a site-specific and activity-specific risk assessment and follow Standard Precautions when handling clinical specimens. See Biological Risk Assessment: General Considerations for Laboratories

Refer to List Nexternal icon on the Environmental Protection Agency (EPA) website for EPA-registered disinfectants that have qualified under EPA’s emerging viral pathogens program for use against SARS-CoV-2.

Cultures of SARS-CoV-2 should be handled in a Biosafety Level 3 (BSL-3) laboratory using BSL-3 practices, and inoculation of animals with infectious wild-type SARS-CoV-2 should be conducted in an Animal Biosafety Level 3 (ABSL-3) facility using ABSL-3 practices and respiratory protection.

Suspected and confirmed SARS-CoV-2 positive clinical specimens, cultures, or isolates should be packed and shipped as UN 3373 Biological Substance, Category B.

https://www.cdc.gov/coronavirus/2019-ncov/lab/lab-biosafety-guidelines.html

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COVID 19 – Media Buying Services – Contracts Finder

The UK Cabinet Office awarded £320,000,000 to OMD GROUP LIMITED for COVID 19 – Media Buying Services in advertising, radio and television. The contract runs between 1st April 2021 to 31 March 2022.

Source: GOV.UK Contracts Finder

https://www.contractsfinder.service.gov.uk/notice/6043d1fd-1f8c-4232-a32a-a658e19abcb1?origin=SearchResults&p=1

Mirror: http://archive.today/LNnYR

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Increased risk for COVID-19 in patients with vitamin D deficiency – Science Direct

Vitamin D deficiency is strongly associated with increased risk for coronavirus disease 2019 (COVID-19).

The odds ratio for COVID-19 increases with vitamin deficiency in black individuals.

Diabetes, obesity, and periodontal disease are associated with an increased risk for both COVID-19 and vitamin D deficiency.

Patients with vitamin D deficiency were 4.6 times more likely to be positive for COVID-19 (indicated by the ICD-10 diagnostic code COVID19) than patients with no deficiency (P < 0.001). The association decreased slightly after adjusting for sex (odds ratio [OR] = 4.58; P < 0.001) and malabsorption (OR = 4.46; P < 0.001), respectively. The association decreased significantly but remained robust (P < 0.001) after adjusting for race (OR = 3.76; P < 0.001), periodontal disease status (OR = 3.64; P < 0.001), diabetes (OR = 3.28; P < 0.001), and obesity (OR = 2.27; P < 0.001), respectively. In addition, patients with vitamin D deficiency were 5 times more likely to be infected with COVID-19 than patients with no deficiency after adjusting for age groups (OR = 5.155; P < 0.001).

https://www.sciencedirect.com/science/article/pii/S0899900720303890

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Is a Mask That Covers the Mouth and Nose Free from Undesirable Side Effects in Everyday Use and Free of Potential Hazards? – MPDI

Many countries introduced the requirement to wear masks in public spaces for containing SARS-CoV-2 making it commonplace in 2020. Up until now, there has been no comprehensive investigation as to the adverse health effects masks can cause. The aim was to find, test, evaluate and compile scientifically proven related side effects of wearing masks. For a quantitative evaluation, 44 mostly experimental studies were referenced, and for a substantive evaluation, 65 publications were found. The literature revealed relevant adverse effects of masks in numerous disciplines. In this paper, we refer to the psychological and physical deterioration as well as multiple symptoms described because of their consistent, recurrent and uniform presentation from different disciplines as a Mask-Induced Exhaustion Syndrome (MIES). We objectified evaluation evidenced changes in respiratory physiology of mask wearers with significant correlation of O2 drop and fatigue (p < 0.05), a clustered co-occurrence of respiratory impairment and O2 drop (67%), N95 mask and CO2 rise (82%), N95 mask and O2 drop (72%), N95 mask and headache (60%), respiratory impairment and temperature rise (88%), but also temperature rise and moisture (100%) under the masks. Extended mask-wearing by the general population could lead to relevant effects and consequences in many medical fields.

https://www.mdpi.com/1660-4601/18/8/4344/htm

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Vaccine Development, Testing, and Regulation – The History of Vaccines

Vaccine development is a long, complex process, often lasting 10-15 years and involving a combination of public and private involvement.

https://www.historyofvaccines.org/content/articles/vaccine-development-testing-and-regulation

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Preliminary Findings of mRNA Covid-19 Vaccine Safety in Pregnant Persons – The New England Journal of Medicine

Among 827 participants who had a completed pregnancy, the pregnancy resulted in a live birth in 712 (86.1%), in a spontaneous abortion in 104 (12.6%), in stillbirth in 1 (0.1%), and in other outcomes (induced abortion and ectopic pregnancy) in 10 (1.2%). A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation (Table 4), and 700 of 712 pregnancies that resulted in a live birth (98.3%) were among persons who received their first eligible vaccine dose in the third trimester. Adverse outcomes among 724 live-born infants — including 12 sets of multiple gestation — were preterm birth (60 of 636 among those vaccinated before 37 weeks [9.4%]), small size for gestational age (23 of 724 [3.2%]), and major congenital anomalies (16 of 724 [2.2%]); no neonatal deaths were reported at the time of interview. Among the participants with completed pregnancies who reported congenital anomalies, none had received Covid-19 vaccine in the first trimester or periconception period, and no specific pattern of congenital anomalies was observed. Calculated proportions of pregnancy and neonatal outcomes appeared similar to incidences published in the peer-reviewed literature 

https://www.nejm.org/doi/full/10.1056/NEJMoa2104983

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Is a Mask That Covers the Mouth and Nose Free from Undesirable Side Effects in Everyday Use and Free of Potential Hazards? – Europe PMC

On the one hand, the advocacy of an extended mask requirement remains predominantly theoretical and can only be sustained with individual case reports, plausibility arguments based on model calculations and promising in vitro laboratory tests. Moreover, recent studies on SARS-CoV-2 show both a significantly lower infectivity and a significantly lower case mortality than previously assumed, as it could be calculated that the median corrected infection fatality rate (IFR) was 0.10% in locations with a lower than average global COVID-19 population mortality rate. In early October 2020, the WHO also publicly announced that projections show COVID-19 to be fatal for approximately 0.14% of those who become ill—compared to 0.10% for endemic influenza—again a figure far lower than expected.

On the other hand, the side effects of masks are clinically relevant.

…We not only found evidence in the reviewed mask literature of potential long-term effects, but also evidence of an increase in direct short-term effects with increased mask-wearing time in terms of cumulative effects for: carbon dioxide retention, drowsiness, headache, feeling of exhaustion, skin irritation (redness, itching) and microbiological contamination (germ colonization).

https://europepmc.org/article/MED/33923935