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Publications

Deaths in Children and Young People in England following SARS-CoV-2 infection during the first pandemic year: a national study using linked mandatory child death reporting data – Research Square

25 CYP died of SARS-CoV-2 during the first pandemic year in England, equivalent to an infection fatality rate of 5 per 100,000 and a mortality rate of 2 per million. Most had an underlying comorbidity, particularly neurodisability and life-limiting conditions. The CYP who died were mainly >10 years and of Asian and Black ethnicity, compared to other causes of the death, but their absolute risk of death was still extremely low. 

https://www.researchsquare.com/article/rs-689684/v1

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Publications

Experimental Assessment of Carbon Dioxide Content in Inhaled Air With or Without Face Masks in Healthy Children – JAMA

Many governments have made nose and mouth covering or face masks compulsory for schoolchildren. The evidence base for this is weak. The question whether nose and mouth covering increases carbon dioxide in inhaled air is crucial. A large-scale survey in Germany of adverse effects in parents and children using data of 25 930 children has shown that 68% of the participating children had problems when wearing nose and mouth coverings.

The normal content of carbon dioxide in the open is about 0.04% by volume (ie, 400 ppm). A level of 0.2% by volume or 2000 ppm is the limit for closed rooms according to the German Federal Environmental Office, and everything beyond this level is unacceptable.

https://jamanetwork.com/journals/jamapediatrics/fullarticle/2781743

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Publications

SARS-CoV-2 elicits robust adaptive immune responses regardless of disease severity – Science Direct

We report broad serological profiles within the cohort, detecting antibody binding to other human coronaviruses. 202(>99%) participants had SARS-CoV-2 specific antibodies, with SARS-CoV-2 neutralization and spike-ACE2 receptor interaction blocking observed in 193(95%) individuals. A significant positive correlation (r=0.7804) between spike-ACE2 blocking antibody titers and neutralization potency was observed. Further, SARS-CoV-2 specific CD8+ T-cell responses were clear and quantifiable in 95 of 106(90%) HLA-A2+ individuals.

https://www.sciencedirect.com/science/article/pii/S2352396421002036

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Publications

The Safety of COVID-19 Vaccinations—We Should Rethink the Policy – MDPI

Conclusions: This lack of clear benefit should cause governments to rethink their vaccination policy.

The present assessment raises the question whether it would be necessary to rethink policies and use COVID-19 vaccines more sparingly and with some discretion only in those that are willing to accept the risk because they feel more at risk from the true infection than the mock infection. Perhaps it might be necessary to dampen the enthusiasm by sober facts? In our view, the EMA and national authorities should instigate a safety review into the safety database of COVID-19 vaccines and governments should carefully consider their policies in light of these data. Ideally, independent scientists should carry out thorough case reviews of the very severe cases, so that there can be evidence-based recommendations on who is likely to benefit from a SARS-CoV2 vaccination and who is in danger of suffering from side effects. Currently, our estimates show that we have to accept four fatal and 16 serious side effects per 100,000 vaccinations in order to save the lives of 2–11 individuals per 100,000 vaccinations, placing risks and benefits on the same order of magnitude.

https://www.mdpi.com/2076-393X/9/7/693/htm

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Publications

Human IgG and IgA responses to COVID-19 mRNA vaccines – PLOS ONE

SARS-CoV-2 spike antigen-specific IgG and IgA elicited by infection mediate viral neutralization and are likely an important component of natural immunity, however, limited information exists on vaccine induced responses. We measured COVID-19 mRNA vaccine induced IgG and IgA in serum serially, up to 145 days post vaccination in 4 subjects. Spike antigen-specific IgG levels rose exponentially and plateaued 21 days after the initial vaccine dose. After the second vaccine dose IgG levels increased further, reaching a maximum approximately 7–10 days later, and remained elevated (average of 58% peak levels) during the additional >100 day follow up period. COVID-19 mRNA vaccination elicited spike antigen-specific IgA with similar kinetics of induction and time to peak levels, but more rapid decline in serum levels following both the 1st and 2nd vaccine doses (<18% peak levels within 100 days of the 2nd shot). The data demonstrate COVID-19 mRNA vaccines effectively induce spike antigen specific IgG and IgA and highlight marked differences in their persistence in serum.

https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0249499

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Publications

Manipulative magnetic nanomedicine: the future of COVID-19 pandemic/endemic therapy – Taylor & Francis Online

Published 14 Dec 2020

Nanobiotechnology is emerging very promising to investigate novel methodologies for managing COVID-19 pandemic/endemic successfully. In this direction, experts have explored the opto-electro-magnetic nanosystem to detect the SARS-CoV-2 virus using a biosensing approach. Such optical, electrical, or magnetic biosensors function based on geno-sensing and immune-sensing has detected the SARS-CoV-2 virus selectively at a very low level. These efficient-miniaturized biosensors can be operated using a smartphone and promoted for clinical application for early-stage diagnostics of COVID-19 infection. The successful integration of these SARS-CoV-2 virus sensors with AI and IoMT enables virus detection at point-of-location and sharing of bioinformatics with the medical center at the same time for timely therapeutics decision. This approach is also useful for tracking tasks and managing COVID-19 infection according to patient infection profiling. To avoid human-to-human SARS-CoV-2 virus transmission, experts have developed stimuli-responsive nanotechnology enable which can not only trap aerosol of virus size but can eradicate viruses on applying external stimulation for example nanoenable photo-sensitive virus degradation. Various types of clothes containing nanoparticles have demonstrated SARS-CoV-2 virus trapping and eradication successfully [2,9]. However, significant attention is required to increase the production and distribution of these masks for public use.

https://www.tandfonline.com/doi/full/10.1080/17425247.2021.1860938

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Opinion Publications

Covid-Status Certification Second Report of Session 2021–22 – PACAC

The introduction a Covid-status certification system would have a serious impact on businesses and individuals and has the possibility of infringing rights and being discriminatory in nature. In light of that, we believe that it would be inappropriate for a system with such a potentially wide adverse impact to be introduced by secondary legislation.

https://committees.parliament.uk/publications/6264/documents/69158/default/

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Publications

Register your Type 1 Opt-out preference – NHS

If you do not want your patient data shared with NHS Digital, you can register a Type 1 Opt-out with your GP practice. You can register a Type 1 Opt-out at any time. You can also change your mind at any time and withdraw a Type 1 Opt-out.

Data sharing with NHS Digital will start on 1 September 2021.

The button will download a 42kB .docx file from the NHS website. If it is not available, you can download an archived copy from here.

https://digital.nhs.uk/data-and-information/data-collections-and-data-sets/data-collections/general-practice-data-for-planning-and-research/transparency-notice#opting-out-of-nhs-digital-collecting-your-data-type-1-opt-out-

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Publications

Temporary Body Storage Service tender for Westminster City Council – GOV.UK

The Authority seeks to procure a framework agreement for temporary body storage in the event of an excess deaths situation for the 32 London boroughs and the City of London, led by Westminster City Council. The framework agreement will appoint a single provider and will be for a period of 4 years. This will be a contingency contract, only called upon in the event that an excess deaths situation arises in the future and existing local body storage capacity needs to be augmented.

The over-arching aim of this tender is to provide a single framework supplier that will be able to provide temporary body storage facilities to house deceased in the event of an excess deaths situation. The deceased will be stored with dignity and respect, at locations to be determined based on local London needs at the time and will require some design elements to accommodate local site conditions and constraints, while being capable of rapid deployment, construction and commissioning to an agreed standard. This framework will be procured by the Authority as the pan-London lead, but all London local authorities may call-off against the framework.

This will be a contingency cover framework and as such there is no minimum guarantee of any level of spend or call-off under the framework agreement.

https://www.find-tender.service.gov.uk/Notice/013120-2021

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Publications

No point vaccinating those who’ve had COVID-19: Findings of Cleveland Clinic study – News-Medical.Net

Scientists from the Cleveland Clinic, USA, have recently evaluated the effectiveness of coronavirus disease 2019 COVID-19) vaccination among individuals with or without a history of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection.

The study findings reveal that individuals with previous SARS-CoV-2 infection do not get additional benefits from vaccination, indicating that COVID-19 vaccines should be prioritized to individuals without prior infection. The study is currently available on the medRxiv* preprint server.

https://www.news-medical.net/news/20210608/No-point-vaccinating-those-whoe28099ve-had-COVID-19-Findings-of-Cleveland-Clinic-study.aspx

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Publications

MHRA awarded over £980,000 for collaboration with the Bill and Melinda Gates Foundation and the World Health Organisation – Gov.uk

Published 15 December 2017

MHRA today announced a partnership worth over £980,000 to improve the safety monitoring of medicines in low and middle-income countries.

https://www.gov.uk/government/news/mhra-awarded-over-980000-for-collaboration-with-the-bill-and-melinda-gates-foundation-and-the-world-health-organisation

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Publications

STUDY ON THE ELECTROMAGNETISM OF VACCINATED PERSONS IN LUXEMBOURG – European Forum for Vaccine Vigilance

In the non-vaccinated group, out of the 30 individuals interviewed, the number of people showing attraction to the magnet was 0 (zero). Therefore the experiment ended there for this group.

In the vaccinated group, on the other hand, 29 of the 30 individuals interviewed showed attraction to the magnet. That is, the magnet adhered to their skin without difficulty.

Of these same 29 individuals, 22 have the magnet adhering to only one shoulder and only to the injection area. These 22 individuals are those who received only one injection. The other 7 people in this same group have the magnet adhering on both shoulders.

https://www.efvv.eu/images/content/2021/0617/study-on-electromagnetism-of-vaccinated-persons-in-luxembourg_6edfa.pdf

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Publications

Necessity of COVID-19 vaccination in previously infected individuals – medRxiv

Conclusions Individuals who have had SARS-CoV-2 infection are unlikely to benefit from COVID-19 vaccination, and vaccines can be safely prioritized to those who have not been infected before.

https://www.medrxiv.org/content/10.1101/2021.06.01.21258176v2

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Publications

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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Publications

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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Publications

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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Publications

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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Publications

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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Publications

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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Publications

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