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Publications

Recent deaths in young people in England and Wales – HART

The mortality data for England and Wales from ONS from 1 May 2021 until 17 September 2021 shows a significant excess, particularly in the 15-19 year age group. Depending on the baseline chosen, the excess for 15-19 year olds is between 16% and 47% above expected levels (see table 1 and 2). COVID-19 deaths were too small in number to account for the excess. A disproportionate number of these excess deaths were in males. A certain amount of variation by random chance would be expected but an increase of this proportion is large enough not to be dismissed without further investigation.

…Mortality has risen in younger age groups since 1st May 2021. The increase in the 15-19 year old age group is particularly noticeable, especially as deaths in this age group are uncommon. The excess deaths have a marked male predominance. An increase in ambulance call outs for patients who have had a cardiac arrest or are unconscious showed a coincidental noticeable rise from May 2021. The period also coincides with the rollout of vaccination. Finally, ONS have reported on a striking rise in age adjusted mortality rates in those with only one dose that accelerated in May 2021 to levels far exceeding those in the unvaccinated.

Table 1 and Table 2: Mortality from 1st May 2021 to 17th September by age group. Table 1 uses a 2020 baseline and table 2 uses a mean from 2015-2019.
Figure 7 Age adjusted non-COVID mortality rates by vaccination status as published by ONS on 13th September 

https://www.hartgroup.org/recent-deaths-in-young-people-in-england-and-wales/

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Publications

Iceland halts Moderna jabs over heart-inflammation fears – Medical Xpress

Iceland on Friday suspended the Moderna anti-COVID vaccine, citing the slight increased risks of cardiac inflammation, going further than its Nordic neighbours which simply limited use of the jabs.

…This decision owed to “the increased incidence of myocarditis and pericarditis after vaccination with the Moderna vaccine, as well as with vaccination using Pfizer/BioNTech,” the chief epidemiologist said in a statement.

https://medicalxpress.com/news/2021-10-iceland-halts-moderna-jabs-heart-inflammation.html

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Publications

Nosocomial outbreak caused by the SARS-CoV-2 Delta variant in a highly vaccinated population, Israel, July 2021 – Eurosurveillance

This nosocomial outbreak exemplifies the high transmissibility of the SARS-CoV-2 Delta variant among twice vaccinated and masked individuals. This suggests some waning of immunity, albeit still providing protection for individuals without comorbidities. However, a third vaccine dose may be needed, particularly in individuals with risk factors for severe COVID-19. Appropriate use of masks, especially in high-risk settings is advised.

https://www.eurosurveillance.org/content/10.2807/1560-7917.ES.2021.26.39.2100822#html_fulltext

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Publications

Covid risk on flights ‘less than 0.1%’ when passengers test negative in advance – Travel Weekly

The research examined data from almost 10,000 passengers on Delta’s Covid-tested flights between New York-JFK and Atlanta to Rome.

It found that a single Covid-19 molecular test performed within 72 hours of departure could decrease the rate of people actively infected on board to a level that is significantly below active community infection rates.

For example, when the average community infection rate was at 1.1% – or about one in 100 people – infection rates on Covid tested flights were 0.05% or five in 10,000 passengers.

http://archive.today/2021.09.10-094930/https://travelweekly.co.uk/news/air/covid-risk-on-flights-less-than-0-1-when-passengers-test-negative-in-advance

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Publications

Electronic Support for Public Health–Vaccine Adverse Event Reporting System (ESP:VAERS) – AHRQ

[F]ewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative. Proactive, spontaneous, automated adverse event reporting imbedded within EHRs and other information systems has the potential to speed the identification of problems with new drugs and more careful quantification of the risks of older drugs.

https://digital.ahrq.gov/sites/default/files/docs/publication/r18hs017045-lazarus-final-report-2011.pdf

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Publications

Comparing SARS-CoV-2 natural immunity to vaccine-induced immunity: reinfections versus breakthrough infections – medRxiv

This study demonstrated that natural immunity confers longer lasting and stronger protection against infection, symptomatic disease and hospitalization caused by the Delta variant of SARS-CoV-2, compared to the BNT162b2 two-dose vaccine-induced immunity. Individuals who were both previously infected with SARS-CoV-2 and given a single dose of the vaccine gained additional protection against the Delta variant.

https://www.medrxiv.org/content/10.1101/2021.08.24.21262415v1

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Publications

Shedding of Infectious SARS-CoV-2 Despite Vaccination – medRxiv

Combined with other studies, these data indicate that vaccinated and unvaccinated individuals infected with the Delta variant might transmit infection. Importantly, we show that infectious SARS-CoV-2 is frequently found even in vaccinated persons when specimen Ct values are low.

https://www.medrxiv.org/content/10.1101/2021.07.31.21261387v4.full

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Publications

Does the FDA think these data justify the first full approval of a covid-19 vaccine? – BMJ

I reiterate our call: “slow down and get the science right—there is no legitimate reason to hurry to grant a license to a coronavirus vaccine.”

FDA should be demanding that the companies complete the two year follow-up, as originally planned (even without a placebo group, much can still be learned about safety). They should demand adequate, controlled studies using patient outcomes in the now substantial population of people who have recovered from covid. And regulators should bolster public trust by helping ensure that everyone can access the underlying data.

http://archive.today/2021.08.24-174356/https://blogs.bmj.com/bmj/2021/08/23/does-the-fda-think-these-data-justify-the-first-full-approval-of-a-covid-19-vaccine/

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Publications

“He who pays the piper calls the tune”: Researcher experiences of funder suppression of health behaviour intervention trial findings – PLOS ONE

Background
Governments commonly fund research with specific applications in mind. Such mechanisms may facilitate ‘research translation’ but funders may employ strategies that can also undermine the integrity of both science and government. We estimated the prevalence and investigated correlates of funder efforts to suppress health behaviour intervention trial findings.

Conclusions
One in five researchers in this global sample reported being pressured to delay, alter, or not publish the findings of health behaviour intervention trials. Regulation of funder and university practices, establishing study registries, and compulsory disclosure of funding conditions in scientific journals, are needed to protect the integrity of public-good research.

http://archive.today/2021.08.26-220224/https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0255704

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Publications

COVID-19 vaccination programme Vaccinating children and young people: frequently asked questions – NHS England

GPs will get a £12.58 service fee and £10 financial supplement for each eligible 12-15 year old vaccinated.

NHS England C1384-Vaccinating-children-and-young-people-frequently-asked-questions screenshot

https://www.england.nhs.uk/coronavirus/wp-content/uploads/sites/52/2021/08/C1384-Vaccinating-children-and-young-people-frequently-asked-questions.pdf

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Publications

CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel – CDC

Note: Commentary on this document by Dr. Naomi Wolf can be found here: FDA document admits “covid” PCR test was developed without isolated covid samples for test calibration, effectively admitting it’s testing something else

Since no quantified virus isolates of the 2019-nCoV were available for CDC use at the time the test was developed and this study conducted, assays designed for detection of the 2019-nCoV RNA were tested with characterized stocks of in vitro transcribed full length RNA (N gene; GenBank accession: MN908947.2) of known titer (RNA copies/µL) spiked into a diluent consisting of a suspension of human A549 cells and viral transport medium (VTM) to mimic clinical specimen.

https://www.fda.gov/media/134922/download

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Publications

SARS-CoV-2 variants of concern and variants under investigation in England Technical briefing 20 – Public Health England

This means that whilst vaccination may reduce an individual’s overall risk of becoming infected, once they are infected there is limited difference in viral load (and Ct values) between those who are vaccinated and unvaccinated. Given they have similar Ct values, this suggests limited difference in infectiousness.

https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1009243/Technical_Briefing_20.pdf

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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

Time to assume that health research is fraudulent until proven otherwise? – BMJ

Stephen Lock, my predecessor as editor of The BMJ, became worried about research fraud in the 1980s, but people thought his concerns eccentric. Research authorities insisted that fraud was rare, didn’t matter because science was self-correcting, and that no patients had suffered because of scientific fraud. All those reasons for not taking research fraud seriously have proved to be false, and, 40 years on from Lock’s concerns, we are realising that the problem is huge, the system encourages fraud, and we have no adequate way to respond.

http://archive.today/2021.08.21-072242/https://blogs.bmj.com/bmj/2021/07/05/time-to-assume-that-health-research-is-fraudulent-until-proved-otherwise/

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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/