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News

CDC links Pfizer Covid vaccine to heart inflammation – latest update and symptoms to spot – The Express

THE CENTERS for Disease Control and Prevention’s safety committee has provided an update on the association between Pfizer-BioNTech and Moderna COVID-19 vaccines and heart inflammation.

On 23 June the US Centers for Disease Control and Prevention’s safety committee said there was a “likely association” between the Pfizer-BioNTech and Moderna COVID-19 vaccines and myocarditis (the medical term for heart inflammation) and pericarditis (inflammation of the tissue that surrounds the heart) in some young adults. The CDC’s Advisory Committee on Immunization Practices said there was a higher than expected number of reports of heart inflammation in people aged 16-24 who had received the mRNA vaccines but that the benefits of vaccination still clearly outweighed the risks.

https://www.express.co.uk/life-style/health/1454457/pfizer-vaccine-side-effects-moderna-heart-inflammation-shortness-of-breath

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Opinion

History shows us why vaccines must be voluntary – Spiked

To this day, many commentators think that coercion is justified in defence of public health. Arguments over ‘vaccine passports’ and obligations to get vaccinated in contracts of employment are already raging. The voluntary principle, however, is a good one. It is what allowed Britain’s vaccination programme to move beyond the controversies of the 1880s, squaring the circle of vaccination and opposition by letting people opt out. Pointedly, the conscientious objection clause over time killed off Britain’s anti-vaccine campaigns by removing the causes célèbres of vaccine martyrdom.

https://www.spiked-online.com/2021/05/31/history-shows-us-why-vaccines-must-be-voluntary/

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Opinion

COVID-19 educational materials in schools use inappropriate emotional pressure – HART

Resources use inappropriate emotional pressure

The Human Medicines Regulations 2012 (the ‘Regulations’) apply to anything ‘designed to promote the … supply … or use of that [medicinal] product’, which according to the regulations amounts to an advertisement. As the materials do not properly encourage critical thinking and present information as fact without substantiation, it is entirely possible that the teaching materials and lessons delivering those materials amount to an advertisement and may constitute an offence.

However well meaning these materials might be, it appears that they have at least the potential to put emotional pressure on children and — potentially — coercively control children’s decisions in relation to the vaccine.  The materials are therefore incompatible with the NC and the government’s advice on Teachers’ Prevent Duty, which are there to help protect children.

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Publications

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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Rapid Response: Do doctors have to have the covid-19 vaccine? – BMJ

Nevertheless, what I am currently struggling with is the failure to report the reality of the morbidity caused by our current vaccination program within the health service and staff population. The levels of sickness after vaccination is unprecedented and staff are getting very sick and some with neurological symptoms which is having a huge impact on the health service function. Even the young and healthy are off for days, some for weeks, and some requiring medical treatment. Whole teams are being taken out as they went to get vaccinated together.

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News

School attendance has ‘minimal impact on serious Covid-19 infection’ – ITV News

Adults who lived with children during the pandemic’s second wave were only slightly more at risk of Covid-19 than those who lived without them, suggesting school attendance has minimal impact on infection rates, a new study has found.

While there was a small increased risk of infection and hospitalisation for those aged 65 and under who lived with school-aged children between September and December last year, they were no more likely to be admitted to intensive care or die than those who lived without children.

The peer-reviewed study, published in the British Medical Journal, found no evidence of a noticeably increased risk of infection during the first wave in the UK between February and August, compared to those adults who do not live with children.

https://www.itv.com/news/2021-03-19/school-attendance-has-minimal-impact-on-serious-covid-19-infection

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Publications

The EMA covid-19 data leak, and what it tells us about mRNA instability – BMJ

Leaked documents show that some early commercial batches of Pfizer-BioNTech’s covid-19 vaccine had lower than expected levels of intact mRNA, prompting wider questions about how to assess this novel vaccine platform, writes Serena Tinari

https://www.bmj.com/content/372/bmj.n627

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Publications

Closing schools is not evidence based and harms children – BMJ

Some 8.8 million schoolchildren in the UK have experienced severe disruption to their education, with prolonged school closures and national exams cancelled for two consecutive years. School closures have been implemented internationally1 with insufficient evidence for their role in minimising covid-19 transmission and insufficient consideration of the harms to children.

https://www.bmj.com/content/372/bmj.n521

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Opinion Publications

Murder by Misinformation – Dr Janet Menage, BMJ

This is a BMJ Rapid Response letter by Dr Janet Menage, Wales, UK, in response to Covid-19: Social murder, they wrote-elected, unaccountable, and unrepentant, by Kamran Abbasi. You can find the full response in the link below.

From a medical perspective, it was clear early on in the crisis that disregarding clinical acumen in favour of blind obedience to abnormal ventilation measures, reliance on an unsuitable laboratory test for diagnosis and management, and abandoning the duty of care to elderly hospitalised patients and those awaiting diagnosis and treatment of serious diseases, would create severe problems down the line.
Doctors who had empirically found effective pharmaceutical remedies and preventative treatments were ignored, or worse, denigrated or silenced. Information regarding helpful dietary supplements was suppressed.

https://www.bmj.com/content/372/bmj.n314/rr-8

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Publications

Conflicts of interest among the UK government’s covid-19 advisers – BMJ

Little is known about the interests of the doctors, scientists, and academics on whose advice the UK government relies to manage the pandemic. Attempts to discover more are frequently thwarted, finds Paul D Thacker.

https://web.archive.org/web/20201210214506/https://www.bmj.com/content/371/bmj.m4716

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Publications

Pandemrix vaccine: why was the public not told of early warning signs? – BMJ (2018)

“We fully support the swine flu vaccination programme … The vaccine has been thoroughly tested,” they declared in a joint statement.

Except, it hadn’t. Anticipating a severe influenza pandemic, governments around the world had made various logistical and legal arrangements to shorten the time between recognition of a pandemic virus and the production of a vaccine and administration of that vaccine in the population. In Europe, one element of those plans was an agreement to grant licences to pandemic vaccines based on data from pre-pandemic “mock-up” vaccines produced using a different virus (H5N1 influenza). Another element, adopted by countries such as Canada, the US, UK, France, and Germany, was to provide vaccine manufacturers indemnity from liability for wrongdoing, thereby reducing the risk of a lawsuit stemming from vaccine related injury.

https://web.archive.org/web/20200408051329/https://www.bmj.com/content/362/bmj.k3948

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Publications

Covid-19: The lost lessons of Tamiflu – BMJ

While the truth about Tamiflu emerged only after years of exhaustive work by the Cochrane review group and investigative journalists, the machinations behind remdesivir’s rapid climb were evident at an early stage. On 29 April, the same day as a trial was published showing no significant effect of remdesivir among patients in hospital, remdesivir’s manufacturer rushed out interim findings of a more favourable trial by press release and with full White House honours. The much vaunted but minimal benefits shown in severely ill people were used to justify FDA approvals and worldwide purchase. Now a much larger trial has found little or no benefit in hospital patients, and a BMJ Rapid Recommendation, produced in collaboration with the World Health Organization and Magic App, has come down against use of remdesivir in patients with covid-19 of any severity.

…Science by press release, on the basis of interim or ad hoc analyses, and without access to the data, also afflicts our knowledge about the covid-19 candidate vaccines. Patients and the public deserve better than this. So do health professionals. Pandemic or no pandemic, decisions must be based on scrutiny of the full data from trials that are independent of drug and vaccine manufacturers.

https://web.archive.org/web/20201205164516/https://www.bmj.com/content/371/bmj.m4701

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Publications

COVID-19 in children: analysis of the first pandemic peak in England – BMJ

Children represented 1.1% (1,408/129,704) of SARS-CoV-2 positive cases between 16 January 2020 and 3 May 2020. In total, 540 305 people were tested for SARS-COV-2 and 129,704 (24.0%) were positive. In children aged <16 years, 35,200 tests were performed and 1408 (4.0%) were positive for SARS-CoV-2, compared to 19.1%–34.9% adults. Childhood cases increased from mid-March and peaked on 11 April before declining. Among 2,961 individuals presenting with ARI in primary care, 351 were children and 10 (2.8%) were positive compared with 9.3%–45.5% in adults. Eight children died and four (case-fatality rate, 0.3%; 95% CI 0.07% to 0.7%) were due to COVID-19. We found no evidence of excess mortality in children.

Children accounted for a very small proportion of confirmed cases despite the large numbers of children tested. SARS-CoV-2 positivity was low even in children with ARI. Our findings provide further evidence against the role of children in infection and transmission of SARS-CoV-2.

https://web.archive.org/web/20201124224223if_/https://adc.bmj.com/content/105/12/1180

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Publications

Covid-19 vaccine candidate is unimpressive: NNTV is around 256 – BMJ

Pfizer’s vaccine “may be more than 90% effective.” (Mahase, BMJ 2020;371:m4347, November 9) Specific data are not given but it is easy enough to approximate the numbers involved, based on the 94 cases in a trial that has enrolled about 40,000 subjects: 8 cases in a vaccine group of 20,000 and 86 cases in a placebo group of 20,000. This yields a Covid-19 attack rate of 0.0004 in the vaccine group and 0.0043 in the placebo group. Relative risk (RR) for vaccination = 0.093, which translates into a “vaccine effectiveness” of 90.7% [100(1-0.093)]. This sounds impressive, but the absolute risk reduction for an individual is only about 0.4% (0.0043-0.0004=0.0039). The Number Needed To Vaccinate (NNTV) = 256 (1/0.0039), which means that to prevent just 1 Covid-19 case 256 individuals must get the vaccine; the other 255 individuals derive no benefit, but are subject to vaccine adverse effects, whatever they may be and whenever we learn about them……We’ve already heard that an early effect of the vaccine is “like a hangover or the flu.” Will vaccinees who are later exposed to coronaviruses have more severe illness as a result of antibody-dependent enhancement of infection (ADEI), a known hazard of coronavirus vaccines? Is there squalene in the Pfizer vaccine? If so, will vaccinees be subject to autoimmune diseases, like Gulf War Syndrome and narcolepsy that have been associated with the adjuvant?

https://www.bmj.com/content/371/bmj.m4347/rr-4

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Opinion Publications

Covid-19: politicisation, “corruption,” and suppression of science – BMJ

Politicians and governments are suppressing science. They do so in the public interest, they say, to accelerate availability of diagnostics and treatments. They do so to support innovation, to bring products to market at unprecedented speed. Both of these reasons are partly plausible; the greatest deceptions are founded in a grain of truth. But the underlying behaviour is troubling.

Politicians and governments are suppressing science. They do so in the public interest, they say, to accelerate availability of diagnostics and treatments. They do so to support innovation, to bring products to market at unprecedented speed. Both of these reasons are partly plausible; the greatest deceptions are founded in a grain of truth. But the underlying behaviour is troubling.

Politicians and governments are suppressing science. They do so in the public interest, they say, to accelerate availability of diagnostics and treatments. They do so to support innovation, to bring products to market at unprecedented speed. Both of these reasons are partly plausible; the greatest deceptions are founded in a grain of truth. But the underlying behaviour is troubling.

The UK’s pandemic response provides at least four examples of suppression of science or scientists. First, the membership, research, and deliberations of the Scientific Advisory Group for Emergencies (SAGE) were initially secret until a press leak forced transparency.2 The leak revealed inappropriate involvement of government advisers in SAGE, while exposing under-representation from public health, clinical care, women, and ethnic minorities. Indeed, the government was also recently ordered to release a 2016 report on deficiencies in pandemic preparedness, Operation Cygnus, following a verdict from the Information Commissioner’s Office.

https://www.bmj.com/content/371/bmj.m4425

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Opinion Publications

When good science is suppressed by the medical-political complex, people die – BMJ

The UK’s pandemic response relies too heavily on scientists and other government appointees with worrying competing interests, including shareholdings in companies that manufacture covid-19 diagnostic tests, treatments, and vaccines. Government appointees are able to ignore or cherry pick science—another form of misuse—and indulge in anti-competitive practices that favour their own products and those of friends and associates.

https://www.bmj.com/content/371/bmj.m4425

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Publications

Covid-19: GPs to get £12.58 per dose to deliver vaccine from December – BMJ

Practices will be paid £12.58 (€14.15; $16.69) per vaccination. This is 25% more than the current £10.06 practices receive for an influenza vaccination, in recognition of the need for extra training, post-vaccine observation, and other associated costs. Practices will need to provide most of the required staff from their own workforce.

https://www.bmj.com/content/371/bmj.m4354

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News

Lockdown cancer warning: Four week delay in treatment will see chance of dying soar – The Express

A four week delay in cancer treatment increases the chance of dying by as much as 13 percent new “staggering and sobering” research reveals.

The research published last week online in the BMJ, was put together in the light of treatment delays resulting from the pandemic and have led to calls for more attention to be given to other deadly health conditions whose treatment is being put at risk by national measures to contain the virus.

https://www.express.co.uk/news/uk/1357434/Lockdown-latest-cancer-warning-treatment-coronavirus-news

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Publications

Harms of public health interventions against covid-19 must not be ignored – BMJ

The harmful consequences of public health choices should be explicitly considered and transparently reported to limit their damage, say Itai Bavli and colleagues

The SARS-CoV-2 pandemic has posed an unprecedented challenge for governments. Questions regarding the most effective interventions to reduce the spread of the virus—for example, more testing, requirements to wear face masks, and stricter and longer lockdowns—become widely discussed in the popular and scientific press, informed largely by models that aimed to predict the health benefits of proposed interventions. Central to all these studies is recognition that inaction, or delayed action, will put millions of people unnecessarily at risk of serious illness or death.

However, interventions to limit the spread of the coronavirus also carry negative health effects, which have yet to be considered systematically. Despite increasing evidence on the unintended, adverse effects of public health interventions such as social distancing and lockdown measures, there are few signs that policy decisions are being informed by a serious assessment and weighing of their harms on health. Instead, much of the discussion has become politicised, especially in the US, where President Trump’s provocative statements sparked debates along party lines about the necessity for policies to control covid-19. This politicisation, often fuelled by misinformation, has distracted from a much needed dispassionate discussion on the harms and benefits of potential public health measures against covid-19.

https://www.bmj.com/content/371/bmj.m4074

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Publications

Will covid-19 vaccines save lives? Current trials aren’t designed to tell us – BMJ

The world has bet the farm on vaccines as the solution to the pandemic, but the trials are not focused on answering the questions many might assume they are.

…But the truth is that the science remains far from clear cut, even for influenza vaccines that have been used for decades. Although randomised trials have shown an effect in reducing the risk of symptomatic influenza, such trials have never been conducted in elderly people living in the community to see whether they save lives.

Only two placebo controlled trials in this population have ever been conducted, and neither was designed to detect any difference in hospital admissions or deaths. Moreover, dramatic increases in use of influenza vaccines has not been associated with a decline in mortality