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Publications

5.3.6 Cumulative Analysis of Post-Authorization Adverse Event Reports of PF-07302048 (BNT162B2) Received Through 28-FEB-2021 – Pfizer

Reference is made to the Request for Comments and Advice submitted 04 February 2021 regarding Pfizer/BioNTech’s proposal for the clinical and post-authorization safety data package for the Biologics License Application (BLA) for our investigational COVID-19 Vaccine (BNT162b2). Further reference is made to the Agency’s 09 March 2021 response to this request, and specifically, the following request from the Agency.

The download link is available from Public Health and Medical Professionals for Transparency.

Important points from this report include:

  • A seven-year-old experienced a stroke.
  • One child and one infant suffered facial paralysis.
  • One infant had a kidney adverse event, either kidney injury or failure.
  • Of the 34 cases, 24 (71%) were classified as serious.
  • Predominantly female patients were affected — at least 25 of 34 (73.5%) patients.
  • Table 6 reports 34 cases of use in pediatric individuals. However, 28 additional cases were excluded because details such as height and weight were “not consistent with pediatric subjects.”
  • Ages ranged from two months to nine years, with median 4.0 years, which means half the children were under four years of age.
  • 132 adverse events were reported in the 34 children – i.e., an average of 3.88 AEs per child.

Summary from Daily Clout journalists:

https://archive.today/2022.12.29-231302/https://www.phmpt.org/wp-content/uploads/2022/04/reissue_5.3.6-postmarketing-experience.pdf

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News

Student dies from sepsis after ringing GP surgery 25 times to be refused appointment – The Mirror

A 19-year-old died from sepsis after trying 25 times to get through to a GP surgery only to be refused an appointment, an inquest heard.

University student Toby Hudson was unable to speak to anyone at the practice because of a faulty phone system and eventually gave up and called again the next day to be told he could not be seen for at least 48 hours.

The tragic teenager was told that due to him being registered at another surgery in his university town of Southampton, Hants, he could either wait two days to re-register or go to an urgent care walk-in centre.

Toby died two days after he had first sought help at the Wyke Regis & Lanehouse Medical Practice in Weymouth, Dorset.

https://www.mirror.co.uk/news/uk-news/student-dies-sepsis-after-ringing-23568942

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Opinion

Dr JOHN LEE: Why should the whole country be held hostage by the one in five who refuse a vaccine? – Daily Mail

But this logic is faulty. For a start, children are almost entirely unaffected by the virus. And anyway, why should the country be held hostage because one-fifth of the population decline to protect themselves?

…Regrettably, we may unintentionally have encouraged more serious variants with lockdowns instead of allowing milder variants to circulate and ultimately prevail.

The science behind fighting Covid is difficult, and politicians need all the help they can get to interpret it correctly. Sadly, Mr Johnson has repeatedly retreated to his comfort redoubt of a handful of key advisers who seem wilfully blind to the fact that their recommendations are tearing apart the fabric of our society.

https://www.dailymail.co.uk/debate/article-9293147/Dr-JOHN-LEE-country-held-hostage-one-five-refuse-vaccine.html

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Opinion

What WAS the point of vaccine triumph if we are doomed to endless curbs, asks Dr JOHN LEE – Dail Mail

Despite the success of the vaccine programme, which will see all vulnerable people protected against Covid-19 in a month, it seems lockdown will largely continue until July.

Restaurants and churches possibly still closed. Travel impossible. Families forbidden to mingle indoors. The Treasury still borrowing billions to keep people on furlough. This is draining the health of our population and our economy.

Anyone would be justified in demanding to know what the past year’s sacrifices have been for, if not to end lockdown as soon as possible.

How can the Government fail to set free the country — particularly after the stellar vaccination campaign? 

https://www.dailymail.co.uk/debate/article-9267781/What-point-vaccine-triumph-doomed-endless-curbs-asks-Dr-JOHN-LEE.html

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News

Five charts that show the impact of Covid-19 on the tourism industry – City AM

The travel and tourism industry has been one of the sectors hit hardest by the pandemic, with lockdowns and travel restrictions all but shutting business at times.

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News

UK children being used in ‘unethical mass experiment’ – demand for urgent action – The Express

EXPERTS have called for urgent action to protect children from the harm of lockdown, saying youngsters are being used in “an unethical mass experiment” and warning we are on the brink of a “national emergency”.

They are urging the Government to take urgent steps to examine and address the collateral damage that has been caused to children from issues such as school closures, lockdowns and social isolation as a result of the pandemic. One specialist is calling for a task force to be launched immediately and to remain in place for10 years, which would include experts in child abuse and neglect, childhood depression, suicide and anxiety, as well as physical, educational and developmental health.

https://www.express.co.uk/news/uk/1397594/UK-children-Covid-lockdown-task-force-10-years-children-mental-health

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Publications

Masks Can Be Detrimental to Babies’ Speech and Language Development – Scientific American

We wanted to know whether and when babies might discover the importance of a talker’s mouth. So, in one study in my lab, we showed videos of talking faces to babies of different ages and tracked their attention by using an eye-tracking device. We discovered that babies begin lip-reading at around 8 months of age. Crucially, the onset of lip-reading at this age corresponds with the onset of canonical babbling, suggesting that babies begin lip-reading because they become interested in speech and language. By lip-reading, babies now gain access to visual speech cues which, as Janet Werker and her colleagues at the University of British Columbia have shown, are clearly perceptible to them. So, the lip-reading now enables babies to see the visible speech cues that they need to figure out which face goes with which voice. Of course, babies cannot access visible speech cues if others are wearing masks.

https://www.scientificamerican.com/article/masks-can-be-detrimental-to-babies-speech-and-language-development/

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Videos

Prof Jay Bhattacharya, Signatory of Gt Barrington Declaration: Why ‘Lockdown’ Will Kill Millions – Naomi Wolf, Daily Clout

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Opinion

‘It’s the isolation’: parents on the impact of lockdown on children

With many primary school pupils learning at home, and toddlers missing out on critical social interactions with their peers,parents of young children have concerns about the long-term impact of long periods spent at home.

https://www.theguardian.com/lifeandstyle/2021/feb/10/its-the-isolation-parents-on-the-impact-of-lockdown-on-children

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News

let’s take a look Pfizer’s history of ‘ethical standards’ – Architects for Social Housing

https://twitter.com/9thfloor/status/1358825646294769664

Last September, Pfizer’s CEO, Albert Bourla, assured the public that ‘we will develop our product, develop our vaccine, using the highest ethical standards’. And the NHS has assured us of the same rigorous standards. So let’s take a look Pfizer’s history of ‘ethical standards’.

In 1992, Pfizer agreed to pay between $165 million and $215 million to settle lawsuits arising from the fracturing of the Bjork-Shiley Convexo-Concave heart valve, which by 2012 had resulted in 663 deaths.

Court approves settlement in Shiley heart-valve case Pfizer Inc. said Wednesday a federal judge has approved the previously announced agreement for settlement of claims to patients with the Bjork-Shiley… upi.com

In 1996, Pfizer conducted an unapproved clinical trial on 200 Nigerian children with its experimental anti-meningitis drug, Trovafloxacin, without parental consent, which led to the death of 11 children from kidney failure and left dozens more disabled. http://news.bbc.co.uk/1/hi/world/africa/6768799.stm …

In 2011, Pfizer paid just $700,000 to four families who had lost a child, and set up a $35 million fund for those disabled by their drug experiment. This cover-up was the basis to the John Le Carré book and film, The Constant Gardener.

Pfizer: Nigeria drug trial victims get compensation US-based pharmaceutical giant Pfizer makes the first compensation payment to Nigerian families affected by a controversial drug trial 15 year… bbc.co.uk

In 2004, Pfizer’s subsidiary, Warner-Lambert, was fined $430 million to resolve criminal charges and civil liabilities for the fraudulent promotion of its epilepsy drug, Neurontin, paying and bribing doctors to prescribe it for uses not approved by the FDA.https://www.justice.gov/archive/opa/pr/2004/May/04_civ_322.htm …

In 2009, Pfizer spent $25.8 million lobbying Congressional lawmakers and federal agencies like the Department of Health and Human Services. Image of government building columns Pfizer Inc Lobbying Profile Pfizer Inc spent $25,819,268 lobbying in 2009. See the details. opensecrets.org

Pfizer’s expenditure on federal lobbying between 2006 and 2014 came to $89.89 million. In 2019 the second largest pharmaceutical company in the world spent $11 million lobbying the US federal government. Image of government building columns Pfizer Inc Lobbying Profile Pfizer Inc spent $11,000,000 lobbying in 2019. See the details. opensecrets.org

In 2009, Pfizer paid the largest health care fraud settlement and criminal fine ever, paying $2.3 billion to avoid criminal and civil liability for fraudulently marketing its anti-inflammatory drug, Bextra, which the FDA had refused due to safety concerns.

Justice Department Announces Largest Health Care Fraud Settlement in American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together “Pfizer”) have agreed to pay $… justice.gov

In 2009, Pfizer paid $750 million to settle 35,000 claims that its diabetes drug, Rezulin, was responsible for 63 deaths and dozens of liver failures. In 1999, an epidemiologist at the FDA said Rezulin was ‘one of the most dangerous drugs on the market’. LA Times logo

Pfizer Agrees to Settle Suit Over Diabetes Drug Rezulin Pfizer Inc. agreed Friday to settle a lawsuit over the diabetes drug Rezulin after a jury earlier in the day awarded $43 million to a Texas woman wh… latimes.com

In 2010, Pfizer was ordered to pay $142.1 million in damages for violating a federal anti-racketeering law by its fraudulent sale and marketing of its epilepsy drug Neurontin for uses not approved by the FDA, including for migraines and bi-polar disorder.

Neurontin Lawsuits – Pfizer Illegal Marketing, Injury Claims Pfizer Marketing Illegal Neurontin. Pfizer Inc. has been ordered to pay $142.1M in damages for violating a federal antiracketeering law in its marketing. yourlawyer.com

In 2010, Pfizer admitted that, in the last 6 months of 2009 alone, it had paid $20 million to 4,500 doctors in the US for consulting and speaking on its behalf, and $15.3 million to 250 academic medical centres for clinical trials.

Pfizer admits paying $35 million to doctors over last 6 months Pfizer among other large pharmaceutical companies recently disclosed payments to doctors and other medical professionals for consulting and … news-medical.net

In 2012, Pfizer paid $45 million to settle charges of bribing doctors and other health-care professionals employed by foreign governments in order to win business. https://www.sec.gov/news/press-release/2012-2012-152htm …

The Chief of the Foreign Corrupt Practices Act Unit said: ‘Pfizer subsidiaries in several countries had bribery so entwined in their sales culture that they offered points and bonus programs to improperly reward foreign officials who proved to be their best customers’.

By 2012, Pfizer had paid $1.226 billion to settle claims by nearly 10,000 women that its hormone replacement therapy drug, Prempro, caused breast cancer.

In 2013, Pfizer agreed to pay $55 million to settle criminal charges of failing to warn patients and doctors about the risks of kidney disease, kidney injury, kidney failure and acute interstitial nephritis caused by its proton pump inhibitor, Protonix.

In 2013, Pfizer set aside $288 million to settle 2,700 claims that its stop-smoking drug, Chantix, caused suicidal thoughts and psychological disorders. The FDA subsequently determined that Chantix is probably associated with a higher risk of heart attack.

In 2013, Pfizer absolved itself of claims that its antidepressant, Effexor, caused congenital heart defects in the children of pregnant woman by arguing that the prescribing obstetrician was responsible for advising the patient about the medication’s use. https://europepmc.org/article/PMC/6424813 …

In 2014, Pfizer paid a further $325 million to settle a lawsuit brought by health-care benefit providers who claimed the company marketed its epilepsy drug, Neurontin, for purposes unapproved by the FDA.

In 2014, Pfizer paid $35 million to settle a law suit accusing its subsidiary of promoting the kidney transplant drug, Rapamune, for unapproved uses, including bribing doctors to prescribe it to patients.

In 2016, Pfizer was fined a record £84.2m for overcharging the NHS for its deregulated anti-epilepsy drug, Phenytoin, by 2,600% (from £2.83 to £67.50 a capsule), increasing the cost to UK taxpayers from £2 million in 2012 to about £50 million in 2013.

In May 2018, Pfizer had 6,000 lawsuits pending against claims that its testosterone replacement therapy products cause strokes, heart attacks, pulmonary embolism and deep vein thrombosis, and were marketed at healthy men for uses not approved by the FDA.

https://archive.is/jOIia

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News

Government estimates 220,000 will be the true death toll of the pandemic – with nearly half lost to non-Covid causes such as cancelled operations – Daily Mail

  • Hospital chaos will have led to 46,000 avoidable deaths by end of next month
  • Cancellations to routine operations may cause 18,000 excess deaths overall
  • Another 40,000 people may die due to the economic impact of lockdown 

More than 100,000 people are likely to die from non-coronavirus causes because of the pandemic, according to an official government estimate.

By the end of next month the chaos in hospitals and care homes will have led to 46,000 avoidable deaths, Department of Health research has suggested.

Cancellations to routine operations may cause 18,000 excess deaths in the long-term, on top of hundreds more from cancer.

Officials calculated that over the next few years another 40,000 people may die due to the economic impact of lockdown, including rising unemployment and mental health issues.

https://www.dailymail.co.uk/news/article-9203279/Government-estimates-220-000-true-death-toll-pandemic.html

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Publications

Pharmaceutical fraud – Wikipedia

$3 billion GSK settlement. On 2 July 2012, GlaxoSmithKline pleaded guilty to criminal charges and agreed to a $3 billion settlement of the largest health-care fraud case in the U.S. and the largest payment by a drug company. The settlement is related to the company’s illegal promotion of prescription drugs, its failure to report safety data, bribing doctors, and promoting medicines for uses for which they were not licensed. The drugs involved were Paxil, Wellbutrin, Advair, Lamictal, and Zofran for off-label, non-covered uses. Those and the drugs Imitrex, Lotronex, Flovent, and Valtrex were involved in the kickback scheme. The government investigation of GSK was launched largely on the basis of information provided by four whistleblowers who filed two qui tam (whistleblower) lawsuits against the company under the False Claims Act. GSK settled the whistleblowers’ lawsuits for a total of $1.017 billion out of the $3 billion settlement, the largest civil False Claims Act settlement to date.

Pfizer $2.3 billion settlement: Pfizer settled multiple civil and criminal allegations for $2.3 billion in the largest case of pharmaceutical and health care fraud in US history. The drugs involved were Bextra (an anti-inflammatory drug), Geodon (an anti-psychotic drug), Lipitor (a cholesterol drug), Norvasc (anti-hypertensive drug), Viagra (erectile dysfunction), Zithromax (antibiotic), Zyrtec (antihistamine), Zyvox (an antibiotic), Lyrica (an anti-epileptic drug), Relpax (anti-migraine drug), Celebrex (anti-inflammatory drug), and Depo-provera (birth control).

Merck $650 million settlement: Merck settled a nominal pricing fraud case in which the company was accused of taking kickbacks and violating Medicaid best price regulations for various drugs.

United States et al., ex rel. Jim Conrad and Constance Conrad v. Forest Pharmaceuticals, Inc, et al. involved a drug manufacturer selling a drug, Levothroid, that had never been approved by the FDA. These allegations settled for $42.5 million due to multiple whistleblowers stepping forward to provide detailed information on the alleged fraud. The collective reward to the relators in this case was over $14.6 million.

Wikipedia snapshot from 28 January 2021:

http://archive.today/WZkcB

Categories
Opinion

Lies, Damned Lies and Statistics: Manufacturing the Crisis – Simon Elmer, Architects for Social Housing

The truth is that there was never a question of whether this Government would impose another lockdown on the UK in 2021. Lockdown isn’t a consequence of the failure of coronavirus-justified programmes and regulations: it’s the product of their success in implementing the UK biosecurity state. After a brief summer recess under the system of tiered restrictions, the following winter will see the lockdown of the UK imposed again under newly notifiable diseases from new viruses and new strains, new protocols for certification and new criteria for deaths, the new medical categorisation of new cases which, like the present ones, present little or no threat to public health, but which like it will be used to enforce new technologies, new programmes and new regulations. This is the ‘New Normal’ we were promised, and it’s being built on a foundation of lies, damned lies and statistics.

https://architectsforsocialhousing.co.uk/2021/01/27/lies-damned-lies-and-statistics-manufacturing-the-crisis/

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News

Depression among the young is at ‘frightening’ levels and keeping schools shut risks having ‘calamitous’ impact on children’s mental health, paediatricians warn – Daily Mail

Depression among pupils is at ‘frightening’ levels, paediatrcians have warned, as they urge the Government to reopen schools or risk a ‘calamitous,’ impact on children’s mental health.

Ten of the UK’s top exerts in child health say anxiety, self harma nd suicidal thoughts have reached frightening levels among children.

https://www.dailymail.co.uk/news/article-9186711/Schools-closures-risk-calamitous-impact-childrens-mental-health-paediatricians-warn.html?__twitter_impression=true

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News

New Study Finds Masks Hurt Schoolchildren Physically, Psychologically, and Behaviorally – Montana Daily Gazette

A new study, involving over 25,000 school-aged children, shows that masks are harming schoolchildren physically, psychologically, and behaviorally, revealing 24 distinct health issues associated with wearing masks.

The health issues and impairments observed in this study were found to affect 68% of masked children who are forced to wear a face covering for an average of 4.5 hours per day. The study also includes 17,854 health complaints submitted by parents.

Some of the health issues found in the study include: increased headaches (53%), difficulty concentrating (50%), drowsiness or fatigue (37%), malaise (42%), and nearly a third of children experience more sleep issues than they had previously and a quarter of children developed new fears.

Though these results are concerning, the study also found that 29.7% of children experienced shortness of breath, 26.4% experienced dizziness, and hundreds of the participants experiencing accelerated respiration, tightness in chest, weakness, and short-term impairment of consciousness.

https://montanadailygazette.com/2021/01/25/new-study-finds-masks-hurt-schoolchildren-physically-psychologically-and-behaviorally/
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News

World’s richest ten people – including Elon Musk, Jeff Bezos, Bill Gates and Mark Zuckerberg – ‘are half a TRILLION dollars richer since Covid-19 pandemic began’ – Daily Mail

  • An Oxfam report has investigated growing inequality caused by the pandemic
  • The wealthiest 1,000 people recouped their losses within ten months of the virus
  • But the world’s poorest could take ten years to recover from their hardship
  • The top ten richest have added billions to their fortune despite the global crisis  

https://www.dailymail.co.uk/news/article-9182661/Oxfam-urges-radical-economic-rejig-post-COVID-world.html

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Opinion Videos

Ivor Cummins on The James Delingpole Channel

Ivor Cummins aka the Fat Emperor – gives James the lowdown on why you can’t trust anything our governments tell us about Covid-19. If you want the facts on Coronavirus – how deadly is it? do lockdowns and masks work? how does it compare with previous pandemics? – you’ve come to the right place

Please support the Delingpod:

Mirror archives are available below if this video is removed from YouTube.

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News

How busy are hospitals in England? – BBC News

When announcing the national lockdown, Prime Minister Boris Johnson said the NHS risked being overwhelmed if the measures weren’t taken.

But statistics suggest that the proportion of beds currently occupied by patients is actually lower than usual.

So how can both things be true?

…To create that wiggle room, there has been a big decrease in patients coming in for non-urgent operations and outpatient appointments, to ensure that space is there and pressures are not increased.

Even in September 2020, when hospitals were beginning to increase the number of operations carried out, these were still 25% lower than in previous years.

This also helps explain why there are also fewer patients in hospitals this year, as well as fewer beds.

The impact of this is a large backlog and the potential for certain treatments – such as cancer care – being delayed.

https://web.archive.org/web/20210107152338/https://www.bbc.co.uk/news/55536762

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Publications

Corona children studies “Co-Ki”: First results of a Germany-wide registry on mouth and nose covering (mask) in children – Research Square

Narratives about complaints in children and adolescents caused by wearing a mask are accumulating. There is, to date, no registry for side effects of masks.

By 26.10.2020 the registry had been used by 20,353 people. In this publication we report the results from the parents, who entered data on a total of 25,930 children. The average wearing time of the mask was 270 minutes per day. Impairments caused by wearing the mask were reported by 68% of the parents. These included irritability (60%), headache (53%), difficulty concentrating (50%), less happiness (49%), reluctance to go to school/kindergarten (44%), malaise (42%) impaired learning (38%) and drowsiness or fatigue (37%).

https://www.researchsquare.com/article/rs-124394/v2

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News

Crude oil prices briefly traded below $0 in spring 2020 but have since been mostly flat – U.S. Energy Information Administration

In the first half of 2020, responses to the COVID-19 pandemic led to steep declines in global petroleum demand and to volatile crude oil markets. The second half of the year was characterized by relatively stable prices as demand began to recover. As petroleum demand fell and U.S. crude oil inventories increased, West Texas Intermediate (WTI) crude oil traded at negative prices on April 20, the first time the price for the WTI futures contract fell to less than zero since trading began in 1983. The next day, Brent crude oil, another global crude oil price benchmark, fell to $9.12 per barrel (b), its lowest daily price in decades.