War is the realm of uncertainty; three quarters of the factors on which action in war is based are wrapped in a fog of greater or lesser uncertainty. A sensitive and discriminating judgment is called for; a skilled intelligence to scent out the truth. Carl von Clausewitz
This is the first of two posts on the Special Medical Operation to rollout the Pfizer COVID vaccine.
This Table appears in the first article reporting on the Pfizer Trial, with Fernando Polack as first author. A few weeks earlier, Albert Bourla, the Pfizer CEO, told the world the Pfizer vaccine was 95% effective. Effective here means if you have had the vaccine, you are less likely to have a lab confirmed test for symptoms of COVID. It does not mean that you will be saved from death or hospital and may not mean you won’t catch COVID.
While Pfizer (and other companies) claimed their vaccines worked extraordinarily well, Governments did not mandate the vaccines to defend people against getting a mostly mild infection, but to reduce transmission which they do not but above all to reduce COVID deaths and hospitalizations. We were told we needed to prevent admissions in order avoid our health services collapsing.
The Table shows 2 deaths on the Vaccine and 4 on Placebo. Not impressive but multiply it up by millions and maybe countries and politicians can claim there is a mandatable something there. The companies, especially Astra-Zeneca, showed us COVID deaths only, which is what everyone is interested in.
Pfizer also claimed variously that 5 placebo volunteers were hospitalized with COVID and none of the vaccinated. The figures vary with figures like 8 v 1 but also are quite low, unless multiplied by millions.
Pfizer is an honorable company. They are all honorable companies. So when reading the entries below remember to keep to the rules and do not link any problem to Comirnaty that happened after dose one and before seven days after dose two. Or any problem that happened more than four weeks after the seven day period is over. These do not get counted as being linked to the vaccine, even though all the ones below were in those who had the vaccine.
Any problems, especially hospitalizations of course can be multiplied by millions.
What about Argentine Case 12315520? Diagnosed with Ophthalmic vein thrombosis/ Venous thrombosis of the right eye, she was categorised as an Eye problem rather than thrombosis or cardiovascular problem. We don’t classify Deep Vein Thromboses under Leg – why put her in Eye?
With the extra cases below we have 50 cardiac SAEs in the Vaccine group and 38 in the placebo group. It would be great if someone could work through the placebo cases for us. Clicking on any of the links above will take you to the document with narratives for serious events happening on placebo and vaccine.
If you need our input, send us the links and we will be happy to review placebo hospitalization and death cases or other vaccine cases with you. There is some weird stuff there.
Do these narratives prove causality? For Pfizer and Barbara Bierer – see Harmatology – something like 45 to 29 would be a statistically significant difference. Until then, these accounts are anecdotes and tell us nothing – she claims.
But statistical comparisons tell us nothing about causality. All of the placebo cases were caused by something – they were not accidents. Equivalent figures in both groups do not prove there was no difference. An identical number of suicidal events can happen in 2 Zoloft trial groups if Zoloft both causes suicide in some and prevents it in others.
In Zoloft trials there was an excess of suicidal events and suicides on Zoloft but these alone are not statistically significant. Looking at the narratives there is a consistent pattern of the Zoloft induced ones happening with clear agitation beforehand, and where the dose is stopped the problem clears up.
A key detail is how often Pfizer didn’t let the subject have dose 2 of the vaccine where the event happened after dose 1. In two cases above they did let the subject go ahead but in most cases they didn’t. This is what Astra Zeneca did to Bri Dressen and Injuries in Vaccine Trials. It is a strong indicator of suspected and likely causality.
If you haven’t already read, see Michelle Mello’s story in Thinking Fast and Slow.
An oddity to take into account is that these 50 vaccinated narratives versus 38 or so on placebo are drawn from a group where US trial sites have double the number of sensitive narratives for placebo compared to vaccinated cases and global cases have a third more placebo cases – 288 v 199 vaccinated. [Pay no heed to this – but 50 from 199 compared to 38 from 288 is statistically significant at a p < 0.001 level].
Given they are not having cardiac events – what is happening to the 250 other placebo cases? Can you help us with this?
A final oddity is that only 170 of 44,000 people tested positive for COVID in the window starting 7 days post Dose 2 of the vaccine. These came from 66 of the 153 sites. Nearly 100 sites had no cases of COVID. Pfizer appear to have breached their own protocol and admitted people who had a longer than specified interval between dose 1 and dose 2 to meet their target case numbers. Statistics can cause people to fetish weird things. More to the point, its one rule for us and another for you.
What about this placebo case? Placebo Case 11671069 developed Congenital Hypertrophic cardiomyopathy. He had two doses of placebo without problems but then developed a congenital (present from birth) cardiomyopathy two months after his second catchup Comirnaty dose.
He was 77 and never had a heart issue in his life. This case is classified as congenital because of an up till then undetected anomaly that had made no difference to him until he got the vaccine.
The way companies play these games he is classified as a placebo cardiac event – doubly hidden from prying eyes.
Also hidden from prying eyes was 11141050, a 63 year old woman who had a sudden cardiac death 6 weeks after dose 2. She has been put in the General Body Disorder category rather than Cardiac category.
We haven’t yet found the narrative on this lady but know her death meant she could be viewed as withdrawn.
Case 12461035 is another. A man hospitalized with chest pain and put on treatments for angina and gastric reflux was coded as General rather than Cardiac.
Case 10011093 had angina but was not coded under Cardiac. Instead he was coded under procedures – he had cardiac catherization for possible stent. The trial monitor reviewing the paperwork told the investigator this was inappropriate, likely never expecting the comment to see the light of day.
How do Fernando Polack’s 2 vaccinated deaths compared to 4 on placebo look now? According to the second paper on this trial (Thomas et al – NEJM March), when all events were looked at in more detail, only 1% of serious adverse events were viewed as related to the investigational agent. This fits with WHO Guidance to never link an adverse event to a vaccine if at all possible – see Harmatology.
It flies in the face of medical common sense.
|Hospitalized, lost to follow up - Dead?|
|10061098||Atrial Fibrillation||Hospitalized Investigator blames Vax but Pfizer doesn't|
|10131084||Renal Artery Stent clotted and blocked||Hospitalized|
|10181132||Cardiac Stress Test|
? Heart Attack
|Hospitalized - in need of cardiac bypass surgery|
|10181159||Radicular Paresthesia||Not Hospital Investigator blames vaccine and Pfizer doesn't|
|10211190||Cerebrovascular Accident - CVA|
|10711023||Blocked Coronary Stent|
|10721007||Transient Ischemic Event (TIA)|
|10921187||Congestive Cardiac Failure|
|10951173||Myocardiac Infarction |
|11181074||Musculoskeletal Chest Pain|
|11311222||Congenital Heart Disease|
Likely Heart Attack
|Required Cardiac Surgery|
|11401002||Coronary Artery Dissection|
|11521497||Syncope (Fainting)||Hospitalization - ICU
|11561006||Deep Vein Thrombosis||Pulmonary Embolus
|11571134||TIA - Minor Stroke||Hospitalized|
Heart Attack or Stroke
|Hospital and Death|
|12241012||TIA - Minor Stroke||Hospitalized|
|12312593||Acute Coronary Syndrome|
|12314001||Acute Coronary Syndrome|
Copyright © Data Based Medicine Americas Ltd.
This comment has just appeared in the BMJ from Rokuro Hama – one of the most extraordinary people in pharmacovigilance
See here for the BMJ version and for references
Husby et al reported that adjusted hazard ratio (aHR) of myocarditis/myopericarditis within 14- day was 1.89(95%CI:1.23-2.90) with BNT162b2 and 5.46(2.97-10.07) with mRNA-1273. We point out that the risk of vaccination may be higher by considering “healthy vaccinee effect” [2,3]. This effect can be estimated by Husby’s own data and may be greater based on other data.
1) One of their data is the low aHR of cardiac arrest or death within 28 days after vaccination (0.51 with BNT162b2 and 0.41 with mRNA-1273). Husby mentioned the fact that SARS-CoV-2 vaccines were rarely given to people with an acute or terminal illness as a likely explanation for low aHRs. This explanation is exactly “healthy vaccinee effect” [2,3].
2) Another is the low aHR of myocarditis/myopericarditis at 29 days or more: 0.47(0.28-0.79) with BNT162B2 and 0.57(0.20-1.66) with mRNA-1273. Husby denied a systemic bias, due to inconsistency of risk pattern. However, the point aHR (0.57) for mRNA-1273 is consistent with that of BNT162B2(0.47) and of cardiac arrest or death. This is another example.
The ratio of aHR of 14-day risk window to aHR of 29-days or more was 4.02(2.05-7.88) with BNT162B2 and 9.58(2.82-32.50) with mRNA-1273 by Kollassa’s method .
3) The same phenomena are observed by analysing several data [5,6]. One is the analysis of non-COVID-19 death using the UK statistics . Monthly non-COVID-19 mortality rate (MR) from January to December, 2021 in unvaccinated were constantly higher than expected MR for 2021 supposing that there was no COVID-19 epidemic in England and Wales (eMR2021: 932.1/100,000 person years). The mortality rate ratio (MRR) to eMR2021 was 1.4 in January and averaged 1.8 over 2021.
On the other hand, non-COVID-19 MRR, 21 days or more after second dose in January was 0.15 to eMR2021 and 0.11(0.08-0.14) to MR of unvaccinated.
Healthy vaccinee effect by SARS-CoV-2 vaccination expressed as MRR in ever vaccinated to eMR2021 at the day of vaccination was estimated approximately at 0.10 to 0.24 by applying the following results [5,6].
4) According to the analysis  using the Dagan’s data , daily odds ratio (OR) of asymptomatic SARS-CoV-2 infection and symptomatic COVID-19 of vaccinated to unvaccinated is the least at the vaccinated day (day1): OR was 0.62(0.47-0.82) for asymptomatic infection, and 0.40(0.31-0.51) for symptomatic COVID-19. Vaccine does not work to reduce incidence of COVID-19 at the vaccinated day. Hence this low OR is the result of “healthy vaccinee effect”. Thereafter OR increased as days passed over 1 to 2 weeks possibly due to adverse effects of the vaccine. It seems that the severer the symptoms, the higher this tendency. For example, for symptomatic COVID-19, the ratio of OR on day 1 (0.40) to OR during day 8-14(1.02) is 0.39 (0.30-0.50). For hospitalised COVID-19, the ratio of ORs (day1-3/day8-14=0.12/0.68) was 0.17 (0.04-0.78).
In addition, OR on day1 decreased as the symptom became severer: OR for asymptomatic, symptomatic, hospitalised, severe and death from COVID-19 were estimated approximately at 0.62, 0.40, 0.27, 0.18 and 0.13, respectively .
5) According to Hippisley-Cox’s data , incidence rate ratios of common venous and arterial thromboembolic events were the lowest on the day of vaccination without exception: 0.29 to 0.46.
If these were applied, the risk of myocarditis/myopericarditis with SARS-CoV-2 vaccine may be greater.
6) A reliable MRR of cardiac arrest or death on the day of vaccination in the Husby’s study can be calculated, because the number of events within 28 days after BNT162B2 is enough: total number is 4438 (more than 150 events/day).
Healthy vaccinee effect should be assessed by calculating the risk on the vaccination day to know more accurate harm and effectiveness of SARS-CoV-2 vaccine.
To make things a little simpler Rokuro is saying that big population studies of all people have vaccines and later clots or heart attacks can look good and falsely reassure – the vaccine causes few problems but this neglects the fact that most people are at very little risk. In the case of people with some problems, the vaccine may be the straw that breaks the camels back.
In the BMJ/Hviid study, the following statement appears :
“Finally, we censored individuals with a positive SARS-CoV-2 test result, to avoid associating outcomes of SARS-CoV-2 infection with outcomes of SARS-CoV-2 vaccination.”
So someone who got covid in 2020 or early 2021 (with a positive test, and it probably represents many individuals), gets a covid vaccine months later, develops a myocarditis within a few days/weeks after the shot is excluded ?
If the study had been properly designed, they would have excluded individuals with myocarditis occuring a few days /weeks after the positive test, and then they should re-enter into the cohort.
Also the following point is quite ridiculous : “Furthermore, individuals who received two different types of vaccines were censored on receipt of their second dose”
Maybe I’ve missed that in the paper but I couldn’t find how many people were excluded from the whole cohort based on those two criterias.
Naomi Wolf reports neuroleptic malignant syndrome by the hundreds. It brings the thought – have some been injected with antipsychotics.
Who knows Chris There’s another scandal being shown on BBC tonight Yet another undercover reveal of abuse and cruelty in yet another hell-hole. Manchester this time
Police launch investigation into mental health unit …https://www.manchestereveningnews.co.uk › ..
10 hours ago — Police launch investigation into mental health unit mistreatment claims. BBC Panorama presented their harrowing footage, gained by an undercover …
The Panorama program sounds grim and the mental health scene in the UK is grim – as it is everywhere and like the causes of this are the same as is happening with COVID and the vaccines. For the moment, however, can we stick with the vaccines.
There will be a follow up – Fog2 – that will offer some scope to broaden out beyond vaccines. And a post on RxISK next week that will also broaden things out beyond vaccines
Sorry it was early should be – Anaphylactic shock, Liver damage, Convulsions, Neuroleptic Malignant syndrome by the hundreds.
Question – apart from AP’s and withdrawal from dopamine agonists is there any other cause of NMS known ?
Its closely related to malignant hyperthermia triggered by Anesthetics. NMS is essentially a catatonic state which can be trigged by physical illness or drugs.
At first it was an irritation by now it’s all more than disturbing……..the only media outlet which reports whats going on by who knows who in the shadows is GB News
With thanks to Maryanne
Maryanne Demasi, PhD from Maryanne Demasi, reports
8:27 AM (1 hour ago)
Open in browser
I’ve just been released from LinkedIn jail…
I’m out on parole
Maryanne Demasi, PhD
Recently, LinkedIn suspended my account, a platform claiming to be “the world’s largest professional network on the internet.” Over the years, I accrued thousands of “network connections,” and in the blink of an eye, it all disappeared.
I’m not the first, and I won’t be the last. I join a long list of dissidents — professors with unimpeachable reputations, such as Harvard University‘s Martin Kulldorff and Flinders University’s Nikolai Petrovsky, who were abruptly cancelled after expressing their objections to covid-19 vaccine mandates.
As many of you know, this heavy-handed approach is not unique to LinkedIn – YouTube, Twitter and Facebook are among the social media platforms censoring information purported to violate their “covid-19 professional community policies.”
LinkedIn gave me a warning. My first offence was posting an article titled “FDA authorised new mRNA formula for kids without a clinical trial.”
Maryanne Demasi, reports
FDA authorised new mRNA formula for kids without a clinical trial
By Maryanne Demasi, PhD In October 2021, Pfizer requested the permission of the US Food and Drug Administration (FDA) to amend the formulation of its covid-19 vaccine for children aged 5-11 yrs. Pfizer wanted to switch the “phosphate- buffered saline” used in previous adult formulations, to “tromethamine (Tris) buffer” and to exclude both sodium chloride…
2 months ago · 5 likes · Maryanne Demasi, PhD
I interviewed eminent experts such as Tom Jefferson, epidemiologist at the University of Oxford, about the lack of regulatory oversight after Pfizer changed the formulation of its mRNA vaccine and rolled it out to millions of children without clinical trials.
LinkedIn notified me that the post had been blocked from public view. I had an opportunity to appeal the decision, and I did, but heard nothing in return.
Two weeks later, I posted an article titled, “A 5th jab – implications for the immune system.”
Maryanne Demasi, reports
A 5th jab? Implications for the immune system
Following the recent authorisation of the new omicron boosters, the former US Surgeon General encouraged Americans to receive two to four mRNA jabs annually. Residents in northeast Australia have been told they might need a fifth dose by the end of the year…
21 days ago · 64 likes · 5 comments · Maryanne Demasi, PhD
I interviewed Cody Meissner, professor at Tufts University School of Medicine, who spoke candidly about his concerns over the potential adverse impacts on a person’s immune response after repeated covid-19 boosters.
LinkedIn explained that my articles violated their “Professional Community Policies.” I asked for details on which specific claims were alleged to be “false” or “misleading” and any corresponding references.
They would not play ball.
Instead, LinkedIn stated it “wouldn’t be able to interpret our User Agreement and professional community guidelines any further,” and pointed me to its website:
“Do not share content that directly contradicts guidance from leading global health organizations and public health authorities; including false information about the safety or efficacy of COVID-19 vaccines.”
The policy defies logic.
Not only does it fail to define what it considers to be “false information,” the guidance from different “leading global health organisations and public health authorities” varies significantly.
The US, for example, recommends boosters for everyone over the age of 12, whereas Denmark no longer recommends boosters for healthy people under 50.
Also, the decisions on who will be censored are inconsistent. For example, Thomas Wilckens, a medical doctor and entrepreneur, posted information that was ultimately removed from LinkedIn, but the same data posted by someone else, remained public.
I was interested to know how my articles came to the attention of LinkedIn censors. Did certain words in my article trigger an algorithm or did someone submit a vexatious complaint? Again, LinkedIn refused to explain:
“We are not in a liberty to share the details about the reason that led to an account restriction or our internal findings.”
So, it’s a black box – no transparency, no insight into the fact-checking process and no procedural fairness.
In order to have my account reinstated, I had to agree to comply with the platform’s User Agreement and Professional Community Policies. I was also warned that any further violation would result in my permanent cancellation from the platform.
I superficially agreed to avoid further breaches, and in return, my account was reinstated. I have just been released from LinkedIn jail and I am now on parole.
Over the last few days, many readers have asked for details on why I was suspended from the platform and how I managed to get reinstated – so here it is.
While I’m none the wiser about what specifically triggered the censorship, it has been an effective deterrent. I doubt that I will post covid-19 vaccine articles on the platform in the future.
If you would like to support independent journalists like myself, please consider becoming a paid subscriber and comment below to share your thoughts on censorship.
From Maryanne D
Re: I’ve just been released from LinkedIn jail…
11:59 AM (7 minutes ago)
Thanks Susanne, I’m happy to go on record and say the following………
The covid-19 policies implemented by these Big Tech platforms are ill-defined and open to interpretation. How do you avoid violating their policies if you dont know what they consider to be “false” or “misleading” information?
They say you must not post information that directly contradicts guidance from public health authorities. But, public health authorities from different countries have vastly different guidance. The US for example, recommends boosting everyone over the age of 12, whereas Denmark doesn’t think any healthy person under 50 should be boosted.
I suspect the guidelines are vague for a reason – they want to keep the process opaque so that you cannot challenge them. I found the process to lack transparency and procedural fairness.
LinkedIn is one PayPal another..just gonna take your dosh November 3rd details – 42min
“Do not share content that directly contradicts guidance from leading global health organizations and public health authorities; including false information about the safety or efficacy of COVID-19 vaccines.”
Mark Steyn Retweeted
‘We’ve forgotten to be objective, balanced and fair.’
Former ITV and Sky News executive Mark Sharman speaks to Mark Steyn about the mainstream media’s coverage of Covid pandemic.
GB News YouTube: https://bit.ly/3vAYaw0
“Where have the authorities been?”
The Campaigning for Boosters is EVERYWHERE, the BBC is alive with it…
Speaking with Brian Gerrish as well:
David I had a look through the responses to the link you gave above (See here for the BMJ version and for references)
Much of it I am not able to follow but there are critical responses which if used to disseminate by ‘activists’ ‘dissenters’ or simply individuals ,would be cancelled How come ‘they’ who cancel linkedin twitter etc accounts don’t challenge the BMJ ? Would there be too much of a backlash which couldn’t be suppressed or kept hidden from public view. ?Bill gates and his network has zillions enough and ability to control and suppress free speech by knocking out the small fry doing a lot of the research and reporting of vital real life experiences which cant be or aren’t included in Journals
Robert F. Kennedy Jr
Exactly! FDA Advisor Paul Offit: “A healthy young person is unlikely to benefit from a booster dose … If there’s not clear evidence of benefit, then it’s not fair to ask people to take a risk.”
“We all have a fundamental right to informed consent and to refuse unwanted medical treatment, particularly jabs with experimental vaccines which are not effective at preventing infection or transmission of COVID-19 and were never proven safe.
“Plaintiffs are disappointed that the court ignored that right, ignored the allegations in the complaint that COVID vaccines do not work and are not safe, and ignored the real-world experience we now possess that vaccines did nothing to stop the spread of COVID-19 and have injured thousands of people.”
The lawsuit also accused Rutgers of having a conflict of interest because the university was working with Pfizer, Moderna and Johnson & Johnson to study and develop the vaccines in clinical trials.
Rutgers would stand to benefit financially if more people were required to take the vaccines, the plaintiffs alleged.
Evidence against COVID vaccines for young, healthy students piles up
In recent weeks, a growing body of evidence has exposed the ineffectiveness — and potential dangers — of COVID-19 vaccines for young adults in particular,
And as recently revealed by The Defender, eminent U.K. cardiologist Dr. Aseem Malhotra, who had previously promoted the COVID-19 vaccines on British television, published a peer-reviewed article in the Journal of Insulin Resistance calling for the immediate end of the COVID-19 vaccine rollout and the “pandemic of misinformation on COVID-19 mRNA vaccines.”
In August, Malhotra wrote an open letter to Prime Minister Boris Johnson and U.S. President Joe Biden calling for the immediate release of the raw data from Pfizer’s original COVID-19 vaccine trial.
Aseem Malhotra Retweeted
Former ITV and Sky News boss Mark Sharman. He’s bang on..
His documentary comes out tonight at 7pm thanks to
News Uncut: Straight Talk, Hard Truths
Safe and Effective: A Second Opinion. Link to tonight’s showing at 7pm:
Wow! Well done guys – it’s all kicking off tonight at 7pm. Former Sky and ITV news boss Mark Sharman
Ex BBC ITV
“Judicial Watch: New Documents Reveal COVID-19 Vaccine Studies Used by HHS were Conducted in China”
And the UK
“HHS records included an “urgent for Dr. Fauci ” email chain, citing ties between the Wuhan lab and the taxpayer-funded EcoHealth Alliance. The government emails also reported that the foundation of U.S. billionaire Bill Gates worked closely with the Chinese government to pave the way for Chinese-produced medications to be sold outside China and help “raise China’s voice of governance by placing representatives from China on important international counsels as high level commitment from China.”
“May 2022: University of Texas Medical Branch (UTMB) records show the former director of the Galveston National Laboratory at the University of Texas Medical Branch (UTMB), Dr. James W. Le Duc warned Chinese researchers at the Wuhan Institute of Virology of potential investigations into the COVID issue by Congress.”
“May 2022: HHS records regarding biodistribution studies and related data for the COVID-19 vaccines show a key component of the vaccines developed by Pfizer/BioNTech, lipid nanoparticles (LNPs), were found outside the injection site, mainly the liver, adrenal glands, spleen and ovaries of test animals, eight to 48 hours after injection.”
“March 2021: HHS records show that NIH officials tailored confidentiality forms to China’s terms and that the World Health Organization (WHO) conducted an unreleased, “strictly confidential” COVID-19 epidemiological analysis in January 2020.”
“An October 2021 lawsuit uncovered that over a 10-year period, Fauci and others at NIH received more link to than $350 million in secretive “royalty” payments from drug companies and other third parties.”
Safe and Effective: A Second Opinion
John Bowe Retweeted
Around the Web :
and more and more and more…
The HighWire is set to air ‘Safe & Effective: A Second Opinion’ Documentary LIVE, TOMORROW, 9/29, on the show. Tomorrow’s Guests:
, and Producer Mark Sharman. TOMORROW, 11am Pacific, (2pm EDT/7pm GMT)
H/T Chris –
The Film should be watched in conjunction with this Interview, in which Mark Sharman gave so much essential background
Challenging the Covid-19 Narrative: Former ITV and BSkyB news boss Mark Sharman speaks with UK Column
Mark Sharman, a retired journalist and broadcasting executive decided to come out of retirement due to the one-sided narrative being presented by the MSM on the covid issue, so he decided to make the documentary Safe and Effective/A Second Opinion.
Being Spread Far and Wide –
The Highwire Tonite…
The Highwire with Del Bigtree
Safe and Effective: A Second Opinion
Del Bigtree is promoting this remarkable Documentary produced by the remarkable Mark Sharmer.
Mark, 72, is retired but using his experience, and a small film production company, Oracle Films, has put together, as he says ‘on the kitchen table’.
A big promotion for this new and powerful Documentary.
Between Dr. Aseem Malhotra and Mark Sharmer, the Investigative Reporter, shared some extraordinary discoveries – one of which was the Study graphs, orange v blue, alluded to in the latest comment over on Rxisk.
The link for the documentary will be permanently displayed on The HighWire.
Dr Aseem Malhotra Retweeted
Aseem Malhotra’s vaccine warnings fall on ever deafer ears
September 30, 2022
FORMER health ministers Sajid Javid and Jeremy Hunt have both ignored doctors’ pleas to help halt the Covid-19 vaccination programme.
NHS cardiologist and public health campaigner Dr Aseem Malhotra, a one-time vaccine advocate who has changed his stance in view of the evidence, has told them that 1 in 800 Covid vaccine recipients suffers a serious adverse reaction, while official figures show that 1 in 116 experience reactions serious enough to report to the Medicines and Healthcare products Regulatory Agency’s (MHRA) Yellow Card Scheme.
Dr Malhotra spoke to Hunt directly, while a senior member of the British Medical Association, the doctors’ trade union, spoke to Javid. Neither has acted or contacted Dr Malhotra to ask him to present his evidence of harms.
The MHRA has consistently failed to take reports seriously despite receiving 2,240 notifications of fatalities and 29,080 reports of acute cardiac events, Dr Malhotra’s area of expertise.
When sent a freedom of information request early in the vaccination campaign asking for the release of Pfizer’s raw safety data, the drugs monitor responded that it was not in the public interest to release it.
Recent re-analysis of the Pfizer and Moderna trial data suggests the risk of suffering serious adverse effects of mRNA vaccines is significantly higher than the risk of being hospitalised with Covid-19. It also showed a rise in cardiac arrests and heart attacks linked to the Pfizer-BioNTech vaccine.
Pfizer’s phase three clinical trials recorded four cardiac arrests in the non-placebo group and one in the placebo group. A significant rise in cardiac arrest calls to ambulances in England was seen in 2021 (an extra 14,000 compared with 2020). Similar data emerged from Israel in the 16-to-39-year-old age group where there was a 25 per cent increase in heart attacks or cardiac arrests associated with the Pfizer-BioNTech vaccine administration, but not associated with Covid-19.
Dr Malhotra has also stated publicly that the vaccination is a likely contributor to his father’s sudden death from heart failure. Dr Kailash Chand was a fit 73-year-old able to beat his son at badminton. Dr Malhotra said: ‘The last time I played him he had me running about the court so much I ruptured my Achilles tendon. He had no sign of a heart condition.’
In his continuing efforts to raise the alarm, Dr Malhotra has written a two-part, peer-reviewed paper. Entitled: ‘Curing the pandemic of misinformation on Covid-19 mRNA vaccines through real evidence-based medicine’, it was published this week in the Journal of Insulin Resistance and presented to the press on Tuesday. He tweeted his findings and the paper has received over 3million views.
Although he is followed on Twitter by many MPs, mainstream media journalists and other influencers, none has contacted him to ask for more information. His paper has also been snubbed by mainstream media. A correspondent from the Times was at the press conference and interviewed Dr Malhotra afterwards but the paper has yet to publish a report.
Dr Malhotra said: ‘There’s been an emotional reaction, but no other doctors have come at me with arguments against the data I’ve used in my paper. The data that I’ve used makes a very clear case that the vaccine is causing significant harm in at least 1 in 800. It’s probably much more than that. That in itself is unprecedented. I don’t know how they’re going to wriggle out of it.
‘The MHRA are in denial, and they’re funded by the industry they’re supposed to regulate. So what do we expect?
‘Traditionally, mainstream media coverage has exposed wrongdoing. I was working with a mainstream media journalist for a couple of months before my paper was published. He came back to me at the last-minute saying, “I can’t do the story,” because he’d got comments from the
British Heart Foundation and the British Immunological Society which contradicted my paper.
‘Doctors don’t even know about the mRNA technology being used in the Pfizer vaccine because it’s new technology. This is the problem. There’s a presumption of knowledge amongst authoritative figures. Most of them have the illusion of knowledge or are ignorant or deliberately ignoring things that they should be looking at.
‘I’ve had email and message exchanges with people like Good Morning Britain presenter Susanna Reid, former GMB presenter Piers Morgan, and the BBC’s Jeremy Vine but none have covered the story.’
His findings are backed by six other leading doctors including Sherif Sultan, professor of vascular surgery and president of the International Vascular Society, who said: ‘These findings raise concerns regarding vaccine-induced undetected severe cardiovascular side effects and underscore the established causal relationship between vaccines and myocarditis, a frequent cause of unexpected cardiac arrest in young individuals.’
Dr Campbell Murdoch, clinical adviser to the Royal College of General Practitioners, said: ‘All healthcare providers must practise evidence-based medicine. In the case of the Covid-19 vaccination Dr Malhotra describes multiple systemic failures in the provision of safe and effective evidence-based medicine. Consequently, it has been impossible for patients and the public to make an informed choice about what is best for their health and life.
‘High quality healthcare requires organisations and individuals to act with complete integrity. Without this, the delivery of safe and effective healthcare will always fail.’
Dr Bob Gill, GP, activist and producer of the documentary The Great NHS Heist, said: ‘This important review highlights significant concerns about the overstated benefits of vaccination especially in low-risk populations, and the under-reporting of adverse events.’ Dr Renee Hoenderkamp, GP, writer and broadcaster, added: ‘I have two young patients with post-vaccine heart conditions confirmed. They were not counselled on the risk of this [myocarditis] as part of an informed consent process.’
Dr Amir Hannan, GP and chair of the West Pennine Local Medical Committee, Greater Manchester, said: ‘We must remain vigilant against over-reliance on the benefits [of vaccine] and minimising or even suppressing the harms.’
Jay Bhattacharya, Professor of Medicine and Epidemiology at the University of Stanford, added: ‘There may be a case for older people to take the vaccine because the benefits may outweigh expected harm, but that may not be the case for younger people.’
Despite their comments, no action has been taken.
Dr Malhotra was due to present his findings to the All-Parliamentary Group on Vaccination on September 16, but the meeting was postponed owing to the death of the Queen.
He is himself double vaccinated and believes in vaccination. Initially, he criticised vaccine hesitancy on television but now says he was ‘wilfully blind to vaccine harms’. He cited the book by Margaret Heffernan, Wilful Blindness, highlighting the phenomenon, and said that the public were guilty of wilful blindness when it came to sex-offenders Harvey Weinstein and Jimmy Savile, and to the atrocities of the Holocaust.
He should be applauded for admitting he was wrong and not lambasted as he has been. Doctors, academics, and scientists need to be able to change their stance without fear of reprisals.
The MHRA did not respond to a request for comment.
A very good post hitting nail on head.
Have just watched the press conference on WCFH. Am wondering what will happen to Dr Malhotra after that and his paper. He references Peter C Gøtzsche, we have seen what happened to him. Far far more, in the hundreds need to come out.. where are they..
Dr Aseem Malhotra
I honestly don’t think they did know. They went in with the best intentions like most of us but perhaps were too trusting of the information coming from an entity ( Big Pharma) that is psychopathic in the way it conducts business
Replying to @DrAseemMalhotra
So did the MHRA , the CDC and all the government organisations. Whitty, Valance & Van Tam knew. They’re all criminal!
Well, a whole picture emerges from the comments, 390, which if you were doing a survey implies
Quite a bit of animosity towards Vallance (Ex GSK/Paroxetine) – Who Knew?
The False Claims case against Pfizer’s product that I filed in 2021 has been described as “the biggest in U.S. history.”
There is an ongoing effort to keep the public from knowing about & following the case.
Today, we start to fight back!
So, your question, Chris, where are they?
This partly answers it…
IMAGINE: We survive the motions to dismiss & we will depose the Pfizer CEO, FDA, CBER, CDC, receive their internal communications, depose trial investigators & site staff & may even be allowed to interview Bill Gates. That’s how huge this case is!
They stupidly mis-use the anti vaxxwer claim to hide that they have scewed the data. Scotland is not the only country which has got together to manipulate and abuse the trust of populations and hide data from scrutiny If this isn’t tackled it cannot be used to protect everyone from potential harms and deaths in future – or even now where vaccines are being pushed . We cant wait another n years for researchers to dig out the truth – or wait for a comparison between say Denmark and UK , which have different policies – the data is likely to be scewed again anyway.
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Scotland’s health watchdog warned hiding Covid data in bid to tackle vaccine doubt may backfire
Public Health Scotland has admitted that its Covid data collection is flawed and it will now hide the most recent results in order to combat what they see as “anti-vaxxers”.
ByJessica NorthPolitics Reporter
16:02, 17 FEB 2022
“Effective here means if you have had the vaccine, you are less likely to have a lab confirmed test for symptoms of COVID.”
And since a negative result may be a false negative, perhaps covid cases were missed in both the vaccine and placebo arms. Since there have been studies about the rate of false negatives during the time period of the covid vaccine trials, we have a rate that we might apply and determine the estimate of the total of false negatives, if only we had access to the number of tests that were performed.
Data about number of PCR tests is missing from the public record.
Someone will say that they don’t do “what ifs.” How then do you determine whether data has been cherry-picked, absent a smoking gun?
An official EU websiteHow do you know?
Back to EUR-Lex homepageEUR-Lex Access to European Union law
JOINT COMMUNICATION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS Tackling COVID-19 disinformation – Getting the facts right
JOIN(2020) 8 final
JOINT COMMUNICATION TO THE EUROPEAN PARLIAMENT, THE EUROPEAN COUNCIL, THE COUNCIL, THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE AND THE COMMITTEE OF THE REGIONS
Tackling COVID-19 disinformation – Getting the facts right
The COVID-19 (‘Coronavirus’) pandemic has been accompanied by an unprecedented ‘infodemic’. 1 A flood of information about the virus, 2 often false or inaccurate and spread quickly over social media, can – according to the World Health Organisation (WHO) – create confusion and distrust and undermine an effective public health response.
Building on the Action Plan against Disinformation, 4 this calls for more coordinated action, in line with our democratic values, to address the risks for open societies. Our common values and democratic institutions, including free expression and free and plural media, are keystones to the resilience of our societies to the challenges of the COVID-19 pandemic.
Following the Commission’s call, platforms 63 have removed millions of misleading advertisements concerning illegal or unsafe products. 64 The Commission coordinated a screening (‘sweep’) of websites, to find out where consumers in the EU are being subjected to content promoting false claims or scam products in the context of COVID-19. The sweep – carried out by the Consumer Protection Cooperation (CPC) Network – involved both a high-level screening of online platforms, and an in-depth analysis of specific advertisements and websites linked to products with demand boosted due to the virus. The result is that platforms have removed or blocked millions of misleading advertisements or product listings.
There are 73 refs – worth a look
The Pfizer documents
2,456,976 views 9 Mar 2022
Dr. John Campbell
Public Health and Medical Professionals for Transparency, Pfizer / FDA FOI
Request, Freedom of Information Act (FOIA)
The court order
List of downloadable documents
5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
Adverse event reports
01 December 2020 through 28 February 2021
Cumulatively, through 28 February 2021,
a total of 42,086 case reports (25,379 medically confirmed and 16,707 non-medically confirmed)
containing 158,893 events.
Most cases (34,762) were received from United States (13,739),
United Kingdom (13,404)
Portugal (866) and
the remaining 7,324 were distributed among 56 other countries.
Since Dec. 11, 2020, the Pfizer-BioNTech COVID-19 Vaccine has been available under EUA
(Approval, 21st August 2021)
Acting FDA Commissioner Janet Woodcock, M.D.
While millions of people have already safely received COVID-19 vaccines, we recognize that for some, the FDA approval of a vaccine may now instill additional confidence to get vaccinated.
Today’s milestone puts us one step closer to altering the course of this pandemic in the U.S.
System Organ Classes (SOCs)
that contained the greatest number (≥2%) of events, in the overall dataset,
were General disorders and administration site conditions (51,335 AEs),
Nervous system disorders (25,957),
Musculoskeletal and connective tissue disorders (17,283),
Gastrointestinal disorders (14,096),
Skin and subcutaneous tissue disorders (8,476),
Respiratory, thoracic and mediastinal disorders (8,848),
Infections and infestations (4,610),
Injury, poisoning and procedural complications (5,590), and Investigations (3,693).
Number of cases: 1403 (3.3% of the total PM dataset),
of which 241 are medically confirmed and 1162 are non-medically confirmed;
5. SUMMARY AND CONCLUSION
Review of the available data for this cumulative PM experience, confirms a favorable benefit: risk balance for BNT162b2.
Peter Marks, M.D., Ph.D., director of FDA’s Center for Biologics Evaluation and Research
“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine.
We evaluated scientific data and information included in hundreds of thousands of pages, conducted our own analyses of Comirnaty’s safety and effectiveness,
and performed a detailed assessment of the manufacturing processes, including inspections of the manufacturing facilities,”
“….. the public is counting on safe and effective vaccines. The public and medical community can be confident that although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”
the law, passed in January, in force since early February,
not proportionate, relatively mild symptoms experienced by most people who contract Omicron
Amy Kelly, Naomi Wolf, Craig Klein webinar Pfizer documents update
Info starts 10 mins in
Guess it all depends if she gets discovery; wonder if the judge has been reading DailyClout
Abstractor will become the ‘goto’ resource for lawyers, the press, independent researchers and anyone interested in finding out what Pfizer submitted in support of it obtaining a EUA in record time.
Did the Covid jab make a famous doctor’s cancer WORSE? Belgian immunonologist claims his lymphoma exploded like ‘fireworks’ after getting booster
Dr Goldman, of Erasme Hospital in Brussels, concluded that the worsening of his condition may have been down to the jab, after scouring through hundreds of scientific papers.
Both Pfizer and Moderna, which make the Covid mRNA vaccines, study all reported jab side effects and have found no link between their injection and cancer.
But in an interview with US magazine Atlantic, Dr Goldman shared concerns that the rapid spread of his cancer may have been triggered by his booster, after weeks of sifting through scientific papers.
However, the immunologist is unsure whether he will get his fourth.
A Case Report on Dr. Goldman, Serge, not mentioned in the Daily Mail article – same ‘exploding like fireworks’ scans
Rapid progression of T-cell lymphoma following Pfizer booster shot:
Dr Ryan Cole on post-vaccination cancer
Covid Vaccines: The Testimonies Project
The Testimonies Project was created to provide a platform for all those who were affected after getting the covid-19 vaccines, and to make sure their voices are heard, since they are not heard in the Israeli media.
We hope this project will encourage more and more people to tell their story.
“I’m honestly just waiting for the third dose to end it.” …
Health Action International Cat and Mouse
MISSING CLINICAL TRIAL DATA IN EUROPE
Home > Resources > Missing clinical trial data in Europe
Report | July 2021 | Download PDF
The report, Missing clinical trial data in Europe: Assessing and comparing the performance of national medicines agencies, based on data collected by researchers at the University of Oxford, shows that national medicines regulators in 14 key European* countries are failing to ensure that potentially life-saving data on new medicines and vaccines is rapidly and consistently made public as required by long-standing European Union transparency rules.
While numerous previous TranspariMED reports have assessed the extent to which companies and institutions follow European transparency rules, this is the first-ever report to assess to what degree national medicines regulators themselves follow and enforce the rules that they are responsible for upholding.
This report documents that many national medicines regulators in Europe fail to:
Make clinical trial registrations visible.
*The UK left the European Union in January 2021, after the data underlying this report had been collected. This report nonetheless includes UK data because it sometimes provides a useful benchmark against which other regulators’ performance can be measured.
Abstractor Peter Selley retired GP in rapid responses thebmj
Vaccine Manufacturers’ Hesitancy
Re: Implementation of covid-19 vaccination in the United Kingdom Azeem Majeed, Katrina Pollock, Simon Hodes, Marisa Papaluca. 378:doi 10.1136/bmj-2022-070344
The vaccine manufacturers have been hesitant in sharing the raw data of their Covid vaccine trials – a criticism supported by this Journal (1)
As Demasi (2) has pointed out, the Public Health and Medical Professionals for Transparency (PHMPT) successfully sued the FDA for access to all the data which the agency used to grant licensure for Pfizer’s covid-19 vaccine.
As a result all the appropriately redacted data will be released over the next few months, and can been accessed on the Public Health and Medical Professionals for Transparency website.
There is also a very useful free program called Abstractor that can search the FDA’s data.
As a result, both professionals and the public can now examine the raw data of the first pivotal trial (3) that led to the worldwide implementation of Covid vaccination.
Robert F. Kennedy Jr
Under the new rubric, the doctor no longer serves the best interest of the patient but acts as an agent of state policy. When governments start practicing medicine, the story never ends well.
Doctors Speak Out Against ‘Medical Totalitarianism’ as Newsom Signs Bill That Punishes Doctors for COVID ‘Misinformation’
California Gov. Gavin Newsom on Friday signed a bill that subjects the state’s doctors to discipline, including the suspension of their medical licenses, for sharing “misinformation” or “disinformation” about COVID-19 with their patients.
“Under the new rubric, the doctor no longer serves the best interest of the patient but acts as an agent of state policy.
“History is replete with nightmarish examples of what happens when doctors stop healing and act instead to advance ‘the greater good.’ Governments have variously cited that phrase to justify euthanasia of the elderly, mental defectives, homosexuals and other ‘useless eaters’ and to enforce ‘one-child’ policies.
“When governments start practicing medicine, the story never ends well.”
UK Covid-19 Inquiry
See new Tweets
UK Covid-19 Inquiry
This is the official Twitter account of the UK Covid-19 Inquiry. The Inquiry will examine the UK’s pandemic response.
Quoted by David H above A sensitive and discriminating judgment is called for; a skilled intelligence to scent out the truth. (Carl von Clausewitz)
Is the judge and her cronies likely to fit the bill….
What a Marvel…
Marvel And Pfizer Team-Up For COVID-19 Vaccine Advocacy Comic Starring The Avengers
Pfizer COVID vaccine clears Japan panel for use with young children
TOKYO, Oct 5 (Reuters) – A Japanese health ministry panel on Wednesday recommended approving Pfizer Inc’s (PFE.N) COVID-19 vaccine for children as young as six months old.
Japan in January expanded use of the vaccine to those as young as five years old. Last month, health authorities started to dispensing Pfizer and Moderna Inc (MRNA.O) booster shots that target the Omicron variant of the virus.
The panel also recommended approval of a version of the Pfizer vaccine that protects against the BA.4 and BA.5 subvariants of Omicron. Moderna said earlier on Wednesday it was seeking Japanese approval of its own subvariant shot. read more
Prof Norman Fenton
Another update on complaints against BBC ‘documentary’ #unvaccinated. Both the BBC and @MHRAgovuk have failed to meet their own deadlines for responding.
17 hours ago
4 min read
MHRA and BBC fail to meet their own deadline for responding to complaints about “Unvaccinated”
Prof Norman Fenton Retweeted
Introducing the Covid SATIRE: ‘Busting Anti-Vax Myths! Seriously EXPERT Arguments for the Covid-Deniers in Your Life’ by Prof. Oisin MacAmadain (Expert). It isn’t what it seems at first….remember, it’s a satire! Comic relief for the lockdown sceptical
Prof. Oisín MacAmadaín is an expert, one of the best, in fact. Founder, sole lecturer and provost of The Termonfeckin Institute of Expertise in Ireland’s beautiful Co. Louth, he knew that if there was one thing governments needed for their response to Covid, it was his enormous brains. Consequently, he has devoted every waking moment of the Covid Era to advising all government cabinets everywhere on the supreme value of masks, lockdowns, mandates and being vaccinated at least once a month.
He was, at a certain point however, utterly horrified to learn of the existence of certain total thickos, tinfoil hat wearers and those who were generally of a conspiratorial disposition. Sensing that the mentally soft among us could be prone to believing any old kind of nonsense, he set out to write a book to counteract the nefarious mis-, dis- and downright crackpot information that is currently being spread among the nether regions of the internet.
Do you have a neighbour or, heaven forbid, friend or family member, who regularly spews utter nonsense in your direction along the lines of ……….
Norman ‘Wisdom’ Fenton –
For the ‘Oirish’ amongst us…
This is amusing. Mac means son of. Amadan with an accent on the last a (not amadain) means fool. Will be interesting to see what comes out of this new Institute
The World loves á
In this video, I discuss my expert recommendations for NPHET to have an emergency vaccination program for hamsters following the arrival of the Mongolian variant (aka the Genghis Khan variant of doom)
Here’s my cat, Fauci. We always mask him up when we have visitors just so as to keep us all safe!!!
Maybe being the son of a fool does not necessarily make him a fool too?!
Have just ordered the book from Amazon UK – the “look Inside” pages were very amusing.
The Short Shot – by Matt Hancock and Patrick Vallance – Pfizzle
To Play, and Be Played –
Covid jab heroine KATE BINGHAM gave up her job to work 15-hour days, seven days a week (unpaid) heading Britain’s world-beating vaccine taskforce. Her reward? To be smeared and pilloried by the Left – and thrown under the bus by a senior No. 10 aide
The sheer intensity of the experience almost blinded me to what we had achieved. The Taskforce team had prioritised a shortlist of vaccines from more than 190 candidates. We had signed contracts for seven vaccines. Against incredible odds those vaccines turned out to be precisely the right calls. And to the joy and relief of me and my team, that December the UK became the first country in the world to launch its Covid vaccination programme.
Adapted from The Long Shot: The Inside Story Of The Race To Vaccinate Britain by Kate Bingham & Tim Hames, to be published by Oneworld on October 20 at £18.99
The Long Shot…
The very next day, Pfizer announced its astonishing data showing that its vaccine was greater than 90 per cent protective against Covid-19 infection.
Thanks to the Taskforce, the UK was the first country in the world to sign a contract with Pfizer. We had secured 40 million doses, which was proportionately higher than any other nation. I felt that, finally, the tide of negative Press should start turning.
“I had assembled a fantastic team around me, which was beginning to hum.”
Did, Poor Kate, get lost in her own story – Pfizzle
Praise for Prof. Oisín MacAmadáin!
‘At last! A book to really annoy the anti-vaxxers. Je l’adore!’ – President Macaroni
‘Wait, am I in this book? Let me make sure I get my hair right.’ – President Trudy-Wudy
‘Phew, it was getting a bit worrying for a second there…. thank God for Oisín.’ – CEO of Pfizzle
‘My biggest fight wasn’t with Covid – it was against grandstanding Matt Hancock and the exasperating ‘Blob”: Head of UK’s vaccine taskforce KATE BINGHAM reveals the struggles and painful bureaucracy behind Britain’s world-beating jab programme
In June 2020, Kate Bingham faced an extraordinary ambush by Matt Hancock
Bingham said she asked Health Secretary for advice ahead of Cabinet meeting
When it came to committee discussion, Hancock ‘traded in Dr Jekyll for Mr Hyde’
Back in early 2020, the Government’s Chief Scientific Adviser, Sir Patrick Vallance, had realised the UK needed a taskforce dedicated to securing, developing and manufacturing life-saving vaccines.
So I made a decision. To protect the Taskforce, we’d hire an outside expert of unimpeachable authority and expertise to review our strategy, our team and our actions.
Which is how I came to call Sir Richard Sykes – formerly chairman of GlaxoSmithKline…
In 2020 he lead an independent review of the workings of the Vaccine Taskforce. On 14 June 2021, Sykes was appointed chair of the Vaccine Taskforce, where he will be responsible for overseeing the delivery of the UK’s COVID-19 vaccination programme, including preparations for booster programmes and encouraging vaccine innovation in the UK.
“Sometimes I would find myself in an Alice in Wonderland situation, with more than a hint of Monty Python to it.” …
Anthony Fauci FINALLY admits he should have been ‘much more careful’ with his words during the pandemic — after flip-flopping on masks and exaggerating vaccine figures to boost uptake
Disease expert made the admission at a medical conference in California
Dr Fauci has been heavily criticized for his flip-flopping on face masks
He also quashed discussion over theories Covid leaked from a lab in China
By CASSIDY MORRISON SENIOR HEALTH REPORTER FOR DAILYMAIL.COM and LUKE ANDREWS HEALTH REPORTER FOR DAILYMAIL.COM
PUBLISHED: 16:05, 5 October 2022 | UPDATED: 17:58, 5 October 2022
Dr Anthony Fauci has finally admitted he got key aspects of his Covid public health advice wrong.
America’s top infectious disease expert said he should have been ‘much more careful’ with his words early in the pandemic.
He told a medical conference on Tuesday that he wished he had been more open about the uncertainties at the time.
The outgoing White House medical adviser was speaking at the University of Southern California’s Center for Health Journalism on Tuesday.
Data collected from the Centers for Disease Control and Prevention’s (CDC) V-safe app reveal that women and also recipients of the Moderna and Johnson & Johnson (J&J) COVID-19 vaccines were disproportionately affected by adverse events following their vaccination.
The data were publicized Oct. 3 by the Austin-based nonprofit Informed Consent Action Network (ICAN) following its successful lawsuit against the CDC and a court order demanding the CDC release the data.
ICAN published the data using a graphical online dashboard and also made the raw data — containing more than 144 million lines of health data — available to the public.
The V-safe smartphone app collected post-vaccination health assessments from approximately 10 million people between Dec. 14, 2020, and July 31, 2022.
Del Bigtree, CEO of ICAN, described the data file as “huge, gigantic” and remarked on the CDC’s failure to make this information available.
“The CDC had billions of dollars to build something like this,” he said. “They didn’t do it, so we did it for them.”
“Why did it take numerous legal demands, multiple appeals, two lawsuits in fact, before the CDC finally handed over the V-safe data … that they could have provided in a matter of minutes at any point?
ICAN described the release of the first batch of V-safe data as “a big win in the nearly two-year-long fight for transparency from our federal agencies on the real safety data for COVID-19 vaccines.”
It’s going to be ‘fun’ to watch how many journalists who so ably aided and abetted start to jump on the goody two shoes bandwagon when it really begins to roll with the corruption stories They need to pick up speed because local groups are already doing a good job.
Key Pfizer covid-19 vaccine trial dataset still not released
Re: Covid-19: Researchers face wait for patient level data from Pfizer and Moderna vaccine trials Jennifer Block. 378:doi 10.1136/bmj.o1731
The U.S. FDA granted a license (in the recent vernacular, “full approval”) to Pfizer’s mRNA covid-19 vaccine, Comirnaty, on August 23, 2021.
The US Code of Federal regulations (21 CFR 601.51(e)) states that “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown…” 
On this basis, a group known as Public Health and Medical Professionals for Transparency (PHMPT, a very large group of which we are co-signatories) submitted a Freedom of Information Act (FOIA) request to FDA requesting these data (i.e. the data Pfizer submitted to FDA to obtain licensure). After the FDA denied PHMPT’s request for expedited processing, PHMPT sued the FDA; in January 2022, a US federal judge ordered the FDA to produce at least 55,000 pages a month (the FDA initially estimated that it held 329,000 pages and argued it should not be required to produce more than 500 pages a month due to limited resources).
Hundreds of thousands of pages have now been released, including 37 patient level datasets for Pfizer’s phase III trial (C4591001), all of which are posted for public download from the PHMPT website.
While release is still not complete, we reviewed the datasets to understand what analyses might be possible with what has been released thus far. To our disappointment, despite some datasets being gigabytes in size, a key analysis dataset known as ADSL (Subject-Level Analysis Data) remains unreleased. Pfizer’s Analysis Data Reviewer Guide states that “This [ADSL] dataset supported the creation of all other analysis datasets” (p.23) and that “ADSL.sas (adsl-sas.txt) must be run first before any other ADaM datasets; all other programs are dependent on ADSL output.” (p.37) 
This means that replicating even the most basic safety and efficacy analyses that Pfizer presented in its reports (see pp.42-65 in ref ) is still not directly possible. (We say “directly” because such analyses may still be “reverse engineered” using the available data.) More than one year after licensure, and nearly two years since widespread use under an Emergency Use Authorization commenced, the inability to directly replicate these analyses is unacceptable.
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What’s behind the scream ? sorry – screen?
HEALTH AND SCIENCE
Influential health group says U.S. doctors should screen more adults for anxiety
PUBLISHED TUE, SEP 20 202212:33 PM EDTUPDATED TUE, SEP 20 20222:47 PM
An influential health group proposed guidelines Tuesday that said U.S. doctors should regularly screen all adults under 65 for anxiety.
Anxiety disorders are among the most common mental health complaints, affecting about 40% of U.S. women at some point in their lives and more than 1 in 4 men.
U.S. doctors should regularly screen all adults under 65 for anxiety, an influential health guidelines group proposed Tuesday.
It’s the first time the U.S. Preventive Services Task Force has recommended anxiety screening in primary care for adults without symptoms. The proposal is open for public comment until Oct. 17, but the group usually affirms its draft guidance.
The recommendations are based on a review that began before the Covid-19 pandemic, evaluating studies showing potential benefits and risks from screening. Given reports of a surge in mental health problems linked with pandemic isolation and stress, the guidance is “very timely,” said Lori Pbert, a task force member and co-author. Pbert is a psychologist-researcher at the University of Massachusetts’ Chan Medical School.
The task force said evidence for benefits, including effective treatments, outweighs any risks, which include inaccurate screening results that could lead to unnecessary follow-up care.
Anxiety disorders are among the most common mental health complaints, affecting about 40% of U.S. women at some point in their lives and more than 1 in 4 men, Pbert noted.
Black people, those living in poverty, people who have lost partners and those who have other mental health issues are among adults who face higher risks for developing anxiety, which can manifest as panic attacks, phobias or feeling always on edge. Also, about 1 in 10 pregnant and postpartum women experience anxiety.
Common screening tools include brief questionnaires about symptoms such as fears and worries that interfere with usual activities. These can easily be given in a primary care setting, the task force said, although it didn’t specify how often patients should be screened.
“The most important thing to recognize is that a screening test alone is not sufficient to diagnose anxiety,” Pbert said. The next step is a more thorough evaluation by a mental health professional, though Pbert acknowledged that finding mental health care can be difficult given shortages of specialists.
The group continues to recommend depression screening for adults and children, but said there isn’t enough evidence to evaluate potential benefits and harms of suicide screening in adults who show no worrisome symptoms.
In April, the group issued similar draft guidance for children and teens, recommending anxiety screening but stating that more research is needed on potential benefits and harms of suicide screening kids with no obvious signs.
Guidelines from the task force often determine insurance coverage, but anxiety is already on the radar of many primary care doctors. In 2020, a group affiliated with the American College of Obstetricians and Gynecologists recommended routine primary care anxiety screening for women and girls starting at age 13.
The intention to squash debate was organised right from the start by the right dishonourables and co. By 2020 it was well under way
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Social media giants agree package of measures with UK Government to tackle vaccine disinformation
Platforms and UK government agree a package of measures to reduce vaccine disinformation
Department for Digital, Culture, Media & Sport, Department of Health and Social Care, The Rt Hon Oliver Dowden CBE MP, and The Rt Hon Matt Hancock MP
8 November 2020
Platforms endorse the principle that no company should be profiting from COVID-19 vaccine mis/disinformation and commit to swifter responses to flagged content
Platforms will step up work with public health bodies to promote factual and reliable messages
Digital Secretary Oliver Dowden and Health Secretary Matt Hancock have agreed with social media platforms new measures to limit the spread of vaccine misinformation and disinformation and help people find the information they need about any COVID-19 vaccine.
At a virtual roundtable to address the growth of vaccine disinformation, Facebook, Twitter and Google committed to the principle that no company should profit from or promote COVID-19 anti-vaccine disinformation, to respond to flagged content more swiftly, and to work with authorities to promote scientifically accurate messages.
As the UK moves closer to developing a safe and effective COVID-19 vaccine, Mr Dowden and Mr Hancock used the roundtable to welcome the progress these companies have made in strengthening their policies towards false coronavirus information and helping publicise the steps people should take to prevent the spread of the virus.
But the ministers raised concerns about the length of time misleading and false information about coronavirus vaccines remains on platforms, and called for swifter action to tackle such content.
Together the platforms have now agreed:
To commit to the principle that no user or company should directly profit from COVID-19 vaccine mis/disinformation. This removes an incentive for this type of content to be promoted, produced and be circulated.
To ensure a timely response to mis/disinformation content flagged to them by the government.
To continue to work with public health bodies to ensure that authoritative messages about vaccine safety reach as many people as possible.
To join new policy forums over the coming months to improve responses to mis/disinformation and to prepare for future threats.
The forums will see the government, social media platforms, public health bodies and academia increase their cooperation and ongoing information sharing to deliver a better understanding of the evolving threat caused by false COVID-19 vaccine narratives.
Digital Secretary Oliver Dowden said:
Covid disinformation is dangerous and could cost lives. While social media companies are taking steps to stop it spreading on their platforms there is much more that can be done.
So I welcome this new commitment from social media giants not to profit from or promote flagged anti-vax content, given that making money from this dangerous content would be wrong.
Health Secretary Matt Hancock said:
After clean water, vaccination is the most effective public health intervention in the world and has saved countless lives across the globe, eradicating one disease entirely.
I am encouraged that social media companies have agreed to do more to prevent the spread of dangerous misinformation and disinformation on their platforms.
We want users to have greater access to reliable and scientifically-accurate information on vaccines from trusted sources like the NHS so they can make informed decisions to protect themselves and their loved ones.
Vaccines are overwhelmingly safe and effective healthcare solutions. Ministers used the meeting, which also included representatives from fact-checking charities, academics and data experts, to highlight that robust action must be taken against misleading messaging and content online which could harm and discourage people from protecting themselves or their loved ones.
Throughout the pandemic the government’s Counter Disinformation Unit has been developing a picture of the extent, scope and reach of disinformation and working with online platforms to ensure appropriate action is taken.
The unit has observed a range of false narratives about coronavirus vaccines across multiple platforms, including widespread misuse of scientific findings and baseless claims challenging the safety of vaccines or plans for their deployment.
Ronan Harris, Google UK Managing Director, said:
Since the beginning of the covid-19 epidemic, we have worked relentlessly to promote authoritative content from the NHS and to fight misinformation. In the last few months, we have continued to update our policies to make sure that content contradicting scientific consensus about the virus is swiftly removed and demonetised. Today, we are redoubling our commitment to take effective action against covid vaccine misinformation and to continue to work with partners across Government and industry to make sure people in the UK have easy access to helpful and accurate Information.
Katy Minshall, Head of UK Public Policy, Twitter UK, said:
We are focused on protecting the public conversation and helping people find authoritative information on Twitter – in May 2019, we launched a search prompt that serves people with credible vaccine information from the NHS. In January this year, we launched a dedicated COVID-19 search prompt, ensuring that when people come to the service for information, they’re met with authoritative, public health information first. To date, over 160 million people have visited the Twitter COVID-19 curated page, over two billion times.
Since introducing COVID misinformation policies in March, and as we’ve doubled down on tech, our automated systems have challenged millions of accounts which were targeting discussions around COVID-19 with spammy or manipulative behaviours. We remain committed to combating misinformation about COVID-19, and continue to take action on accounts that violate our Rules. We look forward to continued collaboration with government and industry partners in our work towards improving the health of the public conversation.
Rebecca Stimson, Facebook’s Head of UK Public Policy, said:
We’re working closely with governments and health authorities to stop harmful misinformation from spreading on our platforms. Ads that include vaccine hoaxes or discourage people from getting a vaccine are banned, we remove harmful misinformation about Covid-19 and put warning labels over posts marked as false by third party fact checkers. We’re also connecting people to accurate information about vaccines and Covid-19 whenever they search for these topics. In the first months of the pandemic we directed more than 3.5 million visits to official advice from the NHS and UK government and we’re pleased to continue to support public health efforts.
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Not so safe. Not so rare. Are we still supposed to trust the FDA?