Friday, July 28, 2023

The truth about myocarditis and Covid vaccines: After Bronny James' cardiac arrest and Elon Musk pushing anti-vaxx theory, leading doctors insist jabs are NOT to blame

The presentation below is reasonable but it depends to an extent on the veracity of official statistics -- which is a very weak reed to lean on indeed. Very often dying WITH Covid has been conflated with dying OF Covid

First the anti-vaxxers jumped on Christian Eriksen, alleging the Covid vaccines were to blame when the Danish footballer suffered a cardiac arrest at Euro 2020.

Then, less than 12 months later, they claimed Pfizer's 'clot shot' was behind Australian cricket icon Shane Warne's sudden heart-related death.

And when NFL safety Damar Hamlin suffered a cardiac arrest during a Buffalo Bills match in January, so-called 'truthers' brandished it as the icing on their Covid conspiracy cake.

Now, however, the anti-vaxx mob have a new target: Bronny James, son of legendary NBA hooper LeBron.

The 18-year-old, expected to follow in his father's footsteps, was rushed to hospital on Monday after suffering a cardiac arrest during practice at the University of Southern California.

Despite it being unconfirmed when, or if, Bronny had a Covid jab, critics were quick to establish a potential link.

Even Elon Musk chipped in, fuelling the conspiracy even further.

Posting on Twitter under a news story about Bronny's cardiac arrest, Musk wrote: 'We cannot ascribe everything to the vaccine, but, by the same token, we cannot ascribe nothing. Myocarditis is a known side-effect. The only question is whether it is rare or common.'

But leading doctors have dismissed the theory.

Two facts — both of which are widely misinterpreted — are central to the claims.

One is that mRNA jabs, like Pfizer's and Moderna's, can cause myocarditis, an extremely rare complication that causes inflammation of the heart muscle. Young people, especially boys, are most at risk.

The other? That heart-related deaths are massively above levels seen pre-pandemic.

Cardiologists and heart health charities say conflating the two is not only incorrect, but irresponsible.

No drug is risk-free. And while there is a very small chance of developing myocarditis from a Covid vaccine, experts insist the benefits, in the form of the tens of thousands of lives saved, clearly outweigh any potential dangers.

Myocarditis can, in some cases, damage the pumping function of the heart, leading to disturbance issues later in life.

But an overwhelming majority of vaccine-induced myocarditis cases are mild, real world evidence shows.

Symptoms generally appear within a week of being jabbed and most patients make a full recovery shortly thereafter, according to the British Heart Foundation.

The charity, which has funded various projects into the hugely controversial topic, also insists there is no evidence vaccine recipients are at increased risk of cardiac arrest afterwards, regardless of whether it is days, or months, later.

Any such link, they argue, would have been spotted by now, given that the jabs — delivered to billions across the world — were first rolled out almost three years ago.

Infections, including Covid itself, can also trigger myocarditis. This, experts argue, is a point conveniently dismissed by anti-vaxxers.

Challenging the second point, that cardiac-related deaths are massively above pre-pandemic levels, proves trickier.

Data undisputedly shows an uptick in England since the unprecedented virus crisis began.

Even the BHF acknowledges there have been nearly 100,000 excess cardiovascular disease deaths since the beginning of the pandemic.

Yet, when broken down by age, overall death rates among young men have not risen significantly compared to pre-pandemic levels — debunking one of the main anti-vaxxer theories that swathes are being mercilessly laid low by jabs.

And they claim the rise in excess deaths, most obvious among over-45s, is partly down to the ailing state of the NHS.

Delays in heart health screening during the pandemic, knock-on disruption of Covid lockdowns themselves, and poor ambulance response times are just some obvious factors at play.

A BHF spokesperson said: 'Every second counts when someone has a heart attack.

'Average ambulance response times for suspected heart attacks and strokes have been above 30 minutes in all but one month since the beginning of 2022, and in December 2022 they even breached 90 minutes.'

They added: 'The pandemic has caused significant disruption to the detection and management of conditions that put millions of people at much greater risk of a heart attack or stroke, like high blood pressure.'

Experts also suspect the lingering health impacts of Covid could have also played a role in total excess deaths

A study from January found people who got infected before the vaccine roll-out were 40 per cent more likely to develop cardiovascular disease, and five times more likely to die in the 18 months after infection.

So, what about data showing heart-related deaths in younger men, the group at the centre of concerns about myocarditis risk, have shot up since the pandemic kicked off?

Well, rates were either highest in 2020 — or no different to levels seen pre-Covid, according to data collated by the Office of National Statistics (ONS).

Rates for young cardiac deaths, defined medically as a person under 35, have since fallen to around pre-pandemic norms.

Then, what is to blame for what feels like a spate of cardiac emergencies among stars of the sporting world? Undeniably, before Covid, instances similar to Bronny's felt few and far between.

In fact, the only high-profile incidents involved footballers Marc-Vivien Foé and Fabrice Muamba, who both collapsed on the field due to a cardiac emergency nine years apart, stick out in people's memory, though over a dozen high-profile incidents, mainly in America, have also been recorded in the past 40 years.

Renowned experts in cardiac health issues in young athletes told MailOnline bluntly — there has been no rise in deaths, or incidents, since Covid vaccines were put out en masse.

A 2012 study in the journal Circulation found that a young athlete dies of a sudden cardiac event every three days on average in the US, totalling between 100 to 150 fatalities each year.

Dr Raghav Bhatia, research fellow at the globally respected cardiovascular clinical academic group at St George’s University of London — one of the world's most renowned sites in this specialist branch of cardiology — said: 'There is no published literature that supports this claim.

'A clear distinction needs to be made between peer-reviewed robust medical literature and hear-say or individual case-reports, which are often found on social media and may often represent misinformation.'

Usually, these are down to undetected cardiac problems, he said.

For example Eriksen's collapse was pinned on an undetected ventricular fibrillation, a heart rhythm disruption.

Meanwhile, Hamlin's was down to case of commotio cordis, where the heart stops due to a high velocity impact from an object like a ball to the chest.

Global reports of myocarditis following Covid vaccination, particularly in young men, spooked health chiefs in 2021, when the vaccines first started being dished out to younger demographics.

But rates in Britain were eventually found to be lower than in the US and Israel, where concerns peaked.

Some experts attributed this to the UK's longer intervals between doses, eight weeks compared to four, and this giving the body greater time to recover.

This, followed by data showing the risk of myocarditis from a jab was much lower than that from a Covid infection itself, led to the jabs continuing to be recommended.

British data on vaccine safety is gathered through the UK Government's Medicines and Healthcare products Regulatory Agency (MHRA).

Its latest report, from November, found there had been 851 reports of myocarditis following a Covid vaccination in the UK since the start of the rollout, of which 15 were fatal.

Considering the millions of jabs that have been dished out to Britons, this provides an overall risk of 10 suspected cases of myocarditis per million doses.

Yet this is likely to be an undercount because not all cases would have been logged or reported to official channels, though reports don't necessarily mean a confirmed case.

The MHRA states that studies show the risk of myocarditis from contracting the virus itself has been estimated at about 1,500 cases per million patients.

Officially less than 100 deaths from Covid vaccines have been recorded the UK. Only a tiny fraction, about three, occurred in under-30s.

While such deaths are tragic, they pale in comparison to the almost 230,000 lives estimated to have been saved by Britain's historic Covid inoculation campaign.

And that's not to mention the knock-on benefits, with jabs credited for ending the cycle of paralysing lockdowns that crippled the economy and the NHS.

Globally, Covid vaccines have been credited with saving almost 20million lives during the first year of their existence.

Like with any medication or vaccine, however, the jabs do have risks. The majority are mild, such as a sore arm, flu-like symptoms and headaches.

Some concerns were raised after vaccines were found in extremely rare cases to trigger myocarditis and pericarditis — inflammation of the heart — especially among young people.

But leading heart experts insist the majority of cases are mild and temporary, and that contracting the virus itself can also cause the condition.

So what is the risk of getting myocarditis or pericarditis after the vaccine? How would I know if I had any heart damage? And is the vaccine safe for people with heart conditions or taking heart medications?

Since 2020 has there been an increase in heart-related deaths?
Yes. A report by the British Heart Foundation in November revealed that there has been just over 30,000 excess deaths involving heart disease in England since the start of the pandemic.

This is, on average, over 230 additional deaths a week above expected.

However, causes of this 'relate to being unable to access care for high blood pressure, heart tests and treatment for heart disease,' according to Dr Martin Lowe, a consultant cardiologist at St Bartholomew's Hospital, London and consultant paediatric cardiologist at Great Ormond Street Hospital, London.

He said the possible effects of Covid on the heart may also be to blame.

Now Covid's threat has been drastically blunted, the virus is no longer thought to be a driving force behind the excess heart disease death rate.

Instead, 'significant and widespread disruption to heart care services' — including rapidly rising ambulance response times and 'unacceptably long waits for diagnosis and treatment of conditions' — is to blame, the BHF warned.

NHS data also shows 2million fewer people were recorded as having controlled hypertension in 2021 compared to the previous year.

Modelling indicates that this reduction in blood pressure control could lead to an estimated 11,190 and 16,702 additional heart attacks and strokes, respectively, over a three year period.

Can the vaccines affect the heart? In short, yes.

Although it is 'very rare', an increased risk of myocarditis and pericarditis has been found with mRNA Covid vaccines — such as Moderna or Pfizer/BioNtech.

Myocarditis is inflammation of the heart muscle, while pericarditis is inflammation of the lining around the heart, also known as the pericardium, he added.

But, the majority of cases that occur after vaccination 'are mild with a complete recovery', Dr Lowe said.

Only in 'extremely rare' cases of severe myocarditis do people require hospitalisation and treatment, he added.

'Importantly, most people who get myocarditis or pericarditis have mild disease and the vast majority make a complete recovery, even children,' said Professor Amitava Banerjee, an honorary consultant cardiologist at University College London.

How common is that side effect?

The risk is low. UK data suggests a risk of one case in every 20,000 vaccine doses in most studies', Dr Lowe added.

Those aged 18-29, particularly young men, appear to be at higher risk. And it is most common after the second dose.

But a 2022 review on myocarditis and pericarditis following vaccination, published by the University of Alberta, found there were up to 15 cases recorded per 100,000 young men.

A 2021 review carried out by the US Centers for Disease Control and Prevention also showed that per million second doses of mRNA Covid vaccine administered to men aged 12–29, it may trigger between 39 and 47 expected cases of myocarditis.

However, it would also prevent 11,000 Covid infections, 560 hospitalisations, 138 intensive care hospital admissions and six deaths.

The Medicines and Healthcare Products Regulatory Agency (MHRA) asks doctors to report side effects via its 'Yellow Card' scheme.

According to latest figures shared by UKHSA, as of November 23 the MHRA had received 851 reports of myocarditis and 579 of pericarditis linked to the Pfizer vaccination.

By comparison, there were 241 reports of myocarditis and 226 reports of pericarditis linked to Oxford's AstraZeneca jab and 251 reports of myocarditis and 149 of pericarditis, with Moderna.

'It is important to note that Yellow Card data and similar vaccine surveillance data from other countries cannot be used to compare the safety profile of Covid vaccines as many factors can influence reporting,' UKHSA said.

Treatment of myocarditis depends on the symptoms experienced, but can include painkillers for the chest pain or medication to calm the inflammation, as well as drinking plenty of fluids and resting.

Do the benefits of vaccination outweigh the potential risks of myocarditis and pericarditis?

'Absolutely yes. Anybody who says otherwise does not understand how to analyse the data,' Professor Banerjee said.

'The risk of heart disease after Covid is much greater than the risk of heart disease after vaccination,' he added.

Among people hospitalised with Covid, around one in 50 people per year will have pericarditis, he said.

Covid also carries a risk of myocarditis – and one that is far higher than the vaccine, at 1,500 cases per million infections.

'Other cardiovascular disease, such as heart failure, is more common and the associated risk is much higher with Covid,' he said.

'Thankfully the vast majority of the these patients have mild heart inflammation only and make a full recovery,' Dr Lowe added.

Some people have reported feeling a faster heartbeat in the days after their Covid vaccine. This can be part of the body's normal immune response to the vaccine and is not normally a cause for concern.

Is the vaccine safe for people with heart conditions and taking heart medications or blood thinners like warfarin, clopidogrel or other antiplatelet drugs?

Yes. People who have heart conditions or who take heart medication such as anti-hypertensives or statins should still get the Covid vaccine, both experts said.

They 'absolutely' agree that the vaccine is 'safe and effective' for people who take blood thinning medication.

It is 'indeed recommended to protect against the effects of Covid infection', Dr Lowe said.

For people with heart diseases, chronic kidney disease or other chronic conditions and those over the age of 70, 'vaccination is especially important', Professor Banerjee added, as their risk of hospital admission from Covid is higher.




Thursday, July 27, 2023

Chase Shuts Down Accounts for Dr. Joseph Mercola’s Companies

JPMorgan Chase is shutting down accounts for companies owned by prominent COVID-19 vaccine critic Dr. Joseph Mercola.

The primary accounts for several Mercola-owned businesses, including Mercola Market, are being shut down in August, according to notices reviewed by The Epoch Times.

“Financial institutions have an obligation to know our customers and monitor transactions that flow through our customers’ accounts,” the notices state. “After careful consideration, we decided to close your account because of unexpected activity on these or another Chase account.”

Accounts for Mercola, CEO Steven Rye, Mr. Rye’s wife, chief financial officer Amalia Legaspi, Mrs. Legaspi’s husband, and Mrs. Legaspi’s son are also being closed.

The accountholders are being given until Aug. 11 to move funds to another institution. They have struggled to get answers on what exactly precipitated the harsh action.

Anthony Anesi, a Chase vice president, told Mr. Rye in a voicemail that he asked for the reason and “was told for legal reasons they can not tell me why they are closing the account.”

Mr. Anesi requested copies of the notices so he could file for reconsideration. “It’s not a guarantee, once we put in for reconsideration, that they will keep the accounts open. There’s no guarantee of that. But we are going to try because you’re a good client of our institution,” Mr. Anesi said.

Mr. Rye told The Epoch Times that in phone calls with Chase representatives, they said changes were made in the backend and that they cannot access the backend to see the changes.

Mr. Rye said that he believes Chase either based its decision on illegal acts from accountholders, which he says did not take place, or from Chase itself, which could run afoul of a new Florida law that bars banks from denying services to people for their religious, political, or social beliefs.

Dr. Mercola has been a strong critic of the government’s response to COVID-19 and the COVID-19 vaccines. Some of his articles are republished by The Epoch Times.

Chase has “refused to provide any reason” for the debanking, Dr. Mercola said in a statement. “They won’t say, ‘Hey, what’s this wire for? What’s this transaction for?” Mr. Rye said. “We’ve been doing business for them forever, right? Even in that voicemail, Tony, who we’ve known forever, says, ‘You guys are great customers.’ I don’t know what’s happening.”

He added: “I think it was a little bit surprising to the timing. The COVID stuff has kind of died down. So I found that a little bit unusual. So I can only speculate. I don’t know exactly why they did it. But we’ve looked at everything within our records. There’s nothing that we did.”

Even if the decisions are reversed, it would be hard to trust Chase enough to keep the accounts, Mr. Rye said. He and others are preparing to move their money to other institutions before the deadline.

A spokesperson for Chase told The Epoch Times in an email that most account closures are done for anti-money laundering or identify verification purposes.

“For privacy reasons, we can’t discuss customer relationships, but we don’t close accounts because of political affiliations, and we didn’t do so in this case,” the spokesperson said.

Mr. Anesi did not respond to a request for comment.

Robert F. Kennedy, a Democrat running for president who has also been critical of the vaccines, was among those decrying what happened.

“Looks like Chase shut down long-time accounts of Mercola’s company, employees, and their family members. No reason given. I wonder if it has anything to do with their medical dissent?” Mr. Kennedy wrote on Twitter. “No payment platform should be allowed to discriminate against people for exercising their right to free speech.”

Chase has a history of shutting down accounts of people with certain beliefs. Chase shut down accounts of three right-wing personalities in moves that did not appear to be based on any official company policies, The Epoch Times reported in 2019.

That included an account for Martina Markota, a performing artist-turned-reporter who had worked for the Daily Caller and The Rebel, and an account for Proud Boys chairman Enrique Tarrio.

Chase stopped providing services to Mr. Tarrio just one day after a reporter claimed an online store he owned was linked to the Proud Boys, which was described as a “hate group.”

A spokeswoman for Chase said at the time the events were unrelated. “He has gotten an email from us, and we have repeatedly talked to him with very clear reasons why. He knows why,” the spokeswoman told The Epoch Times in an email. “If he agrees in writing that I can share that email with you, I’m happy to do so. But as it stands, I’m not able to share it.”

She also said, “We have never, and would never, shut down any account due to political affiliation.”

In a recording of a call between Mr. Tarrio and a Chase representative, the Chase representative called the account closure “mind-boggling,” adding, “I see nothing that indicates any reason why the account should be closed.”


COVID Vaccines Show 24 Times More Adverse Reactions Than Others

The latest report on adverse reactions to vaccines in Western Australia has revealed that COVID-19 vaccinations have 24 times the rate of adverse reactions in the state compared to all other vaccines.

According to the state’s vaccine safety surveillance report (pdf), COVID-19 vaccines showed that for every 100,000 COVID-19 vaccines administered, 264 adverse events following immunisations (AEFIs) were recorded.

For all other vaccinations, 11.1 AEFIs were recorded, making the COVID-19 vaccines 23.8 times more likely than non-COVID-19 vaccines to result in adverse events.

The rate of adverse events varied among different types of COVID-19 vaccines.

The Spikevax (Moderna) vaccine recorded 281.4 AEFIs per 100,000 doses, Comirnaty (Pfizer) recorded 244.8, and the Vaxzevria (AstraZeneca) vaccine, which was removed from the vaccine program after reports emerged of blood clotting in younger people, recorded 306.

Adverse events following vaccination can range from mild, such as a sore arm, to serious conditions, such as anaphylaxis, thrombosis with thrombocytopaenia syndrome (TTS), Guillain-Barré syndrome (GBS), myocarditis, and pericarditis.

Collaboration Continues With 3-in-1 Super Jab

Meanwhile, despite these concerns, the Australian government’s partnership with Moderna to produce vaccines using experimental messenger RNA technology to prepare for the next pandemic means these vaccines are here to stay.

The company has been forming a trifecta jab to address the main respiratory viruses—influenza, COVID-19, and RSV to maintain its market share amid the falling revenue of vaccine companies as the health crisis subsides.

Moderna’s COVID-19 vaccine sales of US$18.4 billion in 2022 are expected to dive to $5 billion this year.

Recently, it was granted expedited approval by Australia’s authority for medicines for its mRNA-1345 (RSV vaccine), meaning that the company will be able to launch the vaccines in Australia before any other country in the world.

A spokesperson from Australia’s Therapeutic Goods Administration told the Epoch Times that Moderna was granted an accelerated approval process on March 30 after satisfying all of the following criteria:

the medicine is new

the medicine is for the treatment, prevention, or diagnosis of a life-threatening condition

no other medicines that are intended to treat, prevent or diagnose the condition are included in the Australian drug register or there is substantial evidence that this medicine provides a significant improvement in efficacy or safety of the treatment, prevention or diagnosis of the condition compared to those goods already included in the register
there is substantial evidence that the medicine provides a major therapeutic advance.

However, phase 3 clinical trials for Moderna’s mRNA version of the seasonal influenza vaccine have been underwhelming, showing a high rate of side effects.

Although the vaccine generates a strong immune response against the A strains of the flu, its efficacy against B strains is not better than existing approved vaccines.

Additionally, 70 percent of trial participants who received the shot reported adverse reactions such as headaches, swelling, and fatigue compared to 48 percent for the conventional flu vaccine.


Yale Study Finds Death Rates for Covid Higher for Republicans

Probably a social class effect

In the fall of 2022, with the United States politically divided over Covid, the Yale University School of Public Health released a report about a working study which found excess deaths due to the Covid pandemic were along partisan political lines even after the coronavirus vaccines were made available to the public. The study was released as a working paper and emphasized the fact that Republican voters in two U.S. states had more deaths than Democratic voters after vaccines for Covid-19 became widely available to counter the disease.

Additionally, this discrepancy didn’t exist prior to the vaccines. The two states were Ohio and Florida. The study found the excess death rate for Republican voters was 5.4 percentage points, or 76%, higher than the excess death rate for Democratic voters. “The gap in excess death rates between Republicans and Democrats is concentrated in counties with low vaccination rates and only materializes after vaccines became widely available,” the authors said in the study.

The authors, Jacob Wallace, assistant professor of public health, Jason L. Schwartz, associate professor of public health and Paul Goldsmith-Pinkham, assistant professor at the Yale School of Management conducted the research using a novel linkage of political party affiliation and mortality data to assess whether there were differences in COVID-19 excess death rates between Republican and Democratic voters. Now, the authors have published their study.

Final study published

The cohort study itself was published this week in JAMA Internal Medicine. The Yale researchers examined the deaths of 538,139 people 25 years and older in Florida and Ohio, between January 2018, and December 2021, with researchers linking them to party registration records. Researchers found the excess death rate for Republicans and Democrats was about the same at the start of the pandemic in March 2020. The following winter members of both political parties experienced a similar sharp increase in deaths, but after April 2021, the number of Republicans who died exceeded the number of Democrats by 7.7% which came out to a 43% rise in deaths for members of the GOP. The median age of death was 78.

“In this cohort study evaluating 538?159 deaths in individuals aged 25 years and older in Florida and Ohio between March 2020, and December 2021, excess mortality was significantly higher for Republican voters than Democratic voters after COVID-19 vaccines were available to all adults, but not before. These differences were concentrated in counties with lower vaccination rates, and primarily noted in voters residing in Ohio. The differences in excess mortality by political party affiliation after COVID-19 vaccines were available to all adults suggest that differences in vaccination attitudes and reported uptake between Republican and Democratic voters may have been a factor in the severity and trajectory of the pandemic in the US.” The study was a “cross-sectional comparison of excess mortality between registered Republican and Democratic voters between March 2020, and December 2021 adjusted for age and state of voter registration was conducted. Voter and mortality data from Florida and Ohio in 2017 linked to mortality records for January 1, 2018, to December 31, 2021, were used in data analysis.”


As reported by the study’s authors:

“In this cross-sectional study, an association was observed between political party affiliation and excess deaths in Ohio and Florida after COVID-19 vaccines were available to all adults. These findings suggest that differences in vaccination attitudes and reported uptake between Republican and Democratic voters may have been factors in the severity and trajectory of the pandemic in the US.” The data didn’t look at voters without a political party affiliation and was limited to Ohio and Florida. “We’re not saying that if you took someone’s political party affiliation and were to change it from the Democratic Party to the Republican Party that they would be more likely to die from Covid-19,” Jacob Wallace said. However, “Our study found evidence of higher excess mortality for Republican voters compared with Democratic voters in Florida and Ohio after, but not before, COVID-19 vaccines were available to all adults in the US. These differences in excess death rates were larger in counties with lower vaccination rates. If differences in COVID-19 vaccination by political party affiliation persist, particularly in the absence of other pandemic mitigation strategies, the higher excess death rate observed among Republican voters may continue through subsequent stages of the pandemic.”




Wednesday, July 26, 2023

Qatar National Study: mRNA Bivalent Booster Bomb! Natural Immunity Superior against XBB

Population health scientist Hiam Chemaitelly and team at Weill Cornell Medicine-Qatar have conducted yet another large population level study. TrialSite has tracked the efforts of this impressive group throughout the COVID-19 pandemic. In their latest study results uploaded to medRxiv the Qatar-based group uses a matched, retrospective, cohort study to evaluate the effectiveness of the bivalent booster mRNA vaccines targeting BA.1 strains. The study included 11,482 persons in the bivalent booster cohort and 56,806 persons in the no-recent vaccination cohort. They found 65 infections recorded in the bivalent cohort and 406 recorded in the no-recent-vaccination cohort. Not one of the Omicron-based infections advanced into a more severe condition, including no deaths.

So, what did Chemaitelly and team find?

The cumulative incidence of infection equaled 0.80% (95% CI: 0.61-1.07%) in the bivalent cohort and 1.00% (95% CI: 0.89-1.11%) in the no-recent- vaccination cohort at 150 days after the start of follow-up.

Furthermore, the outcomes, which haven’t been reviewed yet, lead to the observation that omicron XBB subvariants, including XBB, XBB.1, XBB.1.5, XBB.1.9.1, XBB.1.9.2, XBB.1.16, and XBB.2.3, predominated the cases.

They found that when calculating and applying adjusted hazard ratios to compare incidence of infection in the bivalent cohort to that in the no-recent-vaccination cohort the outcome equaled 0.75 (95% CI: 0.57-0.97).

The Qatar-based Weill Cornell team reports:

Bivalent vaccine effectiveness against infection was 25.2% (95% CI: 2.6-42.6%). Effectiveness was 21.5% (95% CI: -8.2-43.5%) among persons with no prior infection and 33.3% (95% CI: - 4.6-57.6%) among persons with prior infection revealing the superiority of prior infection in the context of this study and its limitations.

The Moderna product (mRNA-1273.214) reduced incidence of SARS- CoV-2 infection, but Chemaitelly and team report that such protection was “modest” at best at 25%.

The modest protection may have risen because of XBB immune evasion or immune imprinting effects, or combination of both.

Study & Support

The study authors were supported both with internal Weill Cornell resources as well as external government and private sector sources.

For example, the Biomedical Research Program and the Biostatistics, Epidemiology, and Biomathematics Research Core, both at Weill Cornell Medicine-Qatar supported the authors.

And externally so did the Ministry of Public Health, Hamad Medical Corporation, and Sidra Medicine. The authors are also grateful for the Qatar Genome Programme and Qatar University Biomedical Research Center for institutional support for the reagents needed for the viral genome sequencing.


A journalist records Covidian Australia's pandemic over-reach

Medically idiotic, economically ruinous, socially disruptive and embittering, culturally dystopian, politically despotic: what was there to like in the Covid era? Billions, if you were Big Pharma. Unchecked power, if you were Big State. More money and power over the world’s governments and people, for the WHO. Template for action for climate zealots. Dreamtime for cops given free rein to indulge their inner bully. Anguished despair, if you were a caring, inquisitive reporter.

In Australia Breaks Apart, John Stapleton, a retired journalist with over 25 years’ experience with the Sydney Morning Herald and the Australian, chronicles the collective madness that suffocated Covidian Australia, but also the resistance movement that began hesitantly and grew organically. It is a tale of the many villains complicit in tyranny and the few heroes of resistance. ‘What will you tell UR kids? Did you rise up or comply’, asked a sign during the Canberra protests. It’s a story of venal, incompetent politicians and brutish police – thugs in uniform – acting at the behest of ‘power drunk apparatchiks’.

If you want to know or recall what happened, read the book. If you questioned and resisted from the start, take heart at the documentation for the record. If you belong to the Covid class in slow retreat from the wastelands you created and now leave behind, take evasive action. An extract was published in the Weekend Australian. Among more than 900 online commentators, one quoted Tony Abbott that in two world wars, many risked their lives to protect our freedoms, but in the last three years, so many gave up freedoms to prolong lives. Some took Stapleton to task for failing to thank our great and good leaders and public health authorities for keeping us safe through the terrifying ordeal of the ‘rona wars. The persistence of the last attitude justifies the book’s publication. It’s an effort to chronicle and, if possible, come to terms with how an entire population was terrorised into fearing a virus and complying with arbitrary and draconian rules. Stapleton laments this is not the Australia he knew and loved. There evolved a co-dependency between the uber surveillance state and a Stasi-like snitch society in which ‘we are all guilty until proven uninfected’.

The unleashing of state violence on peaceful protestors included militarised responses on the streets and in the air that drew gasps of disbelief from around the world. State over-reach included ‘an insane level of micromanagement’. All was done without providing any evidence and cost-benefit analyses in support. It’s all here in grim detail, possibly with generous dollops of hyperbole. But who can blame Stapleton, writing amidst the ‘height of totalitarian derangement’ syndrome.?

Stapleton uses the narrative device of a fictional character called Old Alex who watches what is happening with detachment and growing disenchantment. In 444 pages divided into 19 chapters, he provides a comprehensive catalogue of the milestones, lies, and obfuscations on the relentless march to medical tyranny and vaccine apartheid. He puzzles over the left’s embrace of the Pharma-state’s over-reach. Struggles for words strong enough to convey the depth of contempt for the ‘shameless’, ‘odious’ and ‘loathed’ Scott Morrison, whose name became synonymous for some with the act of defecation as shouts were heard from inside a lavatory: ‘I’m doing a ScoMo, I’m doing a ScoMo’. Readers will encounter many writers from the Spectator Australia and Brownstone stables, which clearly sustained Stapleton through the dark Covid years with emotional connections to many of the world’s leading fellow-dissidents. They will be reminded of many characters whose horror stories were illuminated briefly during the long darkness, such as Anthony and Natalie Reale who run the Village Fix café in Shellharbour, NSW. I wrote about them in the Speccie on 15 January 2022. We encountered the big-hearted and generous family on the drive up from Canberra to our new home in the Northern Rivers in December 2021.

Australia broke apart most obviously in the way in which the Morrison government was complicit in the fracturing of the federation into mini-fiefdoms run by wannabe warlords aka Premiers and their palace courtiers of CHOs and Police Commissioners, some of whom have since been pushed upwards into Governors’ mansions. But it was more. Trust was also broken, perhaps irreparably, with respect to parliaments, the judiciary, human rights machinery, police, medical establishment, experts, and the media. The significant switch to independent media reflects disillusionment as much with social media’s Big Tech platforms that turned into narrative enforcers as with the legacy media that turned into fear-mongering Big State mouthpieces and Big Pharma shills.

It was important for someone to write this instant history under time pressure, an accessible work of record, lest we forget. Or rather, lest they be allowed to forget and move on. This is neither a book by nor for academics. Therein lies some of its failings and much of its strength. ‘The Government is my enemy’, laments a disillusioned citizen. Do not trust politicians and bureaucrats. ‘They lie for a living’, says the cynical reporter. In the years to come a flood of scholarly tomes can be expected, analysing in excruciating detail the excesses of lockdowns, masks, and vaccines and systematic assessments of their successes and failures. Given the paucity of critical journalism, it’s useful to have a record of contemporaneous events before memories fade and stories are conveniently rewritten. The journalistic strengths include on-the-ground reporting from protests like the Canberra Convoy, observation skills, an eye for the human interest story, jargon-free writing, and analysis uncluttered by theoretical explorations. His stories of the personalities encountered during the massive Canberra protests in early 2022 bring out vividly the electric atmosphere, energy, and camaraderie of what became a festive, exultant celebration of shared emotions and commitments to securing the freedoms of future generations of Australians.

This is a book to read, display prominently on the coffee table or discreetly on the bookshelf, recommend for purchase to the public library, and spread awareness by word of mouth. It contains many literary quotations and allusions. It’s appropriate therefore that I am left at the end recalling these lines from Dylan Thomas that apply very much to ‘Old Alex’: ‘Do not go gentle into that good night, Old age should burn and rage at close of day;Rage, rage against the dying of the light.’ ?




Tuesday, July 25, 2023

CDC Changed Definition of Breakthrough COVID-19 After Emails About ‘Vaccine Failure’

The U.S. Centers for Disease Control and Prevention (CDC) altered its definition of COVID-19 cases among the vaccinated, leading to a lower number of cases classified as a breakthrough, according to documents obtained by The Epoch Times.

The CDC in early 2021 defined the post-vaccination cases as people testing positive seven or more days after receipt of a primary vaccination series, according to one of the documents.

The definition was changed on Feb. 2, 2021, to only include cases detected at least 14 days after a primary series, another document shows.

“We have revised the case definition,” Dr. Marc Fisher, the lead of the CDC’s Vaccine Breakthrough Case Investigation Team, wrote to colleagues at the time.

The rationale for the change was redacted.

A CDC spokesperson defended the altered definition.

“CDC made the change to the definition of a breakthrough infection time period due to the most current data that showed that the 14-day period was required for an effective antibody response to the vaccines,” Scott Pauley, the spokesman, told The Epoch Times in an email.

“That, in combination with the data showing that many cases of COVID-19 were incubating for up to two weeks before becoming symptomatic, required the change to refine the time period to eliminate cases where exposure happened before the vaccination response would be effective,” Mr. Pauley added.

Dr. Harvey Risch, professor emeritus of epidemiology at the Yale School of Public Health, said there was “no cogent rationale” for excluding early cases and other events among the vaccinated, whether they occurred within seven days or 14 days.

“With either of these delays, CDC addressed what is the theoretical best that the vaccination could achieve. If the vaccines don’t work for the first 7 or 14 days or increase risk of getting Covid-19 during that period, that is part of what happens when they are deployed in a population,” Dr. Risch told The Epoch Times via email.

Dr. Jay Bhattacharya, professor health policy at Stanford University, said that the CDC should have been focused on advising people that they weren’t as protected immediately after vaccination.

“Rather than playing games with the definition of breakthrough cases,” Dr. Bhattacharya told The Epoch Times in an email, the CDC should have warned “recently vaccinated vulnerable older people that they were at higher risk for being infected during that period.”

The CDC excluded some postvaccination cases because they did not meet the updated definition, the documents show, providing an inflated view of vaccine effectiveness.

One document, for instance, shows that Kansas in early 2021 reported 37 cases among the vaccinated.

Thirty-four were not counted because they occurred after receipt of one dose, not two. A primary series for both vaccines was two doses until recently, with the second dose not advised until at least 21 days after the first dose.

The other three cases happened after a second dose, but they were not counted as breakthrough cases by the CDC because they happened within 13 days of completion of a primary series, Dr. Fisher informed colleagues in an email.

On Jan. 29, 2021, the CDC learned in a call with Maryland health officials that a cluster appeared to stem from a person who was vaccinated with a single dose before experiencing symptoms. A CDC official said it was a “possible breakthrough case,” but the case would not have been counted under the earlier or later breakthrough definition.

In another likely form of suppression of the true number of cases, states weren’t able to report cases through the National Notifiable Diseases Surveillance System until February 2021, according to one of the emails. Kansas was the first state to send info through the system, according to a Feb. 1, 2021, email reporting the 37 cases.

States could also report cases outside of the system through calls, as could health care providers, according to another email. Reports to the Vaccine Adverse Event Reporting System were also analyzed for possible inclusion.

The CDC started reporting the number of breakthrough cases on April 15, 2021. Some of the breakthrough cases led to hospitalization and death. CDC officials discussed breakthrough cases sporadically in public settings, but also made false claims about vaccine effectiveness, including claiming in March 2021 that vaccinated people did not get sick.

The breakthrough case definition was revised after multiple CDC officials emailed about the vaccines failing to prevent infection.

Dr. Fisher said in one missive on Dec. 21, 2020, that he was directed by a superior “to start working on a protocol to evaluate COVID vaccine failures or breakthrough cases.”

Dr. Rochelle Walensky, the CDC director at the time, highlighted an editorial on Jan. 30, 2021, that described variants as a “growing threat” of escaping the protection from vaccines and said she’d spoken to the head of the U.S. National Institutes of Health about the matter.

Around the same time, CDC officials circulated a one-page document about investigating post-vaccination cases.

“What? There is a 1-pager from Tom about vaccine failures?” Dr. Nancy Messionnier, another top CDC official, said on Jan. 27, 2021, after hearing about the document, which was being distributed by CDC medical officer Dr. Thomas Clark.

The version of the document The Epoch Times received was fully redacted. After Dr. Clark was asked for an unredacted version, the CDC declined to provide any other versions of the document.

Dr. Fisher also made a presentation near the end of January 2021 on breakthrough cases and sent those slides to colleagues after emphasizing he’d developed them “for internal use” and that the slides “have not been reviewed or cleared by anyone.” Dr. Fisher did not respond when asked for the slides.

Soon after the change, the CDC was alerted to a college athlete who tested positive for COVID-19 about three weeks after completing a Pfizer primary series. One CDC official described it as a “potential breakthrough case” and said data would have to be reviewed to see whether it would be counted.

In a document distributed to states, the CDC outlined a number of ways post-vaccination cases, even one detected at least 14 days after a primary series, would not be counted. That included excluding people who received a vaccine that was not authorized in the United States, people with only a positive antibody test, and people who tested positive within 44 days of their latest test.

Time Exclusion

The CDC initially floated (pdf) counting a person as “fully vaccinated” as early as seven days after completion of a primary series but ultimately settled on 14 days after completion.

The CDC declined to provide the name of the official who decided on the definition of fully vaccinated. The agency, in response to a Freedom of Information Act, also said it did not have any records on deciding to exclude cases that occur in what amounts to at least 35 days after the first vaccine dose.

Officials pointed to U.S. Food and Drug Administration (FDA) materials that outlined the results from clinical trials from Pfizer and Moderna, which make the vaccines that the FDA authorized in 2020.

The trials found efficacy against symptomatic COVID-19 was much lower within days of vaccination. In Pfizer’s trial, for instance, suspected cases within seven days of a vaccine dose were 409 among the vaccinated versus 287 among placebo recipients. Moderna estimated a 50.8 percent efficacy within 14 days of dose one, compared to 92 percent efficacy 15 or more days after the dose.

Observational data have also indicated lower or negative shielding in the days after vaccination, and almost immediately after the vaccines were rolled out, some vaccinated people were reporting getting infected anyways.


Rubio: Stop the Moderna & Chinese mRNA Deal

TrialSite recently reported on Moderna’s deal with the Chinese government to research and manufacture novel mRNA medicines and vaccines. Importantly, the deal was termed exclusively only for the Chinese people. It’s important to note that China classifies life sciences industry generally as a matter of national security. While China’s biotech industry has made great strides with a modernization of regulations and a rapidly maturing life science-focused investment ecosystem, the country has tailed America and Europe when it comes to the development of mRNA technologies. Now, the latest Moderna deal is meant to change that.

But given growing geopolitical tensions between the United States and the People’s Republic of China, was this deal a smart thing to do? Moderna is seeking to tap into and exploit the Chinese market for medicines and vaccines, the second biggest worldwide according to some sources. For its investors, Moderna's move makes sense. But let us not forget that Moderna’s financial position now is far better thanks to U.S. government contracts both before, during and now, after the pandemic. The company went from money loser to highly profitable because of government contracts during COVID-19.

U.S. Senator Marco Rubio has gone on the record, openly questioning the wisdom of allowing such a deal. Rubio sent a letter to Stéphane Bancel, the company’s CEO, regarding the national security implications of the agreement and requested information on the details of the arrangement, including how the company plans to protect technology funded by American taxpayers to the tune of billions of dollars.

Rubio and team fret publicly that China’s “genocidal regime” benefits with “exclusive access to critical intellectual property.” The Florida senator correctly identifies China's policy of enticing investment in Mainland China, only to leverage or exploit intellectual property insight, transferring such knowledge from Western investment to mainland monetization.

But Rubio goes a step further, playing the blame game of the COVID-19 pandemic itself. The Florida senator points to “significant evidence that COVID-19 came from a government-run lab in China” and continues to cover up such a connection.

TrialSite has accumulated enough evidence suggesting that the U.S. government (which includes Rubio) has likely covered up elements of the COVID-19 pandemic along with the Chinese government, but likely, for different reasons. We continue to refer to the DARPA memo sent to us, authored by a military officer explicitly calling out that SARS-CoV-2 was a unique American development. After requesting an explanation from DARPA, a communications chief could not verify nor refute the veracity of the memo that included the official DARPA seal. Interestingly, the DARPA officer cited that the DoD’s research agency was not funding EcoHealth Alliance. It was EcoHealth Alliance, that coronavirus specialist, that served as an intermediary between the National Institute of Allergy and Infectious Diseases, (NIAID), part of the National Institute of Health, and the Wuhan Institute of Virology.

Lots of evidence points to a complicated entanglement between elements of both the Chinese and U.S. governments, despite the public positioning of both to the opposite. It’s likely that both the Chinese and American governments are covering up aspects of the deadly pandemic, one that took nearly 7 million lives worldwide. America experienced more COVID-19 mortality than any other nation, with 1.12 million deaths. It is likely, however, that this number would be markedly lower if those deaths that were primarily due to other reasons were counted. Regardless, the pandemic wreaked havoc on nations, economies and human life.

Now, Rubio calls out to Moderna’s chief, that “Allowing the PRC to monopolize the benefits of research and production that Moderna performs on Chinese soil is a betrayal of the American taxpayers whose hard-earned dollars made this technology possible.”




Monday, July 24, 2023

Important Study on Masking & Evidence: Does CDC Use Junk Science to Promulgate Mask Mandates?

A trio of well-respected University of California, San Francisco (UCSF)-affiliated medical researchers recently conducted a retrospective cross-sectional study of regular weekly reports generated by the Centers for Disease Control and Prevention (CDC) known as the MMWR publication with a focus on the subject of masks covering the time period of 1978 to 2023.

This study’s main question concerns mask effectiveness. The importance of this investigation uploaded to the preprint server medRxiv should not be understated—the MMWR reports have substantial influence on American public health policy, if not beyond. While not peer reviewed, TrialSite has suggested in multiple analyses how MMWR output was exploited during the pandemic by political forces to effectuate various policies and agendas. Hence, the importance of a critical vetting of the scientific process associated with the CDCs output. The topic of concern with this latest piece concerns mask policies during COVID-19. Ultimately, 77 studies published since 2019 met the authors’ study design inclusion criteria, with 97.4% of these studies originating in the United States. Not surprisingly, observational studies without a comparator group 22/77 (28.6%) were most frequent. As was the case often with COVID-19 vaccine analysis in MMWR, community settings in this systematic analysis were most common (36/77; 45.5%). Not one randomized study was identified even though this category of study generates the strongest evidence. Of the analysis, 23/77 (29.9%) assessed mask effectiveness, with 11/77 (14.3%) being statistically significant, yet the great majority 58/77 (75.3%) stating masks as effective. Out of those, 41/58 (70.7%) used causal language. The authors found that just one mannequin study actually employed use of causal language in the appropriate manner (1.3%). 72/77 (93.5%) of the studies related to SARS-CoV-2 only, and none of these studies cited randomized data. Just one study (1/77 (1.3%) cited conflicting evidence.

The bombshell finding: “MMWR publications pertaining to masks drew positive conclusions about mask effectiveness over 75% of the time despite only 30% testing masks and <15% having statistically significant results. No studies were randomized, yet over half drew conclusions were most often unsupported by the data. Our findings raise concern about the reliability of the journal for informing health policy.”

The study makes important points that cannot be ignored, let alone discounted. While the results are not yet peer reviewed, and generally evidence needs that validation (and this is no exception), TrialSite has monitored the CDC’s use of the MMWR during the pandemic and repeatedly reported on what appeared to be successful attempts at influencing various societally important decisions without the necessary evidence. Put another way, these CDC reports appear to serve as a justification for various decisions and policies, less the sufficient evidence justifying any particular decision or policy.

For example, during November 2022, TrialSite introduced, “CDC Releases Limited Data Snapshot: White House Exploits for Sweeping Declarations of Bivalent Vaccine Booster Success.” This MMWR output was timed conveniently to coincide with a White House COVID-19 press briefing touting the success of the bivalent BA4/BA5 mRNA booster vaccines. The product had just been authorized two months previous, and uptake was slow. While the data in this MMWR had severe limitations which are explained in the TrialSite article, the White House used the data output for backing sweeping declarations of vaccine success.

The subject: masking

In this latest study, corresponding author Tracy Høeg, M.D., Ph.D. Department of Epidemiology and Biostatistics at University of California, San Francisco, (UCSF), and two colleagues, also from UCSF Alyson Haslam, Ph.D. and Vinay Prasad, M.D., MPH convey that before the COVID-19 pandemic, evidence was lacking for surgical and N95 respirator masks in the community and healthcare setting. In fact, prior to the pandemic, the CDC had never recommended mask wearing for health members of the population, which aligns with the general advisory of the Surgeon General.


Yet, despite the lack of evidence Høeg and colleagues shared in the United States, “Over several weeks in March and early April 2020, a coordinated social media campaign to recommend masks began.” By April 3, 2020, the CDC then recommended that persons aged 2 years and up wear a cloth face covering in public. By July 15, then CDC director Rochelle Walensky issued the recommendation that all Americans don a mask as a means to “get the epidemic under control.”

The evidence backing this claim: a MMWR study involving two hairstylists in Missouri. Universal masking ensued by the fall of 2020—in schools and day care facilities for example per CDC recommendations. Next came the widespread mandates enacted at the state, county and school district levels for children down to the age of two. By January 2021, federal mandates led to mandates for masking on public transport.


Despite the overwhelming influence of the MMWR during the COVID-19 as described above, less than 20% of these weekly reports targeting masks were based on any statistical evidence of mask effectiveness. The CDC used no randomized studies while 75% of their weekly tracking output led to a favorable conclusion about the use of masks and SARS-CoV-2. As TrialSite has explained with these same reports and the COVID-19 vaccines, MMWR data output are used by health authorities and governing agencies to support and back various policy measures.

This, despite the fact that there was a complete lack of any evidence for mask effectiveness according to the authors’ study. In this important study, the trio of well-respected San Francisco-based authors point out the need for caution and output from the MMWR. Their findings lead them to observe “the journal’s lack of reliance on high-quality data and a tendency to make strong but unsupported causal conclusions about mask effectiveness.” The systematic embrace and use of subpar scientific evidence to back profound societal policies, emergency or not, must be critically vetted.


‘Serious Doubt’ About COVID-19 Vaccine Safety After Forced Release of 15,000 Pages of Clinical Trial Data: Legal NGO

Conservative public interest advocacy group Defending the Republic (DTR) has obtained almost 15,000 pages of Moderna’s COVID-19 vaccine clinical trial data, claiming the data show an “utter lack of thoroughness” of the trials and calls the vaccine’s safety into “serious doubt.”

As a result of successful Freedom of Information Act (FOIA) litigation against the U.S. Food and Drug Administration (FDA), the group recently announced it had obtained—and is releasing—nearly 15,000 pages of documents relating to testing and adverse events associated with “Spikevax,” Moderna’s COVID-19 vaccine.

Since 2022, the group has been involved in litigation against the FDA relating to the production of data submitted by Moderna in support of its application to federal regulators for approval of its vaccine.

As a result, the FDA agreed to produce around 24,000 pages of the Moderna records by the end of this year, with the 15,000 pages being the first instalment.

The records, some of which relate to adverse events related to the vaccine, include important information related to the safety profile of Spikevax, which was first authorized for emergency use in the United States in December 2020 and in January 2022 received full approval for adults.

“The public can be assured that Spikevax meets the FDA’s high standards for safety, effectiveness and manufacturing quality required of any vaccine approved for use in the United States,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement earlier this year.

But the new data call this view into question. The advocacy group says that the tens of thousands of pages of clinical trial data released by the FDA supports the conclusion that there is “serious doubt” about both the safety of Spikevax and the FDA’s standards for approval.

Neither Moderna nor the FDA immediately responded to a request for comment.

More Details

DTR filed its FOIA lawsuit after the FDA rejected requests to produce the Moderna COVID-19 records, justifying its decision by claiming there was no pressing need for the public to review the information.

The documents obtained as part of the group’s litigation against the FDA are the first significant release of data from Moderna’s COVID-19 clinical trials.

The studies reveal the causes of deaths, serious adverse events, and instances of neurological disorders potentially associated with Spikevax.

One of the key takeaways from the documents is that many of those who died after receiving the Moderna vaccine were not given an autopsy.

“According to one study, 16 individuals died after being administered the Moderna vaccine. The study’s authors indicated that out of those 16 deaths, only two autopsies were performed, five of the dead were not autopsied, and the autopsy status of nine of the dead was ‘unknown,’” DTR said in a statement.

“Yet this did not stop those running these ‘studies’ from concluding, despite the absence of evidence, that the Moderna vaccine was not related to these deaths,” the group added.

As an example, the group gave the case of a 56-year-old woman who experienced ‘sudden death’ 182 days after receiving the second dose of the Moderna vaccine.

“The cause of death was unknown, and no autopsy was conducted. It seems they purposely decided not to investigate suspicious deaths in case the Moderna vaccine might be the cause,” the group stated.

There were also numerous examples in the clinical trial data of participants diagnosed with post-vaccination Bell’s Palsy and Shingles, with numerous vaccinated trial participants seeing the onset of Shingles less than 10 days after getting the shot.

The studies also showed that there were a number of serious adverse events noted in the vaccinated groups, with a number of participants experiencing heart attacks, pulmonary embolisms, and spontaneous miscarriages.

Overall, the group concludes that the 15,000 pages of data create “serious doubt concerning the safety of the Moderna vaccine and the FDA’s standards and approval of the Moderna vaccine.”

The 15,000 pages or so of data released by DTR, all of which can be found here, add to the growing body of evidence suggesting that the COVID-19 vaccines may not be as safe as advertised.

FDA Ordered to Speed Up Release of COVID-19 Data

Elsewhere, a federal judge in Texas ordered the FDA to make public data it relied on to license COVID-19 vaccines at an accelerated rate, requiring all documents to be made public by mid-2025 rather than, as the FDA wanted, over the course of about 23.5 years.

In a May 9 decision hailed as a win for transparency by the lawyer representing the plaintiffs (the parents of a child injured by a COVID-19 vaccine) in a lawsuit (pdf) against the FDA, the agency was ordered to produce the data on Moderna’s vaccine for adults and Pfizer’s for children about 10 times faster than the agency wanted.

“Democracy dies behind closed doors,” is how U.S. District Judge Mark Pittman opened his order (pdf), which requires the FDA to produce the data on Moderna’s and Pfizer’s COVID-19 vaccines at an average rate of at least 180,000 pages per month.
The FDA had argued it would be “impractical” to release the estimated 4.8 million pages at more than between 1,000 and 16,000 pages per month, which would have taken at least 23.5 years.

The January 2022 order (pdf), also issued by Pittman, forced the FDA to produce all its data on Pfizer’s COVID-19 vaccine for those aged 16 and older at a rate of 55,000 pages per month, or much faster than the 75 years the agency had sought.

“That production should be completed in a few more months,” Siri said in a statement, referring to the earlier Pfizer data for those aged 16 and up.

The latest order requires the FDA to produce all of its data on Pfizer’s COVID-19 vaccine for 12- to 15-year-olds (and Moderna’s product for adults) by June 31, 2025.

FDA officials didn’t respond to a request for comment on the ruling.




Sunday, July 23, 2023

Study Shows Breast Milk Conferred Immunity to Infants Against Covid-19

Previous studies have indicated that breast milk of women who’ve been vaccinated against Covid -19 can transfer immunity to their infants. “The data suggests a likely positive impact as measured by antibodies which are imputed to imply protection against COVID-19.” There is some disagreement on the long term effects of a vaccinated mother breast feeding her infant. “Post-marketing studies have shown that mRNA passes into breast milk and could have adverse effects on breast-fed babies. Long-term expression, integration into the genome, transmission to the germline, passage into sperm, embryo/fetal and perinatal toxicity, genotoxicity and tumorigenicity should be studied in light of the adverse events reported in pharmacovigilance databases.” Now, a recent study confirms breast milk conferred immunity to infants against Covid-19.

The study

A multi-national peer reviewed study published in Cureus found that “the abundance of immunoprotective characteristics found in breast milk, coupled with the lower incidence and severity of infections in breastfed children, suggests that breastfeeding may play an important role in protecting infants from COVID-19.

The presence of antibodies, particularly IgA, in breast milk, can provide passive and active immunity to the infant, thereby aiding in the prevention of respiratory diseases.

Recent findings indicate that breast milk from mothers who have been vaccinated or recovered from a SARS-CoV-2 infection contains maternal antibodies against the virus, offering acquired protection for the newborn and a low risk of infection. Although rare instances of detecting SARS-CoV-2 RNA in breast milk samples have been reported, the virus has not been successfully cultured from these samples, suggesting a minimal risk of transmission to breastfed babies.

Nevertheless, additional research is required to comprehensively understand the extent of protection provided by breast milk against COVID-19 and the potential impact of different stages of lactation.

Large-scale cohorts are needed to investigate the timing of viral shedding in milk and the neutralizing capacity of transmitted antibodies to draw appropriate conclusions on breastfeeding-acquired immunity against COVID-19. However, based on the current evidence, breastfeeding is considered safe and beneficial for both newborns and mothers during the ongoing pandemic. Promoting breastfeeding, along with appropriate safety measures, can contribute to the overall health and well-being of infants in the face of COVID-19.”


The study team employed systematic review of multiple studies, seeking to better understand the scientific evidence involving breast milk and immunity against COVID-19.

The team conducted a systematic review of 55 articles published over the past 27 years, tapping into PubMed and Science Direct.

Breast milk

The study emphasizes that human breast milk is an important factor in a newborn’s development. “Although the newborn's immune system is exposed to the mother's microbial flora during pregnancy, the infant's microbial environment undergoes abrupt changes during and after birth, making the infant highly vulnerable to illnesses. The components of breast milk assist newborns in developing immunocompetence and provide active and passive immunity. With the rapid evolution of pathogens such as SARS-CoV-2 and the infant's immature immune system, infants rely on defense factors from their mothers. Immune transfer is achieved through the transplacental transport of immunoglobulin G (IgG) antibodies during the fetal period and the transport of immunoglobulin A (IgA) antibodies through breast milk after birth.”

The study concludes by saying human breast milk is renowned for its qualities in providing infant nutrition and provides a wide range of antimicrobial components, including virus-neutralizing antibodies which offer numerous health benefits to protect a newborn. Regarding Covid-19, the researchers point out more study is needed but breast feeding is a necessity for the health and wellbeing of a newborn even during the Covid pandemic.


Australia: Many censored social media posts did not contain Covid-19 misinformation

Many of 4000 social media posts secretly censored by government during the height of the Covid-19 pandemic contained ­factual information and reasonable arguments rather than ­misinformation, new documents reveal.

Digital posts released after Freedom of Information applications show the censored information shared facts such as the ineffectiveness of vaccines in preventing Covid-19 infection and transmission or argued against measures such as mask mandates and lockdowns.

For instance, the then Coalition government sought the removal of an Instagram post in April 2021 that claimed “Covid-19 vaccine does not prevent Covid-19 infection or Covid-19 transmission”.

That statement clearly was accurate yet the official intervention via the Home Affairs Department claimed it breached Instagram’s community guidelines because it was “potentially harmful information” that was “explicitly prohibited” by the platform.

A large proportion of posts the government targeted for removal by the digital platforms promoted wild conspiracy theories and misinformation but many others ­simply questioned the effectiveness of lockdowns and masks, shared information now accepted as accurate, and urged people to protest against pandemic ­measures.

An April 2021 tweet was challenged because it claimed “Covid-19 was released or escaped from Wuhan laboratory in China and that it was funded by the US government”.

The Home Affairs Department claimed this was “explicitly prohibited” under Twitter’s rules because it might “invoke a deliberate conspiracy by malicious and/or powerful forces”, yet American intelligence agencies have found the most likely source of the virus was the Wuhan Institute of Virology, and it has been revealed that some work at the laboratory was funded by the US.

Over three years up until last month, the federal government paid World Services Australia, an arm of London-based global communications firm M&C Saatchi, more than $1m to monitor Covid-19 posts online and alert it to controversial material.

The Weekend Australian previously revealed how the federal government, under the Coalition and later Labor, intervened more than 4000 times seeking the removal of social media posts by digital giants such as Twitter, Facebook, Instagram and YouTube, using the companies own community standards as the ­trigger.

The information came to light as a result of FOI applications by Liberal senator Alex Antic.

Questions on notice from Senator Antic have now produced details of these interventions, revealing extensive efforts to suppress even factual information.

Senator Antic said this had confirmed his worst fears. “During the Covid period, Home Affairs actively sought censorship of true statements such as ‘lockdowns are ineffective’ and compelled social media companies to penalise dissent from the government’s position,” Senator Antic said.

“This is gravely concerning for all Australians who care about freedom of speech.”

One Facebook video post in January 2021 was targeted for removal because it encouraged “civil disobedience”.

It depicted a “recognised misinformation influencer” in Melbourne’s Royal Botanic Gardens “blatantly walking up to signs that ask people to maintain physical distancing and hiding them from view”.

Many other social media posts were censored for opposing mask mandates and questioning the ­effectiveness of lockdowns and vaccines.

This was censorship on an industrial scale, with the private contractor tasked to trawl through social media posts 24/7.

Senator Antic said the revelations were “gravely concerning” to all Australians who cared about freedom of speech.

He said this amounted to a “censorship industrial complex” and raised fears about this type of intervention being expanded under the proposed Misinformation Bill that would allow for the issuing of multimillion-dollar fines against platforms found to be hosting “misinformation or disinformation”.

“It’s never been more imperative that we protect freedom of speech in Australia and reject this bill,” Senator Antic said.


Left Demands Boycott of In-N-Out Burgers Over Mask Policies

Conservatives successfully boycotted Bud Light, due to the organization’s explicit political goal. However, it now appears the left has discovered an alternative boycott objective after becoming enraged with In-N-Out Burger.

By informing staff that the coronavirus crisis has ended, meaning there is hardly a need for masks in work environments, the fast food behemoth has drawn the wrath of the left.

Really, why couldn’t the gigantic burger chain do this? There is no serious evidence that proves masking prevents the transmission of COVID. Masks simply don’t work as they should.

Left-wing Dr. Lucky Tran became so enraged that he began a lengthy Twitter stream in which he bemoaned the burger chain and exhorted his fellow leftists to engage in online harassment of the business.

Tran, a mask fanatic who refers to himself as “a global scientist,” was upset after a judge in the state of California decided that staff members are unable to sue their employer if they contract COVID-19 while at their jobs.

Then, Tran wrote that this week, In-N-Out prohibited its workers from using masks. This is awful, he complained. On top of that, the doctor began displaying links to the burger joint’s comments area.

Other Democrats picked up the onslaught against In-N-Out. Babs, a Twitter user, encouraged leftists to contact the hotline number of the business and voice their complaints.

Liberals were encouraged to “BE LOUD” in their criticism of In-N-Out for its masking practice by another strident leftist.

“On this, we must fight back. We must voice our disapproval LOUDLY! Email and phone In-n-out! Instruct them that this is not appropriate.”

“Organizations and policymakers should voice their opinions. Businesses can’t ban masks while endangering the lives and health of their employees,” she stated.

Boycotts Demanded

Additionally, “oh dear”, a user of Twitter demanded a boycott against the fast food restaurant. ?