Friday, January 27, 2023


Stroke After Pfizer Booster May Be Connected to Flu Vaccine: Officials

Instances of stroke following receipt of Pfizer’s new booster in the elderly may be connected to the influenza vaccine, officials said on Jan. 26.

One-hundred thirty cases of ischemic stroke, which can be deadly, were recorded among people aged 65 or older within 21 days of a bivalent Pfizer booster, the U.S. Food and Drug Administration’s Vaccines and Related Biological Products Advisory Committee heard on Thursday.

That was higher than the 92 cases recorded in the 22- to 42-day window following vaccination, triggering a safety signal.

The U.S. Centers for Disease Control and Prevention (CDC) and the administration (FDA) revealed the signal on Jan. 13 but had not said how many cases were recorded from the U.S. government’s Vaccine Safety Datalink surveillance system, which contains records from 12.5 million people across 11 sites.

A preliminary review of medical records at one site, which saw 24 ischemic stroke cases in the three weeks following Pfizer vaccination, revealed that a majority of the people who suffered a stroke had an influenza vaccine administered on the same day as the COVID-19 vaccine.

None of the patients had a history of stroke or transient ischemic attack, which is similar to a stroke and could be a non-vaccine cause of ischemic stroke.

Three of the patients died, including a man who perished one month after the stroke. His death was determined to likely be related to the health event.

Overall, 40 cases of ischemic stroke following both COVID-19 and flu vaccination were identified among people who suffered stroke through Dec. 17, 2022. That post-signal analyses heightened the safety signal, which is a sign a vaccine may cause a condition. Only 34.5 cases were expected based on background rates.

There were 60 cases among elderly people who received a bivalent COVID-19 vaccine without receiving a flu vaccine on the same day. That number did not meet the definition of a signal.

Officials decided to compare the cases recorded among boosted people one to 21 days after vaccination with boosted people 22 to 42 days after vaccination for the primary analysis. The rationale given was that people who recently received a vaccine were “expected to be more similar to current vaccinees than unvaccinated individuals.”

Officials also revealed that they excluded post-vaccination ischemic stroke cases if a person had a personal history of certain conditions, including transient ischemic attack or atrial fibrillation, also known as irregular heartbeat.

The new information came from a set of slides that Dr. Tom Shimabukuro, a CDC official, and Dr. Nicola Klein, a Kaiser Permanente official who works closely with the CDC, presented to the FDA’s vaccine advisory panel.

“CDC and FDA are engaged in epidemiologic analyses regarding coadministration of COVID-19 mRNA bivalent booster and flu vaccine,” one slide stated, following the detection of a “significant cluster” of post-vaccination cases of the ischemic stroke.

The CDC and FDA said previously that an examination of other surveillance systems showed no signal of ischemic stroke for the bivalent boosters but failed to mention that an analysis of reports to the Vaccine Adverse Event Reporting System, which the agencies co-manage, for the original Pfizer and Moderna COVID-19 vaccines triggered the signal for ischemic stroke and hundreds of other adverse events. Both the original vaccines are still administered in the United States; the bivalents can only be obtained as boosters.

Pfizer and its partner BioNTech said in a recent joint statement that the companies were made aware of “limited reports of ischemic stroke” observed in the Vaccine Safety DataLink system.

“Neither Pfizer and BioNTech nor the CDC or the U.S. Food and Drug Administration (FDA) have observed similar findings across numerous other monitoring systems in the U.S. and globally and there is no evidence to conclude that ischemic stroke is associated with the use of the companies’ COVID-19 vaccines,” the companies stated.

Israel and the European Union have said that they have not detected a signal for ischemic stroke following bivalent vaccination. European officials said they also looked at Pfizer’s original vaccine.

Signal First Identified in 2022

The slides also showed that the safety signal from the Vaccine Safety Datalink was first identified in 2022.

The first time the condition met the signal was Nov. 27, 2022, one slide showed. It did not stop meeting the signal as of Jan. 8, 2023.

The signal has been “persistent for 7 weeks,” one slide stated.

While the rate ratio, or the result of the analyses, “has slowly attenuated from 1.92 to 1.47,” it “has continued to meet signaling criteria,” the slides acknowledged.

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Judge Blocks California’s COVID-19 Misinformation Law

A California judge on Wednesday halted the state’s so-called COVID-19 misinformation and disinformation law, which was challenged by doctors in two lawsuits, claiming it violates their constitutional rights.

In Hoeg v. Newsom, five doctors alleged that the state law, AB 2098, is unconstitutional under the First and Fourteenth Amendments of the U.S. Constitution. A separate related lawsuit, Hoang v. Bonta, makes similar allegations.

Both lawsuits sought a preliminary injunction to prevent California from enforcing the law.

The five doctors, Tracy Hoeg, Ram Duriseti, Aaron Kheriaty, Pete Mazolewski, and Azadeh Khatibi, filed their lawsuit against Gov. Gavin Newsom and other officials, including the president and members of the Medical Board of California.

They argued the law prevents them from providing information to their patients that may contradict what the law permits or prohibits. They also alleged the law was used to intimidate and punish physicians who disagreed with prevailing views on COVID-19.

Judge William Shubb, a George W. Bush appointee, wrote in his ruling (pdf) it was plausible that the medical board would determine their conduct violates AB 2098, and therefore the doctors’ fears are reasonable “given the ambiguity of the term ‘scientific consensus’ and of the definition of ‘misinformation’ as a whole.”

Shubb noted that this weighed in favor of the plaintiffs having standing.

“Because the definition of misinformation ‘fails to provide a person of ordinary intelligence fair notice of what is prohibited, [and] is so standardless that it authorizes or encourages seriously discriminatory enforcement,’ the provision is unconstitutionally vague,” Shubb wrote. “Accordingly, the court concludes that plaintiffs have demonstrated a likelihood of success on the merits of their vagueness challenges.”

The Law

Newsom signed the bill into law in September 2022, and it took effect on Jan. 1, 2023.

The law defines misinformation as “false information that is contradicted by contemporary scientific consensus,” and prohibits physicians from disseminating “misinformation or disinformation related to COVID-19, including false or misleading information regarding the nature and risks of the virus, its prevention and treatment; and the development, safety, and effectiveness of COVID-19 vaccines.”

Doctors who deviate from the established U.S. Centers for Disease Control and Prevention’s guidance by attempting to assess and advise their patients as individuals may run afoul of the new law.

The state medical board is required by law to act against any licensed doctor charged with unprofessional conduct.

The court’s ruling effectively halts the law while the legal challenge plays out.

The legal organization representing the doctors said their clients were put in a difficult position, fearing repercussions for acting in the best interests of their patients by giving them honest information, depriving them of their right to receive advice and hear treatment options without fear of professional discipline.

According to American Civil Liberties Alliance (ACLA), the First Amendment, which protects Americans’ rights to free speech and expression, applies to minority views and majority opinions.

The doctors alleged they have been threatened by other doctors and individuals on social media to use AB 2098 to have their licenses taken away, according to ACLA.

“They are being put between a rock and a hard place, fearing repercussions for acting in their patients’ best interests by honestly giving them the information they believe their patients need in order to make informed care decisions,” ACLA said in a summary of the case of its website.

One of the doctors in Hoeg v. Newsom welcomed the judge’s ruling.

“The ruling bodes well for our case: it indicates that our arguments that this law is unconstitutional have strong pre-trial facial plausibility,” Kheriaty wrote on Twitter. “Not to get ahead of ourselves, of course, or try to predict the final outcome of the case, but this is a very positive development.”

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Thursday, January 26, 2023


Did China Make a Mistake by Ending COVID Restrictions?

Never forget that the New York Times kicked off disease panic in the United States in late February 2020, about a month after China had locked down Wuhan and violated its citizens’ rights to associate on a massive scale. Two weeks earlier, the World Health Organization sponsored a Western junket that was attended by Fauci’s deputy assistant and others. They came back and declared that lockdowns are great and should be adopted by all governments.

The first media outlet in the United States to amplify this China communist propaganda was the New York Times. On Feb. 27, 2020, Donald G. McNeil, the lead virus reporter who was later fired for unrelated reasons, predicted mass death from this virus unless the United States locks down just like China.

The next day, the newspaper published his op-ed arguing for the “medieval” method of virus control. On the same day, the paper ran an article by Peter Dazsak, head of EcoHealth Analysis, which was Fauci’s third-party funding choice to get cash to the Wuhan Institute of Virology for gain-of-function research.

This is a grim history, and one might suppose the newspaper would have moved on. But no! Just yesterday, the same paper ran a piece by Michael V. Callahan, an infectious disease specialist who has been working in China and Southeast Asia for ten years. Listen to what he actually typed:

“China rolled back its longstanding pandemic strategy ‘zero Covid,’ which had protected the country for nearly three years, in early December. This reversal came after historic public protests calling for an ease in restrictions …. The timing could not have been worse.”

Can you even imagine such a thing appearing in any paper, much less the New York Times? We are really being told that this grotesque experiment in mega-totalitarianism that treated the entire population like lab rats was really a successful effort that “protected the country.”

Protected the country! In other words, what we have here is an ongoing effort by the top organ of the mainstream press continuing to shill for the Chinese Communist Party (CCP). It’s astonishing really, and not only because it is utterly inhumane. It is also a fact that China’s lockdown did not protect the country. What it did was weaken immune systems and make China more vulnerable than ever.

Pretending for a moment that Xi Jinping’s policies were not just a grotesque push for massive power, it was never clear what the exit strategy for zero COVID was supposed to be. Stay locked down forever, as in some dystopian movie? And then what happens on the first exposure to anything? We know from history. Half the native population in the United States died from disease when exposed to colonial travelers. It’s happened to countless native tribes around the world. This is an extremely bad idea, and it is a wonder that a supposed civilized country could ever consider such a thing, and yet most countries in the world did.

Xi actually seemed to believe that he could make a virus go away by muscling his people with enough force and intimidation. It’s arrogance for the ages. But the New York Times was all for it—was and still is!

What is it that Dr. Callahan desires now? He wants the United States to help out this poor country that mistakenly allowed its countrymen to have a modicum of freedom back. His great idea is to export “successful strategies from the United States’ Operation Warp Speed playbook, which accelerated the delivery of mRNA vaccines from the manufacturer into people’s arms. This huge logistical challenge can be revised for the rapid deployment of a new Chinese-made mRNA vaccine.”

What to say to this idea? The CCP is evil but not crazy.

In any case, it appears that China, even after three years of lockdown crazy, is going to deal with this virus the old-fashioned way: get it and shake it off. China’s epidemiologists are now saying that upwards of 80 percent of the population has already been exposed and thus acquired some level of protection. This is how it works: exposure and then protection. It’s what should have happened three years ago. This is how the entire planet will deal with COVID. It adds one more coronavirus to the four that are already endemic.

Let’s turn to Dr. Callahan himself. Why exactly is he the one to author an article urging the United States to work with China to get mRNA shots into billions of arms? Well, the scientist Robert Malone explains his own contact with this man, who might have been responsible for among the first communications from China to the U.S. that warned of a coming virus.

Dr. Malone writes:

“on approximately 04 January 2020 I received an unexpected phone call from Dr. Michael Callahan (known to me to have been a CIA agent, and separately confirmed to me by NY Times reporter Davey Alba in February 2022 as a ‘former’ CIA agent). During this call, Dr. Callahan revealed to me that he was calling from China, and that he was in the country under cover of his Harvard Professor appointment. Further information regarding Dr. Callahan can be found in this article by Raul Diego, with research support by Whitney Webb, entitled ‘DARPA’s Man in Wuhan.’ It is important to know that Callahan has provided advice in the White House to at least three US Presidents, including Obama and Trump. On 04 January 2020, Dr. Callahan told me that there was a novel coronavirus circulating in the Wuhan region, it was looking like a significant biothreat, and I should get ‘my team’ engaged in seeking ways to mitigate the risk of this new agent.”

Malone explains further and more deeply how he comes to the following conclusion concerning Callahan:

“Based on this timeline and history, as well as my own direct personal communication with Dr. Callahan, I strongly suspect that both the gross clinical mismanagement of ventilatory support during the first phase of the outbreak (responsible for up to 30,000 deaths) as well as the stunningly poor management practices of Nursing Home and Extended Care facilities throughout the USA can be directly traced to the influence of Dr. Michael Callahan, DARPA’s Man in Wuhan and arguably the top U.S. Government/CIA expert in both biowarfare and gain of function research.”

If this is the case, let’s just say there are many unquestioned questions, including how it comes to be that Callahan raided the pages of the New York Times only yesterday to praise the CCP’s handling of the virus, adding only that China needs to work with the United States to mass vaccinate its population, even though that strategy has worked nowhere in the world and in fact only prolonged the pandemic and increased infections.

But these days, it seems like facts do not matter anymore, at least not at the New York Times, which has been shilling for the virus police here and abroad for fully three years.

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FDA wants once-a-year COVID shots for most Americans

The Food and Drug Administration on Monday proposed once-a-year COVID-19 shots for most Americans. U.S. health officials see this as a simplified approach for future vaccination efforts and protection against the mutating virus.

If approved, Americans would no longer have to monitor how many shots they had or how many months it’s been since their last vaccine.

More than 80% of Americans have had at least one vaccine dose, and only 16% have received the latest boosters authorized in August.

The FDA will consult its panel of outside vaccine experts at a meeting on Thursday. The agency is expected to take the panel’s advice into consideration while deciding future vaccine requirements for manufacturers.

In documents posted online, FDA scientists say many Americans now have “sufficient preexisting immunity” against the coronavirus because of vaccination, infection or a combination of the two. That baseline of protection should be enough to move to an annual booster against the latest strains in circulation and make COVID-19 vaccinations more like the yearly flu shot, according to the agency.

A two-dose combination may be needed for the protection of immunocompromised adults and very small children, according to FDA scientists. Vaccine companies would need additional research on vaccination, infection rates, and other data to come up with who should receive a single shot versus a two-dose series.

The FDA outside panel will vote on whether all vaccines should target the same strains.

In 2020, the initial shots or the primary series from Pfizer and Moderna target the Alpha strain. The updated boosters introduced in October last year were also tweaked to target the dominant omicron strain.

The FDA’s proposal will make the agency, independent experts and manufacturers decide yearly on which strains to target by the early summer. This will allow manufacturers several months to produce and launch updated shots before the fall, similar to the way strains for flu vaccines are changed annually.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Recent findings show that vaccination is much less protective against the latest Covid variants

A high-powered group of scientists employed at Beth Israel Deaconess Medical Center and Los Alamos National Laboratory submitted some correspondence to the New England Journal of Medicine declaring more challenges with the current mass vaccination program targeting COVID-19.

Reminding that the Omicron BA.5 variant was the predominant strain in circulation from July to November 2022, there was evidence of “substantial neutralization escapes as compared with previous variants.” This variant was followed by ensuing sublineages such as BA.4.6 as well as mutations from BA.5, including BF.7 and BQ.1.1, and mutations derived from BA.2.75.2 and the BA.2 lineages, including recombinant XBB.1. What’s in common with these variants? They all have the R346T mutation in the spike protein. Now, BQ.1.1 and XBB.1 have replaced the one dominant BA.5 around the globe. It’s not clear yet, however, how well these latest mutations evade vaccine-induced antibodies targeting the spike protein of both the original Wuhan variant and BA.5.

Enter the Study

The group of scientists embarked on a study to evaluate the neutralizing antibodies associated with the COVID-19 vaccines. The first study focused on 16 participants who were vaccinated as well as boosted with the monovalent mRNA vaccine BNT162b2 (Pfizer-BioNtech) in 2021.

Summary of findings

In the first investigation, the group looked at neutralizing antibody titers before and after receipt of the monovalent mRNA booster 2021 in 16 subjects finding:

“The median neutralizing antibody titers to the BQ.1.1 and XBB.1 variants were lower than the median titer to BA.5 by factors of 3 and 8, respectively.”

Study number two and three centered on neutralizing antibody titers before and after receipt of the monovalent mRNA booster as well as the bivalent booster in 2022. With 15 and 18 participants, respectively, a majority of the subjects had received three previous doses of the COVID-19 vaccine.

A third of the participants were infected with Omicron, but this was likely due to the high prevalence of circulation and ensuing infection in 2022.

The authors write:

“The median neutralizing antibody titers to the BQ.1.1 and XBB.1 variants were lower than the median titers to BA.5 by factors of 7 and 17, respectively, in the monovalent booster cohort and by factors of 7 and 21, respectively, in the bivalent booster cohort.”

Unfortunately, the authors continue:

“Our data show that the BQ.1.1 and XBB.1 variants escaped neutralizing antibodies substantially more effectively than the BA.5 variant by factors of 7 and 17, respectively, after monovalent mRNA boosting and by factors of 7 and 21, respectively after bivalent mRNA boosting. The neutralizing antibody titers to BQ.1.1 and XBB.1 were dramatically lower than titers to the WA1/2020 strain by factors of 53 and 127, respectively, in the monovalent booster cohort and by factors of 80 and 232, respectively, in the bivalent booster cohort.”

Furthermore:

These findings suggest that the BQ.1.1 and XBB.1 variants may reduce the efficacy of current mRNA vaccines and that vaccine protection against severe disease with these variants may depend on CD8 T-cell responses.”

The spike in neutralizing antibody titers against omicron variants associated with the monovalent boost in 2022 over 2021 suggests an accumulation of vaccination and natural immunity linked to prior infection, which was frequent.

Is convergent evolution a result of the propagation of the R346T mutation across variants? The authors believe so. This study again emphasizes the challenges with the current mass COVID-19 vaccine strategy chasing variants of concern.

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Bivalent Boosters Creating Adverse Childhood Experiences in Kids Ages 5-11

We often remember events from our childhood that came from physical experiences, such as a broken arm or falling into a stream. Most patients from yesteryear remember childhood rheumatic or scarlet fever. Parents bringing their children aged 5-11 years for COVID-19 vaccination may be creating adverse childhood experiences based on the most recent CDC safety data published by Hause et al. in MMWR:

"Safety Monitoring of Bivalent COVID-19 mRNA Vaccine Booster Doses Among Children Aged 5-11 Years - United States, October 12-January 1, 2023"

Moderna, which had greater frequency of adverse events than Pfizer, for example, caused 30% of children to have fever and vomit. Combined, 22% reported that boosters had a negative health impact, 14% could not perform daily activities to return to school, and 2% were so sick they required acute medical care. Adverse childhood experiences can have lasting social and psychological ramifications later in life, particularly if they are repeated.

No vaccine, no matter how theoretically compelling, should be in public use with these symptomatic side effects. Vaccines should have acceptable safety profiles with <5% having any significant short-term symptoms, be safe over the long term, provide at least 50% protection against a disease, inhibit transmission, and last at least a year.

Faulty vaccines that underperform or make our kids sick should be rejected by parents and removed from the market to protect public safety.

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Australia: Conservative minor party to host controversial Covid sceptic

Clive Palmer’s United Australia Party will host a series of coronavirus vaccine conferences next month headlined by controversial American cardiologist Doctor Peter McCullough

Nations across the globe have “completely de-emphasised and almost obfuscated” effective coronavirus treatments in their public health approach to the pandemic, says professor of medicine Dr Peter McCullough.

Doctor Peter McCullough has been heavily criticised for controversial views on the coronavirus, with calls from some quarters for Australian immigration officials to deny him a visa to enter the country.

Numerous health officials and websites have criticised Dr McCullough, who gained widespread attention after an appearance on the podcast of American personality Joe Rogan where he made a series of provocative claims, including that the pandemic was planned as part of a conspiracy.

Several health industry websites have devoted sections to debunking Dr McCullough’s claims, which include statements that masks were useless against Covid and that test subjects in an Australian vaccination trial contracted HIV.

However, speaking on the Gold Coast on Tuesday, Mr Palmer said it was time to hear different points of view on the pandemic and vaccines and he expected conferences on the Gold Coast and Sunshine Coast to sell out. He said Dr McCullough was a “well respected” cardiologist with “impeccable” credentials.

Mr Palmer, a high-profile opponent of coronavirus vaccines, said he was told he “had six hours to live” at one point during his own Covid health battle, but was treated with alternative therapies in hospital.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Tuesday, January 24, 2023



No Help for the Vaccine Injured: The Government agency involved Is an Abject Failure

Summary:

TrialSite has tracked growing coverage of COVID-19 vaccine injuries by the mainstream media. From Reuters to CBC and even the BBC as well as local affiliated media across the United States such as NBC affiliate in Atlanta, Georgia, WXIA-TV television which recently showcased the plight of Allen Storey, injured by the COVID-19 vaccines.

Despite him and several thousand others filing claims with the U.S. government’s vaccine injury project for emergencies—the Countermeasures Injury Compensation Program (CICP)—few have received any decisions. TrialSite has reported that no planning from either the Trump or Biden administrations went into the potential externalities of a mass vaccination program—side effects. That even with an injury rate of 0.005 per 100, over a million would be injured in America alone based on the number of procedures.

Enter Allen Storey, and yet another horror story about how the U.S. government has left its taxpayers (the people) left out of any care despite unprecedented mandates across American society.

In detail:

While he was glad he went ahead and got the COVID-19 vaccine to reduce the risk of severe illness or even death, Mr. Storey ended up having an acute brain stem stroke accompanied by numerous medical diagnoses, likely because providers don’t know how to even diagnose these injuries. According to reporter Rebecca Lindstrom, this process has left the vaccine-injured patient “financially and emotionally dazed and confused.”

Not so-called “Anti-vaxxers” by any means, both Mr. Storey, his wife, as well as their daughter, received the COVID-19 immunization. While Storey’s wife and daughter were left unscathed just days after the first jab, Storey’s response was noticeably different. While his doctors thought he might have vertigo, reports WXIA-TV (11Alive), “His mind was 100% working inside his body. His body just couldn’t move,” as he experienced a form of stroke-induced paralysis explained to his wife.

Both Storey and his wife were unemployed by this point, and given the lack of any support from the CICP, financial catastrophe was just around the corner. The family had to give up their home of 25 years as it wasn’t wheelchair accessible.

Storey’s wife Beverly told the local media, “The burden of proof on you, and that became a problem with cost and logistics.” With medical records scattered across five hospitals, navigating both the CICP application plus obtaining the documentation to advocate for her husband’s case became extremely challenging.

While not surprisingly, doctors refuse to officially connect the injury to the vaccine, they ironically are adamantly opposed to him getting a second jab.

And nearly two years later, the CICP’s response to Storey’s claims: crickets. Although it’s part of the executive branch and subject to congressional funding, Ms. Storey told the local news outlet, “You don’t get any answers. Nobody calls back, nobody has sent anything in the mail.”

Are politicians and governors aware of the situation?

Absolutely. The Storeys wrote not only a letter to President Biden but also to their U.S. Senators Jon Ossoff and Raphael Warnock. 11Alive reached out to Senator Ossof’s office, wrote Lindstrom, and apparently, the Senator did respond and request more information.

The Georgia media not only reached out to both Senators but also to Mike Lee, Sen. Utah, who has sponsored a bill making accessing COVID-19 vaccine injury claims easier. A hot potato-like topic, Lee’s office refused to talk, declining to speak on his own legislation, reports Lindstrom.

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New Zealand Population Study: Pfizer’s mRNA Vaccine Statistically Significant Linked to Myo/Pericarditis

Researchers from the New Zealand Ministry of Health as well as University of Auckland conducted a real-world observational study probing rates of adverse events of special interest (AESIs) associated with a primary dose of the Pfizer-BioNTech mRNA COVID-19 vaccine, BNT162b2, in the New Zealand population aged 5 years and up vaccinated from February 19, 2021, to February 10, 2022. Tapping into electronic health records, the Kiwi investigators looked for risk within the period of day 0 to 21 days after the jab compared with expected rates based on background health data from 2014 to 2019. Deriving an ‘incidence rate ratio " or "IRR " for each AESI, the study team estimated with 95% confidence intervals (CI), adjusting by age to calculate a risk difference and ultimately estimate the excess numbers of AESIs per 100,000 persons vaccinated.

The results of this study recently surfaced via preprints with The Lancet.

Overall Study—Population-level Cohort Analysis

By February 10, 2022, 4,277,163 had received a first dose, and 4,114,364 second doses of BNT162b2 were administered to the eligible New Zealand population in the cohort covered by the study (age 5 and up). The study authors couldn’t find a statistical delta between the observed rates of AESI and the expected rates.

For example, the authors report:

“The IRR (95% CI) of myo/pericarditis following the first dose was 2.6 (2.2– 2.9) with a risk difference (95% CI) of 1.6 (1.1– 2.1) per 100,000 persons vaccinated and was 4.1 (3.7– 4.5) with a risk difference of 3.2 (2.6– 3.9) per 100,000 persons vaccinated following the second dose. The highest IRR was 25.8 (95% CI 15.6– 37.9) in the 5-19 years age group, following the second dose of the vaccine, with an estimated 5 additional myo/pericarditis cases per 100,000 persons vaccinated. An increased incidence of acute kidney injury (AKI) was observed following the first (1.6 (1.5– 1.6)) and second (1.7 (1.6– 1.7)) dose of BNT162b2.”

Clearly, the risks in the young persons cohort (age 5 to 19) were markedly higher post the second dose of the vaccine which corresponds with other real-world data suggesting risks of this cardiovascular-related set of conditions associated with mRNA COVID-19 vaccines. In fact, in the State of Florida the Surgeon General there has gone on the record recommending that healthy young people don’t receive the vaccine. The message from Florida—the risks of serious side effects are higher than the risk of COVID-19 infection for a healthy young population.

Interestingly, the New Zealand government-sponsored study also reports nominal increases in acute kidney injury, but less than the rates associated with myocarditis and pericarditis.

Interpretation

The New Zealand Ministry of Health reports from this study that while “rare” a “statistically significant association between BNT162b2 [Pfizer’s vaccine] and myo/pericarditis and AKI was observed.” They acknowledge that this association has been confirmed internationally but the Ministry of Health-funded investigators do recommend more research into the association with AKI.

Interestingly, the study authors point out that most of the AESIs identified were not associated with the Pfizer vaccine which offered them authors “reassurances around the safety of the vaccine.”

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Monday, January 23, 2023


Covid-19 drugmakers pressured twitter to censor activists pushing for generic vaccine

In mid-December 2020, Nina Morschhaeuser, a lobbyist for Twitter in Europe, emailed colleagues with a dire warning. The drugmaker BioNTech, along with the German government, had contacted her with news of an imminent “campaign targeting the pharmaceutical companies developing the COVID-19 vaccine,” she wrote.

“The authorities are warning about ‘serious consequences’ of the action, i.e. posts and a flood of comments ‘that may violate TOS’ as well as the ‘takeover of user accounts’ are to be expected,” wrote Morschhaeuser. “Especially the personal accounts of the management of the vaccine manufacturers are said to be targeted. Accordingly, fake accounts could also be set up.”

The campaign they were concerned about was the launch of an international push to force the drug industry to share the intellectual property and patents associated with coronavirus vaccine development. Making the patents available, in turn, would allow countries across the world to swiftly manufacture generic vaccines and other low-cost therapeutics to deal with the ongoing pandemic.

Morschhaeuser, while alerting several site integrity and safety teams at Twitter, forwarded on an email from BioNTech spokesperson Jasmina Alatovic, who asked Twitter to “hide” activist tweets targeting her company’s account over a period of two days.

Morschhaeuser flagged the corporate accounts of Pfizer, BioNTech, Moderna, and AstraZeneca for her colleagues to monitor and shield from activists. Morschhaeuser also asked colleagues to monitor the hashtags #PeoplesVaccine and #JoinCTAP, a reference to the World Health Organization’s Covid-19 Technology Access Pool, a program promoted by developing countries to accelerate the development of vaccines through the equitable sharing of research and manufacturing capacity. She noted that the group Global Justice Now was spearheading the action with an online sign-up form.

It is not clear to what extent Twitter took any action on BioNTech’s request. In response to Morschhaeuser’s inquiry, several Twitter officials chimed in, debating what action could or could not be taken. Su Fern Teo, a member of the company’s safety team, noted that a quick scan of the activist campaign showed nothing that violated the company’s terms of service, and asked for more examples to “get a better sense of the content that may violate our policies.”

But it shows the extent to which pharmaceutical giants engaged in a global lobbying blitz to ensure corporate dominance over the medical products that became central to combatting the pandemic. Ultimately, the campaign to share Covid vaccine recipes around the world failed.

The Intercept accessed Twitter’s emails after the company’s billionaire owner, Elon Musk, granted access to several reporters in December. This is the second story I have reported through access to these files. The first centered on the Pentagon’s network of fake Twitter accounts used to spread U.S. narratives in the Middle East.

In reporting this story, as with the last, Twitter did not provide unfettered access to company information; rather, they allowed me to make requests without restriction that were then fulfilled on my behalf by an attorney, meaning that the search results may not have been exhaustive. I did not agree to any conditions governing the use of the documents, and I made efforts to authenticate and contextualize the documents through further reporting. The redactions in the embedded documents in this story were done by The Intercept to protect privacy, not Twitter.

Twitter did not respond to a request for comment. BioNTech’s Alatovic, in response to a request for comment, stressed that the firm “takes its societal responsibility seriously and is investing in solutions to improve the health of people regardless of their income.”

A spokesperson for the German Federal Office for Information Security, the cybersecurity agency that Morschhaeuser said contacted Twitter on behalf of BioNTech, emailed The Intercept after publication of this article to say that the agency had raised a “cyber security alert” out of concern the People’s Vaccine campaign amounted to a “DDoS attack.” The agency further claimed that this warning “independent of any content-related or political orientation of an online campaign such as the one planned here.”

IN NOVEMBER, the Bureau of Investigative Journalism published a lengthy report showing that pharmaceutical companies went to great lengths to stifle efforts to share pandemic-related patents and IP, including threats to the leadership of Belgium, Colombia, and Indonesia. The Intercept has also detailed the domestic lobbying push to block support for a special World Trade Organization waiver necessary for the rapid creation of generic pandemic medicine. German media has similarly reported on the aggressive effort by BioNTech to build support from the German government in opposing the waiver at the WTO.

In May 2021, the Biden administration reversed its earlier position and that of the Trump administration and voiced support for the WTO waiver, making the U.S. one of the largest wealthy countries to support the idea, backed by a coalition led by India and South Africa. But infighting at the international trade body, along with staunch opposition from other wealthy countries, prevented any effective progress on the issue.

The largely successful assault against the creation of generic vaccines resulted in an unprecedented explosion in profit for a few select biopharmaceutical drug interests. Pfizer and BioNTech generated a staggering $37 billion in revenue from its shared mRNA vaccine in 2021 alone, making it one of the most lucrative drug products of all time.

Moderna, which made $17.7 billion from vaccine sales in 2021, recently announced its plan to hike the price of its Covid shot by about 400 percent.

The high cost of vaccines and concentrated ownership meant supplies in 2021 were hoarded in the European Union, United Kingdom, United States, Canada, Japan, and other wealthy countries, while much of the developing world was forced to wait for excess vaccines the following year.

“To try and stifle digital dissent during a pandemic, when tweets and emails are some of the only forms of protest available to those locked in their homes, is deeply sinister.”
“For more than two years, a global movement has been speaking out against pharmaceutical greed and demanding that everyone, everywhere has the tools to combat pandemics,” said Maaza Seyoum, a campaigner for the People’s Vaccine Alliance.

“Whatever nasty tricks companies and governments pull,” she added, “we cannot and will not be silenced.”

Nick Dearden, director of Global Justice Now, noted that at the time of BioNTech’s censorship request, much of the world was under various lockdown orders, making digital forms of protest all the more vital for influencing public policy.

“To try and stifle digital dissent during a pandemic, when tweets and emails are some of the only forms of protest available to those locked in their homes, is deeply sinister,” he said.

Stronger, a campaign run by Public Good Projects, a public health nonprofit specializing in large-scale media monitoring programs, regularly communicated with Twitter on regulating content related to the pandemic. The firm worked closely with the San Francisco social media giant to help develop bots to censor vaccine misinformation and, at times, sent direct requests to Twitter with lists of accounts to censor and verify.

Internal Twitter emails show regular correspondence between an account manager at Public Good Projects, and various Twitter officials, including Todd O’Boyle, lobbyist with the company who served as a point of contact with the Biden administration. The content moderation requests were sent throughout 2021 and early 2022.

The entire campaign, newly available tax documents and other disclosures show, was entirely funded by the Biotechnology Innovation Organization, a vaccine industry lobbying group. BIO, which is financed by companies such as Moderna and Pfizer, provided Stronger with $1,275,000 in funding for the effort, which included tools for the public to flag content on Twitter, Instagram, and Facebook for moderation.

Many of the tweets flagged by Stronger contained absolute falsehoods, including claims that vaccines contained microchips and were designed to intentionally kill people. But others hinged on a gray area of vaccine policy through which there is reasonable debate, such as requests to label or take down content critical of vaccine passports and government mandates to require vaccination.

One tweet flagged by the BIO-backed moderation effort read, “if a vaccinated person and an unvaccinated person have roughly the same capacity to carry, shed and transmit the virus, particularly in its Delta form, what difference does implementing a vaccination passport actually make to the spread of the virus?”

Public health experts and civil libertarians strongly debated the constitutionality of such passports, an idea that was eventually discarded by U.S. policymakers.

Joe Smyser, the chief executive of Public Good Projects in charge of the Stronger campaign, said his organization’s work was a good-faith effort to battle disinformation. “BIO contributed money and said, ‘You guys are planning on running a pro-vaccine, anti-vaccine misinformation effort and we will give you $500,000 [per year] no questions asked,’” said Smyser.

Many pharmaceutical lobby groups made exaggerated claims about the danger of sharing vaccine technology. PhRMA, another drug industry lobby group, falsely claimed on Twitter that any effort to allow the creation of a generic Covid vaccine would result in placing all 4.4 million jobs supported by the entire American drug industry at risk.

I asked Smyser whether his group ever flagged any content distributed by the pharmaceutical lobby as “misinformation.”

Smyser agreed that policy debate was important, and if misinformation was spread by pharmaceutical companies, any global citizen “should be aware of it,” but that his organization never flagged or focused on any drug industry content.

“I understand why someone would be skeptical, because as a researcher, it matters where your money comes from,” Smyser said. But, he argued, “my job is, how do people figure out where to go get vaccinated? And how do I encourage them to get the vaccine? That was it.”

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Sunday, January 22, 2023



Not Just Misinformation: In Emails to White House, Facebook Admits Suppressing ‘Often-True Content’ on COVID-19 Vaccines

Facebook told an official at the Biden White House that the Big Tech company not only suppressed misinformation but took action against the “virality” of “often-true content” regarding the COVID-19 vaccines.

Missouri Attorney General Andrew Bailey released the documents earlier this week. Bailey obtained them through a court case, Missouri v. Biden, alleging that some of President Joe Biden’s top officials “colluded with Big Tech social media companies to violate Americans’ right to free speech under the First Amendment.”

“I want to protect Missourians and the freedoms they enjoy, which is why as attorney general, I will always defend the Constitution,” Bailey told The Daily Signal in an email Thursday. “This case is about the Biden administration’s blatant disregard for the First Amendment and its collusion with Big Tech social media companies to suppress speech it disagrees with.”

“I will always fight back against unelected bureaucrats who seek to indoctrinate the people of this state by violating our constitutional right to free and open debate,” the Missouri attorney general pledged.

In an email to the White House dated March 21, 2021, a Facebook staff member discussed “levers for tackling vaccine hesitancy content” with Andrew Slavitt, then a senior adviser on Biden’s COVID-19 response team, and Rob Flaherty, White House director of digital strategy.

“You also asked us about our levers for reducing virality of vaccine hesitancy content,” wrote the Facebook staffer, whose identity was redacted. “As you know, in addition to removing vaccine misinformation, we have been focused on reducing the virality of content discouraging vaccines that does not contain actionable information. This is often-true content, which we allow at the post level because it is important for people to be able to discuss both their personal experiences and concerns about the vaccine, but it can be framed as sensation, alarmist, or shocking.”

“We’ll remove these Groups, Pages, and Accounts when they are disproportionately promoting this sensationalized content,” the Facebook staffer added. He or she then promised, “More on this front as we proceed to implement.”

In this email to the White House, the Facebook representative admitted to preventing exposure of content that doesn’t violate Facebook’s policies—content that isn’t “actionable.” The staffer also suggested that the White House had asked Facebook to take these measures.

In an April 22, 2021, email, Flaherty told Google staff that the White House remains “concerned that Youtube [sic] is ‘funneling’ people into hesitance and intensifying people’s hesitancy. We certainly recognize that removing content that is unfavorable to the cause of increasing vaccine adoption is not a realistic—or even good—solution.”

The White House’s digital strategy chief added that combating vaccine hesitancy “is a concern that is shared at the highest (and I mean highest) levels of the WH [White House],” an apparent reference to the president himself.

In an April 14, 2021, email to Facebook, Flaherty suggested the social media platform should take action to suppress Fox News host Tucker Carlson and conservative journalist Tomi Lahren.

“Since we’ve been on the phone—the top post about vaccines today is tucker [sic] Carlson saying they don’t work,” Flaherty wrote. “Yesterday was Tomi Lehren [sic] saying she won’t take one. This is exactly why I want to know what ‘Reduction’ actually looks like—if ‘reduction’ means ‘pumping our most vaccine hesitant audience with tucker [sic] Carlson saying it doesn’t work’ then … I’m not sure it’s reduction!”

In a May 12, 2021, email, the White House’s Flaherty faulted Instagram, which Facebook owns, for failing to remove “bad information” from its search function. He appears aggressive in pushing for censorship.

“You know and I know that the universe of undecided people searching Instagram for ‘vaccines’—as compared to, say, Google—is probably low,” Flaherty wrote. “But ‘removing bad information from search’ is one of the easy, low-bar things you guys do to make people like me think you’re taking action. If you’re not getting that right, it raises even more questions about the high bar stuff.”

“You say in your note that you remove accounts that discourage vaccination from appearing in recommendations (even though you’re using ‘primarily’ to give yourself wiggle room),” Flaherty added. “You also said you don’t promote those accounts in search.”

Then Flaherty compared Instagram to other social media platforms.

“Youtube [sic], for their warts, has done pretty well at promoting authoritative info in search results while keeping the bad stuff off of those surfaces,” the White House official said. “Pinterest doesn’t even show you any results other than official information when you search for ‘vaccines.’ I don’t know why you guys can’t figure this out.”

These documents confirm the close relationship between the federal government and Big Tech companies revealed in the recently reported “Twitter Files.”

Internal Twitter documents, released under the direction of new CEO Elon Musk, showed the Justice Department and FBI pressuring tech companies such as Twitter to stifle and suppress “misinformation,” particularly on the COVID-19 pandemic. In some cases, Twitter executives and government officials took aim at scientists who shared their professional opinions on the social media platform.

The FBI also paid Twitter more than $3 million while the intelligence community was pressuring the tech company to suppress news about Hunter Biden, the president’s son.

Big Tech’s censorship has not abated, either. In December, YouTube removed a video presentation featuring two doctors and a Heritage Foundation expert, claiming the video violated its misinformation policy on COVID-19 vaccines. YouTube didn’t identify which of the four speakers supposedly had violated the policy.

Roger Severino, former director of the Office for Civil Rights at the Department of Health and Human Services and currently vice president for domestic policy at The Heritage Foundation, called the move “Kafkaesque.” (The Daily Signal is The Heritage Foundation’s news outlet.)

“I wish I knew exactly what triggered YouTube’s ire, but they remain imperiously vague,” Severino told The Daily Signal. “It is Kafkaesque to be placed in YouTube jail and not be told what the alleged crime was or even who committed it.”

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Covid’s warped model: Injured people mean big business for Big Pharma

Rebecca Weisser

‘Is curing patients a sustainable business model?’ That’s what Goldman Sachs analysts asked in an April 2018 report on ‘The Genome Revolution’. The analysts didn’t think so, arguing that there was little money to be made on ‘one shot cures’. But there is endless money to be made from chronically injured people, they argued.

A recent report analysing Bureau of Labor Statistics in the US up to November 2022 by the Phinance Technologies Team shows a dramatic increase in disabilities in people aged 16-64 which coincides with the rollout of the vaccines. Treating those people will certainly be a viable business model for Big Pharma for the foreseeable future.

How does this relate to the extraordinary level of injury and death that experts say the Covid vaccines are causing?

Dr Richard Ennos, a retired professor of evolutionary biology at Edinburgh University, is the latest eminent academic to call for the immediate withdrawal of the mRNA Covid vaccines writing that ‘Glaring safety signals are apparent, indicating harm to the lymph system, the heart and to female reproduction.’

Dr Ennos came to this conclusion after conducting a thorough analysis of detailed data collected by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) through its Covid-19 Yellow Card vaccine adverse event database which the agency finally agreed to release after stalling for more than 18 months. It claimed that it would be too onerous to pass on the raw data despite the fact that the raw data is sent immediately to Pfizer and Moderna.

Dr Ennos is scathing about the MHRA writing that its regular summary of Yellow card reporting has been ‘an exercise in defending the Covid-19 vaccines from criticism rather than defending the UK public from the Covid-19 vaccines’. He damns the reports as lacking any scientific rigour, not providing a single piece of statistical analysis to support conclusions and calls them ‘an affront to the huge number of individuals who have been injured or killed doing what they believe to be “the right thing”’.

Ennos dedicates his report to the innocent UK public and to the dedicated physicians who filed the Yellow Card reports, writing, ‘I would like you to know that your suffering and endeavours have not been in vain.’

The work of Ennos bookends an open letter sent by Dr Tess Lawrie in June 2021 to Dr. June Raine, chief executive of the MHRA, demanding the halt of the mass rollout of COVID vaccines after discovering a ‘high number of COVID-19 vaccine-attributed deaths and adverse drug reactions that have been reported via the Yellow Card system’.

Dr Ennos and Dr Lawrie are not alone. In the last fortnight Dr Joseph Fraiman, lead author of peer-reviewed research re-analysing the Pfizer and Moderna Covid vaccine trial data, called for an immediate suspension of the vaccines saying, ‘We have conclusive evidence that the vaccines are inducing sudden cardiac death.’ Before him, prominent UK cardiologist Dr Aseem Malhotra, who also conducted a peer-reviewed study of the vaccines, called for their suspension. Top US cardiologist Dr Peter McCullough has also called for an immediate suspension of the vaccines saying, ‘I’m going to be very clear about this. The vaccine is killing people and it’s killing large numbers of people.’

Masanori Fukushima, a distinguished oncologist, professor emeritus at Kyoto University, and Director of the Translational Research Informatics Centre, agrees. Together with other eminent Japanese professors he has called for an immediate halt to the use of the mRNA vaccines which he describes as ‘an unprecedented disaster’ saying he can’t imagine how many people have really died in Japan and the report of 2,000 deaths is just the ‘tip of the iceberg’.

Masanori is a specialist in pharmacy-epidemiology, which he describes as the ‘study of stopping drug disasters’. He has been actively involved in evaluating the Covid vaccines and is planning to sue the Japanese government for refusing to disclose vital information that could save lives.

Masanori says he asked government officials to disclose Covid mortality in the vaccinated compared with the unvaccinated on 1 August 2022. After stalling for two months, they refused. Apparently, the government disclosed this information earlier and it had shown that in people under 65 years the mortality rate was lower for unvaccinated people than for vaccinated people. Masanori thinks this was embarrassing for the government so they have refused to disclose any further information.

Interestingly, from May to December 2022, the NSW government also disclosed Covid deaths by vaccine status and these statistics also showed a slightly lower rate of mortality for the unvaccinated compared with the vaccinated. Like Japan, NSW will also no longer disclose Covid deaths by vaccine status.

Yet when the Centres for Disease Control and the Food and Drug Administration investigated a possible link between Pfizer’s bivalent Covid/flu vaccine and an increased risk of stroke, they stated within days that it was ‘very unlikely’ that the vaccine was the cause. Yet as one pundit observed, the Securities and Exchange Commission repeatedly investigated Bernie Madoff without finding evidence of fraud.

Part of the problem appears to be regulatory capture on a grand international scale.

Dr Raine gave a speech in which she boasted that the MHRA had gone from being a watchdog to being an ‘enabler’ and that in regulating the Covid vaccines the MHRA ‘tore up the rule book’.

In the US, there is a revolving door between big pharmaceutical companies and the regulatory agencies of whom Scott Gottlieb is only the most prominent example. He worked at the FDA, then in the private sector, returned to be FDA commissioner and since 2019 has served on the board of Pfizer. Similarly, Stephen Hahn served as the head of the FDA from 2019 to 2021 before becoming the chief medical officer of Flagship Pioneering, the venture firm behind Moderna.

Another problem is the fact that the vaccines have been authorised under emergency use authorisation in the US and provisionally in Australia, giving pharmaceutical companies indemnity which appears to have made them indifferent to the harms vaccines have caused. And control of social media by the Biden administration in the US and the Trusted News Initiative internationally have shielded vaccine manufacturers from almost all criticism. So far, it appears to be a more sustainable business model than curing patients.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Saturday, January 21, 2023


My recipe blog

I have just put up another recipe on my Recipe Blog. It is for an unusual but very tasty meal

Friday, January 20, 2023



The Ongoing Mutation of SARS-CoV-2 & Attempts at Vaccination-based Control

Summary:

Top scientists investigating the crossroads of genomics, immunology, microbiology, and infectious disease concluded the extreme difficulty of RNA virus immunization in a 2018 research paper titled “Immune Responses to RNA Viruses,” all but cautioning public health agencies’ responses to most RNA viruses and their respective threats to public safety. They wrote that in the aggregate, RNA pathogens, including human immunodeficiency virus (HIV), hepatitis C virus (HCV), Ebola virus, Zika virus, respiratory syncytial virus (RSV), influenza viruses, yellow fever virus, dengue virus, rhinoviruses (common cold), human T-lymphotropic virus type 1 (HTLV-I), poliovirus, and measles virus take hundreds of millions of lives daily worldwide. Published just a year-and-a-half before the outbreak of SARS-CoV-2, the authors acknowledged the current state of science: “that at the present time, no vaccine or specific treatment is available for many of these viruses, and some of the available vaccines and treatments are not highly effective.” So, this is for viruses known to human science for decades in some cases. What about a brand-new pathogen with certain heretofore not seen qualities making the RNA virus far more transmissible? How could government research entities and industry be so confident as to a blockbuster vaccine response that would control the pathogen, leading to herd immunity? After all, this was the initial impetus behind the mass vaccine development as evidenced by underlying drivers to control the virus by achieving a 70% vaccination rate. Well-intentioned to rapidly respond to a deadly pathogen, time is now to critically evaluate options with a willingness to let go of any faulty assumptions.

In Detail:

The human innate immune system represents a key force in sensing RNA viruses and, thus, a considerable influence on the antiviral responses and the pathogenesis of diseases caused by such RNA viruses. Yes, special attention needs to be directed toward the immune response to RNA viruses and SARS-CoV-2. In that 2018 piece, the authors Said et al. introduce an RNA virus, HIF, as an example of the interaction between an RNA virus and the immune system and how such interactions control the pathophysiology of the disease caused by the virus.

While in the COVID-19 response to the novel RNA virus called SARS-CoV-2, health authorities across public agencies and their apex research institutes sought to use an mRNA vaccine developed across the finish line in just about 10 months as a means of mass controlling the pathogen as evidenced by repeated targeting of 70% of vaccination rates by the World Health Organization initially to achieve herd immunity to stop the spread of the pathogen, not just to protect the highest risk populations viral surges with bolstered human antibody responses.

No, early on it was clear that from health authorities to governments and elected officials to the vaccine developers (pharma) that the vaccine was a means of eradicating the viral pathogen from existence. Even with clear evidence by the spring of 2021 that the novel vaccines would not stop viral transmission, intense public campaigns commenced, including announced mandates by POTUS precisely to stop viral spread.

Despite these intensive public health initiatives seeking to control the COVID-19 pandemic, wave after wave of viral mutation, starting first with the Delta variant of concern, followed by a series of Omicron subvariant mutants, the recent entry of the highly infectious, considerably resistant, and intensely immune system-evading XBB.1.5 SARS-CoV-2 subvariant merely represents the latest such pathogen, not something that should be surprising the scientific community at this point, yet the popular press treats it as a novelty.

The latest RNA-based viral mutation comes out of the XBB lineage, which emerged after a natural co-infection of a human host with two key Omicron subvariants, including BA.2.10.1 and BA.2.7 first identified in India several months ago (summer 2022). The “fifth grandchild” of the first XBB variant, it could be the most genetically sophisticated and contagious of the Omicron subvariants to date since the initial advent of this version of SARS-CoV-2 in November 2021.

In circulation in nearly 40 nations, as reported by the World Health Organization (WHO), it’s now dominating in the United States. Importantly, the current vaccine booster (Omicron bivalent BA.4/BA.5) was developed for a version that is on its way toward extinction while this untargeted mutant surges, especially on the east coast. XBB.1.5 will more than likely become the predominant SARS-CoV-2 pathogen, that RNA class of virus that scientists all along have suggested is extremely difficult to stop.

Current SARS-CoV-2 Viral Variants Across the USA
The Centers for Disease Control and Prevention (CDC) report on variant representation and distribution across America.

XBB.1.5 now represents 43% of all SARS-CoV-2 variants in circulation as of January 14, 2023, reports the CDC.

There is limited data about the ability of XBB.1.5 to cause serious illness. According to the World Health Organization, XBB.1.5 does not have any specific mutations that make it any more dangerous than its ancestral subvariants.

Nonetheless, XBB.1.5 is perceived as being equally capable of causing serious illness in elderly and immunocompromised persons compared to previous Omicron subvariants of concern.

It’s not clear how dangerous this particular variant will be as measured by contribution to morbidity and mortality rates, but evidence suggests higher transmission rates yet likely, lower mortality rates.

But while public health messaging continues to declare repeatedly that vaccination is the best means of stopping serious SARS-CoV-2 illness, XBB.1.5 and other variants such as XBB.1 under the Omicron umbrella, represent the pathogens with the most immune-evasive properties as discussed by WHO directly.

Initial laboratory study results didn’t bode well for the prospects of the Omicron bivalent BA.4/BA/5 booster vaccine targeting this latest mutation (XBB.1.5). TrialSite reported that a notable team at University of Texas Medical Branch reported that a group of scientists at the University of Texas Medical Branch (UTMB) in Galveston, Texas reports the mutating Omicron subvariants such as BA.2.75.2, BQ.1.1., and XBB.1 feature additional spike mutations, further inhibiting COVID-19 vaccine booster effectiveness. Led by Pei-Yong Shi, Ph.D., UTMB’s Vice President for Research, co-corresponding authors Ping Re, Ph.D., an epidemiologist, and Xuping Xie, Ph.D., an assistant a professor of biochemistry and molecular biology, the UTMB investigators reported that this particular vaccine now aggressively promoted by the U.S. government failed to generate robust neutralization against the newly emerged BA.2.75.2, BQ.1.1, or XBB.1. At the time (Dec 7), TrialSite reported that unfortunately, BQ.1 and BQ.1.1 represent the fastest growing Omicron subvariants across America.

This media also reported on a study with disturbing results from a large retrospective cohort study sponsored by the Cleveland Clinic, tapping into robust data associated with the hospital’s electronic health records. The data suggests a growing number of SARS-CoV-2 infections associated with number of vaccination boosters. But several confounding factors could influence that outcome.

TrialSite reported on the lab results from Columbia University’s David Ho, revealing declining bivalent BA.4/BA.5 booster performance against XBB.1.5, 155-fold lower than against the wild-type virus after a boost targeting the monovalent strain. See TrialSite’s “Bivalent Bombshell? BA.4/BA.5 mRNA Booster Dose Fails Comparative Antibody Titer Test: Could it be Antigenic Sin?”

Even renowned vaccine expert and FDA Vaccine and Related Biological Products Advisory Committee (VRBPAC) member, Dr. Paul Offit, has gone to the press announcing the current COVID-19 vaccine trajectory has all but failed at this point.

One other recent study result shows concerns such as “T-cell exhaustion” that implies with multiple boosters comes the prospect of externalities with unknown implications, although the study may be underpowered.

So, what degree of protection does the current booster doses offer people against XBB.1.5?
Regardless of point of view, the unfolding science appears clear now that both monovalent and bivalent booster jabs cannot be counted on for sufficient protection against XBB.1.5, yet government scientific agencies’ stance continues to remain to the contrary.

Some state level health officials have moved in the direction of the unfolding science such as in Florida, subjecting all involved to intense public scrutiny and pressure. There in the Sunshine State, given the large percentages of the American population have either been previously vaccinated and/or infected, even the State of Florida’s Surgeon General Joseph Ladapo now recommends against healthy young people getting the COVID-19 vaccine booster. This recommendation, however, goes against CDC, and other major medical associations and societies that remain steadfast that boosting with the latest dose, even if BA.5 is not much in circulation, offers some degree of protection for at least, the handful of cold winter months where populations will be more vulnerable.

Back to the scientific challenges posed with RNA viruses at the onset of this article, any attempt to use vaccination thus far as means of actually controlling the SARS-CoV-2 based pandemic hasn't worked out well. More people have died during the first year of mass vaccination versus the first year of the pandemic, although vaccination does provide a surge of antibodies that does protect people from more serious hospitalization, at least temporarily. But how long remains an open question—part of an unfolding science. As of August 2022, the Washington Post itself reported that the pandemic was no longer one of the “unvaccinated,’ as more deaths involved the vaccinated than the unvaccinated.

Of course, this is explained in part by the fact that about 70% of the American population is fully vaccinated. But this also demonstrates how mutating variants such as XBB.1.5 more easily evade neutralizing antibodies. Assessments of the U.S. [and world] pandemic response are in order. See TrialSite’s founder Daniel O’Connor’s “Pandemic Response 2.0---How Could it be Better: A Review of What We Know.”

We do now that commonsensical measure for protection range from good hygiene practices—such as handwashing, respect of people’s space [distancing], masking--although controversial [at least indoors in public spaces], and if one has an upper respiratory infection, remaining at home and resting and not increasing the probability of spreading the virus to others is a good start.

Existing monoclonal antibodies don’t work well, if at all, against the mutating variants such as XBB.1.5, meaning the ongoing intense evolution of this RNA virus makes it difficult for pharmaceutical products designed against a specific variant of concern. The antiviral Paxlovid offers some protection for some cohorts fitting in the inclusion criteria for the drug although rebound cases are reported.

David Boulware recently reported to TrialSite that metformin appears to have supportive effect against SARS-CoV-2—more so than even fluvoxamine. While TrialSite reported this on the day after Christmas the mass media was strangely silent on this good news. See TrialSite’s “Bramante & Boulware Deliver an Early Christmas Gift: Metformin Lowers Risk of Long COVID.”

Front line physicians independent of health systems have taken matters into their own hands. For example, the controversial but much loved Front Line Covid-19 Critical Care (FLCCC) Alliance, or Dr. Peter McCullough, treats patients with various protocols involving repurposed medicines.

In typical times, licensed physicians and consenting patients can without controversy use off label drugs to treat conditions so long as this is done responsibly with full patient consent, and the like. But during the pandemic, with an unprecedented centralizing of medicinal response, discussing off label regimen such as ivermectin is classified as “misinformation,” and in states like California with its new law in effect, can lead to the loss of licensure for physicians that dare to utter alternative approaches.

Meanwhile, no medicinal products are perfect. Some vaccines may have rare side effects. In the case of the SARS-CoV-2 vaccines, given the magnitude and scale of the pandemic response with 225 million plus fully vaccinated, even a 0.2% serious side effect rate equals nearly half-a-million vaccine-injured persons. Due to intense social pressures doctors and health systems are not recognizing this problem, leading to stigmatization and a lack of care. Groups such as React19 have been formed to represent vaccine injured. They should be properly funded, advocating for the injured as the vaccines were mandated on the population. A much larger long COVID group needs attention and care as well as nations attempt now to transition to an endemic reality.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Thursday, January 19, 2023


Moderna and Regulatory Agencies Caught Leaving Out Bivalent Vaccine Data, Physicians Skeptical of Timing

Moderna and regulatory agencies did not present clinical data on bivalent shots at the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) committee meetings in June and September 2022, respectively.

Presentations to the FDA and CDC advisory committee excluded data from Moderna’s own clinical study that showed bivalent boosters may be no better at preventing infections than previous booster shots.

The data showed that among people who were never infected, 3.2 percent who took the bivalent booster got infected afterward, while 1.9 percent who took the monovalent booster were later infected.

Advisors to the FDA and CDC expressed concerns of lack of transparency.

Dr. William Schaffner from Vanderbilt University, a nonvoting member of the CDC advisory committee, said that he was disappointed that the data were not presented.

“I think in the interests of transparency, those data should have been presented,” Schaffner said, “though they were very limited, and early data.”

FDA advisor and a professor of clinical pediatrics at the University of California San Diego, Dr. Mark Sawyer, said that he understands people’s concern with the data being excluded, but not all information can be presented.

The committee has limited time, so the information presented must be relevant to the big picture.

“Seeing that data would not have changed my opinion about the outcome,” said Sawyer, “and it would certainly have distracted from the discussion.”

The four advisors for the FDA and CDC who were contacted by The Epoch Times agreed that if the data were presented, it may have prolonged the discussion, but would not have changed the voting outcomes.

Both the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting and the CDC’s Advisory Committee on Immunization Practices (ACIP) meeting approved Moderna bivalent boosters.

The excluded data come out of a Moderna study with 772 participants. The study compared bivalent boosters containing mRNA components of the original and the BA.1 Omicron strain against the original Wuhan-strain booster.

The study primarily investigated the safety and immunogenicity of boosters, but also looked into the infection and reactogenicity of the subjects.

Immunogenicity, the focus of the study, is defined as the ability of the vaccine to trigger an immune response. Though the study authors reiterated that the trial does not examine vaccine efficacy, the authors acknowledged that immunogenicity has been used to infer efficacy.

Three days before the FDA VRBPAC meeting on June 28, 2022, Moderna published the study as a preprint, and in September, published the study in the New England Journal of Medicine (NEJM).

Both the preprint and peer-reviewed study included data on immunogenicity, safety, reactogenicity, as well as infection.

Moderna’s spokesman Christopher Ridley also told CNN that the company shared the infection data with the FDA and published the study before the FDA panel meeting.

At the VRBPAC meeting, Moderna president Stephen Hoge made several references to the study’s immunogenicity data, which showed that people who took the bivalent shots had a higher antibody level than those who took the monovalent booster, as an argument for the bivalent booster’s superiority.

Hoge also made references to the same study’s data on safety and reactogenicity, but infection rates were excluded.

The FDA’s documents provided to the committee panel on the same day, also referenced the study’s data on immunogenicity, safety, and reactogenicity, yet the infection data were similarly excluded.

According to CNN, the FDA spokesman explained in an email that the data on infection were not included, as “the FDA received the preprint less than a day prior to the advisory committee meeting,” and “generally the FDA only discusses data at advisory committee meetings that the agency has had the opportunity to substantively review.”

This means that the FDA could review the study’s data on immunogenicity, safety, and reactogenicity, but had no opportunity to examine infection data.

VRBPAC member and professor of microbiology and immunology from the University of Iowa, Dr. Stanley Perlman, said that with the absence of these data, there is always the concern that the public will lose trust in the health care system.

At the end of the meeting, the VRBPAC committee ruled in favor of using the Omicron variant’s mRNA in boosters to produce the bivalent COVID-19 vaccines in a 19-2 motion.

It is worth noting that by the time of the FDA committee meeting, the BA.1 strain of the Omicron variant was no longer dominant.

Though the presentations referenced data on bivalent boosters composed of the BA.1 and Wuhan mRNA components, the boosters that were later FDA-emergency authorized contained BA.4 and BA.5 components rather than BA.1.

None of the presentations on Moderna boosters contained clinical data on participants who were inoculated with BA.4/BA.5 bivalent boosters.

The CDC’s meeting with members of the Advisory Committee on Immunization Practices (ACIP) on Sep. 1, 2022, presented by Moderna staff Dr. Jacqueline Miller, also excluded data on infection rates in the presentation (pdf).

Hours into the CDC meeting, voting member of the ACIP Dr. Sybil Cineas asked whether there were any data on breakthrough infections between two experimental groups.

Miller said that between the overall cohort of people who received the bivalent vaccine, the infection rate was 2.5 percent, and for the monovalent group, the rate of 2.4 percent.

However, she failed to mention that for people who never had a previous infection, 3.2 percent of those who took the bivalent vaccine became infected, while 1.9 percent of subjects who took the monovalent developed an infection.

The ACIP members approved Moderna bivalent boosters being made available to people aged 18 and over in a 13-1 vote.

Limitations of Study

Dr. Cody Meissner, a VRBPAC member and a professor in the division of infectious diseases and international health from Dartmouth Health Children’s, also pointed out that the infection data came out of a non-randomized and non-blinded study.

This introduces the risk of bias into the study, as those assigned to bivalent or monovalent boosters were not based on random chance, and trial administrators would know what booster participants received.

While this possibly discounts the significance of the data on infection rates, it can also affect the validity of the findings on immunogenicity, safety, and reactogenicity.

Biochemist and mRNA platform inventor Dr. Robert Malone raised the point that immunogenicity data that only look at antibody levels are not good surrogate measures for vaccine efficacy.

Antibody levels are also not a good measure of immunity, as antibodies will and should wane with time. The long-term immunity they provide is therefore unknown.

It is also unconfirmed if the antibodies produced are neutralizing antibodies that can block the virus and spike proteins, or if they may actually prevent the immune system from killing and controlling the virus, a scenario known as antibody-dependent enhancement.

Increasing Scrutiny of Bivalent Boosters

Bivalent boosters have come under increasing scrutiny for their rapidly declining effectiveness.

A December 2022 preprint study on bivalent vaccines, authored by the Cleveland Clinic, found that the higher the number of previous vaccinations, the greater the risk of contracting COVID-19.

In a letter to the editor (pdf) published in the NEJM, researchers from Columbia University compared antibody serum responses among people who received bivalent boosters, monovalent boosters, and those who were infected.

The authors found that there was no significant difference in neutralizing abilities among these groups when tested against Omicron and other variants.

Dr. Paul Offit, an advisor on the VRBPAC committee who voted against bivalent boosters at the meeting, also published a commentary, saying that young and healthy people shouldn’t get the latest boosters.

“I believe we should stop trying to prevent all symptomatic infections in healthy, young people by boosting them with vaccines containing mRNA from strains that might disappear a few months later,” wrote Offit, also an FDA vaccine panel adviser and professor of pediatrics at the Children’s Hospital of Philadelphia, in the NEJM on Jan. 11, 2023.

In his article, Offit cited two studies suggesting that bivalent boosters, which target the original COVID-19 strain and two Omicron subvariants BA.4 and BA. 5, do not “elicit superior immune responses.”

“Why did the strategy for significantly increasing BA.4 and BA.5 neutralizing antibodies using a bivalent vaccine fail?” he asked.

“The most likely explanation is imprinting. The immune systems of people immunized with the bivalent vaccine, all of whom had previously been vaccinated, were primed to respond to the ancestral strain of SARS-CoV-2. They therefore probably responded to epitopes shared by BA.4 and BA.5 and the ancestral strain, rather than to new epitopes on BA.4 and BA.5.”

Meissner, likewise, expressed that healthy people younger than 65 years of age may not need bivalent boosters.

“We don’t know … how many or how often boosters are necessary. And could there be consequences from giving multiple vaccine doses that we don’t fully understand at this time?”

A peer-reviewed study published on Jan. 12 in Germany also showed that people who received higher numbers of mRNA vaccines had a higher IgG4 antibody response. The authors did not further discuss what these antibody levels may indicate, but studies have associated IgG4 antibodies with immune tolerance, which is when the body reduces its immune response to fight off an infection.

People who had a previous infection or vaccination with the adenovirus COVID-19 vaccine had zero or low IgG4 antibody responses, respectively.

The Timing of Discovery of Excluded Data Is Dubious: Physicians

Retired clinical trialist and epidemiologist Dr. Andrew Bostom was skeptical of the timing of the discovery of the withheld data.

“Why did it take so long to follow up on these findings?” Bostom asked.

Bostom himself noticed the infection data signals when the study was published in the NEJM on Sep. 16, 2022, and posted his findings on his now-reactivated Twitter account.

Even before the FDA’s announcement of emergency-use authorizations of the bivalent vaccines on Aug. 31, 2022, pharmacies and health centers were already being encouraged to take preorders for the bivalent boosters.

“In many ways, the U.S. government was already committed. They already bought these before they knew the results,” board-certified internist and cardiologist Dr. Peter McCullough said.

McCullough argued that it is far too late to discuss the nuances of withheld data and immunogenicity, with increasing reports of vaccine injury and adverse events.

Meissner and Sawyer said that the VRBPAC committee is following the rapidly emerging research on the boosters and that there would be further discussion of all available data at the meeting on Jan. 26.

The FDA, CDC, and Moderna did not respond to requests for comment.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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Wednesday, January 18, 2023


DOJ Still Fighting in Court for Forced Masking on Transportation

On April 18, 2022 U.S. District Judge Kathryn Kimball Mizelle struck down President Joe Biden's mask mandate for air and rail transportation. The Department of Justice quickly appealed the decision after a request from the Centers for Disease Control.

"To protect CDC’s public health authority beyond the ongoing assessment announced last week, CDC has asked DOJ to proceed with an appeal in Health Freedom Defense Fund, Inc., et al., v. Biden, et al. It is CDC’s continuing assessment that at this time an order requiring masking in the indoor transportation corridor remains necessary for the public health. CDC will continue to monitor public health conditions to determine whether such an order remains necessary. CDC believes this is a lawful order, well within CDC’s legal authority to protect public health," the CDC released in a statement.

At the time, the White House admitted the appeal was to preserve the power of the federal government.

When the mandate was lifted, flights erupted with cheers.

Nearly a year later, federal attorneys are still working to force masking on transportation.

The Eleventh Circuit of Appeals will hear arguments over a federal mask mandate on Tuesday, Jan. 17.

Beginning at 9 a.m., attorneys will present arguments over the transportation mask mandate.

The appeal drew criticism from the U.S. Travel Association, which along with other industry groups had been pressuring the Biden administration for months to end the mask mandate for travel.

The Health Freedom Defense Fund outlined arguments in court documents, stating they believe the CDC has no legal authority to adopt a mask mandate.

Following today's hearing, the court will decide whether to affirm the decision to strike down the mask mandate. A judge will draft a written decision which may go through several rounds before a majority of the court agrees and the written decision is published.

DOJ continues this fight despite President Joe Biden declaring the pandemic is over and after a recent admission from White House COVID Response Coordinator Dr. Ashish Jha that masks don't work to mitigate the spread of COVID-19.

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Omicron Subvariant XBB.1.5 Could Be More Likely to Infect Vaccinated: NYC Health Officials

The Omicron XBB.1.5 variant of COVID-19 is more likely to infect individuals who have been vaccinated, according to New York City health officials.

“Omicron subvariant XBB.1.5 now accounts for 73 percent of all sequenced COVID-19 cases in NYC. XBB.1.5 is the most transmissible form of COVID-19 that we know of to date and may be more likely to infect people who have been vaccinated or already had COVID-19,” the NYC Department of Health and Mental Hygiene wrote on Twitter on Jan. 13.

Despite this, the department urged New Yorkers to get vaccinated and receive the updated COVID-19 booster shot, stating that doing so “is still the best way to protect yourself from hospitalization and death from COVID-19, including from these new variants.”

The XBB.1.5 variant is quickly becoming the dominant subvariant in the United States. Data from the Centers for Disease Control and Prevention (CDC) show that XBB.1.5 accounted for an estimated 43 percent of COVID-19 cases in the country for the week ending Jan. 14.

World Health Organization (WHO) Director-General Tedros Adhanom Ghebreyesus said earlier this month that the subvariant is on the rise in the United States and Europe and has now been identified in more than 25 countries.

The subvariant has now overtaken the BQ.1.1 subvariant, which was first identified in September, and which now accounts for an estimated 28.8 percent of cases in the country, according to CDC data.

XBB.1.5 Unlikely to Increase Severity

Although there has been a surge in XBB.1.5 cases, the WHO has stated that the variant does not have any mutations known to increase the severity of the virus in individuals.

In a risk assessment (pdf) published on Jan. 11, the health body said that XBB.1.5, based on its genetic characteristics and early growth rate estimates, may contribute to a surge in cases around the world but it “does not carry any mutation known to be associated with potential change in severity.”

Barbara Mahon, head of the CDC’s proposed Coronavirus and Other Respiratory Viruses Division, also told CBS News on Jan. 6 that there is no suggestion that XBB.1.5 is more severe than previous strains of Omicron.

The WHO in its risk assessment did, however, note that “the overall confidence in the assessment is low” owing to a lack of data on the subvariant, most of which come from the United States, and said that more data and laboratory testing is needed to know for sure how severe the subvariant is.

The health body also noted that XBB.1.5 is one of the COVID-19 subvariants that is most resistant to antibodies acquired from vaccination or previous infection.

According to the CDC, approximately 666,511,603 vaccine doses have been administered in the United States, of which 268,556,888 people have received at least one dose of the vaccine and 229,359,062 have completed the primary series of vaccinations.

Vaccine Effectiveness Only Lasts 3 Months

Additionally, 15.9 percent of the U.S. population aged 5 and over have received the updated bivalent booster shot.

In an interview with Science News on Jan. 13, infectious diseases specialist Peter Chin-Hong of the University of California, San Francisco, stated that vaccinations are likely to provide just three months of protection against the XBB.1.5 variant of COVID-19.

“The new updated boosters generally work a little better than the old vaccines in terms of overall efficacy and preventing infection. But with these new slippery variants like XBB.1.5 … if you’re looking to prevent infections, even a mild infection, the vaccines are probably going to last maybe three months,” Chin-Hong said.

“But if you’re talking about preventing me from dying or going to the hospital, those vaccines are going to give me a boost of protection for many, many months, probably until next winter for most people. For older people, older than 65, if they’re not boosted today, then it’s a problem,” the infectious diseases specialist added.

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Here's Why the CDC Just Launched 'Additional Investigation' of COVID Vaccine Safety

The Centers for Disease Control and Prevention (CDC) announced on Friday afternoon — in something of a pre-weekend news dump — that the agency's Vaccine Safety Datalink (VSD) has "met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent."

It's worth noting that the CDC's VSD is different from its Vaccine Adverse Event Reporting System (VAERS).

The CDC's Friday updated emphasized that "[t]o date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal" and that "[n]o change is recommended in COVID-19 vaccination practice" at this time while an additional investigation is conducted.

The CDC explains more about the signal that met its threshold for additional investigation:

Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-44 following vaccination.

This preliminary signal has not been identified with the Moderna COVID-19 Vaccine, Bivalent. There also may be other confounding factors contributing to the signal identified in the VSD that merit further investigation.

Furthermore, it is important to note that, to date, no other safety systems have shown a similar signal and multiple subsequent analyses have not validated this signal:

A large study of updated (bivalent) vaccines (from Pfizer-BioNTech and Moderna) using the Centers for Medicare and Medicaid Services database revealed no increased risk of ischemic stroke

A preliminary study using the Veterans Affairs database did not indicate an increased risk of ischemic stroke following an updated (bivalent) vaccine

The Vaccine Adverse Event Reporting System (VAERS) managed by CDC and FDA has not seen an increase in reporting of ischemic strokes following the updated (bivalent) vaccine

Pfizer-BioNTech’s global safety database has not indicated a signal for ischemic stroke with the updated (bivalent) vaccine
Other countries have not observed an increased risk for ischemic stroke with updated (bivalent) vaccines

Although the totality of the data currently suggests that it is very unlikely that the signal in VSD represents a true clinical risk, we believe it is important to share this information with the public, as we have in the past, when one of our safety monitoring systems detects a signal. CDC and FDA will continue to evaluate additional data from these and other vaccine safety systems. These data and additional analyses will be discussed at the upcoming January 26 meeting of the FDA’s Vaccines and Related Biological Products Advisory Committee.

So while the CDC is firm in its belief that a "true clinical risk" does not exist in terms of ischemic stroke in the three weeks after a person over 65 received the Pfizer COVID vaccine, there have been enough reports for a signal to trigger further investigation which has not yet allowed the potential risk to be ruled out.

Dr. Marty Makary shared the CDC's update on vaccine safety and issued a call for the raw data that prompted the additional level of review to be made public, allowing Americans and their doctors to have all the information that exists to use in their decisions about vaccination.

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Also see my other blogs. Main ones below:

http://edwatch.blogspot.com (EDUCATION WATCH)

http://antigreen.blogspot.com (GREENIE WATCH)

http://pcwatch.blogspot.com (POLITICAL CORRECTNESS WATCH) Also here

http://australian-politics.blogspot.com (AUSTRALIAN POLITICS)

http://snorphty.blogspot.com (TONGUE-TIED)

https://immigwatch.blogspot.com (IMMIGRATION WATCH) Also here

https://awesternheart.blogspot.com (THE PSYCHOLOGIST)

http://jonjayray.com/blogall.html More blogs

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