Wednesday, February 16, 2022
Eli Lilly monoclonal antibody Covid drug received FDA authorization
A new monoclonal antibody drug has become available in the U.S., as the Food and Drug Administration (FDA) authorized Ely Lilly's bebtelovimab for use in non-hospitalized Covid patients who are at a high risk of severe complications from the virus.
The move comes only weeks after the agency pulled authorization from another monoclonal antibody treatment produced by Eli Lilly - along with a drug produced by Regeneron - since they were deemed to be ineffective against the Omicron variant.
This drug showed effectiveness against the strain that now makes up nearly 100 percent of active cases in the U.S., though, and will soon begin to be administered to infected patients.
Monoclonal antibody drugs were considered to be the top treatment for the virus after a person was already infected, though administering the drugs is very resource intensive so officials have instead showed preference towards antiviral pills like molnupiravir and Paxlovid in recent weeks.
'Today's action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,' said Dr Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.
'This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.'
The United States has already purchased 600,000 doses of the drug for $720 million, which will be distributed for free to Americans in need. The deal was pending FDA authorization.
Before July 31, the U.S. is allowed to purchase 500,000 more doses at a pre-arraigned price.
Trials for the drug included two parts, one with a low risk and one with a high risk population group.
The low risk group included 380 people, and the drug was tested alone and alongside other similar drugs. The FDA reports the trials found a 'sustained' resolution of symptoms among people who received the drug.
A second trial for high risk individuals included 150 patients. There was no placebo group in this trial, with half the patients receiving bebtelovimab alone and half receiving it mixed with another drug.
The drug was effective at preventing hospitalization and death from Covid in the high risk group as well, and it is equally effective when used alone as it is when used along with another available monoclonal antibody drug.
Monoclonal antibody drugs were the most effective treatment against the virus until very recently when more effective, easier to administer, antiviral pills began to hit the market.
The antibodies are still valuable tools, though. The drugs pump a person's body full of virus fighting antibodies that are similar to those generated by vaccination or natural immunity from previous infection.
Those antibodies then assist a person's immune system in stopping the virus from replicating and neutralizing infected cells.
The drugs have been a favorite of some conservative politicians like former President Donald Trump and Florida Gov Ron DeSantis.
Monoclonal antibody drugs do come with some major downsides. Some experts believe a focus on them, especially in conservative circles, has given the indication that the drug can replace the vaccines - which the FDA notes is not the case.
Administering the drugs can be a challenge for hospitals as well, especially during times where they are near capacity due to case surges.
A patient receiving the drugs requires constant monitoring and also a lot of tubing and machinery. Monoclonal antibodies are also significantly more expensive than the vaccines.
The FDA pulling the drugs last month for being ineffective against Omicron was a controversial decision that DeSantis described as 'authoritarianism'.
The agency stood by its decision, though, and has no brought Eli Lilly's monoclonal antibodies back into the mix with this recent authorization.
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Could antihistamines help with long COVID?: Scientists launch study after healthcare worker took pills by accident and her symptoms eased
Antihistamines could provide relief for millions of people suffering from the painful and debilitating symptoms of long COVID that can be so severe that daily life can be affected.
The effects of COVID-19 on individuals can range from mild symptoms to several weeks of illness, but various ailments including brain fog, joint pain and fatigue can last for months after the initial infection - collectively known as long COVID.
The realization that antihistamines could provide some relief came by chance after two otherwise healthy, active middle-aged women with long COVID found that the pills helped.
Both women, who have not been identified, were taking over-the-counter antihistamines to treat other conditions.
The first woman, a healthcare worker in her 40s, triggered a dairy allergy by eating cheese, and the second woman had run out of the allergy medication she usually took, and experienced improved cognition and far less fatigue the following morning.
In the first instance, the woman with long COVID-19 was unable to do exercise and would suffer from chest pain, headaches, a rash and bruising, while the second had to deal with joint and abdominal pain, as well as the rashes and lesions known as 'COVID toes.' She is believed to have been one of the first people in the United States to fall ill with COVID.
In the first case, after accidentally eating some cheese about six months into having long COVID she took a 50 mg pill of the antihistamine diphenhydramine, and suddenly noticed her fatigue had virtually disappeared.
The woman did not take another antihistamine for 72 hours; when her symptoms reappeared, she took the medication and again found relief.
Her doctor then prescribed a daily antihistamine dosage that significantly reduced her long COVID-19 symptoms. She ultimately reported she had regained 90 percent of her pre-COVID-19 daily function. Nine months later, she is said to be still doing well.
In the second case, the woman took a different over-the-counter antihistamine as a substitute for what she had taken for years to manage her seasonal allergies.
She noticed that her long COVID-19 fatigue and overall cognition had improved. She also continued to take it daily together with other allergy medicine.
The second woman also found that she significantly reduced her additional long COVID-19 symptoms regaining 95 percent of her overall functioning, prior to contracting the illness.
Both cases were examined by nursing scholars at the University of California, Irvine with the findings published in the Journal for Nurse Practitioners.
'Patients tell us they wish more than anything that they could work and do the most basic activities they used to before they got sick with long COVID. They are desperately searching for something to help them get back on their feet,' said report author, Melissa Pinto, associate professor of nursing at UC Irvine to UCI News.
'Currently, there is no cure for [for long COVID], only symptom management. A number of options are being tried, with antihistamines being one of them. The possibility that an easy-to-access, over-the-counter medication could ease some of the symptoms should offer hope to the estimated 54 million people worldwide who have been in distress for months or even years.'
If correct, it would tally what had been found in earlier studies including those documented in the Journal of Investigative Medicine and Pulmonary Pharmacology & Therapeutics, which also showed similar benefits to using antihistamines to treat long COVID.
'Most patients tell us that providers have not recommended anything that has helped. If patients wish to try over-the-counter antihistamines, I urge them to do so under medical supervision. And because providers may not know about new potential treatments, I would encourage patients to be active in their care and consider taking research and case reports like ours to appointments with providers so they can help create a regimen that will work,' Pinto said.
'The next steps for this research into antihistamine treatment are to conduct broad-based trials in order to evaluate efficacy and to develop dosage schedules for clinical practice guidelines.'
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Astonishing list highlighting what's REALLY causing Covid-19 deaths in Australia: 'It wasn't Covid that claimed their lives'
There were 2,639 Covid-related deaths nationally between March 2020 and January 31 - of which 2,556 (96.8 per cent) had an underlying health condition - according to new figures from the Australian Bureau of Statistics.
There were 32,000 deaths from heart disease in Australia in that period, with Covid deaths making up only one per cent of all fatalities nationwide.
Another 100,000 died from cancer during those 22 months.
'We're not overplaying the situation and we're not ignoring the victims,' the 2GB host said. 'But these records expose the overblown scare campaign we've witnessed.
'Ninety-two per cent had other underlying health issues - an average of three [underlying health issues] per person. It wasn't Covid that claimed their lives.'
Those underlying health issues ranged from pneumonia to kidney infection or chronic heart illnesses, according to the ABS data.
Fordham said the health advice during Australia's lockdowns of 2020 and 2021 should have focused more on countering one of the worst Covid co-morbities- obesity.
'Why aren't we warning people that one of the biggest risk factors is carrying around too much weight,' he said. 'Were we worried about fat-shaming?'
The US, where 16 states have obesity rates of higher than 35 per cent, has the world's highest Covid death rate with 947,895 fatalities.
The 2GB host said it wasn't 'overplaying the situation' to say the new records expose 'the overblown scare campaign we've witnessed'
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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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
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Tuesday, February 15, 2022
Denial of Natural Immunity in Vaccine Mandates Unprecedented
COVID-19 injection mandates raise glaring questions, with a key one revolving around natural immunity. Your immune system is designed to work in response to exposure to an infectious agent. Your adaptive immune system, specifically, generates antibodies that are used to fight pathogens that your body has previously encountered.
If you’ve had COVID-19, the research is strong that you’re well protected against reinfection. New data from the U.S. Centers for Disease Control and Prevention even show that prior COVID-19 infection, i.e., natural immunity, is more protective than COVID-19 injections.
However, people with natural immunity continue to be discriminated against and are still expected to get double- or triple-jabbed in order to comply with vaccine mandates — an unprecedented move in history.
‘Unprecedented’ Denial of Natural Immunity
The U.S. Supreme Court recently upheld a vaccine mandate at the Centers for Medicare & Medicaid Service (CMS), which is part of the U.S. Department of Health and Human Services. The mandate affects 10.4 million health care workers employed at 76,000 medical facilities, making no exceptions for those who have natural immunity to COVID-19 due to prior infection.
Speaking with The Epoch Times, Dr. Scott Atlas, a former White House COVID-19 Task Force adviser, called the SCOTUS ruling “another denial of scientific fact,” adding:
“Our continued denial of superior protection in recovered individuals, with or without vaccination, compared to vaccinated individuals who’ve never had the infection … the denial of that is simply unprecedented in modern history. Proven fact and decades of fundamental immunology are somehow denied. If we are a society where the leaders repeatedly deny the fact, I’m very concerned about the future of such a society.”
While upholding the vaccine mandate for medical facilities that accept Medicare or Medicaid payments, SCOTUS blocked a White House mandate that would have required private companies with 100 or more employees to ensure staff have gotten a COVID-19 injection or were tested regularly for COVID-19 — or face steep fines.
The Labor Department’s Occupational Safety and Health Administration (OSHA) was supposed to be in charge of enforcing the rule, which would have affected more than 80 million U.S. workers. Of their decision, the court noted:
“Although Congress has indisputably given OSHA the power to regulate occupational dangers, it has not given that agency the power to regulate public health more broadly. Requiring the vaccination of 84 million Americans, selected simply because they work for employers with more than 100 employees, certainly falls in the latter category.”
Despite the private business vaccine mandate being struck down, the White House urged states and businesses to voluntarily enact sweeping vaccine mandates, again ignoring the fact that many people are already naturally immune.
World No. 1 tennis player Novak Djokovic is a prime example — despite previously having COVID-19, and therefore having acquired natural immunity, he was barred from playing at the Australian Open because he didn’t get the COVID-19 injection.
Natural COVID-19 Immunity Superior to Shot-Derived Immunity
Data from New York and California health officials, published in the CDC’s Morbidity and Mortality Weekly Report, show that people who had previously had COVID-19 were far better protected against COVID-19 infection with the Delta variant than people who had been jabbed. The report states:
“By the week beginning October 3, compared with COVID-19 cases rates among unvaccinated persons without a previous COVID-19 diagnosis, case rates among vaccinated persons without a previous COVID-19 diagnosis were 6.2-fold (California) and 4.5-fold (New York) lower; rates were substantially lower among both groups with previous COVID-19 diagnoses, including 29.0-fold (California) and 14.7-fold lower (New York) among unvaccinated persons with a previous diagnosis, and 32.5-fold (California) and 19.8-fold lower (New York) among vaccinated persons with a previous diagnosis of COVID-19.
During the same period, compared with hospitalization rates among unvaccinated persons without a previous COVID-19 diagnosis, hospitalization rates in California followed a similar pattern. These results demonstrate that vaccination protects against COVID-19 and related hospitalization, and that surviving a previous infection protects against a reinfection and related hospitalization.
Importantly, infection-derived protection was higher after the Delta variant became predominant, a time when vaccine-induced immunity for many persons declined because of immune evasion and immunologic waning.”
In another study, researchers reviewed studies published in PubMed and found that the risk of reinfection with SARS-CoV-2 decreased by 80.5% to 100% among people who had previously had COVID-19. Additional research cited in their review found:
Among 9,119 people who had previously had COVID-19, only 0.7% became reinfected.
At the Cleveland Clinic in Cleveland, Ohio, the incidence rate of COVID-19 among those who had not previously been infected was 4.3 per 100 people; the COVID-19 incidence rate among those who had previously been infected was zero per 100 people.
The frequency of hospitalization due to a repeated COVID-19 infection was five per14,840 people, or .03%, according to an Austrian study; the frequency of death due to a repeated infection was one per 14,840 people, or .01%.
Given these findings, the researchers concluded that previous infection status should be documented and recovered patients counseled on their risk for reinfection. They stated:
“Given the evidence of immunity from previous SARS-CoV-2 infection, however, policy makers should consider recovery from previous SARS-CoV-2 infection equal to immunity from vaccination for purposes related to entry to public events, businesses, and the workplace, or travel requirements.”
It’s Rare to Get Reinfected by SARS-CoV-2
In a letter to the editor of The New England Journal of Medicine, Dr. Roberto Bertollini of the Ministry of Public Health in Doha, Qatar, and colleagues estimated the efficacy of natural immunity against reinfection by comparing data in the national cohort.
They found that immunity acquired from previous infection was 92.3% effective against reinfection with the beta variant and 97.6% effective against reinfection with the alpha variant. Protection persisted even one year after the primary infection.
Researchers from Ireland also conducted a systematic review including 615,777 people who had recovered from COVID-19, with a maximum duration of follow-up of more than 10 months. “Reinfection was an uncommon event,” they noted, “… with no study reporting an increase in the risk of reinfection over time.” The absolute reinfection rate ranged from zero percent to 1.1%, while the median reinfection rate was just 0.27%.15,16,17
Another study revealed similarly reassuring results. It followed 43,044 SARS-CoV-2 antibody-positive people for up to 35 weeks, and only 0.7% were reinfected. When genome sequencing was applied to estimate population-level risk of reinfection, the risk was estimated at 0.1%.
Again, there was no indication of waning immunity over seven months of follow-up, with the researchers concluding, “Reinfection is rare. Natural infection appears to elicit strong protection against reinfection with an efficacy >90% for at least seven months.”
Another study from Israel also had researchers questioning “the need to vaccinate previously-infected individuals,” after their analysis showed similar risks of reinfection among those with vaccine-induced or natural immunity. Specifically, vaccination had an overall estimated efficacy of preventing reinfection of 92.8%, compared to 94.8% for natural immunity acquired via prior infection.
Evidence from Washington University School of Medicine also shows long-lasting immunity to COVID-19 exists in those who’ve recovered from the natural infection. At both seven months and 11 months after infection, most of the participants had bone marrow plasma cells (BMPCs) that secreted antibodies specific for the spike protein encoded by SARS-CoV-2.
The BMPCs were found in amounts similar to those found in people who had been vaccinated against tetanus or diphtheria, which are considered to provide long-lasting immunity. “Overall, our data provide strong evidence that SARS-CoV-2 infection in humans robustly establishes the two arms of humoral immune memory: long-lived BMPCs and memory B cells,” the researchers noted.
This is among the best available evidence of long-lasting immunity, because this immunological memory is a distinct part of the immune system that’s essential to long-term protection, beyond the initial immune response to the virus.
Getting the Shot May Be Worse After Prior Infection
If you’ve had COVID-19, getting injected may pose an even greater risk, to the extent that Dr. Hooman Noorchashm, Ph.D., a cardiac surgeon and patient advocate, has repeatedly warned the FDA that “clear and present danger” exists for those who have had COVID-19 and subsequently get the injection.
At issue are viral antigens that remain in your body after you are naturally infected. The immune response reactivated by the COVID-19 injection can trigger inflammation in tissues where the viral antigens are present. The inner lining of blood vessels, the lungs and the brain may be particularly at risk of such inflammation and damage.25 Writing in Lancet Infectious Diseases, researchers also explained:
“Some people who have recovered from COVID-19 might not benefit from COVID-19 vaccination. In fact, one study found that previous COVID-19 was associated with increased adverse events following vaccination with the Comirnaty BNT162b2 mRNA vaccine (Pfizer–BioNTech). In addition, there are rare reports of serious adverse events following COVID-19 vaccination.”
As it stands, the U.S. CDC continues to push universal injections, despite past infection status, and natural immunity is not considered adequate to enter the growing number of venues requiring vaccine passports. This isn’t the case in Switzerland, where residents who have had COVID-19 in the past 12 months are considered to be equally as protected as those who’ve been injected.
The end-goal of vaccine passports, though, isn’t to simply track one shot. Your entire identity, including your medical history, finances, sexual orientation and much more, could soon be stored in a mobile app that’s increasingly required to partake in society. While some might call this convenience, others would call it oppression.
You can fight back against vaccine mandates and their related vaccine passports by not supporting establishments that require proof of a shot or a negative test, and avoiding all digital identities and vaccine ID passports offered as a means of increasing “access” or “convenience.”
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Also see my other blogs. Main ones below:
<a href="https://edwatch.blogspot.com">http://edwatch.blogspot.com</a> (EDUCATION WATCH)
<a href="https://antigreen.blogspot.com">http://antigreen.blogspot.com</a> (GREENIE WATCH)
<a href="https://pcwatch.blogspot.com">http://pcwatch.blogspot.com</a> (POLITICAL CORRECTNESS WATCH)
<a href="https://australian-politics.blogspot.com/">http://australian-politics.blogspot.com/</a> (AUSTRALIAN POLITICS)
<a href="https://snorphty.blogspot.com/">http://snorphty.blogspot.com/</a> (TONGUE-TIED)
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Monday, February 14, 2022
Hugely important study published in Nature finds that having Covid significantly increases the long-term risk of developing a wide range of cardiovascular diseases, including heart failure, stroke, myocarditis, arrythmia, blood clots in the lungs
Long-term cardiovascular outcomes of COVID-19
Abstract
The cardiovascular complications of acute coronavirus disease 2019 (COVID-19) are well described, but the post-acute cardiovascular manifestations of COVID-19 have not yet been comprehensively characterized. Here we used national healthcare databases from the US Department of Veterans Affairs to build a cohort of 153,760 individuals with COVID-19, as well as two sets of control cohorts with 5,637,647 (contemporary controls) and 5,859,411 (historical controls) individuals, to estimate risks and 1-year burdens of a set of pre-specified incident cardiovascular outcomes. We show that, beyond the first 30 d after infection, individuals with COVID-19 are at increased risk of incident cardiovascular disease spanning several categories, including cerebrovascular disorders, dysrhythmias, ischemic and non-ischemic heart disease, pericarditis, myocarditis, heart failure and thromboembolic disease. These risks and burdens were evident even among individuals who were not hospitalized during the acute phase of the infection and increased in a graded fashion according to the care setting during the acute phase (non-hospitalized, hospitalized and admitted to intensive care). Our results provide evidence that the risk and 1-year burden of cardiovascular disease in survivors of acute COVID-19 are substantial. Care pathways of those surviving the acute episode of COVID-19 should include attention to cardiovascular health and disease.
https://www.nature.com/articles/s41591-022-01689-3
********************************************Government action caused excess Covid deaths
Here is our detailed scientific study from the best all-cause mortality data by time, age, jurisdiction, gender... compared to state-population characteristics...:
The abstract of our landmark paper is:
We investigate why the USA, unlike Canada and Western European countries, has a sustained exceedingly large mortality in the “COVID-era” occurring from March 2020 to present (October 2021). All-cause mortality by time is the most reliable data for detecting true catastrophic events causing death, and for gauging the population-level impact of any surge in deaths from any cause. The behaviour of the USA all-cause mortality by time (week, year), by age group, by sex, and by state is contrary to pandemic behaviour caused by a new respiratory disease virus for which there is no prior natural immunity in the population. Its seasonal structure (summer maxima), age-group distribution (young residents), and large state-wise heterogeneity are unprecedented and are opposite to viral respiratory disease behaviour, pandemic or not. We conclude that a pandemic did not occur.
We infer that persistent chronic psychological stress induced by the long-lasting government-imposed societal and economic transformations during the COVID-era converted the existing societal (poverty), public-health (obesity) and hot-climate risk factors into deadly agents, largely acting together, with devastating population-level consequences against large pools of vulnerable and disadvantaged residents of the USA, far above preexisting pre-COVID-era mortality in those pools. We also find a large COVID-era USA pneumonia epidemic that is not mentioned in the media or significantly in the scientific literature, which was not adequately addressed. Many COVID-19-assigned deaths may be misdiagnosed bacterial pneumonia deaths. The massive vaccination campaign (380 M administered doses, 178 M fully vaccinated individuals, mainly January-August 2021 and March-August 2021, respectively) had no detectable mitigating effect, and may have contributed to making the younger population more vulnerable (35-64 years, summer-2021 mortality).
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Britain's unethical Covid messaging must never be repeated
Dr Gary Sidley
Over the last two years – under the guise of a Covid-19 communications strategy – the British people have faced a psychologic bombardment from their own government.
Who can forget the constant images during the pandemic warning people to stay indoors to ‘save lives’, students being told that breaking the rules would be ‘killing their granny’, or the ‘Look him in the eyes’ campaign, which showed Covid patients in hospital wearing an oxygen mask, imploring people to never bend the rules and to keep a ‘safe distance’ from others. Even now, as the number of Covid cases continues to fall, we are surrounded by billboards showing black Covid particles hanging in the air like smoke, enveloping people going about their everyday lives.
The consequences of this unprecedented state-sanctioned campaign have been visible everywhere: from the old lady in the street, paralysed with fear of contamination from another human, darting into the road to avoid someone walking the other way, to the neighbour donning a face covering and plastic gloves to wheel the dustbin to the end of her drive. These kinds of incidents are the product of an intensive messaging campaign, designed by the government’s behavioural scientists, to ‘nudge’ us into compliance with the Covid-19 restrictions and the subsequent vaccine rollout.
The deployment of behavioural science as a means of inducing people to adopt what the state deems to be the ‘right’ actions gained impetus with the advent of the ‘Behavioural Insight Team’ (BIT) in 2010. From humble beginnings as a seven-person unit working with the UK government, the BIT has rapidly expanded to become a ‘social purpose company’ operating in many countries across the world.
Throughout the Covid-19 crisis, several BIT members – along with other psychologists with ‘nudging’ expertise – have been an integral part of the Scientific Pandemic Insights Group on Behaviour (SPI-B), a Sage subgroup tasked with advising government about how to maximise the impact of its pandemic communications strategy. Behavioural science expertise is also deployed across many other areas of government.
Human beings spend 99 per cent of their time on automatic pilot, making moment-by-moment decisions without conscious reflection. Although this is cognitively efficient, it also leaves us vulnerable to behavioural-science ‘nudges’ which can shape our actions without us knowing. Behavioural scientists have a range of techniques at their disposal (as described in a Cabinet Office and Institute for Government ‘Mindspace’ report published in 2010) and many of them have been woven into the Covid-19 messaging campaign.
But three particular interventions during the pandemic raise major ethical concerns: fear inflation, equating compliance with virtue and the encouragement of peer pressure to conform. The use of these covert psychological strategies infringe the basic ethical principles of psychological practice.
It can be argued that a civilised society should not strategically frighten, shame and scapegoat its citizens as a way to increase compliance. This deliberate creation of distress resembles the tactics used by regimes to eliminate beliefs and behaviours that the state thinks is deviant.
And the collateral damage associated with these methods is considerable. It is likely that fear inflation may have significantly contributed to non-Covid excess deaths recorded during the pandemic. Meanwhile, the shaming and scapegoating of the those deemed to be non-compliers has inevitable created minority outgroups (the unvaccinated, for example) that others feel empowered to vilify and verbally abuse.
Second, behavioural scientists have routinely infringed a sacrosanct cornerstone of ethical practice: the need to obtain a recipient’s informed consent prior to the delivery of a medical or psychological intervention. Professor David Halpern (chief executive of the BIT and a Sage member), co-authored the 2010 ‘Mindspace’ document that explicitly recognised the significant ethical dilemmas associated with ‘nudges’ that act subconsciously on their targets. The report noted then that ‘Policymakers wishing to use these tools… need the approval of the public to do so’. No attempt has yet been made to obtain the public’s permission to use these psychological interventions.
Attempts by psychologists and behavioural scientists to justify the use of ‘nudges’ have, to date, been inadequate and disingenuous. The British Psychological Society (BPS) – the formal guardians of ethical psychological practice in the UK – when challenged about the morality of these covert psychological strategies, claimed that members involved in these practices were exempt from seeking consent as they had acted with ‘social responsibility’. Seemingly, the BPS believes that the government’s Covid-communications strategy was intended to influence some anonymous collective rather than the actions of as many individuals as possible.
The behavioural science tentacles extend far beyond the public health domain. For example, a recent document outlining a collaboration between Sky TV and the Behavioural Insights Team, titled The Power of TV: Nudging Viewers to De-carbonise, suggests that news, drama and documentary programmes could soon be underpinned by covert messages prompting us to adopt lifestyles that enable the realisation of the zero-carbon goal. No doubt the ‘nudgers’ would argue that they are enabling the British people to do the right thing, but who decides what is ‘right’? In democratic societies desirable goals, and subsequent policies are typically included in political parties’ election manifestoes and voted for (or rejected) via the ballot box, rather than being unilaterally determined by the state.
In light of these escalating concerns about the government’s deployment of behavioural science, I – together with 54 other health professionals – have written an open letter to the Public Administration & Constitutional Affairs Committee (a Commons select committee chaired by William Wragg MP) to formally request an independent inquiry into the government’s use of covert psychological strategies. Denying individuals rational choices, and an over-reliance upon subliminal influence, is both unethical and undemocratic. Transparency regarding how government departments use ‘nudge’ techniques is now long overdue.
https://www.spectator.com.au/2022/02/britains-unethical-covid-messaging-must-never-be-repeated
***********************************************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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
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Sunday, February 13, 2022
Big controlled study of Ivermectin as a preventive
The only thing holding up official acceptance of Ivermectin is that Trump recommended it
They Just Issued Mandatory Ivermectin Use, What Happened Next…
Another proof that will slap the left about their disbelief on Ivermectin’s potential.
Previously, Dr. Volnei José Morastoni, City Mayor of Itajaí, a southern city in Brazil in the state of Santa Catarina has announced a citywide use of Ivermectin against COVID-19.
NIH Website reported that Mayor Volnei has distributed Ivermectin kits totaling 1.5 million tablets to the residents of Itajaí.
A comprehensive study confirms that regular usage of ivermectin as a prophylactic agent was associated with significantly reduced COVID-19 infection, hospitalization, and death rates. The ivermectin non-users were two times more likely to die of COVID-19 than ivermectin users in the overall population analysis.
The summary of the study:
Materials and methods: We analyzed data from a prospective, observational study of the citywide COVID-19 prevention with ivermectin program, which was conducted between July 2020 and December 2020 in Itajaí, Brazil. Study design, institutional review board approval, and analysis of registry data occurred after completion of the program. The program consisted of inviting the entire population of Itajaí to a medical visit to enroll in the program and to compile baseline, personal, demographic, and medical information. In the absence of contraindications, ivermectin was offered as an optional treatment to be taken for two consecutive days every 15 days at a dose of 0.2 mg/kg/day. In cases where a participating citizen of Itajaí became ill with COVID-19, they were recommended not to use ivermectin or any other medication in early outpatient treatment. Clinical outcomes of infection, hospitalization, and death were automatically reported and entered into the registry in real-time. Study analysis consisted of comparing ivermectin users with non-users using cohorts of infected patients propensity scores matched by age, sex, and comorbidities. COVID-19 infection and mortality rates were analyzed with and without the use of propensity score matching (PSM).
Results: Of the 223,128 citizens of Itajaí considered for the study, a total of 159,561 subjects were included in the analysis: 113,845 (71.3% of the population above 18 years old) regular ivermectin users and 45,716 (23.3%) non-users. Of these, 4,311 ivermectin users were infected, among which 4,197 were from the city of Itajaí (3.7% infection rate), and 3,034 non-users (from Itajaí) were infected (6.6% infection rate), with a 44% reduction in COVID-19 infection rate (risk ratio [RR], 0.56; 95% confidence interval (95% CI), 0.53-0.58; p < 0.0001). Using PSM, two cohorts of 3,034 subjects suffering from COVID-19 infection were compared. The regular use of ivermectin led to a 68% reduction in COVID-19 mortality (25 [0.8%] versus 79 [2.6%] among ivermectin non-users; RR, 0.32; 95% CI, 0.20-0.49; p < 0.0001). When adjusted for residual variables, reduction in mortality rate was 70% (RR, 0.30; 95% CI, 0.19-0.46; p < 0.0001). There was a 56% reduction in hospitalization rate (44 versus 99 hospitalizations among ivermectin users and non-users, respectively; RR, 0.44; 95% CI, 0.31-0.63; p < 0.0001). After adjustment for residual variables, reduction in hospitalization rate was 67% (RR, 0.33; 95% CI, 023-0.66; p < 0.0001).
Of the 113,845 prophylaxed subjects from the city of Itajaí, 4,197 had a positive RT-PCR SARS-CoV-2 (3.7% infection rate), while 3,034 of the 37,027 untreated subjects had positive RT-PCR SARS-CoV-2 (6.6% infection rate), a 44% reduction in COVID-19 infection rate (risk ratio [RR], 0.56; 95% confidence interval (95% CI), 0.53-0.58; p < 0.0001). An addition of 114 subjects who used ivermectin and were infected was originally from other cities but was registered as part of the program, in a total of 4,311 positive cases among ivermectin users. For the present analysis, the 4,311 positive cases among subjects that used ivermectin and 3,034 cases among subjects that did not use ivermectin were considered. After PSM, two cohorts of 3,034 subjects were created.
Baseline characteristics of the 7,345 subjects included before PSM and the baseline characteristics of the 6,068 subjects in the matched groups are shown in Table 1. Prior to PSM, ivermectin users had a higher percentage of subjects over 50 years old (p < 0.0001), higher prevalence of T2D (p = 0.0004), hypertension (p < 0.0001), and CVD (p = 0.03), and a higher percentage of Caucasians (p = 0.004), than non-users. After PSM, all baseline parameters were similar between groups
After employing PSM, of the 6,068 subjects (3,034 in each group), there were 44 hospitalizations among ivermectin users (1.6% hospitalization rate) and 99 hospitalizations (3.3% hospitalization rate) among ivermectin non-users, a 56% reduction in hospitalization rate (RR, 0.44; 95% CI, 0.31-0.63). When adjustment for variables was employed, the reduction in hospitalization rate was 67% (RR, 0.33; 95% CI, 023-0.66; p < 0.0001).
https://dailyheadlines.net/they-just-issued-mandatory-ivermectin-use-what-happened-next/
***********************************************Where do we stand with Omicron?
There has been a flood of new data in the past few weeks regarding Omicron’s impact throughout the world, and specifically on the influence of vaccination (with or without boosters) on symptomatic infections, hospitalizations, and deaths, including durability. It’s actually remarkable how much and how quickly we are learning about Omicron and our ability to reduce its toll, considering this virus strain was reported less than 2 months ago.
The New Data
Clearly, there’s a major problem with vaccine breakthrough Omicron infections. Recall that with a booster vs Delta, the vaccine effectiveness was restored to ~95% as Ravin Gupta and I recently reviewed all of the reported studies in Science
The problem with the booster with Omicron is that instead of getting vaccine effectiveness vs infections (symptomatic or all) up to 95%, it is about 50% from 4 new reports, summarized in this Table. To date, the best study comes from Qatar with over 400,000 people boosted with either Pfizer or mRNA
The Math
That level—about 50% effectiveness for the booster (vs Omicron)—would be associated with 10-fold more breakthrough infections than seen with a 95% effectiveness (Delta) So it’s no wonder there is the public perception that Omicron breakthroughs are omnipresent, that “vaccines aren’t working”. They aren’t working well, but it isn’t true that they’re not working to protect vs infections and transmission. It’s just much less. For context, remember that the FDA criteria for approving a Covid vaccine was set at a 50% reduction of symptomatic infections, so there’s unquestionably some efficacy here, just not nearly what we’ve been accustomed to seeing.
As I was quoted in the Washington Post coverage, “A booster is essential for preventing severe disease, hospitalization and deaths,” said Eric Topol, a molecular medicine professor at Scripps Research, referring to the findings. Public health officials need to communicate clearly that although the vaccines and booster shots are “not holding up against omicron infections, they are holding up the wall against severe disease … and that’s phenomenal.”
Now let’s turn to hospitalizations where the data are extraordinary, consistent, potent protection, and by all we have to go on, very durable. There are 3 reports: the UKHSA, the Kaiser Permanente Southern California, and the new CDC MMWR as summarized in this Table. It is exceptionally rare to see such consistency in triplicate—88, 89, and 90 for booster effectiveness vs Omicron. That is substantially improved compared with 2 shots (44-68%). And, importantly, it appears to be quite durable (83-90%) after 3 months, an attrition level fully in keeping with what we have seen over time with the Delta variant. As I previously wrote, We’re very lucky. Damn lucky.
This new CDC graph compares the effectiveness of vaccination with or without a booster against Delta and Omicron hospitalizations. The 3rd dose gets to near parity for the 2 strains even though Omicron is the most immune evasive variant we’ve seen., with far more extensive waning of protection that with Delta.
There really is an Omicron booster vaccination dichotomy—protection vs infections vs protection vs severe disease (hospitalizations and deaths)—that has led to much confusion. The booster’s effect is dual: it induces neutralizing antibodies at high levels and expands memory B and T cells as previously reviewed. The latter is what really accounts for protection vs severe disease, and that also would be expected to be quite durable. Which makes the case that the 3rd shot may be long-lasting for such benefit, at least against Omicron. Early in the pandemic we focused on symptomatic infections (there primary endpoint of the pivotal clinical trials) since they tracked so closely with severe disease outcomes. That relationship markedly changed with Omicron; they are now dissociated to a substantial degree.
The new Israeli data for a 4th dose (2nd booster) vs the initial booster during its Omicron wave shows a similar pattern of reduction of infections (very) short term, but we await data regarding hospitalizations and deaths, which are incubating.
The Patterns
It is quite clear in reviewing the patterns from some of countries hit hard by Omicron that vaccination and booster rates are playing a critical role in keeping severe disease in check. One example is Portugal, with 90% 2-shot vaccinated and over 40% boosted. New cases have gotten extremely high during its Omicron wave, but the impact for ICU admits or deaths, fortunately, has been small to date.
Similar patterns, perhaps less pronounced with respect to the case vs ICU/deaths dissociation, are evident in Denmark, Ireland, and the United Kingdom, all going through Omicron waves.
However, this is a very different look from the United States, where hospitalizations have soared to a new record, ICU admits are close to their pre-vaccination phase peak, and deaths are again on a steep rise (nearly 4,000 reported yesterday, one of the highest for the US pandemic). These severe disease outcomes are likely a function of very low vaccination rates (63%) and booster rate (24%) compared with the European countries cited. It is also noteworthy that the United States was into its second Delta surge at the time when Omicron emerged in December, so these increases are superimposed. Further, in comparison to South Africa and some other countries, there are different demographics, such as age, and co-existing conditions, such as obesity or diabetes.
There’s been a lot written about Omicron’s sharp case descent, which was seen in Gauteng and throughout South Africa. But it isn’t so clearcut in other countries yet, especially normalized for reduced testing. It actually is somewhat wobbly, stuttering in the United Kingdom, one of the first countries outside of South Africa to begin its descent. So Omicron’s future trajectory isn’t clear, and we cannot rule out 2nd surges of Omicron at this point in places around the world. That occurrence may be influenced, at least in part, by the immunity wall built prior to and during the Omicron wave (from prior Covid, vaccinations and boosters), and only time will tell.
The Exit?
So where do we go from here? Is Omicron, by infecting “up to half the world’s population” going to serve as our exit ramp from pandemic to a contained, endemic state?
That isn’t clear and it would be foolish to predict that, even though that occurred this week Omicron’s going to help in building an immunity wall, but whether that will be sufficient is indeterminate. We’re so far from containing the virus at this point, enabling further accelerate evolution to a new variant that could potentially have a higher level of immune evasion (not so lucky as with Omicron), more fully evading our current vaccines, or even the Omicron-specific vaccine expected later this year.
That is why it’s so essential to push on the pan-coronavirus vaccine, oral and nasal vaccines that build mucous immunity and help block transmission, and get mass production of Paxlovid along with other safe and effective anti-Covid pills that are very likely variant-proof, not relying on our immune system.
As the Washington Post editorial board wrote today, and which I’m in total agreement":
“Ultimately, in chasing variants, we are always going to be behind the curve. Along with the immediate battle with omicron, renewed effort must be made to develop next-generation vaccines that will provide broader and longer protection and dampen transmission. Ideally, scientists will develop a universal coronavirus vaccine that encompasses all of these characteristics, capable of protecting against many — or all — known variants. That day cannot come soon enough.”
Now is not the time to rely on sharp descents and that somehow “it’s over". If that happens, and we quickly get to containment and low levels of circulating virus that are no more threatening than annual flu, terrific. It seems quite unlikely with so much of the world’s population, especially in low and middle income countries, have yet to be vaccinated. If there's one thing we learned about predicting the path of SARS-CoV-2, it’s that it’s unpredictable. So we shouldn’t plan on a rosy picture. There’s too much we can do right now to seize control in case the most optimistic scenarios don’t play out.
https://erictopol.substack.com/p/where-do-we-stand-with-omicron (See the original for graphics)
***********************************************
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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
*************************************
Friday, February 11, 2022
Scripps Research discovery could enable broad coronavirus vaccine
LA JOLLA, CA—The COVID-causing virus SARS-CoV-2 harbors a vulnerable site at the base of its spike protein that is found also on closely related coronaviruses, according to a new study from Scripps Research. The discovery, published Feb 8 in Science Translational Medicine, could inform the design of broad-acting vaccines and antibody therapies capable of stopping future coronavirus pandemics.
The scientists had previously isolated an antibody from a COVID-19 survivor that can neutralize not only SARS-CoV-2 but also several other members of the family of coronaviruses known as beta-coronaviruses. In the new work, they mapped at atomic scale the site, or “epitope,” to which the antibody binds on the SARS-Cov-2 spike protein. They showed that the same epitope exists on other beta coronaviruses, and demonstrated with animal models that the antibody is protective against the effects of SARS-CoV-2 infection.
“We’re hopeful that the identification of this epitope will help us develop vaccines and antibody therapies that work against all beta-coronaviruses, including coronaviruses that may jump from animals to humans in the future,” says study co-senior author Raiees Andrabi, PhD, an institute investigator in the Department of Immunology and Microbiology at Scripps Research.
Beta-coronaviruses have emerged recently as major, ongoing threats to public health. These coronaviruses include SARS-CoV-1, which killed about 800 people, mostly in Asia, in a series of outbreaks in 2002-04; MERS-CoV, which has killed about 900 people, mostly in the Middle East, since 2012; and, of course, SARS-CoV-2, which by now has killed over 5 million people worldwide in the COVID-19 pandemic. Two other beta coronaviruses, HCoV-HKU1 and HCoV-OC43, cause only common colds, but are suspected of having caused deadly pandemics centuries ago, when they first jumped from animals to humans. Researchers widely believe that future coronavirus pandemics initiated by animal-to-human spread are inevitable.
That prospect has spurred efforts towards the development of a pan-beta-coronaviral vaccine or antibody therapy. Scripps researchers took an initial step in that direction in 2020 when they identified an antibody, in a blood sample from a COVID-19 survivor, that could neutralize both SARS-CoV-2 and SARS-CoV-1. Although neutralizing tests weren’t available for all other beta-coronaviruses, they found that the antibody at least bound to most of these viruses.
In the new study, the team used X-ray crystallography and other techniques to precisely map the antibody’s binding site on the SARS-CoV-2 spike protein. They showed that the same site is found on most other beta coronaviruses—which helps explain the antibody’s broad effect on these viruses.
“The site is on the stem of the viral spike protein and is part of the ‘machinery’ the virus uses to fuse with cell membranes in its human or animal hosts after the virus has initially bound to a cell-surface receptor,” says study co-senior author Dennis Burton, PhD, Chair of the Department of Immunology and Microbiology at Scripps Research. “Fusion allows the viral genetic material to enter and take over host cells, and the crucial role of this machinery explains why the site is consistently present across beta-coronaviruses.”
By contrast, the receptor binding site at the top of the viral spike protein mutates relatively rapidly and thus tends to vary greatly from one beta-coronavirus to the next—making it a poor target for broad beta-coronavirus vaccines or antibody therapies.
The researchers now are following up with efforts to find other, perhaps even more broadly effective antibodies, in their search for optimal antibodies and vaccines against coronaviruses.
Decades-Old Drug May Help Protect Against Severe COVID-19 Symptoms: Study
A drug that was approved by U.S. regulators more than 70 years ago may help protect against two major COVID-19 symptoms, according to a new study.
Disulfiram, approved to treat alcoholism, protected rodents infected with COVID-19 from lung injury in the preclinical study done by researchers at Weill Cornell Medicine and Cold Spring Harbor Laboratory.
Certain white blood cells called neutrophils form inside some people suffering from COVID-19, damaging the lungs. No drugs have yet been found to prevent this from happening, researchers said.
Disulfiram, though, dramatically reduced the formation of neutrophil extracellular traps (NET), which cause fluid to accumulate in the lungs and sometimes lead to blood clots.
Researchers dosed the mice with disulfiram a day before and three hours after infecting them with the virus that causes COVID-19. Some 95 percent of those mice survived, compared to 40 percent not treated with the drug.
The new study and a previous one that linked disulfiram with reduced NET formation and improved survival “suggest that disulfiram could be useful in the management of pathologies involving NETs, including lung injuries, sepsis, thrombosis, and cancer,” the researchers said in the paper, which was published by The Journal of Clinical Investigation on Feb. 8.
“As we learn more about the underlying biology of these lung injuries, we may be able to specifically target the processes that are damaging the lung tissue,” Dr. Robert Schwartz, an associate professor of medicine in the gastroenterology and hepatology division at Weill Cornell Medicine, said in a statement.
“Currently there aren’t any good treatment options for COVID-related lung injury, so disulfiram appears to be worth investigating further in this regard, particularly in severe COVID-19 patients.”
Disulfiram has previously been associated in observational studies with lowering the risk of infection from SARS-CoV-2, also known as the CCP virus, which causes COVID-19.
One study of the drug in human patients with moderate COVID-19 was completed in 2021, but results haven’t yet been posted. A separate trial testing the drug against COVID-19 in humans has not yet been completed.
The new study was funded by the Cold Spring Harbor Laboratory Cancer Center and the Pershing Square Foundation, among other institutions.
Other drugs approved for different uses have shown some success against COVID-19, including ivermectin, hydroxychloroquine, and fluvoxamine, though U.S. health officials primarily recommend ones such as paxlovid that are specifically approved for combating the illness.
************************************************
‘There’s No Law’: Physician Experienced in Investigating Biological Warfare Challenges Medical Board’s Misinformation Allegation
Though Dr. Meryl Nass, a board-certified internal medicine physician, has been untangling narratives of dis- and misinformation long before COVID-19, it wasn’t until recently that her license was temporarily suspended under the allegation that she is now spreading it.
Her research has brought her before Congress and state legislatures to give testimonies on bioterrorism, Gulf War syndrome, and vaccine safety.
Throughout her career, she’s consulted for international health and intelligence agencies regarding prevention, investigation, and mitigation of chemical and biological warfare and pandemics.
She spent three years investigating what had been deemed a naturally occurring anthrax outbreak during Rhodesia’s civil war.
Nass was able to prove that it was due to biological warfare, with her findings published in a 1992 paper that marked a new achievement in scientific research.
“This was important because it was the first time in history potential perpetrators learned they could be identified,” Nass told The Epoch Times. “You couldn’t just start an epidemic somewhere and assume that no one was ever going to prove it because there wasn’t any scientific way to prove that it was done. I established that way.”
She was the main author, along with Robert F. Kennedy Jr. (author of “The Real Anthony Fauci”) and Children’s Health Defense, of a citizen’s petition to the Food and Drug Administration (FDA) and its vaccine advisory committee regarding the authorization of COVID vaccines and why she said they’re not suitable for children.
As censorship and disinformation have thickened around the COVID narrative, Nass has followed and written about the suppression of early-treatment medication such as hydroxychloroquine and ivermectin.
Given this background, the Maine Medical Board of Licensure nevertheless saw it appropriate to charge Nass—a physician for 41 years—with misinformation, an allegation that came with no explanation as to what misinformation she was spreading.
“Never before has any censorship been imposed by a collection of organizations who are attempting to make law by whining in unison about misinformation with threats to licenses and board certifications—while there is no legal mechanism by which they can strip certification,” Nass said. “There are no rules, regulations, or laws underpinning the threats of punishment for ‘spreading misinformation.’”
The Maine Medical Board of Licensure didn’t respond to The Epoch Times’ request for comment.
**********************************************
Big Tech Censored Dozens of Doctors, More Than 800 Accounts for COVID-19 ‘Misinformation,’ Study Finds
Major technology companies and social media platforms have removed, suppressed or flagged the accounts of more than 800 prominent individuals and organizations, including medical doctors, for COVID-19 “misinformation,” according to a new study from the Media Research Center.
The study focused on acts of censorship on major social media platforms and online services, including Facebook, YouTube, Instagram, Twitter, LinkedIn, Google Ads, and TikTok.
Instances of censorship included Facebook’s decision to flag the British Medical Journal with a “fact check” and “missing context” label, reducing the visibility of a post, for a study delving into data-integrity issues with a Pfizer vaccine clinical trial.
Facebook also deleted the page of the Great Barrington Declaration, an open letter led by dozens of medical professionals, including Dr. Jay Battacharya, a Stanford epidemiologist, and Dr. Martin Kulldorff, a former employee of the Centers for Disease Control and Prevention, which advocated for less restrictive measures to address the dangers of COVID-19.
“Big Tech set up a system where you can’t disagree with ‘the science’ even though that’s the foundation of the scientific method,” Dan Gainor, MRC vice president of Free Speech America, told the Daily Caller National Foundation. “If doctors and academic journals can’t debate publicly, then it’s not science at all. It’s ‘religion.’”
Big Tech also scrubbed podcast host Joe Rogan’s interviews with scientists Dr. Peter McCullough and Dr. Robert Malone, the latter of whom was instrumental in pioneering mRNA technology. Twitter banned Malone from its platform permanently in late December over the virologist’s tweets questioning the efficacy and safety of the COVID-19 vaccine.
“We tallied 32 different doctors who were censored, including mRNA vaccine innovator Dr. Robert Malone,” Gainor said. “Censoring views of credentialed experts doesn’t ensure confidence in vaccines. It undermines faith in government COVID-19 strategies.“
In addition to medical doctors, the study examined instances in which members of Congress were censored by tech platforms.
These included an incident last August in which YouTube suspended Sen. Rand Paul, R-Ky., for posting a video arguing that “cloth masks” are not effective against the coronavirus, a view later echoed by many prominent medical commentators.
Twitter also flagged a tweet from Rep. Thomas Massie, R-Ky., in which he wrote “studies show those with natural immunity from a prior infection are much less likely to contract and spread COVID than those who only have vaccine-induced immunity.”
The study also examined Big Tech censorship of prominent media personalities, such as Rogan, Tucker Carlson, and Dan Bongino.
***********************************************
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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
*************************************
LA JOLLA, CA—The COVID-causing virus SARS-CoV-2 harbors a vulnerable site at the base of its spike protein that is found also on closely related coronaviruses, according to a new study from Scripps Research. The discovery, published Feb 8 in Science Translational Medicine, could inform the design of broad-acting vaccines and antibody therapies capable of stopping future coronavirus pandemics.
The scientists had previously isolated an antibody from a COVID-19 survivor that can neutralize not only SARS-CoV-2 but also several other members of the family of coronaviruses known as beta-coronaviruses. In the new work, they mapped at atomic scale the site, or “epitope,” to which the antibody binds on the SARS-Cov-2 spike protein. They showed that the same epitope exists on other beta coronaviruses, and demonstrated with animal models that the antibody is protective against the effects of SARS-CoV-2 infection.
“We’re hopeful that the identification of this epitope will help us develop vaccines and antibody therapies that work against all beta-coronaviruses, including coronaviruses that may jump from animals to humans in the future,” says study co-senior author Raiees Andrabi, PhD, an institute investigator in the Department of Immunology and Microbiology at Scripps Research.
Beta-coronaviruses have emerged recently as major, ongoing threats to public health. These coronaviruses include SARS-CoV-1, which killed about 800 people, mostly in Asia, in a series of outbreaks in 2002-04; MERS-CoV, which has killed about 900 people, mostly in the Middle East, since 2012; and, of course, SARS-CoV-2, which by now has killed over 5 million people worldwide in the COVID-19 pandemic. Two other beta coronaviruses, HCoV-HKU1 and HCoV-OC43, cause only common colds, but are suspected of having caused deadly pandemics centuries ago, when they first jumped from animals to humans. Researchers widely believe that future coronavirus pandemics initiated by animal-to-human spread are inevitable.
That prospect has spurred efforts towards the development of a pan-beta-coronaviral vaccine or antibody therapy. Scripps researchers took an initial step in that direction in 2020 when they identified an antibody, in a blood sample from a COVID-19 survivor, that could neutralize both SARS-CoV-2 and SARS-CoV-1. Although neutralizing tests weren’t available for all other beta-coronaviruses, they found that the antibody at least bound to most of these viruses.
In the new study, the team used X-ray crystallography and other techniques to precisely map the antibody’s binding site on the SARS-CoV-2 spike protein. They showed that the same site is found on most other beta coronaviruses—which helps explain the antibody’s broad effect on these viruses.
“The site is on the stem of the viral spike protein and is part of the ‘machinery’ the virus uses to fuse with cell membranes in its human or animal hosts after the virus has initially bound to a cell-surface receptor,” says study co-senior author Dennis Burton, PhD, Chair of the Department of Immunology and Microbiology at Scripps Research. “Fusion allows the viral genetic material to enter and take over host cells, and the crucial role of this machinery explains why the site is consistently present across beta-coronaviruses.”
By contrast, the receptor binding site at the top of the viral spike protein mutates relatively rapidly and thus tends to vary greatly from one beta-coronavirus to the next—making it a poor target for broad beta-coronavirus vaccines or antibody therapies.
The researchers now are following up with efforts to find other, perhaps even more broadly effective antibodies, in their search for optimal antibodies and vaccines against coronaviruses.
https://www.science.org/doi/10.1126/scitranslmed.abi9215
*********************************************Decades-Old Drug May Help Protect Against Severe COVID-19 Symptoms: Study
A drug that was approved by U.S. regulators more than 70 years ago may help protect against two major COVID-19 symptoms, according to a new study.
Disulfiram, approved to treat alcoholism, protected rodents infected with COVID-19 from lung injury in the preclinical study done by researchers at Weill Cornell Medicine and Cold Spring Harbor Laboratory.
Certain white blood cells called neutrophils form inside some people suffering from COVID-19, damaging the lungs. No drugs have yet been found to prevent this from happening, researchers said.
Disulfiram, though, dramatically reduced the formation of neutrophil extracellular traps (NET), which cause fluid to accumulate in the lungs and sometimes lead to blood clots.
Researchers dosed the mice with disulfiram a day before and three hours after infecting them with the virus that causes COVID-19. Some 95 percent of those mice survived, compared to 40 percent not treated with the drug.
The new study and a previous one that linked disulfiram with reduced NET formation and improved survival “suggest that disulfiram could be useful in the management of pathologies involving NETs, including lung injuries, sepsis, thrombosis, and cancer,” the researchers said in the paper, which was published by The Journal of Clinical Investigation on Feb. 8.
“As we learn more about the underlying biology of these lung injuries, we may be able to specifically target the processes that are damaging the lung tissue,” Dr. Robert Schwartz, an associate professor of medicine in the gastroenterology and hepatology division at Weill Cornell Medicine, said in a statement.
“Currently there aren’t any good treatment options for COVID-related lung injury, so disulfiram appears to be worth investigating further in this regard, particularly in severe COVID-19 patients.”
Disulfiram has previously been associated in observational studies with lowering the risk of infection from SARS-CoV-2, also known as the CCP virus, which causes COVID-19.
One study of the drug in human patients with moderate COVID-19 was completed in 2021, but results haven’t yet been posted. A separate trial testing the drug against COVID-19 in humans has not yet been completed.
The new study was funded by the Cold Spring Harbor Laboratory Cancer Center and the Pershing Square Foundation, among other institutions.
Other drugs approved for different uses have shown some success against COVID-19, including ivermectin, hydroxychloroquine, and fluvoxamine, though U.S. health officials primarily recommend ones such as paxlovid that are specifically approved for combating the illness.
************************************************
‘There’s No Law’: Physician Experienced in Investigating Biological Warfare Challenges Medical Board’s Misinformation Allegation
Though Dr. Meryl Nass, a board-certified internal medicine physician, has been untangling narratives of dis- and misinformation long before COVID-19, it wasn’t until recently that her license was temporarily suspended under the allegation that she is now spreading it.
Her research has brought her before Congress and state legislatures to give testimonies on bioterrorism, Gulf War syndrome, and vaccine safety.
Throughout her career, she’s consulted for international health and intelligence agencies regarding prevention, investigation, and mitigation of chemical and biological warfare and pandemics.
She spent three years investigating what had been deemed a naturally occurring anthrax outbreak during Rhodesia’s civil war.
Nass was able to prove that it was due to biological warfare, with her findings published in a 1992 paper that marked a new achievement in scientific research.
“This was important because it was the first time in history potential perpetrators learned they could be identified,” Nass told The Epoch Times. “You couldn’t just start an epidemic somewhere and assume that no one was ever going to prove it because there wasn’t any scientific way to prove that it was done. I established that way.”
She was the main author, along with Robert F. Kennedy Jr. (author of “The Real Anthony Fauci”) and Children’s Health Defense, of a citizen’s petition to the Food and Drug Administration (FDA) and its vaccine advisory committee regarding the authorization of COVID vaccines and why she said they’re not suitable for children.
As censorship and disinformation have thickened around the COVID narrative, Nass has followed and written about the suppression of early-treatment medication such as hydroxychloroquine and ivermectin.
Given this background, the Maine Medical Board of Licensure nevertheless saw it appropriate to charge Nass—a physician for 41 years—with misinformation, an allegation that came with no explanation as to what misinformation she was spreading.
“Never before has any censorship been imposed by a collection of organizations who are attempting to make law by whining in unison about misinformation with threats to licenses and board certifications—while there is no legal mechanism by which they can strip certification,” Nass said. “There are no rules, regulations, or laws underpinning the threats of punishment for ‘spreading misinformation.’”
The Maine Medical Board of Licensure didn’t respond to The Epoch Times’ request for comment.
**********************************************
Big Tech Censored Dozens of Doctors, More Than 800 Accounts for COVID-19 ‘Misinformation,’ Study Finds
Major technology companies and social media platforms have removed, suppressed or flagged the accounts of more than 800 prominent individuals and organizations, including medical doctors, for COVID-19 “misinformation,” according to a new study from the Media Research Center.
The study focused on acts of censorship on major social media platforms and online services, including Facebook, YouTube, Instagram, Twitter, LinkedIn, Google Ads, and TikTok.
Instances of censorship included Facebook’s decision to flag the British Medical Journal with a “fact check” and “missing context” label, reducing the visibility of a post, for a study delving into data-integrity issues with a Pfizer vaccine clinical trial.
Facebook also deleted the page of the Great Barrington Declaration, an open letter led by dozens of medical professionals, including Dr. Jay Battacharya, a Stanford epidemiologist, and Dr. Martin Kulldorff, a former employee of the Centers for Disease Control and Prevention, which advocated for less restrictive measures to address the dangers of COVID-19.
“Big Tech set up a system where you can’t disagree with ‘the science’ even though that’s the foundation of the scientific method,” Dan Gainor, MRC vice president of Free Speech America, told the Daily Caller National Foundation. “If doctors and academic journals can’t debate publicly, then it’s not science at all. It’s ‘religion.’”
Big Tech also scrubbed podcast host Joe Rogan’s interviews with scientists Dr. Peter McCullough and Dr. Robert Malone, the latter of whom was instrumental in pioneering mRNA technology. Twitter banned Malone from its platform permanently in late December over the virologist’s tweets questioning the efficacy and safety of the COVID-19 vaccine.
“We tallied 32 different doctors who were censored, including mRNA vaccine innovator Dr. Robert Malone,” Gainor said. “Censoring views of credentialed experts doesn’t ensure confidence in vaccines. It undermines faith in government COVID-19 strategies.“
In addition to medical doctors, the study examined instances in which members of Congress were censored by tech platforms.
These included an incident last August in which YouTube suspended Sen. Rand Paul, R-Ky., for posting a video arguing that “cloth masks” are not effective against the coronavirus, a view later echoed by many prominent medical commentators.
Twitter also flagged a tweet from Rep. Thomas Massie, R-Ky., in which he wrote “studies show those with natural immunity from a prior infection are much less likely to contract and spread COVID than those who only have vaccine-induced immunity.”
The study also examined Big Tech censorship of prominent media personalities, such as Rogan, Tucker Carlson, and Dan Bongino.
***********************************************
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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
*************************************
Thursday, February 10, 2022
Matters of concern in the defense data dump
"Data appears to show a marked increase in 2021 in conditions that have been observed to be *side effects* of the COVID-19 vaccines"
By ROBERT W. MALONE
These are dangerous times, and we are in a 21st century global information war. Cannon balls are flying, and there are false flag operations and concern trollery to the left, right and center of us. And yet onward we ride. The Light Brigade.
And then unexpectedly, onto the public stage, steps Drs. Samuel Sigoloff, Peter Chambers, and Theresa Long. Department of Defense whistleblowers who downloaded a massive trove of unclassified data (to download the Excel file see the link “Data from the Defense Medical Epidemiology Database (DMED) shows”) on the incidence of various diseases before and after the onset of illegal forced genetic COVID-19 vaccination of our military forces.
Now these are basically raw data from the Defense Medical Epidemiological Database (DMED). For the detail oriented, this is the scrubbed and de-identified (HIPAA compliant) database derived from the Defense Medical Surveillance System (DMSS), which pulls directly from patient records and other US Department of Defense-related medical record information streams. These data were pulled with full chain-of-custody documentation based on various CPT codes that are related to known genetic COVID-19 vaccine side effects.
As raw data, this information needs to be reviewed with care and considered to be both rough and preliminary. For the uninitiated, there are major risks associated with reliance on large, raw (uncorrected) data sets for retrospective (backwards in time) data analyses. The key technical term here is “confounding variables”, but data entry errors (such as multiple entries for the same diagnostic event) or process changes can also introduce huge sources of bias into large data sets like this. With raw data, it is most useful to consider any data plotting to be sort of a first draft, useful for identifying potential trends or topics that deserve more detailed analysis. But sometimes, when the observed effect size in the raw data is very large or potentially important, alarm bells start ringing even before full analysis is completed. And that seems to be the case with these data.
Nick Hudson, the Chairman of the South African PANDATA group (a leader in providing accurate data analysis throughout this pandemic), summarizes the situation like this “The DMED record data appears to show a marked increase in 2021 in conditions that have been observed to be side effects of the COVID-19 vaccines. For many of these, mechanistic explanations have been established or at least proposed. It is important to rule out distortions owing to recent changes to the system, such as increased coverage (for example, broader selections of personnel or inclusion of family members), changes in handling of multiple records from single cases, and changes in propensity to report owing to changes in policy, access to the system, participating entities or recent advisories or advertising of the system. An instructive test would be to check that we do not see a similar rise for conditions that could not plausibly exhibit a significant association with the vaccines, such as broken legs or burns. This is especially important since the total reports of diseases and injuries have apparently risen by an order of magnitude, which would suggest extremely high prevalence of adverse events among a population that is likely healthier and fitter than the general population. The data are presented in summary format. Underlying data with dates and depersonalized patient indices, together with vaccination records for the population covered by the database would likely deliver swift and incisive conclusions.”
Now for some reason, although this database has apparently been managed for years by the same NIH subcontractor, and has been included in the CDC datasets including those reviewed by the CDC’s COVID-19 Vaccine Safety Technical (VaST) Work Group, the geniuses that have been managing it have never identified any issues before the whistleblowers grabbed this download. Does not inspire confidence, no matter what the final “official” explanation becomes.
Based on this presentation dated 04 February, Slides 3 and 13 both indicate that Fauci and colleagues at the NIH are working with the DoD, and the data from the DMED database was being shared. This makes it VERY difficult to argue that Fauci did not know this data. It also makes it even harder to believe that, with all these agencies watching the same data, no one thought the historical data was incorrect until the whistleblowers sounded their alert.
Despite this, as the data entered the public sphere with the “second opinion” public Senate hearing convened by Senator Ron Johnson, the DoD saw fit to communicate with Politifact rather than the Senator, providing the following statement:
“But Peter Graves, spokesperson for the Defense Health Agency’s Armed Forces Surveillance Division, told PolitiFact by email that "in response to concerns mentioned in news reports" the division reviewed data in the DMED "and found that the data was incorrect for the years 2016-2020."
Officials compared numbers in the DMED with source data in the DMSS and found that the total number of medical diagnoses from those years "represented only a small fraction of actual medical diagnoses." The 2021 numbers, however, were up-to-date, giving the "appearance of significant increased occurrence of all medical diagnoses in 2021 because of the underreported data for 2016-2020," Graves said.
The DMED system has been taken offline to "identify and correct the root-cause of the data corruption," Graves said.”
As noted above, among the many curious aspects of this statement is that the CDC VaST has apparently been monitoring these data for years, and never identified this “data corruption” as an issue.
So, what do the original data show (prior to Defense Health Agency’s Armed Forces Surveillance Division correction of the “data corruption”)?
In reviewing these data, what we see are baseline data from 2016 to 2019 (pre SARS-CoV-2/COVID-19), 2020 (the first year of SARS-CoV-2/COVID-19 when no vaccines were available), and 2021 (the year that vaccines were available and mandated for the US Military).
As noted above, there are many potential confounding variables, but whatever the cause, if these data are not due to longstanding and previously undiscovered “data corruption”, then we have a major issue with the overall health of our armed services.
And if they are due to previously undiscovered “data corruption”, why wasn’t someone running around with their pants on fire trying to figure out what is going on here long before the whistleblowers brought this to national attention?
Covid drugs a booster for Pfizer sales
As Pfizer forecasts strong sales this year for its Covid-19 vaccine and treatment, the drugmaker is on the hunt for deals to bolster its pipeline of experimental products.
Pfizer said on Tuesday night that surging sales of its Covid-19 treatment and continued demand for its shots should boost the company’s revenue to around $US100bn ($140bn) this year. The company estimated that sales of its antiviral pill Paxlovid will reach about $US22bn while the vaccine will add $US32bn.
That is on top of last year’s sales of $US36.8bn for the vaccine, also known as Comirnaty, the highest annual sales total for any pharmaceutical product. Paxlovid sales last year totalled $US76m.
The company has done a handful of recent acquisitions and partnerships to bolster its pipeline of drugs and vaccines, including several partnerships announced last month to boost its growing mRNA business. In December, Pfizer said it would acquire Arena Pharmaceuticals for $US6.7bn. Pfizer says it has invested $US25bn on business development since 2019.
With a growing chest of cash, Pfizer says its deal-making strategy will focus on drugs in early and late-stage development in areas the company is already focusing on, such as oncology, immunology and rare diseases. The New York-based drugmaker forecasts new deals to generate $US25bn in additional revenue by 2030. “We would like to deploy capital in scientific areas that we have expertise in so we can choose the right targets,” chief executive Albert Bourla said in an interview.
The prospect of further deal making could address concerns from analysts and investors who are watching what Pfizer does with its windfall from the pandemic. Sales from the pandemic vaccine and treatment will taper over time and the company faces drops in sales as innovative products lose their patent protection. Pfizer shares had fallen more than 4 per cent on Tuesday night following its earnings. The drop was because investors were expecting Pfizer’s guidance on this year’s earnings per share to be higher than $US6.35 to $US6.55, according to Evercore ISI analyst Umer Raffat.
“It’s our all-time record high,” chief financial officer Frank D’Amelio said, regarding the company’s guidance. He said analysts may have had higher expectations because of the pandemic products, but noted that Pfizer’s estimates only include finalised agreements.
Pfizer is in discussions with more than 100 countries for Paxlovid, so revenues are likely to come in higher than the $US22bn should it strike more agreements.
To fight Omicron surges, some countries are handing out second booster shots. In Israel, early data suggest a…
Paxlovid is cleared for use in people in the US 12 years and older who are at high risk of developing severe disease. The company said it expects to begin a study of the drug for children 6 years to 18 by the end of March. Results from studies of the drug in adults who are at standard risk for severe disease and household exposure should come later this year, Pfizer said.
The drug remains in short supply, and has been difficult to find in the US as Pfizer increases production to 120 million courses of treatment this year.
While Pfizer says Paxlovid works safely, and was effective against the Omicron variant in laboratory studies, it says it is working on a new treatment, too. The potential drug is designed to counter possible viral resistance to Paxlovid, require fewer pills in a course, and to work without the aid of the antiviral ritonavir that is given with Paxlovid, but carries safety risks for patients taking some common medications, according to Pfizer.
“We are not taking any chances; we’re going to stay on the forefront of the scientific efforts to battle the pandemic,” said Mr Bourla.
The company says it will begin studying the new Covid-19 treatment in the second half of this year.
While Pfizer says demand for the vaccine may wane, it expects growing demand for the treatment. Yet sales of both will combine for more than half of annual $US98bn to $US102bn Pfizer forecasted revenue for 2022. Pfizer says the virus won’t be fully eradicated in the near term because it is difficult to contain, has been shown to mutate, and that data shows natural infections don’t lead to long-term protection needed to prevent transmission and mutations.
The Covid-19 vaccine from Pfizer and partner BioNTech SE has grown into one of the most widely used shots globally. Pfizer’s booster shots have also seen the greatest use in the U.S. Nearly 50 million have been administered.
In the last three months of 2021, Pfizer’s vaccine achieved $US12.5bn in sales, contributing to overall revenue of $US23.84bn. A year earlier, Pfizer’s fourth-quarter revenue was $US11.63bn.
Adjusted earnings grew to $US1.08 a share, from 43c a share in the year-ago quarter. Analysts polled by FactSet had forecast adjusted earnings of 87c a share on sales of $US24.16bn.
***********************************************
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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
*************************************
"Data appears to show a marked increase in 2021 in conditions that have been observed to be *side effects* of the COVID-19 vaccines"
By ROBERT W. MALONE
These are dangerous times, and we are in a 21st century global information war. Cannon balls are flying, and there are false flag operations and concern trollery to the left, right and center of us. And yet onward we ride. The Light Brigade.
And then unexpectedly, onto the public stage, steps Drs. Samuel Sigoloff, Peter Chambers, and Theresa Long. Department of Defense whistleblowers who downloaded a massive trove of unclassified data (to download the Excel file see the link “Data from the Defense Medical Epidemiology Database (DMED) shows”) on the incidence of various diseases before and after the onset of illegal forced genetic COVID-19 vaccination of our military forces.
Now these are basically raw data from the Defense Medical Epidemiological Database (DMED). For the detail oriented, this is the scrubbed and de-identified (HIPAA compliant) database derived from the Defense Medical Surveillance System (DMSS), which pulls directly from patient records and other US Department of Defense-related medical record information streams. These data were pulled with full chain-of-custody documentation based on various CPT codes that are related to known genetic COVID-19 vaccine side effects.
As raw data, this information needs to be reviewed with care and considered to be both rough and preliminary. For the uninitiated, there are major risks associated with reliance on large, raw (uncorrected) data sets for retrospective (backwards in time) data analyses. The key technical term here is “confounding variables”, but data entry errors (such as multiple entries for the same diagnostic event) or process changes can also introduce huge sources of bias into large data sets like this. With raw data, it is most useful to consider any data plotting to be sort of a first draft, useful for identifying potential trends or topics that deserve more detailed analysis. But sometimes, when the observed effect size in the raw data is very large or potentially important, alarm bells start ringing even before full analysis is completed. And that seems to be the case with these data.
Nick Hudson, the Chairman of the South African PANDATA group (a leader in providing accurate data analysis throughout this pandemic), summarizes the situation like this “The DMED record data appears to show a marked increase in 2021 in conditions that have been observed to be side effects of the COVID-19 vaccines. For many of these, mechanistic explanations have been established or at least proposed. It is important to rule out distortions owing to recent changes to the system, such as increased coverage (for example, broader selections of personnel or inclusion of family members), changes in handling of multiple records from single cases, and changes in propensity to report owing to changes in policy, access to the system, participating entities or recent advisories or advertising of the system. An instructive test would be to check that we do not see a similar rise for conditions that could not plausibly exhibit a significant association with the vaccines, such as broken legs or burns. This is especially important since the total reports of diseases and injuries have apparently risen by an order of magnitude, which would suggest extremely high prevalence of adverse events among a population that is likely healthier and fitter than the general population. The data are presented in summary format. Underlying data with dates and depersonalized patient indices, together with vaccination records for the population covered by the database would likely deliver swift and incisive conclusions.”
Now for some reason, although this database has apparently been managed for years by the same NIH subcontractor, and has been included in the CDC datasets including those reviewed by the CDC’s COVID-19 Vaccine Safety Technical (VaST) Work Group, the geniuses that have been managing it have never identified any issues before the whistleblowers grabbed this download. Does not inspire confidence, no matter what the final “official” explanation becomes.
Based on this presentation dated 04 February, Slides 3 and 13 both indicate that Fauci and colleagues at the NIH are working with the DoD, and the data from the DMED database was being shared. This makes it VERY difficult to argue that Fauci did not know this data. It also makes it even harder to believe that, with all these agencies watching the same data, no one thought the historical data was incorrect until the whistleblowers sounded their alert.
Despite this, as the data entered the public sphere with the “second opinion” public Senate hearing convened by Senator Ron Johnson, the DoD saw fit to communicate with Politifact rather than the Senator, providing the following statement:
“But Peter Graves, spokesperson for the Defense Health Agency’s Armed Forces Surveillance Division, told PolitiFact by email that "in response to concerns mentioned in news reports" the division reviewed data in the DMED "and found that the data was incorrect for the years 2016-2020."
Officials compared numbers in the DMED with source data in the DMSS and found that the total number of medical diagnoses from those years "represented only a small fraction of actual medical diagnoses." The 2021 numbers, however, were up-to-date, giving the "appearance of significant increased occurrence of all medical diagnoses in 2021 because of the underreported data for 2016-2020," Graves said.
The DMED system has been taken offline to "identify and correct the root-cause of the data corruption," Graves said.”
As noted above, among the many curious aspects of this statement is that the CDC VaST has apparently been monitoring these data for years, and never identified this “data corruption” as an issue.
So, what do the original data show (prior to Defense Health Agency’s Armed Forces Surveillance Division correction of the “data corruption”)?
In reviewing these data, what we see are baseline data from 2016 to 2019 (pre SARS-CoV-2/COVID-19), 2020 (the first year of SARS-CoV-2/COVID-19 when no vaccines were available), and 2021 (the year that vaccines were available and mandated for the US Military).
As noted above, there are many potential confounding variables, but whatever the cause, if these data are not due to longstanding and previously undiscovered “data corruption”, then we have a major issue with the overall health of our armed services.
And if they are due to previously undiscovered “data corruption”, why wasn’t someone running around with their pants on fire trying to figure out what is going on here long before the whistleblowers brought this to national attention?
https://www.independent.org/news/article.asp?id=13987&omhide=true&trk=rm
**************************************************Covid drugs a booster for Pfizer sales
As Pfizer forecasts strong sales this year for its Covid-19 vaccine and treatment, the drugmaker is on the hunt for deals to bolster its pipeline of experimental products.
Pfizer said on Tuesday night that surging sales of its Covid-19 treatment and continued demand for its shots should boost the company’s revenue to around $US100bn ($140bn) this year. The company estimated that sales of its antiviral pill Paxlovid will reach about $US22bn while the vaccine will add $US32bn.
That is on top of last year’s sales of $US36.8bn for the vaccine, also known as Comirnaty, the highest annual sales total for any pharmaceutical product. Paxlovid sales last year totalled $US76m.
The company has done a handful of recent acquisitions and partnerships to bolster its pipeline of drugs and vaccines, including several partnerships announced last month to boost its growing mRNA business. In December, Pfizer said it would acquire Arena Pharmaceuticals for $US6.7bn. Pfizer says it has invested $US25bn on business development since 2019.
With a growing chest of cash, Pfizer says its deal-making strategy will focus on drugs in early and late-stage development in areas the company is already focusing on, such as oncology, immunology and rare diseases. The New York-based drugmaker forecasts new deals to generate $US25bn in additional revenue by 2030. “We would like to deploy capital in scientific areas that we have expertise in so we can choose the right targets,” chief executive Albert Bourla said in an interview.
The prospect of further deal making could address concerns from analysts and investors who are watching what Pfizer does with its windfall from the pandemic. Sales from the pandemic vaccine and treatment will taper over time and the company faces drops in sales as innovative products lose their patent protection. Pfizer shares had fallen more than 4 per cent on Tuesday night following its earnings. The drop was because investors were expecting Pfizer’s guidance on this year’s earnings per share to be higher than $US6.35 to $US6.55, according to Evercore ISI analyst Umer Raffat.
“It’s our all-time record high,” chief financial officer Frank D’Amelio said, regarding the company’s guidance. He said analysts may have had higher expectations because of the pandemic products, but noted that Pfizer’s estimates only include finalised agreements.
Pfizer is in discussions with more than 100 countries for Paxlovid, so revenues are likely to come in higher than the $US22bn should it strike more agreements.
To fight Omicron surges, some countries are handing out second booster shots. In Israel, early data suggest a…
Paxlovid is cleared for use in people in the US 12 years and older who are at high risk of developing severe disease. The company said it expects to begin a study of the drug for children 6 years to 18 by the end of March. Results from studies of the drug in adults who are at standard risk for severe disease and household exposure should come later this year, Pfizer said.
The drug remains in short supply, and has been difficult to find in the US as Pfizer increases production to 120 million courses of treatment this year.
While Pfizer says Paxlovid works safely, and was effective against the Omicron variant in laboratory studies, it says it is working on a new treatment, too. The potential drug is designed to counter possible viral resistance to Paxlovid, require fewer pills in a course, and to work without the aid of the antiviral ritonavir that is given with Paxlovid, but carries safety risks for patients taking some common medications, according to Pfizer.
“We are not taking any chances; we’re going to stay on the forefront of the scientific efforts to battle the pandemic,” said Mr Bourla.
The company says it will begin studying the new Covid-19 treatment in the second half of this year.
While Pfizer says demand for the vaccine may wane, it expects growing demand for the treatment. Yet sales of both will combine for more than half of annual $US98bn to $US102bn Pfizer forecasted revenue for 2022. Pfizer says the virus won’t be fully eradicated in the near term because it is difficult to contain, has been shown to mutate, and that data shows natural infections don’t lead to long-term protection needed to prevent transmission and mutations.
The Covid-19 vaccine from Pfizer and partner BioNTech SE has grown into one of the most widely used shots globally. Pfizer’s booster shots have also seen the greatest use in the U.S. Nearly 50 million have been administered.
In the last three months of 2021, Pfizer’s vaccine achieved $US12.5bn in sales, contributing to overall revenue of $US23.84bn. A year earlier, Pfizer’s fourth-quarter revenue was $US11.63bn.
Adjusted earnings grew to $US1.08 a share, from 43c a share in the year-ago quarter. Analysts polled by FactSet had forecast adjusted earnings of 87c a share on sales of $US24.16bn.
***********************************************
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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
*************************************
Wednesday, February 09, 2022
CDC’s new study proves natural immunity is real and should lead to COVID policy changes
A recently released study by the Centers for Disease Control and Prevention (CDC) showing that “persons who survived a previous [COVID] infection had lower case rates than persons who were vaccinated alone” should lead to COVID policy and mandates changes.
The six-month long study of four groups of people in California and New York offers the best evidence so far that natural immunity is real. The report indicates researchers knew as early as October that natural immunity was stronger at preventing COVID than vaccines alone, yet the CDC chose to withhold their findings until late January.
Throughout last fall, President Joe Biden and his administration aggressively pushed vaccine mandates on private employers, members of the military, federal contractors, and federal workers.
In mid-December President Biden held a news conference in which he warned Americans “We are looking at a winter of severe illness and death for the unvaccinated — for themselves, their families and the hospitals they’ll soon overwhelm.”
But the CDC knew at that time that millions of Americans already had natural immunity to COVID and ought to have been exempted from any vaccine mandates.
“This administration is the most dishonest in all of American history,” said Richard Manning, President of Americans for Limited Government. “Biden knew, or ought to have known in October that natural immunity was real, yet he chose to push mandates that impacted the livelihoods of about estimated 100 million Americans, nearly two-thirds of the American workforce.”
It is unclear how many Americans with natural immunity lost their jobs because of the mandates. What is clear is that the mandates are not based on science.
“I’m not a medical doctor but I didn’t need a CDC study to tell me that natural immunity is real,” Manning said. “Vaccines are man’s attempt to mimic naturally acquired immunity. There is no excuse for this administration’s persistence in pushing bad science.”
The Biden administration’s mandates and CDC guidelines appear to have influenced private employers and organizations to adopt discriminatory policies toward unvaccinated Americans.
In November Green Bay Packers quarterback Aaron Rodgers and another player were fined by the NFL for attending a Halloween Party in violation of NFL COVID policies.
A tweet from ESPN’s Kevin Seifert shows just what those policies are, at least as of last summer. Unvaccinated players are subject to all sort of harassment, including being tested every day, masked at club facilities and during travel, banned from sauna, banned from eating with teammates, banned from promotional work, and being told “they may not leave hotel to eat in restaurants and may not interact with anyone outside of Team Traveling party during team travel.”
In November Rodgers tested positive for COVID and spoke out against COVID mandates and discriminatory practices. So-called media fact checkers attacked Rodgers’ claims of natural immunity as false.
“Where are those same fact checkers today?” Manning asked rhetorically. Of course, they are nowhere to be found.”
There hasn’t been a single update, correction, or retraction from the so-called fact checkers on Rodgers’ case.
And that is the problem with all of this. The Biden administration came into office promising to “follow the science,” but as the science has changed, they have dogmatically pushed mandates based on outdated, debunked, and outright false information.
The new CDC study, combined with the research by Johns Hopkins University showing that lockdowns are ineffective at preventing COVID spread, ought to point policy makers in a new direction. House and Senate lawmakers in Washington should vote to defund all of Biden’s vaccine mandates in next week’s Continuing Resolution spending bill.
“Any lawmaker who claims to be for limited government but votes for a spending bill that includes vaccine mandates, will be held accountable in November,” Manning concluded.
***************************************************
Demand for limited government makes a comeback amid national distress
The categorically bleak outlook of American voters on a broad range of issues nine months before the midterms could fuel demand for limited government solutions.
From skyrocketing energy prices to a constant tide of illegal aliens, a possible war in Eastern Europe, and inflation levels not seen since the early 1980s, our faith in the federal government has collapsed.
A new Gallup poll paints a startingly dismal portrait of voter sentiment one year into President Biden’s first term and reveals over two-thirds of Americans are dissatisfied with the size of the federal government.
Gallup reports that only 32% of Americans are satisfied with the size and power of the federal government, compared to 68% who are unsatisfied. Although Americans have been dissatisfied with the federal government for decades, this sentiment has spiked sharply since 2020.
There have been significant declines in voter satisfaction in ten policy areas since 2021, with satisfaction on energy policy, the nation’s military strength, and the state of the economy taking the biggest hits according to Gallup.
Satisfaction with the nation’s energy policies took the steepest dive this year, falling 15 percentage points since 2021.
“Of all the issues and societal aspects measured in the survey, satisfaction with energy policies has fallen the most this year,” Gallup reports. “Higher gas prices are likely the reason this sentiment has dropped 15 percentage points in the past year. … The 27% currently satisfied with energy policies is the lowest Gallup has measured in its trend.”
Satisfaction with the nation’s military strength and preparedness has also suffered greatly under the Biden administration and led to a 13-point decline in the past year. This shift is unsurprising considering President Biden led a disastrous exit from Afghanistan that cost 13 U.S. servicemembers their lives and returned the nation directly to the Taliban. To add insult to injury, Biden is flirting with a war with Russia, something that over two-thirds of the American public is opposed to.
Satisfaction with the economy has also taken a hit in the past year, suffering a 10-point decline since 2021 and clocking in at 33%. Despite a modest rise in national wages at the close of last year, inflation grew to 7%, resulting in a net pay cut for most Americans. On top of that, historically low housing inventory levels, increasing materials costs, and low interest rates have pushed the price of a home out of reach for many families.
While satisfaction with energy prices, military preparedness, and the economy fell the most in the past year, satisfaction with a number of other issues have fallen significantly since 2020.
Satisfaction with overall quality of life has dropped 15 points since 2020 from 84% to 69%, and satisfaction with our system of government and how it works has dropped 13 points from a barely acceptable 43% to a deeply troubling 30%.
Gallup’s survey comes on the heels of a sixty-page research survey released last November that shows over half of Americans say life has taken a turn for the worse since the 1950s.
The survey, released by a DC think tank called Public Religion Research Institute (PRRI), found Americans say 52% to 47% that American culture and way of life have mostly changed for the worse since the 1950s. These results are a dire change from one year prior in the fall of 2020 when Americans said 55% to 44% that life had changed for the better since the 1950s.
The survey also found Americans say 52% to 48% that, “today, America is in danger of losing its culture and identity.” A full 80% of Republicans, 50% Independents, and even 33% of Democrats say America is in danger of losing its culture and identity.
A significant share of Americans also say they feel like strangers in their own country. A full 40% of Americans say, “things have changed so much that I often feel like a stranger in my own country.” Republicans and Independents are more likely to say they feel like strangers in their own country (56% and 39% respectively), but three in ten Democrats (31%) also say they feel like strangers in their own country.
A January NBC News poll backs up the Gallup and PRRI sentiment and characterizes Americans as “divided, doubting democracy, falling behind, and tuning out”, in the words of Democratic pollster Jeff Horwitt. NBC News reports that President Biden’s approval rating is in the low 40s and, “key Democratic groups are losing interest in the upcoming election.”
Republicans may be the most dissatisfied about the direction of the country at the moment, but according to NBC News, “Republicans enjoy a double-digit advance on enthusiasm ahead of November’s elections, with 61 percent of Republicans saying they are very interested in the upcoming midterms — registering their interest either as a 9 or 10 on a 10-point scale — compared with 47 percent of Democrats who say the same.”
These findings reveal a nation in a state of deep concern not only about kitchen table issues like inflation and the economy, but about more intangible issues like a loss of identity with their country and a decline in quality of life.
While left-wing analysts are rightly worried about their party’s prospects and bracing for a battle this November, big government globalists and the GOP status quo should be worried too.
As Richard Manning, president of Americans for Limited Government warns, Republicans should not take the political winds blowing in their favor as an opportunity for passivity.
“The abrupt and surprising leftward lurch of the federal government on every issue has Americans returning to their limited government roots”, Manning says. “However, Republicans who think they can politically benefit by engaging in a passive resistance campaign will discover that Americans want them to stand up and challenge these Biden’s broadsides against American culture, history and greatness rather than simply providing meek complaints in fear of being cancelled.”
Americans want a change not just in leadership but in direction, away from the vast federal government’s failure. The temperament of the nation is looking a lot like it did in 2015, right before an unexpected non-politician walked out of left field and secured the presidency.
***********************************************
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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
*************************************
Tuesday, February 08, 2022
This Op-Ed on Masks and School Kids. It Will Probably Trigger the Left
The science is becoming clearer on mask-wearing as COVID becomes an endemic problem. It doesn't work. Everyone is going to get infected eventually. COVID is now part of our lives…forever. Have no fear; we do the same with cold and flu season. We have therapeutics. We have vaccines. It's time to move on with our lives. The masks requirements just need to die. Infections are all over the place. They have not curbed the spread.
This is classic "horse has left the barn" territory. And now, this protocol applied to school districts needs to die as well. Even ardent feminists and liberals are unsure about this requirement as its psychological impact is scarring their kids. Jennifer Block's young son had a self-drawing with no nose or mouth, which prompted her to call for a return to reason amid this "COVID and our schools" debate in the pages of The San Francisco Chronicle.
And now, two scientists have joined the chorus of experts who are finally starting to talk sense, though it's still too few and far between. They're in the heart of liberal America. Berkeley, California, schools said that KN95 masks would be required for everyone attending school. They looked at the data. The risks done to kids wearing masks far outweighed the benefits. They were blunt: it's not going to work for a variety of reasons, not least being that every child needs a mask that's custom-fitted and approved by OSHA. Second, kids' faces are too small for this type of mask. Third, even when properly fitted, the mask is a nightmare to wear, even causing bruising among those with approved KN95s (via Newsweek):
The Berkeley Unified School District (BUSD) in the SF Bay Area where we live, announced on Tuesday that it was planning on "transitioning all students and staff" to KN95 respirators. If worn properly, such respirators filter 95 percent of particles the size of those that carry the SARS-CoV-2 virus. The BUSD has proposed this measure as a means to slow the spread of COVID-19 and keep schools open. These respirators would be required for the entire school day, including outdoors during gym and recess.
Unfortunately, the effectiveness of respirators is vastly overestimated, and there is scant evidence that they stop community transmission. Moreover, NIOSH-approved respirators are tight, uncomfortable, and can impede breathing. OSHA requires both fit testing and a medical evaluation before workers can wear them. We've all seen images of health care workers with bruised faces from properly worn respirators.
The truth is, the burdens of these masks outweigh their benefits for kids. We need to consider more effective, less harmful interventions as we come together to keep schools open and safe.
We know masks have become a highly contentious issue. But as a physician with a PhD in computational mathematics and a professor of data science, we have read the studies on this topic. We both have children and want them to be safe. But we also don't want them burdened with measures that won't help protect them or their peers. And mandating respirators on kids is out of step with CDC guidance and international norms.
What is the evidence for respirators stopping the spread of covid19? Studies on Influenza provide guidance. Though respirators provide better filtration in perfect laboratory conditions, people who wear them are just as likely to catch flu whether they are wearing a surgical mask or a respirator. Though respirators have higher filtration capabilities, a Cochrane review and an independent metanalysis both revealed there were not clear differences between the effectiveness of surgical masks and respirators in preventing infections like Influenza. The Influenza virus and SARS-CoV-2 virus are of comparable size and rates of transmission of infection between close contacts are similar.
The good news is that this piece was published on January 24. The school district then backtracked and said the KN95 mask requirement wouldn't be mandatory. Shed your fear, folks. The virus is already here. It's already spread. There's little a mask can do when it's everywhere. Given that COVID is now something we must deal with annually throughout the course of our lives, most people are eventually going to get infected. Just like a ton of people get colds every year. And just like tens of millions contract the flu every year. Everyone is done with this kabuki theater.
And Joe Biden, of all people, should be looking to pivot away from this since more people will soon have died of COVID under him than Trump
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Israeli study offers strongest proof yet of vitamin D’s power to fight COVID
Israel scientists say they have gathered the most convincing evidence to date that increased vitamin D levels can help COVID-19 patients reduce the risk of serious illness or death.
Researchers from Bar Ilan University and the Galilee Medical Center say that the vitamin has such a strong impact on disease severity that they can predict how people would fare if infected based on nothing more than their ages and vitamin D levels.
Lacking vitamin D significantly increases danger levels, they concluded in newly peer-reviewed research published Thursday in the journal PLOS One.
The study is based on research conducted during Israel’s first two waves of the virus, before vaccines were widely available, and doctors emphasized that vitamin supplements were not a substitute for vaccines, but rather a way to keep immunity levels from falling.
Vitamin D deficiency is endemic across the Middle East, including in Israel, where nearly four in five people are low on the vitamin, according to one study from 2011. By taking supplements before infection, though, the researchers in the new Israeli study found that patients could avoid the worst effects of the disease.
“We found it remarkable, and striking, to see the difference in the chances of becoming a severe patient when you are lacking in vitamin D compared to when you’re not,” said Dr. Amiel Dror, a Galilee Medical Center physician and Bar Ilan researcher who was part of the team behind the study.
He noted that his study was conducted pre-Omicron, but said that the coronavirus doesn’t change fundamentally enough between variants to negate vitamin D effectiveness.
“What we’re seeing when vitamin D helps people with COVID infections is a result of its effectiveness in bolstering the immune systems to deal with viral pathogens that attack the respiratory system,” he told The Times of Israel. “This is equally relevant for Omicron as it was for previous variants.”
Health authorities in Israel and several other countries have recommended vitamin D supplements in response to the coronavirus pandemic, though data on its effectiveness has been sparse until now.
In June, researchers published preliminary findings showing that 26 percent of coronavirus patients died if they were vitamin D deficient soon before hospitalization, compared to 3% who had normal levels of vitamin D.
They also determined that hospitalized patients who were vitamin D deficient were 14 times more likely, on average, to end up in severe or critical condition than others.
While the scientific community recognized the importance of the results, questions arose as to whether recent health conditions among the patients might have been skewing the results.
The possibility was raised that patients could have been suffering from conditions that both reduce vitamin D levels and increase vulnerability to serious illness from COVID-19, meaning the vitamin deficiency would be a symptom rather than a contributing factor in disease severity.
To zero out that possibility, Dror’s team delved deeper into the data, examining each of its patients’ vitamin D levels over the two-year stretch before coronavirus infection. They found that the strong correlation between sufficient vitamin D levels and ability to fight the coronavirus still held, and the level of increased danger in their preliminary findings remained almost identical.
“We checked a range of timeframes, and found that wherever you look over the two years before infection, the correlation between vitamin D and disease severity is extremely strong,” Dror said.
“Because this study gets such a good picture of patients’ vitamin D levels, by looking at a wide timeframe instead of just the time around hospitalization, it offers much stronger support than anything seen so far emphasizing the importance of boosting vitamin D levels during the pandemic,” he added.
A flood of dubious claims about natural remedies to the coronavirus, including a theory that Israelis had immunized themselves with lemons and baking soda, have left some skeptical about claims of vitamins warding off the virus.
But Dror insisted that his team’s research showed that the importance of vitamin D was not based on incomplete or flawed data.
“People should learn from this that studies pointing to the importance of taking vitamin D are very reliable, and aren’t based on skewed data,” he said. “And it emphasizes the value of everyone taking a vitamin D supplement during the pandemic, which, consumed in sensible amounts in accordance with official advice, doesn’t have any downside.”
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Nick Coatsworth shares US Covid data comparing states with mask mandates
The face of Australia's Covid vaccine rollout has shared US data which shows states that introduced mask mandates only had slightly more cases than those which did not.
Australia's former deputy chief medical officer Dr Nick Coatsworth used the controversial statistics to rail against calls to make N95 masks mandatory.
He also branded demands to install stringent air ventilation systems in all buildings a 'colossal cost and minimal benefit'.
The graph shared by Dr Coatsworth shows little difference in Covid case numbers in the US from November 1 to January 31, despite face mask mandates.
The data does not show that masks are ineffective against transmitting the virus, as those living in states without mandates may still be wearing face coverings at comparable levels.
It could also be possible that infection rates in states with mandates may have been far higher if the restrictions were not introduced.
But Dr Coatsworth suggests enforcing face mask mask requirements has a muted effect in society.
'When plausibility meets reality. The null hypothesis lands a knockout punch on the precautionary principle,' he tweeted alongside the graph.
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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)
http://australian-politics.blogspot.com/ (AUSTRALIAN POLITICS)
http://snorphty.blogspot.com/ (TONGUE-TIED)
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