Ebook:
2 sided flyer on COVID vaccines:
Thursday, November 4, 2021
VA study: by October, the 3 vaccines averaged 48% efficacy in preventing infection/Science magazine
https://www.science.org/doi/10.1126/science.abm0620
Excerpt:
We report SARS-CoV-2 vaccine effectiveness against infection (VE-I) and death (VE-D) by vaccine type (n = 780,225) in the Veterans Health Administration, covering 2.7% of the U.S. population. From February to October 2021, VE-I declined from 87.9% to 48.1%, and the decline was greatest for the Janssen vaccine resulting in a VE-I of 13.1%. Although breakthrough infection increased risk of death, vaccination remained protective against death in persons who became infected during the Delta surge. From July to October 2021, VE-D for age 65 years was 73.0% for Janssen, 81.5% for Moderna, and 84.3% for Pfizer-BioNTech; VE-D for age ≥65 years was 52.2% for Janssen, 75.5% for Moderna, and 70.1% for Pfizer-BioNTech.
But this may be overly optimistic. In the UK, the vaccines still worked somewhat in those under 30. But for the older age groups, the vaccine actually had negative efficacy. That means you were more likely to get COVID if you were vaccinated, compared to the unvaccinated. If you were over 40, you were twice as likely to get COVID if you had been vaccinated, for a negative efficacy of 100%. I am sure a reader can provide the link to the official UK publication.
Oh, I found it:
But the MSM simply publish the CDC fantasies that are designed to entrap parents and children in the vaccine nightmare. How does the headline below pass the smell test for "careful, fact-based" reporting by the WaPo? Lena Sun has been a reliable narrative protector for years and years at this rag. By the way, this article is not behind a paywall, suggesting that CDC paid the WaPo to publish it. Dr. Andrew Pavia, widely quoted in the article, is a hack vaccine apologist who also wanted to vaccinate people with experimental bird flu vaccines, just in case a bird flu showed up some day, around 2005--yes, Andrew, I have been watching your uneducated BS for over a decade, and your quotes today are priceless evidence for the Nuremberg 2 trials. We won't forget.
Andrew T. Pavia, a professor of pediatrics and infectious diseases at the University of Utah, said in an email Monday [about] the new CDC science review, “I think there is a tension between conveying the scientific gray areas and the need to combat the ‘natural infection is better’ misinformation that has taken hold. I think the review threads that needle well.”
WaPo: CDC finds immunity from vaccines is more consistent than from infection, but both last at least six months
The public responded with over 1350 comments, and WaPo won't accept any more.
Paul Elias Alexander on why children should not be vaccinated
Please read the entire article by Paul Elias Alexander, who is furiously compiling the evidence on recovered immunity (over 80 articles) and other important issues. I am only posting the second half below.
https://childrenshealthdefense.org/defender/vaccinate-children-covid-natural-exposure-immunity/
Here are six studies that make the case for not vaccinating children:
1. A 2020 Yale University report indicates children and adults display very diverse and different immune system responses to SARS-CoV-2 infection which explains why they have far less illness or mortality from COVID.
According to the study:
“Since the earliest days of the COVID-19 outbreak, scientists have observed that children infected with the virus tend to fare much better than adults … researchers reported that levels of two immune system molecules — interleukin 17A (IL-17A), which helps mobilize immune system response during early infection, and interferon gamma (INF-g), which combats viral replication — were strongly linked to the age of the patients. The younger the patient, the higher the levels of IL-17A and INF-g, the analysis showed…these two molecules are part of the innate immune system, a more primitive, non-specific type of response activated early after infection.”
2. Studies by Ankit B. Patel and Dr. Supinda Bunyavanich show the virus uses the ACE 2 receptor to gain entry to the host cell, and the ACE 2 receptor has limited (less) expression and presence in the nasal epithelium in young children (potentially in upper respiratory airways).
This partly explains why children are less likely to be infected in the first place, or spread it to other children or adults, or even get severely ill. The biological molecular apparatus is simply not there in the nasopharynx of children. By bypassing this natural protection (limited nasal ACE 2 receptors in young children) and entering the shoulder deltoid, this could release vaccine, its mRNA and LNP content (e.g. PEG), and generated spike into the circulation that could then damage the endothelial lining of the blood vessels (vasculature) and cause severe allergic reactions (e.g., here, here, here, here, here).
3. William Briggs reported on the n=542 children who died (0-17 years (crude rate of 0.00007 per 100 and under 1 year old n=132, CDC data) since January 2020 with a diagnosis of COVID linked to their death. This does not indicate whether, as Johns Hopkins’ Dr. Marty Makary has been clamoring, the death was “causal or incidental.” That said, from January 2020, 1,043 children 0-17 have died of pneumonia.
Briggs reported:
“There is no good vaccine for pneumonia. But it could be avoided by keeping kids socially distanced from each other — permanently. If one death is “too many,” then you must not allow kids to be within contact of any human being who has a disease that may be passed to them, from which they may acquire pneumonia. They must also not be allowed in any car … in one year, just about 3,091 kids 0-17 died in car crashes (435 from 0-4, 847 from 5-14, and 30% of 6,031 from 15-24). Multiply these 3,000 deaths in cars by about 1.75, since the COVID deaths are over a 21-month period. That makes about 5,250 kids dying in car crashes in the same period — 10 times as many as Covid.”
Briggs concluded: “there exists no justification based on any available evidence for mandatory vaccines for kids.”
4. Weisberg and Farber et al. suggest (and building on research work by Kumar and Faber) that the reason children can more easily neutralize the virus is that their T cells are relatively naïve. They argue that since children’s T cells are mostly untrained, they can thus immunologically respond (optimally differentiate) more rapidly and nimbly to novel viruses such as SARS-CoV-2 for an effective robust response.
5. Research published in August 2021 by J. Loske deepens our understanding of this natural type biological/molecular protection even further by showing that “pre-activated (primed) antiviral innate immunity in the upper airways of children work to control early SARS-CoV-2 infection … the airway immune cells in children are primed for virus sensing…resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults.”
6. When one is vaccinated or becomes infected naturally, this drives the formation, tissue distribution and clonal evolution of B cells, which is key to encoding humoral immune memory.
Research published in May 2021 showed that blood examined from children retrieved prior to COVID-19 pandemic have memory B cells that can bind to SARS-CoV-2, suggestive of the potent role of early childhood exposure to common cold coronaviruses (coronaviruses). This is supported by Mateus et al. who reported on T cell memory to prior coronaviruses that cause the common cold (cross-reactivity/cross-protection).
There is no data or evidence or science to justify any of the COVID-19 injections in children. Can the content of these vaccines cross the blood-brain barrier in children? We don’t know because it wasn’t studied.
There is no proper safety data. The focus rather has to be on early treatment and testing (sero antibody or T-cell) to establish who is a credible candidate for these injections, as it is dangerous to layer inoculation on top of existing COVID-recovered, naturally acquired immunity.
There is no benefit and only potential harm/adverse effects (here, here, here).
White House delays Covid-19 vaccine mandates for contractors till January
The White House is delaying its mandate for contractors to get vaccinated against Covid-19 until Jan. 4, the administration announced Thursday, as it rolled out more details about its sweeping vaccination mandates.
Contractors previously had until Dec. 8 to get vaccinated, per a September executive order from the White House. They now have until Jan. 4, as do health workers at hospitals and facilities that participate in Medicare and Medicaid.
Under a separate policy, companies with 100 or more employees will also have until Jan. 4 to mandate full vaccinations for their workers or offer a plan for weekly testing. But by Dec. 5, they must require unvaccinated workers to wear masks and undergo weekly testing...
Alaska's Governor Dunleavy Issues Administrative Order Defending Alaska from Federal Government Overreach
Today, Alaska Governor Mike Dunleavy took action against the efforts of President Joe Biden to undermine the sovereignty of the State of Alaska. The Governor issued Administrative Order No. 325, laying out the steps Alaska’s state government will take to protect its constitution and the rights of Alaskans from blatant federal overreach.
“The Biden Administration has imposed a long list of encroachments against the State of Alaska in attempts to control the health and welfare of Alaskans,” said Governor Dunleavy. “The recent actions or attempts are threatening the State’s sovereign authority under the 10th Amendment. We will not let the federal government usurp our power. We will fight against these threats, enforce Alaska’s sovereignty and protect the rights and freedoms of all Alaskans.”
The Biden Administration over 11 months has introduced many plans which jeopardize the constitutional rights of individual Alaskans. The administration introduced a plan that would force banks and financial institutions to provide the Internal Revenue Service (IRS) with personal information from private bank accounts when cumulative financial transactions of $600 or more occur in a year. After Americans expressed outrage, the IRS proposed increasing the financial threshold. The Biden IRS proposal would monitor the banking activities of Alaskans and store their financial information – violating existing protections for such records under the Federal Right to Financial Privacy Act.
The Department of Justice under President Biden plans to use Federal law enforcement personnel and resources to monitor, and potentially prosecute, parents as potential domestic terrorists, for protesting issues at local school board meetings (like mask mandates, curriculum choices, and other issues).
President Biden is also directing the Occupational and Safety Health Administration to implement regulations requiring that private employer, and certain public employers, with over 100 employees mandate their employees to be fully vaccinated or to submit to regular COVID-19 testing.
Lastly, last week the Biden Administration attempted to mandate that all federal contractors require their employees to be vaccinated without clear statutory authority. Earlier, they imposed vaccine mandates on military and National Guard members without adequate protections in place for individuals with religious objections.
To fight this federal government overreach, the Dunleavy Administration is ordering:
1. The Attorney General to review any federal vaccine mandate issued by the Biden Administration and determine whether there are legal grounds to challenge such mandates in court.
2. To the extent allowable by law, no state agency shall participate in, or use state funds or personnel, to further a federal vaccine mandate for employers.
3. The AG will review and oppose efforts by the Federal Government to monitor and negatively affect the ability of Alaskan parents to exercise their constitutional rights by participating in school board meetings.
4. To the extent allowable by law, no state agency shall participate with a federal agency, or spend state funds to participate in, or further any action by a federal agency that infringes on the constitutional rights of Alaskans. Nor may a state agency take actions that would unconstitutionally chill free speech or infringe upon other constitutional rights exercised by citizens against or in support of local school district policies. State agencies shall continue to enforce the criminal code of the State of Alaska.
5. If a federal agency proposes action to a state agency that would require a state agency to act in a manner that may violate the Alaska or U.S. Constitution, the agency’s commissioner shall immediately inform the Attorney General for the State of Alaska and seek legal advice as to how to proceed.
CDC weighs in, comparing recovered immunity to vaccine-induced immunity. I comment on CDC's assertions
Below is CDC's executive summary. My responses are in blue--Nass
Executive Summary
Key findings and considerations for this brief are as follows:
- Available evidence shows that fully vaccinated individuals and those previously infected with SARS-CoV-2 each have a low risk of subsequent infection for at least 6 months. Really? A massive VA study (780,000 people) shows otherwise:
"We report SARS-CoV-2 vaccine effectiveness against infection (VE-I) and death (VE-D) by vaccine type (n = 780,225) in the Veterans Health Administration, covering 2.7% of the U.S. population. From February to October 2021, VE-I declined from 87.9% to 48.1%, and the decline was greatest for the Janssen vaccine resulting in a VE-I of 13.1%. Although breakthrough infection increased risk of death, vaccination remained protective against death in persons who became infected during the Delta surge. From July to October 2021, VE-D for age 65 years was 73.0% for Janssen, 81.5% for Moderna, and 84.3% for Pfizer-BioNTech; VE-D for age ≥65 years was 52.2% for Janssen, 75.5% for Moderna, and 70.1% for Pfizer-BioNTech."
https://www.science.org/doi/10.1126/science.abm0620
- Data are presently insufficient to determine an antibody titer threshold that indicates when an individual is protected from infection. This is the standard answer, but it has not stopped FDA from accepting antibody titers as evidence of immunity from the vaccine manufacturers in all the vaccine clinical trials.
- At this time, there is no FDA-authorized or approved test that providers or the public can use to reliably determine whether a person is protected from infection. This is true--but WHY has FDA failed to inform the public which tests most reliably indicate immunity? Why has it failed to approve tests, when it has had over 18 months, in the middle of a pandemic, to evaluate most of them?
- The immunity provided by vaccine and prior infection are both high but not complete (i.e., not 100%). Nothing is ever 100%; CDC says this to try to diminish the close to 100% immunity of the recovered
- Multiple studies have shown that antibody titers correlate with protection at a population level, but protective titers at the individual level remain unknown. Because that is the way FDA and CDC want it, to prevent individuals from demonstrating they are protected and therefore will not benefit from vaccination.
- Whereas there is a wide range in antibody titers in response to infection with SARS-CoV-2, completion of a primary vaccine series, especially with mRNA vaccines, typically leads to a more consistent and higher-titer initial antibody response. Briefly yes, but as you already pointed out, antibody levels are not a surrogate for protection, so why focus on them?
- For certain populations, such as the elderly and immunocompromised, the levels of protection may be decreased following both vaccination and infection. True, but apparently this is a bigger problem with vaccination than recovered immunity
- Current evidence indicates that the level of protection may not be the same for all viral variants. Duh
- The body of evidence for infection-induced immunity is more limited than that for vaccine-induced immunity in terms of the quality of evidence (e.g., probable bias towards symptomatic or medically-attended infections) and types of studies (e.g., observational cohort studies, mostly retrospective versus a mix of randomized controlled trials, case-control studies, and cohort studies for vaccine-induced immunity). There are insufficient data to extend the findings related to infection-induced immunity at this time to persons with very mild or asymptomatic infection or children. This is a load of hogwash, as there is very high quality evidence, of many types, supporting the superiority of recovered immunity--and the same is true for virtually every other infection. CDC tries to reinvent the wheel, using a square rather than a circle.
- Substantial immunologic evidence and a growing body of epidemiologic evidence indicate that vaccination after infection significantly enhances protection and further reduces risk of reinfection, which lays the foundation for CDC recommendations. This is more hogwash. The best studies show practically 100% protection after infection and vaccinating the recovered does NOT improve on this.
In this recent official UK publication, it is apparent that after a few months, the vaccinated are at higher risk for COVID than the unvaccinated.
Wednesday, November 3, 2021
NIH OFFICIALS WORKED WITH ECOHEALTH ALLIANCE TO EVADE RESTRICTIONS ON CORONAVIRUS EXPERIMENTS/ The Intercept
https://theintercept.com/2021/11/03/coronavirus-research-ecohealth-nih-emails/
Emails show that NIH officials allowed EcoHealth Alliance to craft oversight language governing its own gain-of-function research.
Detailed notes on NIH communications obtained by The Intercept show that beginning in May 2016, agency staff had an unusual exchange with Peter Daszak, the head of EcoHealth Alliance, about experiments his group was planning to conduct on coronaviruses under an NIH grant called “Understanding the Risk of Bat Coronavirus Emergence.” The notes were taken by congressional staff who transcribed the emails.
EcoHealth was entering the third year of the five-year, $3.1 million grant that included research with the Wuhan Institute of Virology and other partners. In a 2016 progress report, the group described to NIH its plans to carry out two planned experiments infecting humanized mice with hybrid viruses, known as “chimeras."
The plans triggered concerns at NIH. Two staff members — Jenny Greer, a grants management specialist, and Erik Stemmy, a program officer handling coronavirus research — wrote to EcoHealth Alliance to say that the experiments “appear to involve research covered under the pause,” referring to a temporary moratorium on funding for gain-of-function research that would be reasonably anticipated to make MERS and SARS viruses more pathogenic or transmissible in mammals. Generally, gain-of-function research involves manipulating viruses to give them new attributes; it becomes of concern to the government when the altered viruses appear likely to cause more severe disease or spread more easily among humans.
One of the experiments proposed by EcoHealth Alliance involved making chimeras from the MERS virus. The other experiment used chimeras developed from bat viruses related to SARS. The researchers went on to infect the genetically engineered mice with the altered viruses.
Initially, NIH staff appeared intent on enforcing the funding pause. The two administrators requested additional information from EcoHealth Alliance within 15 days and noted that the next round of funding would be withheld until the information was received. They also asked the group to provide a detailed description of changes that would allow the researchers to pursue their aims without conducting the dangerous experiments.
Agency staff adopted language that EcoHealth Alliance crafted to govern its own work.
But what happened next sets off alarm bells for biosafety advocates: Agency staff adopted language that EcoHealth Alliance crafted to govern its own work. The agency inserted several sentences into grant materials describing immediate actions the group would take if the viruses they created proved to become more transmissible or disease-causing as the result of the experiments.
Although the experiments demonstrate a lack of oversight and present dangers to public health, according to several scientists contacted by The Intercept, none of the viruses involved in the work are related closely enough to SARS-CoV-2 to have sparked the pandemic.
Serious Risks
In December 2017, the funding for some gain-of-function research was resumed under carefully constructed guidelines for “Potential Pandemic Pathogen Care and Oversight,” or P3CO — but the language suggested by Daszak helped the group evade this oversight as well. In July 2018, NIAID program officers decided that the experiments on humanized mice — which had been conducted a few months earlier — would get a pass from these restrictions as long as EcoHealth Alliance immediately notified appropriate agency officials according to the circumstances that the group had laid out.
While it is not unusual for grantees to communicate with their federal program officers, the negotiation of this matter did not appropriately reflect the gravity of the situation, according to Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center. “The discussions reveal that neither party is taking the risks sufficiently seriously,” said Bloom. “MERS-CoV has killed hundreds of people and is thought to pose a pandemic risk, so it’s difficult to see how chimeras of MERS-CoV with other high risk bat coronaviruses shouldn’t also be considered a pandemic risk.”“It’s absolutely outrageous,” said Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris. “The NIH is bending over backward to help people it’s funded. It isn’t clear that the NIH is protecting the U.S. taxpayer.”
The NIH did not respond to questions about the communications with Daszak. EcoHealth Alliance did not immediately respond to questions.
In a written response to questions submitted in September and October, an NIH spokesperson told The Intercept that the rule that was supposed to trigger a stop to the research was added “out of an abundance of caution.” Similarly, in a letter sent to the House Committee on Oversight and Reform last month, NIH principal deputy director Lawrence Tabak called the rule “an additional layer of oversight,” implying that the agency had devised the rule itself. But the notes reviewed by The Intercept show that the language was inserted at Daszak’s suggestion and that the NIH and EcoHealth Alliance worked together to evade additional oversight.
Daszak responded to the NIH on June 8, 2016, arguing that, because EcoHealth Alliance’s proposed hybrid viruses were significantly different from the SARS virus, which was already known to infect humans, the experiments were not gain-of-function research and should not be restricted.
While it is not unusual for grantees to communicate with their federal program officers, the negotiation of this matter did not appropriately reflect the gravity of the situation, according to Jesse Bloom, a virologist at the Fred Hutchinson Cancer Research Center. “The discussions reveal that neither party is taking the risks sufficiently seriously,” said Bloom. “MERS-CoV has killed hundreds of people and is thought to pose a pandemic risk, so it’s difficult to see how chimeras of MERS-CoV with other high risk bat coronaviruses shouldn’t also be considered a pandemic risk.”“It’s absolutely outrageous,” said Simon Wain-Hobson, a virologist at the Pasteur Institute in Paris. “The NIH is bending over backward to help people it’s funded. It isn’t clear that the NIH is protecting the U.S. taxpayer.”
The NIH did not respond to questions about the communications with Daszak. EcoHealth Alliance did not immediately respond to questions.
In a written response to questions submitted in September and October, an NIH spokesperson told The Intercept that the rule that was supposed to trigger a stop to the research was added “out of an abundance of caution.” Similarly, in a letter sent to the House Committee on Oversight and Reform last month, NIH principal deputy director Lawrence Tabak called the rule “an additional layer of oversight,” implying that the agency had devised the rule itself. But the notes reviewed by The Intercept show that the language was inserted at Daszak’s suggestion and that the NIH and EcoHealth Alliance worked together to evade additional oversight.
Daszak responded to the NIH on June 8, 2016, arguing that, because EcoHealth Alliance’s proposed hybrid viruses were significantly different from the SARS virus, which was already known to infect humans, the experiments were not gain-of-function research and should not be restricted.
Daszak also pointed out that WIV1, the parent of the proposed chimeric SARS-like viruses, “has never been demonstrated to infect humans or cause human disease,” according to the transcribed emails. And he said that previous research “strongly suggests that the chimeric bat spike/bat backbone viruses should not have enhanced pathogenicity in animals.” The NIH would go on to accept these arguments.
But the group’s argument that its viral research did not pose a risk of infection appears to contradict the justification for the work: that these pathogens could potentially cause a pandemic. “The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,” said Bloom. “Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?”
The NIH has not made the correspondence public. Instead, the agency arranged for an “in camera” review for select congressional staff. The staffers were allowed to read and take notes on printed copies of the written exchange — an unusual approach for grant communications that are in the public interest. The Intercept reviewed notes taken by congressional staff.
“Given the importance and interest in this topic, it’s important for the NIH to be fully transparent about the research they support and how they make crucial decisions about the regulation of research on potential pandemic pathogens,” said Bloom.
In a July 7 letter to EcoHealth Alliance, NIH’s Greer and Stemmy formally accepted Daszak’s proposed rule. The chimeric viruses were “not reasonably anticipated” to “have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route,” the administrators concluded, according to the transcribed emails.
The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: “Should any of the MERS-like or SARS-like chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain you must stop all experiments with these viruses.”
But when the scientists conducted the experiments in 2018, one of the chimeric viruses grew at a rate that produced a viral load of log 4 — or 10,000 times — greater than the parent virus. Even so, the work was allowed to proceed.
Despite the careful wording meant to assure the agency that the research would be immediately halted if it enhanced the viruses’ pathogenicity or transmissibility, EcoHealth violated its own rule and did not immediately report the concerning results to NIH, according to the letter from NIH’s Tabak.
In a letter sent to NIH on October 26, Daszak insisted EcoHealth Alliance did comply with all the requirements of its NIH grant, pointing out that the group reported the results of its experiment in its year four progress report, which it submitted to the agency in April 2018 — and that no one at the agency responded to the description of the experiment. “At no time did program staff indicate to us that this work required further clarification or secondary review,” he wrote.
Daszak also argued in the letter that the viral growth reported in the year four progress report did not correspond to the viral growth outlined in the rule he himself had devised. “The experiment we reported to NIH actually shows genome copies per gram not viral titer.”
Daszak emphasized that the growth of the chimeric viruses in the genetically engineered mice was enhanced only in the early part of the experiment. “By day 6-8, there was no discernably significant difference among the different viral types,” he wrote.
Yet virologists contacted by The Intercept dismissed both the distinction between viral titer and viral growth and the focus on the latter part of the mouse experiment, when the rate of growth between the viruses had evened out.
“I don’t agree with their interpretation,” said Wain-Hobson, of the Pasteur Institute. He described the EcoHealth Alliance’s response as “hairsplitting” and said that viral growth inevitably peters out. “Every growth of a virus comes to a plateau. This has been known since time immemorial,” said Wain-Hobson, who explained that the eventual cessation of viral growth is due to a lack of nutrients. “They have chosen this interpretation because it suits them.”
NIH officials have previously stated unequivocally that the agency did not fund any gain-of-function research in Wuhan. “The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology,” said Anthony Fauci, the head of the NIAID, during a Senate hearing in May. Fauci is scheduled to testify before the Senate health committee tomorrow morning.
In its statement to The Intercept, an NIH spokesperson wrote, “the Agency did not support the kind of ‘gain of function’ research warranting the additional and unique P3CO oversight identified by stakeholders during extensive prior policy development. To claim otherwise is incorrect and irresponsible.” And in his letter last month, Tabak reiterated the claim that the research was not gain-of-function.
But the correspondence with Daszak makes clear that at least some at the agency were concerned that EcoHealth Alliance’s proposed experiments met the criteria for gain-of-function research of concern as early as 2016.
According to Richard Ebright, a molecular biologist at Rutgers University who has criticized the lack of federal oversight of gain-of-function research, the fact that the NIH allowed EcoHealth Alliance to write its own rules is further evidence of the NIH’s regulatory failure. “This is like the teacher giving you the opportunity to write your own homework problem and grade your own homework when you turn it in. Then you decide the teacher is so lenient, there’s no need to hand it in,” said Ebright. “The oversight process clearly failed.”
Beyond the question of oversight, others question whether these experiments should be conducted at all.
“In addition to the legalistic questions of whether EcoHealth and NIH were adhering to current guidelines,” said Bloom, “we urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.”
But the group’s argument that its viral research did not pose a risk of infection appears to contradict the justification for the work: that these pathogens could potentially cause a pandemic. “The entire rationale of EcoHealth’s grant renewal on SARS-related CoVs is that viruses with spikes substantially (10-25%) diverged from SARS-CoV-1 pose a pandemic risk,” said Bloom. “Given that this is the entire rationale for the work, how can they simultaneously argue these viruses should not be regulated as potential pandemic pathogens?”
The NIH has not made the correspondence public. Instead, the agency arranged for an “in camera” review for select congressional staff. The staffers were allowed to read and take notes on printed copies of the written exchange — an unusual approach for grant communications that are in the public interest. The Intercept reviewed notes taken by congressional staff.
“Given the importance and interest in this topic, it’s important for the NIH to be fully transparent about the research they support and how they make crucial decisions about the regulation of research on potential pandemic pathogens,” said Bloom.
The Escape Clause
Regulating risky research is the NIH’s role. But Daszak gave his group a way out. If the recombinant viruses grew more quickly than the original viruses on which they were based, he suggested, EcoHealth Alliance and its collaborators would immediately stop its research and inform their NIAID program officer. Specifically, he suggested a threshold beyond which his researchers would not go: If the novel SARS or MERS chimeras showed evidence of enhanced virus growth greater than 1 log (or 10 times) over the original viruses and grow more efficiently in human lung cells, the scientist would immediately stop their experiments with the mutant viruses and inform their NIAID program officer.In a July 7 letter to EcoHealth Alliance, NIH’s Greer and Stemmy formally accepted Daszak’s proposed rule. The chimeric viruses were “not reasonably anticipated” to “have enhanced pathogenicity and/or transmissibility in mammals via the respiratory route,” the administrators concluded, according to the transcribed emails.
The language that the NIH later inserted into the grant was strikingly similar to what Daszak proposed: “Should any of the MERS-like or SARS-like chimeras generated under this grant show evidence of enhanced virus growth greater than 1 log over the parental backbone strain you must stop all experiments with these viruses.”
But when the scientists conducted the experiments in 2018, one of the chimeric viruses grew at a rate that produced a viral load of log 4 — or 10,000 times — greater than the parent virus. Even so, the work was allowed to proceed.
Despite the careful wording meant to assure the agency that the research would be immediately halted if it enhanced the viruses’ pathogenicity or transmissibility, EcoHealth violated its own rule and did not immediately report the concerning results to NIH, according to the letter from NIH’s Tabak.
In a letter sent to NIH on October 26, Daszak insisted EcoHealth Alliance did comply with all the requirements of its NIH grant, pointing out that the group reported the results of its experiment in its year four progress report, which it submitted to the agency in April 2018 — and that no one at the agency responded to the description of the experiment. “At no time did program staff indicate to us that this work required further clarification or secondary review,” he wrote.
Daszak also argued in the letter that the viral growth reported in the year four progress report did not correspond to the viral growth outlined in the rule he himself had devised. “The experiment we reported to NIH actually shows genome copies per gram not viral titer.”
Daszak emphasized that the growth of the chimeric viruses in the genetically engineered mice was enhanced only in the early part of the experiment. “By day 6-8, there was no discernably significant difference among the different viral types,” he wrote.
Yet virologists contacted by The Intercept dismissed both the distinction between viral titer and viral growth and the focus on the latter part of the mouse experiment, when the rate of growth between the viruses had evened out.
“I don’t agree with their interpretation,” said Wain-Hobson, of the Pasteur Institute. He described the EcoHealth Alliance’s response as “hairsplitting” and said that viral growth inevitably peters out. “Every growth of a virus comes to a plateau. This has been known since time immemorial,” said Wain-Hobson, who explained that the eventual cessation of viral growth is due to a lack of nutrients. “They have chosen this interpretation because it suits them.”
NIH officials have previously stated unequivocally that the agency did not fund any gain-of-function research in Wuhan. “The NIH has not ever and does not now fund gain-of-function research in the Wuhan Institute of Virology,” said Anthony Fauci, the head of the NIAID, during a Senate hearing in May. Fauci is scheduled to testify before the Senate health committee tomorrow morning.
In its statement to The Intercept, an NIH spokesperson wrote, “the Agency did not support the kind of ‘gain of function’ research warranting the additional and unique P3CO oversight identified by stakeholders during extensive prior policy development. To claim otherwise is incorrect and irresponsible.” And in his letter last month, Tabak reiterated the claim that the research was not gain-of-function.
But the correspondence with Daszak makes clear that at least some at the agency were concerned that EcoHealth Alliance’s proposed experiments met the criteria for gain-of-function research of concern as early as 2016.
According to Richard Ebright, a molecular biologist at Rutgers University who has criticized the lack of federal oversight of gain-of-function research, the fact that the NIH allowed EcoHealth Alliance to write its own rules is further evidence of the NIH’s regulatory failure. “This is like the teacher giving you the opportunity to write your own homework problem and grade your own homework when you turn it in. Then you decide the teacher is so lenient, there’s no need to hand it in,” said Ebright. “The oversight process clearly failed.”
Beyond the question of oversight, others question whether these experiments should be conducted at all.
“In addition to the legalistic questions of whether EcoHealth and NIH were adhering to current guidelines,” said Bloom, “we urgently need a broader discussion about whether it’s a good idea to be making novel chimeras of coronaviruses that are at this point universally acknowledged to pose a pandemic risk to humans.”
During ACIP's public hearing yesterday, David Wiseman let them have it. But the members were blind, deaf and awfully dumb. Here is his excellent testimony
David Wiseman, Ph.D. ACIP Meeting November 2, 2021
Thank you, Chairwoman Lee.
Former FDA medical officer Dr. David Gortler just wrote that FDA Failed In Its Duty To Ensure Vaccine Safety For Children.
After criticizing the UK for rushing to approve Pfizer's vaccine, Dr. Fauci called FDA "the gold standard of regulation."
With extensive medical industry experience, I say this is the gold standard of regulatory dereliction
FDA touted its children’s vaccine review as thorough and transparent. Far from it.
For safety 1500 patients followed less than 3 months and another 1500 only 2.4 weeks?
Only a small immunobridging study against the Wuhan strain, still with no immune correlation of protection?
A similar study against delta was marked, "Assay not yet validated; Analyses not verified by FDA" -- where is FDA?
The efficacy study yielded only 16 placebo and 3 vaccine cases. With a large imbalance of mysteriously excluded vaccinated subjects, bias in this observer-blinded, but not double blinded, study could drop the 90% efficacy to zero.
See today’s BMJ for allegations of trial unblinding. Where is FDA?
Why was the efficacy analysis not verified by FDA – where was FDA?
Where is Pfizer’s study on troponin levels and subclinical myocarditis? Where is FDA?
FDA’s risk benefit analysis failed to consider:
42% seroprevalence (% kids already immune back in June)
Non-myocarditis serious AE reports are as many as for myocarditis?
Improperly modeled pandemic waves and waning efficacy omitted from the model?
When properly accounted for, we find risks outweigh benefits by nearly 2 to 1 before underreporting
The one thing FDA got right was revealing an almost fivefold VAERS underreporting factor – which is at least fivefold,
and claiming a database more reliable than VAERS that CDC doesn’t know about?
Pfiizer has changed its vaccine formulation, now using a tris buffer that could change particle charge
But no assessment of particle distribution in animals. No safety nor efficacy study. Where was FDA?
With no cancer or mutagenicity studies, especially in young animals, FDA has not assuaged the concern for radiation-like toxicity of this gene therapy product.
With CDC's study on all-cause mortality and vaccination, we find positive correlations between vaccine coverage and mortality.
Adults receive benefit from the shots from 4 to 26 weeks post immunization, while before or after this time period there are detriments.
In non-vaccinated children all cause deaths correlate with adult vaccine coverage.
Vaccination already appears to harm non-vaccinated children.
Will ACIP request our analysis?
No emergency. Unblinding. Unverified efficacy data, missing and limited safety data, faulty risk-benefit analysis.
You (ACIP members) have nothing to work with and FDA shunted the work of defining risk groups onto you...
While VRBPAC member Eric Rubin, NEJM editor-in-chief, callously remarked, "We're never gonna learn about how safe the vaccine is until we start giving it."
FDA has abandoned its responsibility to our children. Will you?
!!! Ontario and Quebec back down: No mandate for health workers, cannot afford loss of tens of thousands of HCWs
There is tremendous strength in numbers. Hang on, hold tight. This is a huge victory!
I hope my governor, Dem. Janet Mills, sees she is on the losing side after the US election results and eastern Canada's decision to stop shooting itself in the foot. Will the Dems keep digging their own graves? Maine is a swing state and Janet's party will be swinging unless she changes course.
Premier Doug Ford has announced he will not mandate COVID-19 vaccines for hospital workers, saying he's "not prepared to jeopardize the delivery of care to millions of Ontarians."
In a statement on Wednesday, Ford said mandatory vaccines for hospital workers is a "complex issue" that could result in the "potential departure of tens of thousands of health-care workers."
Ford said the government will keep monitoring the situation but has decided for now to maintain a "flexible approach by leaving human resourcing decisions up to individual hospitals..."
https://globalnews.ca/news/8346947/quebec-drops-vaccine-mandate-among-health-care-workers/
Tuesday, November 2, 2021
Navy Approves Five Permanent Medical, No Religious Exemptions for COVID-19 Vaccine to Date/ USNI News
The Navy has so far approved five exemptions for the required COVID-19 vaccination — all medical, a Navy official told USNI News.
The service has approved five permanent medical exemptions for the COVID-19 vaccine so far, said Navy spokesperson Lt. Cmdr. Andrew DeGarmo. No one has been separated or discharged, as of Nov. 1, for not receiving the vaccine and the final snapshot will likely not be ready until Nov. 28, DeGarmo said.
The Navy has not released how many administrative exemptions — which is the category religious exemptions fall under — have been granted in terms of the COVID-19 vaccine, which is mandatory for all active-duty sailors and reservists. However, the Navy has not approved a religious waiver for vaccinations in the past seven years, DeGarmo said...
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