November 30th, 2020 3-5PM ET
Monday on The Robert Scott Bell Show:
“Stay of Action” Filed Against FDA to STOP Approval of COVID Vaccine for Using Faulty PCR Tests in Trials An ADMINISTRATIVE STAY OF ACTION has been filed with the Department of Health and Human Services and Food and Drug Administration (FDA) for the new Pfizer COVID vaccine that has been submitted for “emergency use authorization” (EUA). It is widely expected that the FDA is going to grant EUA fast-track approval to Pfizer’s experimental COVID vaccine within days. The STAY OF ACTION is a Petition for Administrative Action Regarding Confirmation of Efficacy End Points of Phase III Clinical Trials of COVID19 Vaccines. The STAY OF ACTION is based upon the faulty PCR tests that were used in the vaccine trials:Before an EUA or unrestricted license is issued for the Pfizer vaccine, or for other vaccines for which PCR results are the primary evidence of infection, all “endpoints” or COVID-19 cases used to determine vaccine efficacy in the Phase 3 or 2/3 trials should have their infection status confirmed by Sanger sequencing, given the high cycle thresholds used in some trials. High cycle thresholds, or Ct values, in RT-qPCR test results have been widely acknowledged to lead to false positives.
Retraction request letter to Eurosurveillance editorial board We, an international consortium of life-science scientists, write this letter in response to the article “Detection of 2019 novel coronavirus (2019-nCoV) by real-time RT-PCR” published in Eurosurveillance (January 23rd, 2020) and co-authored by Victor M Corman , Olfert Landt , Marco Kaiser , Richard Molenkamp, Adam Meijer, Daniel KW Chu, Tobias Bleicker , Sebastian Brünink, Julia Schneider , Marie Luisa Schmidt , Daphne GJC Mulders , Bart L Haagmans , Bas van der Veer , Sharon van den Brink, Lisa Wijsman, Gabriel Goderski, Jean-Louis Romette, Joanna Ellis, Maria Zambon, Malik Peiris, Herman Goossens, Chantal Reusken, Marion PG Koopmans, and Christian Drosten.
This paper (hereafter referred to as “Corman-Drosten paper”), published by “Eurosurveillance” on 23 January 2020, describes an RT-PCR method to detect the novel Corona virus (also known as SARS-CoV2). After careful consideration, our international consortium of Life Science scientists found the Corman-Drosten paper is severely flawed with respect to its biomolecular and methodological design. A detailed scientific argumentations can be found in our review “External peer review of the RTPCR test to detect SARS-CoV2 reveals 10 major scientific flaws at the molecular and methodological level: consequences for false positive results”, which we herewith submit for publication in Eurosurveillance. Further, the submission date and acceptance date of this paper are January 21st and January 22nd, respectively. Considering the severe errors in design and methodology of the RT-PCR test published by “Eurosurveillance”, this raises the concern whether the paper was subjected to peer-review at all.
Approval of COVID-19 Vaccines Will Change Nature of Clinical Trials Moreover, they observe, long-term trials are especially important for vaccines that use mRNA technology, because less is known about them than about traditional kinds of vaccines. The authors also point out that early licensing of any vaccine might make it harder to evaluate vaccines that haven’t yet been approved. “Once a vaccine is licensed, new placebo-controlled RCTs [randomized controlled trials] of other vaccines will not be acceptable ethically, and noninferiority RCTs will be the most likely alternative. “The goal of noninferiority trials will be to demonstrate that the immune response (that is, neutralizing antibody titers or levels) of the candidate vaccine is not inferior to that of the approved vaccine within a prespecified margin, which the FDA has established as less than 10% for COVID-19 vaccines,” the authors note. Dial Hewlett, Jr, MD, medical director for disease control services, Westchester County Department of Health in White Plains, New York, told Medscape Medical News that the ethicists raise important issues that have been discussed in other forums, including a recent webinar of the National Academy of Medicine.
Special Guest – Rick Jaffe Esq.
Richard Jaffe is a health care litigator, counselor and crisis manager, focusing on cutting-edge medical/legal issues. He represents practitioners, clinics, companies and health related organizations in complex health care regulatory matters throughout the United States, especially legal cases and investigations brought by federal and state government agencies. He has extensive experience in FDA matters, including clinical trials and new drug issues, Medicare and insurance fraud, professional licensure and criminal and civil scheduled drug prescribing problems. He has extensive experience in the stem cell field, both in the criminal and civil sides, and also works on matters involving dietary supplements.
The Supreme Court Does an About Face on Church/Synagogue Restrictions As you all know by now, on Wednesday night the Supreme Court stayed enforcement of NY Governor Cuomo’s restrictions on religious gatherings, in Roman Catholic Diocese of Brooklyn, New York v Andrew Cuomo. It is is just an temporary stay pending appeal, so technically it is not necessarily the Court’s final word on the matter, but nonetheless it is extremely significant as a predictor of future cases. It also may have significance for those interested in the mandatory vaccine issue. But first and foremost, the decision demonstrates the first principle of Constitutional interpretation, namely, the Constitution means what five justices say it means at any given time, and that can change radically in a short period of time, because of circumstance, the most important one being the make-up of the Court.
Churches Still Closed While Strip Clubs Reopen In California California remains firm in keeping establishments, such as churches, schools, and gyms, closed even as as the court allowed strip clubs to reopen last Friday. In a ruling dated Nov. 6, San Diego Superior Court Judge Joel R. Wohlfeil granted a temporary restraining order on the state’s cease-and-desist orders that banned strip clubs from providing live entertainment. Under the county public health order, strip clubs are not allowed to operate. In October, San Diego County Public Health Officer Dr. Wilma Wooten issued cease-and-desist orders to such establishments to curtail the spread of COVID-19, saying such a measure is in line with the executive order from Governor Gavin Newsom. However, two strip club owners brought the case to court. They filed lawsuits against the county’s public health orders and accused the government of violating constitutional rights and equal protection under the law. They argued that live entertainment is a form of constitutionally protected speech. They also stated they complied with the social distancing requirements as implemented by the California authorities. The business owners said they will suffer financial ruin if they face another shutdown. The court sided with the business owners and ordered that Wooten’s order be lifted temporarily. A full hearing will take place at the end of the month, according to Washington Free Beacon.
Johns Hopkins study explodes COVID death hoax; it’s re-labeling on a grand scale “This patient who died had an ordinary heart attack.” “Not anymore. We’re repackaging it as COVID.” November 30, 2020 NoMoreFakeNews.com Don’t blink. Johns Hopkins may delete or retract their analysis at any moment. Their author’s study is devastating. Too hot to handle. UPDATE: Yes, I wrote that opener a few hours before Johns Hopkins stepped in and DID retract the article. Boom.     Hopkins claims the article has been used to spread misinformation about the pandemic, and contains factual errors. CDC is cited as one correct source of facts. Hmm. Regardless, here is my article, finished before the Johns Hopkins retraction. Since then, I’ve only polished it a bit in several places, for clarity: Months ago, I told you this, in a number of articles: The overwhelming percentage of people who are “dying from the virus” are actually dying from traditional diseases. These people have been relabeled and repackaged as “COVID-19.” It has nothing to do with “the virus.” A new analysis from Johns Hopkins confirms this in spades. The Johns Hopkins News-Letter article, in a student publication, is headlined, “A closer look at US deaths due to COVID-19.” It lays out the case made by “Genevieve Briand, assistant program director of the Applied Economics master’s degree program at Hopkins.” As you keep reading, keep this in mind: If the so-called increase in mortality from COVID is offset, almost exactly, by a decrease in deaths from all other major diseases…
Moderna submits vaccine for approval, says trial shows 100% efficacy against ‘severe’ COVID Moderna will submit its coronavirus vaccine for regulatory approval on Monday, the company said — the second leading drug to pass the milestone this month. The Massachusetts biotech firm said it will ask the Food and Drug Administration for emergency use authorization after completing its Phase 3 trial, finding the vaccine was 94.1 percent effective against Covid-19. Moreover, Moderna said the vaccine was 100 percent effective at preventing severe cases of the disease. These results were the same across all age, race and gender categories, the company said in a statement. There have been no serious safety concerns so far, it added, with the most common side effects being fatigue, headaches, and muscle and joint pain. Moderna said it expects the FDA’s Vaccines and Related Biological Products Advisory Committee to convene on Dec. 17 to discuss its submission. That is a week after the FDA is expected to discuss another candidate, developed by the U.S. pharma giant Pfizer and its German partner BioNTech, which has also applied for regulatory approval having observed a similar level of efficacy. Both the Moderna and Pfizer-BioNTech drugs involve inserting special code called mRNA into the body, tricking it into developing an immune response. No mRNA-based drug has ever won approval before.
Could mRNA COVID-19 vaccines be dangerous in the long-term? Israelis celebrated on Friday when Prime Minister Benjamin Netanyahu announced that the country had signed a deal with Pfizer Inc. to buy its novel coronavirus vaccine. But the fact remains that if Pfizer succeeds – or Moderna, with whom Israel also has a contract – these will be the first-ever messenger RNA (mRNA) vaccines brought to market for human patients. In order to receive Food and Drug Administration approval, the companies will have to prove there are no immediate or short-term negative health effects from taking the vaccines. But when the world begins inoculating itself with these completely new and revolutionary vaccines, it will know virtually nothing about their long-term effects. “There is a race to get the public vaccinated, so we are willing to take more risks,” Tal Brosh, head of the Infectious Disease Unit at Samson Assuta Ashdod Hospital, told The Jerusalem Post. When Moderna was just finishing its Phase I trial, The Independent wrote about the vaccine and described it this way: “It uses a sequence of genetic RNA material produced in a lab that, when injected into your body, must invade your cells and hijack your cells’ protein-making machinery called ribosomes to produce the viral components that subsequently train your immune system to fight the virus.”
Peter Doshi: Pfizer and Moderna’s “95% effective” vaccines—let’s be cautious and first see the full data Only full transparency and rigorous scrutiny of the data will allow for informed decision making, argues Peter Doshi In the United States, all eyes are on Pfizer and Moderna. The topline efficacy results from their experimental covid-19 vaccine trials are astounding at first glance. Pfizer says it recorded 170 covid-19 cases (in 44,000 volunteers), with a remarkable split: 162 in the placebo group versus 8 in the vaccine group. Meanwhile Moderna says 95 of 30,000 volunteers in its ongoing trial got covid-19: 90 on placebo versus 5 receiving the vaccine, leading both companies to claim around 95% efficacy. Let’s put this in perspective. First, a relative risk reduction is being reported, not absolute risk reduction, which appears to be less than 1%. Second, these results refer to the trials’ primary endpoint of covid-19 of essentially any severity, and importantly not the vaccine’s ability to save lives, nor the ability to prevent infection, nor the efficacy in important subgroups (e.g. frail elderly). Those still remain unknown. Third, these results reflect a time point relatively soon after vaccination, and we know nothing about vaccine performance at 3, 6, or 12 months, so cannot compare these efficacy numbers against other vaccines like influenza vaccines (which are judged over a season). Fourth, children, adolescents, and immunocompromised individuals were largely excluded from the trials, so we still lack any data on these important populations.
The Germans Are Back! Break out the Wagner, folks…the Germans are back! No, not the warm, fuzzy, pussified, peace-loving, post-war Germans … the Germans! You know the ones I mean. The “I didn’t know where the trains were going” Germans. The “I was just following orders” Germans. The other Germans. Yeah…those Germans. In case you missed it, on November 18, the German parliament passed a law, the so-called “Infection Protection Act” (“Das Infektionsschutzgesetz” in German) formally granting the government the authority to issue whatever edicts it wants under the guise of protecting the public health. The government has been doing this anyway — ordering lockdowns, curfews, travel bans, banning demonstrations, raiding homes and businesses, ordering everyone to wear medical masks, harassing and arresting dissidents, etc. — but now it has been “legitimized” by the Bundestag, enshrined into law, and presumably stamped with one of those intricate official stamps that German bureaucrats like to stamp things with. Now, this “Infection Protection Act,” which was rushed through the parliament, is not in any way comparable to the “Enabling Act of 1933,” which formally granted the government the authority to issue whatever edicts it wanted under the guise of remedying the distress of the people. Yes, I realize that sounds quite similar, but, according to the government and the German media, there is absolutely no equivalence whatsoever, and anyone who suggests there is is “a far-right AfD extremist,” “a neo-Nazi conspiracy theorist,” or “an anti-vax esotericist,” or whatever.
Question of The Day!
This question is for Don –
I also live in Oregon outside of Portland – and totally agree with you about our so called leader. Can she mandate that adults get the shot? Did you happen to listen to her press conference on 11/25? she said there will be vaccines for everyone… and earlier she stumbled when asked about supply and said “shot for those who want them” but stumbled in her answer… I don’t trust her one little bit and afraid about what she might do.
Comment of The Day!
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