Publisher's Note: The Reader is pleased to present our second Q&A with the Scott and Rock Island County Health Departments on controversies, contradictions, and conflicts that continue to plague the COVID-19 pandemic narrative. Questions were sent to both county health departments and simultaneously published in our June 2021 edition. And once again, to their huge credit, Scott and Rock Island health officials have fully engaged in this process, providing comprehensive responses for Quad Citians to consider. (Here is last Fall's response from County officials to the Reader's questions regarding COVID.)
Presented below is the communication provided by Scott County Medical Director Dr. Louis Katz, unedited except for formatting and labeling. Katz provided commentary and feedback on much of Reader Editor Kathleen McCarthy's assertions we published in our June edition, in addition to responses to the eight specific questions she posed. After many of the county health departments' responses provided by Katz, we are publishing follow-up commentary from McCarthy. Note that the documentation Katz provided in .pdf format is all available at the online version of this article or by going to RCReader.com/y/covidkids.
Below is the video recording of the joint media briefing presented by the Scott and Rock Island County Health Departments on June 28, 2021, which are available at this link, here.
Thank you for your vigorous participation. The SCHD/RICHD are always welcome in the Reader. The Quad Cities is a stronger, better informed, more engaged community thanks to your willingness to share your knowledge and perspectives amid difficult topics, complex content, controversies and differences, but most of all in the advancement our common desire to thrive.
10 June 2021 To: Todd McGreevy, Publisher, River Cities’ Reader
From: Louis M. Katz MD, Medical Director, Scott County Health Dept. Cheryl True MD, Medical Director, Rock Island County Health Dept. Amy Thoreson MPH, Director, Scott County Health Dept. Nita Ludwig, Public Health Administrator, Rock Island County Health Dept. Brooke Barnes MPP, Community Health Consultant, Scott County Health Dept. Janet Hill MPH, Chief Operating Officer, Rock Island County Health Dept.
Re: Your inquiries regarding COVID-19 vaccinations (and other topics).
Mr. McGreevy: In public health, our mission pivots on media cooperating to distribute information that is accurate based on the best science available at the time. With that in mind, and confident your publication shares our mission, we thank you for the opportunity to respond to your questions and to address some errors of fact that premise them.
Allow us to apologize for the length of these responses, but your readership needs to understand the chasm between what the evidence demonstrates and the assertions underlying your questions.
Links are included and selected references are provided (under separate cover) that we think represent a consensus among physicians and public health based on the “totality of the evidence”. The latter are restricted, with a single exception, to the peer-reviewed literature to provide a glimpse at the evidence behind our responses.
Publications that arrive at conclusions contrary to consensus are common and critically important. Attending to evidence from conflicting studies is key to self-correction by science and public health; while we are confident that what follows are accurate descriptions of what is known today, we encourage you to provide us any peer-reviewed dissenting sources to which you have referred.
We ask that you post and publish our responses verbatim, with your preambles and questions exactly as you provided them to us. We reserve the right to disseminate and post this document independently as needed.
RCR QUESTION 1 SETUP: It is well-documented by the FDA and CDC that, even though not FDA-approved for licensure and mass distribution, the emergency use authorization (EUAs) for “mRNA and Vector vaccinations” do not provide recipients inoculated immunity from getting, transmitting, being hospitalized, or dying from COVID-19. Instead, these experimental injections, whether Pfizer Biotech, Moderna, J&J Janssen, and AstraZeneca, claim only to reduce moderate-to-mild symptoms of COVID19, and this benefit only lasts for approximately two months.
RICHD/SCHD Response: This statement misrepresents the breadth of clinical trial and “real- world” data widely available to the public. These CDC links are a good place to start and provide access to the primary literature as well. The FDA documents tend to be more narrowly focused on the data submitted for EUA. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/keythingstoknow.html, https://www.cdc.gov/media/releases/2021/p0514-covid-19-vaccine-effectiveness.html, https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
(Note that the Astra Zeneca vaccine has been neither authorized nor a submission completed to FDA for use in the US.)
No vaccine is 100-percent effective, but these are incredibly so. For example, in large phase 3 trials of the mRNA vaccines (Pfizer and Moderna), the efficacy, mainly against symptomatic COVID-19 associated with SARS-CoV-2 infection was over 90 percent. Further, among vaccinees who become infected with any of the US EUA vaccines (including J&J), illness was prevented or attenuated, and forward transmission to contacts blocked, including to those at highest risk from infection. The emergency use authorized (EUA) vaccines demonstrate remarkable efficacy in preventing hospitalization, ICU stays and death. In some groups these effects approach 100 percent. Even in the highest risk cohorts, for example residents in long term care facilities with multiple comorbidities and impaired immune responsiveness, efficacy surpasses the minimum criteria established by FDA.
The clinical trials leading to EUAs were as rigorous as those for approval of prior vaccines. The vaccine technologies used are characterized as new but have been developed over almost 30 years of basic and applied research. The speed of EUA was unprecedented, as befits an emergency, but was the result of intensive taxpayer support for the parallel execution of multiple steps in the regulatory authorization process that are, in non-emergency times, typically performed sequentially. This was financially risky, but not an unsafe approach. Safety evaluations during the clinical trials and before granting EUA extended beyond the interval for which serious unexpected adverse effects have been documented for other vaccines. Also, the follow up of phase 3 vaccinees will continue for a minimum of two years.
In addition to the phase 3 trials’ efficacy endpoints, we now have an expanding body of real-world effectiveness evidence. Efficacy and effectiveness are not the same. The former is assessed under strictly controlled circumstances in a clinical trial, the latter reflects experience in the much more “chaotic” real world. Performance in the real world is entirely consistent with the clinical trial data. References to this point have been provided.
RCR QUESTION 1: Why is this inoculated immunity, with a two-month shelf life, via these experimental injections, considered more medically desirable in achieving herd immunity than achieving it from natural immunity that lasts for a lifetime in COVID-19-recovered people, whose rate of survival from COVID-19 is 99.9 percent?
RICHD/SCHD Response: Your statement about the “shelf life” of immunity after vaccination is incorrect. Clinical protection due to “inoculated immunity” appears to be a minimum of 8-10 months persistence and counting. We think it will be longer but cannot say more about the duration of clinical protection when the first shots in clinical trials were not given until July 2020. Follow up is ongoing. As always, we await more robust data, especially the identification of in vitro correlates of protection to allow using blood tests to estimate the durability of clinical protection without the need for expensive and complicated epidemiological studies of vaccinees vs. unvaccinated controls.
Recent in vitro data (studies enumerating long-lived immune cells in the blood and bone marrow) suggest the duration of protection may be much longer. By some measures (certain antibody levels), the immunity induced by COVID-19 immunization may be more potent than that from natural infection. The strength of those data informs the current recommendation that even those recovered from COVID-19 should seek immunization.
Speculating that there is “natural immunity that lasts a lifetime” after COVID-19 recovery (or after vaccination) is premature, inappropriate, potentially dangerous, and unfounded in any data we have seen. Early reports find a small number of SARS-CoV-2 reinfections occurring within months of recovery from COVID-19, when we assume immunity to be at its highest. Likewise, small numbers of vaccine breakthrough infections are being documented. The bottom line is we do not yet have a clear understanding of the time course of immunity. Its impact on the need for boosters to combat waning immunity or for vaccine-escape variants, all analogous to decades of influenza vaccine experience, is yet to be understood.
To achieve herd immunity, as you suggest, by natural infection will necessarily inflict unneeded illness, hospitalization, death (minimally 590,000 and counting in the US alone), and extended illnesses (“Long COVID”) on your family and neighbors. The “costs” to the health care enterprise (dollar costs and disruptions) and to society as a whole (lost productivity etc.) would be large compared to immunization. The infection fatality rate approaches 0.5-1 percent depending on a variety of demographics, not 0.1 percent as incorrectly alleged in your question.
Finally, vaccines address the wild card of COVID-19 variant evolution very effectively so far. Variants do not pop out of thin air. The “wild type” virus must infect and undergo rapid replication in people for mutated variants to arise, then be favored by some biological advantage and emerge in the population. Driving down the pool of susceptible people with vaccine drives down infection, replication, and variant emergence. The good news is that data to date suggest the US EUA vaccines remain very protective against severe disease caused by the current variants of concern.
RCR QUESTION 2 SETUP: As more people are injected with the COVID “vaccines,” adverse reactions are presenting in greater numbers. This is especially true for COVID- recovered recipients, who later got the jab triggering a condition known as Antibody Dependent Enhancement (ADE). In essence, ADE is an autoimmune response that causes adverse health consequences in otherwise healthy participants who already possess strong protective natural immunity from having been infected and recovered from COVID.
RICHD/SCHD Response: This is incorrect. ADE was NOT observed with vaccination, nor with convalescent plasma transfusion or monoclonal antibody therapy that are essentially antibody infusions. ADE was an important and explicit safety endpoint in the vaccine trials and evaluation of monoclonal antibodies and was specifically assessed in outcomes from the convalescent plasma expanded access protocols and trials. If you have peer-reviewed literature suggesting otherwise that we have missed please supply it.
It is true that reactogenicity is not trivial after the authorized vaccines and may be somewhat worse when vaccination follows natural infection. Data from US and EU surveillance systems supports this. These data have not to date been sufficient that anyone in public health believes there is a material change in the risk-benefit balance. A sore arm and fever for 24-72 hours vs. a contagious and potentially lethal infection is the more relevant calculus.
RCR QUESTION 2: What is the medical rationale for excluding natural immunity in reaching the goal of 70-90-percent herd immunity, instead focusing on inoculated immunity only, causing COVID-recovered people with established natural immunity from COVID- 19 and many variants, to unwisely consent to unnecessary inoculated immunity as a matter of policy for achieving global herd immunity goals?
RICHD/SCHD Response: The speculation is incorrect. Ignoring the serious question whether herd immunity is even achievable, using natural infection to approach herd immunity condemns many high-risk individuals here and in the developing world to unnecessary illness and death from COVID-19. This is especially true in areas lacking advance medical facilities for support of critical illness (for example South Sudan, the Sudan and Kenya, one of our children, deployed by Doctors Without Borders, has personally observed recently). It is critical that developed countries like the US make maximal use of our experience with these vaccines in the humanitarian effort to support robust immunization programs where they do not exist.
High global vaccine uptake also looks like the best approach to suppress variant emergence. It will prevent replication of the virus in humans. Variant evolution cannot occur without virus growth in humans, and vaccines prevent this. While some of the variants are less effectively neutralized by vaccine immunity than others, evolving evidence suggests they are still inhibited substantially in fully immunized people. This is especially true of the B.117 variant, first recognized in the U.K., which has become dominant in the U.S.
RCR EDITOR COMMENTARY ON RICHD/SCHD RESPONSES TO QUESTIONS 1 & 2:
Both questions were misunderstood by SCHD/RICHD, evidenced by the responses. The questions ask why inoculated or acquired immunity is more desirable by health authorities in reaching herd immunity, a goal strived for strictly through inoculated or acquired immunity, excluding innate or natural immunity?
Neither question is about innate immunity from COVID infection as a replacement for acquired immunity through vaccination, rather both are seeking an explanation for why inoculated immunity is more desirable to the medical community to the exclusion of those who are COVID-recovered and not inoculated, yet possess strong natural immunity?
The oft-stated goal of 70-percent herd immunity includes inoculating COVID-recovered people who are already producing immune responses, arguably more robustly than immune responses from the experimental injections. Confirmation of this could be easily confirmed with antibody testing prior to jabs. Yet the recommendation is to inoculate COVID-recovered persons, regardless. There is no medical justification for this protocol. More importantly, those COVID-recovered with innate immunity may be harmed by synthetic mRNA that competes with naturally established antigen responses. More studies are needed to sort all this out, and the medical community fully acknowledges this.
Lifetime natural immunity from infectious diseases are well-documented, including from chickenpox, measles, mumps, and others. It is not a big leap to consider the possibility of lifelong innate immunity after recovery from coronaviruses, such as SARS-CoV-2 and COVID19. Notably, this residual benefit is proving true for those exposed to SARS-CoV back in the early 2000s, who still possess antibodies that not only continue to protect against SARS1, but appear to provide some protection against SARS2, as well.
The SCHD/RICHD response proposed innate immunity as threatening to vulnerable populations in undeveloped countries. This assumes there are no therapeutics or treatments available, such as Ivermectin and/or Hydroxychloroquine, both of which are traditionally easily accessible and affordable in less developed countries. Medical data from countries, such as India and many African nations, demonstrate that, until recently, these therapeutics were regularly prescribed with remarkable success in treating COVID-19. Unlike the U.S., where vulnerable patients with COVID are largely left untreated until they are hospitalized, usually in distress and/or in critical condition, less developed countries successfully treat their people with combinations of tried and trusted anti-virals, antibiotics, vitamins and minerals.
A positive aspect relative to COVID is that we readily identify our vulnerable, thus are able to proactively mitigate accordingly, especially when they represent less than one percent of the entire human population. Said differently, 99.7 percent of all humans infected will survive COVID-19, according to well-established mortality data from prominent health authorities worldwide, including the WHO, CDC, John Hopkins, European Medicines Agency, and global data centers such as Euromomo and Worldometer, most of whom now incorporate real-world numbers and values, replacing most predictive computer modeling.
Finally, challenging innate immunity as inferior to acquired immunity has little basis in science, especially as it relates to mRNA experimental injections. The mRNA injections cause replication of particular spike proteins, triggering highly specific single-task antibodies to fight infection. A natural immune response triggers a vastly wider array of more versatile antibodies with memory that multitask in the fight against infection, and also supply a microbiological Praetorian guard, so to speak, against the current and similar viruses.
None of the links provided by SCHD/RICHD support any of its claims that experimental COVID injections provide “clinical protection due to inoculated immunity appears to be a minimum of 8-10 months persistent and counting.” But what a nice surprise if any acquired immunity is provided at all (even two months worth), as it was never a claim of these particular emergency use “vaccinations” more accurately described as gene therapies, to prevent recipients from getting or transmitting COVID in the first place.
As for COVID variants, including Delta, they have been circulating under different original names. Delta was previously the Indian variant. As a viral rule, mutations/variants are normally more infectious but almost always less virulent, therefore less dangerous. The mortality data showing rising cases with the Delta variant have no correlating increase in deaths or hospitalizations. That said, the UK's Public Health England recently reported a significant increase in cases with the Delta variant in fully vaccinated people. https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/997418/Variants_of_Concern_VOC_Technical_Briefing_17.pdf
Variants are the more recent versions of SARS-CoV-2 infections and have virtually no track record with inoculated immunity, especially as it relates to new technology such as mRNA experimental injections, which basically replicate spike proteins, themselves now proving to be problematic. (Due to space constraints, all sources and links will be provided online.)
RCR QUESTION 3 SETUP: Prior to COVID-19, “asymptomatic spread” referred strictly to a much shorter period of “pre-symptomatic spread” (usually one to two days from infection to symptom onset) of respiratory infectious diseases, especially from coronaviruses. Before COVID-19, it was medically accepted that if a person became infected with a coronavirus, but didn't present with symptoms and was never sick, that person already had natural immunity due to: (a) a previous encounter with the same or similar virus; or (b) that person's immune system activated upon encountering the invading virus, effectively beating it into oblivion. Either way, no asymptomatic transmission/spread was possible due to the vanquished viral infection, meaning that person had no infectious virus to transmit.
RICHD/SCHD Response: These assertions are wrong. Presymptomatic transmission is transmission in the two days or so before onset of illness from an infected person, while asymptomatic transmission is from those who never develop symptoms but still shed infectious virus. Neither assumes anything about preexisting nor about acquired immunity. The evidence for asymptomatic transmission is described below.
An absence of transmission in the absence of illness was well established for both influenza A and the two prior severe coronaviruses (SARS-1 and MERS). For all three, focusing on isolation of symptomatic patients and quarantining their defined contacts were, thus, quite effective. The important early mistake was relying on past experience with those viruses to inform our response to SARS- CoV-2. By March and April 2020, when asymptomatic transmission was clearly established, it was too late to contain broad spread using otherwise tried and true population and individual level techniques for managing contacts.
The existence of pre- and asymptomatic transmission is a key argument for widespread testing, especially of apparently well contacts of cases of COVID-19. Such testing allows quarantine and isolation during the interval when those folks are clinically unrecognizable but infectious.
As case counts drop with immunization, resource intensive contact tracing programs to identify and quarantine well, but potentially infectious exposed individuals, are being decommissioned. This makes maintenance of vaccine immunity even more important for sustained pandemic control.
RCR QUESTION 3 SETUP: Most COVID “cases” are confirmed using unreliably high PCR testing cycle thresholds of 40-45 in the Quad Cities (according to Dr. Fauci, anything over 33 is useless). Yet the huge majority of those cases had no epidemiological evidence of infectious disease. In other words, these people were not sick. The explanation for this phenomenon has been to label them “asymptomatic cases,” that in turn automatically became asymptomatic carriers, giving birth to the theory of asymptomatic spread.
RICHD/SCHD Response: These statements are incorrect. Please provide a reference for the “useless” statement attributed to Dr. Fauci.
Cases of infection and cases of illness are not the same thing. Simplistically, infection is the presence of the virus in tissue, while illness is the presence of symptoms as a result of infection. Well understood contemporary examples of transmission without illness include HIV, hepatitis B and hepatitis C. With SARS- CoV-2 the medical literature is replete with evidence of transmission in the absence or before the onset of illness and references have been included.
Recall that for the first half of the pandemic, testing was largely limited to symptomatic persons due to resource constraints. Eighty-seven percent of individuals testing positive with completed interviews in Scott County since the start of the pandemic have had symptoms when tested.
Generally speaking, for reasons that seem arcane to the general public, cycle thresholds (Cts) are not routinely included with test reports. Virus cultures from respiratory specimens are often negative when Ct values are high but detectable, but PCR Ct values are not standardized across the many authorized tests (275 on 4 June 2021), so Cts are not approved by FDA for use in clinical management. CDC does not endorse or recommend use of Ct values to assess when a person is no longer infectious. This is a link to a statement from the Infectious Diseases Society of America that states “[At] the current time, routine use of Ct values to inform clinical decision making is not advised.”
RCR QUESTION 3: Even though the large majority of cases were not symptomatic/sick themselves, these people were conveniently labeled as infectious carriers of COVID-19, capable of transmitting COVID to others. Yet curiously, there is not a scintilla of proof for this newly discovered pandemic-causing asymptomatic transmission, nor has it ever been associated with the epidemiology of any previously known respiratory infectious disease, especially from coronaviruses.
What proof is there for asymptomatic spread of COVID-19, especially if the 80-90 percent of the cases are not actually confirmed due to faulty PCR testing?
RICHD/SCHD Response: These are incorrect assertions presented as facts (“not a scintilla of proof...”) about both the performance of PCR (see above) and rates of asymptomatic, pre-symptomatic and symptomatic illness. See attached peer-reviewed articles. Again, as noted, among completed evaluations, 87 percent of positives in Scott County have been symptomatic.
Asymptomatic and presymptomatic spread were first described in as early as late January and into February and March 2020. They were based on detailed contact tracing exercises in China and elsewhere. In the first cases, homebound individuals with well characterized and limited social interactions became infected by well characterized source patients who either never developed symptoms or developed them only after their homebound contacts had become ill. Similar chains of transmission are well documented wherever they have been looked for.
A proportion of well COVID-19 contacts who have virus cultures excrete large amounts of infectious viruses (not PCR, but virus) after exposure and never become symptomatic – including some super spreaders – or they become symptomatic only after they have infected their own contacts. It is very likely that north of 20 percent of infections are transmitted from people without recognizable symptoms at the time of transmission – easily sufficient to sustain transmission in the absence of interventions like masking, social and physical distancing.
RCR QUESTION 4: To date, asymptomatic spread of COVID-19 is only theoretical and never definitively proven as a viable means of transmission, and certainly not proven as causal of a coronaviral pandemic. Studies old and new bear this out. Yet this mode of transmission underpins the COVID narrative, justifying most of the mitigations that flow from it because 80 percent of COVID cases are attributed to asymptomatic spread.
Do the Scott and Rock Island County Health Departments use some value for asymptomatic spread as an input in predictive computer modeling to predict cases (e.g. Ro inputs), case rates, death rates, etc., using predictive outcomes that are then used to justify mitigation policy (quarantine, lockdowns, social distancing, masks, etc)? If not, what method(s) are used to account for asymptomatic spread since it is purely theoretical?
RICHD/SCHD Response: These are repeated erroneous statements about the well-established phenomena of asymptomatic and presymptomatic spread. Please provide us with the primary literature (i.e., “[S]tudies old and new”] to which you refer.
We follow confirmed infection rates (esp. 14-day and 7-day moving averages), and test positive rates. Population rate trends are generally more informative than case counts. Hospitalization data, ICU admissions and mortality data are also tracked over time (recognizing the 7-14-day and 21-28-day lags after infection respectively for these latter metrics) and serve to validate the infection rate trends. As morbidity and mortality decline, mainly due to penetration of vaccination into the population, it is likely that hospitalization and death rates will decouple somewhat from infections. In addition, we follow variant prevalence in the upper Midwest using data from both regional public health labs and CDC. Our recommendations, with very few exceptions adhere to those of CDC, based on all these metrics.
RCR QUESTION 5: If and when predictions from computer modeling do not match actual numbers of cases, hospitalizations, deaths, etc., how do you adapt and revise the models/predictions to reflect actual data? What difference/percentages in modeling and actual numbers triggers adjustments to mitigations? What is the usual time delay to account for any differences in predictions and actual data, and for warranted mitigation modifications?
RICHD/SCHD Response: We are not modeling locally. We use the local and regional metrics enumerated and apply them to guidelines from CDC and the peer-reviewed literature to calibrate our recommendations over time. Further, we are in frequent communication with state health authorities to assess broader trends.
(Note: the authority to mandate, as opposed to recommend, the broad mitigation measures needed is in the hands of state policymakers, not local public health departments. In Iowa, the state has not ceded their authority. As a result, we make recommendations are made.)
RCR EDITOR COMMENTARY ON RICHD/SCHD RESPONSES TO QUESTIONS 3, 4, & 5:
Herein lies a disconnect. SCHD/RICHD can refute assertions about asymptomatic spread as theoretical, but doing so simply isn't persuasive. Asymptomatic spread has never been conclusively established. Health authorities asserted early on that a positive PCR tests alone suffice for an official diagnoses of a COVID-19 case, with no clinical observation of symptoms required.
The trouble with this protocol is that PCR testing, especially at cycle thresholds higher than 35, cannot determine the amount of virus present (viral load) in a person who tests positive. Quad Cities' testing routinely uses cycle thresholds of 40+, as does much of the nation, as approved for emergency use, according to CDC 2019-Novel Coronavirus (2019-nCoV) Real-Time RT-PCR Diagnostic Panel For Emergency Use Only; page 35: “Effective: 07/13/20.”
FDA: “…a specimen is considered positive for 2019-nCoV [virus] if all 2019-nCoV marker (N1, N2) cycle threshold growth curves cross the threshold line within 40.00 cycles (< 40.00 Ct).” https://www.fda.gov/media/134922/download
More importantly, PCR tests using cycle thresholds above 35 are inherently unreliable because they cannot distinguish whether any virus detected is alive, or just dead nucleotides. Either way, the amount of virus present is so small that it is not replicate-competent and incapable of causing disease, therefore also not transmissible. This arguably eliminates asymptomatic spread as the predominate means of transmission, if at all.
During an interview with This Week in Virology, Jul 16, 2020, Dr. Anthony Fauci explained this precise diagnostic weakness with PCR testing that uses cycle thresholds above 35. “If you get a cycle threshold of 35 or more…the chances of it being replication-competent are miniscule…you almost never can culture virus from a 37 threshold cycle…even 36…it’s just dead nucleotides, period.” https://www.microbe.tv/twiv/twiv-641/
The overarching controversy that reasonably contradicts COVID-19 as a lethal pandemic justifying ongoing extreme mitigations relys on PCR tests as the sole diagnostic tool for a) determining definitive cases of COVID and b) classifying cases as asymptomatic capable of transmission.
Several studies have been done, but precious few to any kind of scale to determine whether asymptomatic spread is a factor in transmission of COVID, all of which found asymptomatic spread to be statistically inconclusive. It begs the question why no such peer-reviewed controlled studies have been undertaken in the U.S. One study did a meta-analysis of 13 studies and also found a relatively low instance of asymptomatic spread, suggesting more study was needed for verification. https://www.medrxiv.org/content/10.1101/2020.05.10.20097543v3.full-text
One measure would be to lower the PCR cycle thresholds to at least <28 for previously uninfected people, going forward. The cycle thresholds are currently lowered to <28 for PCR testing of people suspected of breakthrough cases of COVID after “vaccination.”
While this new protocol is suspect – because lowering the cycle thresholds will no longer detect miniscule remnant fragments or dead nucleotides often detected at the higher thresholds and automatically designated as a case. The lack of detection at the lower cycle threshold(s) will be conveniently interpreted as “vaccine” effectiveness.
The world has accepted that COVID is highly infectious and transmissible even though only 20 percent of the world's population who test positive actually experience symptoms of this disease. The other 80 percent who test positive have no symptoms and most have no idea they are infected until a positive PCR test confirms them as such. This group is classified as asymptomatic and infectious based solely on PCR testing that is functionally unreliable as a diagnostic tool, yielding 50-75 percent false positives, which means well over half of people with positive PCR tests are misdiagnosed and not COVID cases at all.
Regardless, by the WHO's and CDC's own admission, 99.7 percent of humans will survive COVID if infected. Deaths traditionally define lethality of epidemics and pandemics, except as they pertain to COVID, which is instead defined by the number of cases worldwide.
Finally a note about HIV, Hep B and Hep C as examples of asymptomatically spread. These retro viral diseases are latent but to actually spread them, infected persons must engage in specific activities to transmit, such as sex or intravenous drug use. Approximate closeness and aerosol projection is not a transmittable condition as characterized by coronaviruses. Also, specific tests can immediately and definitively determine whether someone is infected with HIV, Hep B and Hep C, unlike PCR testing, which can only detect the presence of coronaviruses buy not whether in quantities to cause infectious disease.
RCR QUESTION 6: What is the rationale for continuing to test using PCR cycle thresholds above 33 to confirm COVID-19 cases in unvaccinated people, and for reducing PCR cycle thresholds to 28 for diagnosing COVID-19 in people who have been previously vaccinated for COVID?
RICHD/SCHD Response: A word about testing. No test is free of false positives and false negatives, but polymerase chain reaction (PCR) is uniquely sensitive (when positive PCR correctly identifies infection). It is also highly specific (is negative without infection), i.e., the positives are nearly all true positives. In practice, PCR is so sensitive that some folks remain PCR positive for several weeks after infection, in the absence of infectious virus – even after full recovery from COVID- 19. This is why the duration of quarantine is mainly based on time elapsed from contact or diagnosis and does not depend on a negative test result.
Given these performance characteristics of PCR, essentially all individuals with high Cts really are “recently” infected but may not be infectious virus. If and when sufficient data are submitted to FDA that allow the agency provide clearance for PCR Ct claims about when an individual is infectious, we may be allowed to use Ct data for such judgements and the recommendations that flow from them. Tracking infection trends over time using currently permitted test interpretations, along with the other metrics mentioned, is sufficient. Again, the direction of trends is often more informative than the raw case numbers.
RCR QUESTION 7 SETUP: Emergency Use Authorization (EUA) requires: (1) an emergency declaration; (2) no therapeutics available for treatment; (3) the benefit(s) must demonstrably outweigh the risk(s); and (4) limited in duration of time.
If EUAs permit expanded use, how can the original application cover children, who are in an entirely different demographic group, with substantially different medical variables alone, not accounted for in the early trials that were accepted for EUA for adults. This means that safety issues for any demographic, let alone children, cannot have been adequately addressed in such a short period, including for pregnant women.
RICHD/SCHD Response: This is incorrect. EUAs specify how a drug or test is to be used strictly based on the populations included in the studies submitted in the application for the EUA. Children were excluded in the original vaccine studies and thus excluded from the original EUAs. Pfizer subsequently submitted their vaccine clinical trial data from children and adolescents 12-15 years of age to both the FDA and presented it (publicly) to the Advisory Committee on Immunization Practices (ACIP). Only then was the EUA extended to children and did public health recommend vaccination of that age cohort. Moderna and J&J have not done so and have no indication for administration to children at this time.
The Vaccine Associated Adverse Event Reporting System (VAERS ) is successful at accruing events that are temporally associated with immunization since anything that happens after vaccination is reportable, but raw VAERS data severely overestimates events attributable to vaccines. This requires that CDC investigate reports for imputability – the likelihood that an event occurring after immunization was caused by immunization. An example of VAERS incredible performance during this public health emergency is the identification, within weeks of its EUA, of a very rare complication associated with the J&J vaccine – thrombocytopenic thrombosis syndrome (TTS). The following links will take you to the available VAERS data on COVID-19 vaccines, including TTS associated with the J&J preparation. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety.html, https://www.cdc.gov/mmwr/volumes/70/wr/mm7018e2.htm
Beyond the clinical trials and VAERS, are several population-based systems using healthcare networks, the VA and Department of Defense that are in use but getting much less publicity than VAERS.
For medications, EUAs similarly require high-quality evidence from appropriately designed trials and reporting of adverse events. The question arises as to whether you prefer these drugs not be made widely available to appropriate, often critically ill, patients? They are called emergency use authorizations for a reason. 590,000 deaths in the U.S. in 15 months (with likely at least a 15-25 percent underreporting) seems an objective metric of an emergency.
Children and pregnant women can be treated and studied with some or all of these drugs under the emergency Investigational New Drug and New Device exemption regulations (IND and IDE), wherein FDA approves clinical trials and in individual cases can waive EUA criteria in return for reporting of the experience. Emergency INDs and IDEs can be approved within hours by FDA over the phone.
Pregnant women have historically been excluded from clinical trials for understandable, if controversial, reasons. Use of COVID-19 vaccines in pregnancy, subject to the constraints of the EUA, as for most new drugs and vaccines, is left to shared decision-making involving the woman and her health care provider. The key element of that decision-making is an individual risk- benefit estimation. What are the risks from COVID vs. from the vaccine? Evidence has accumulated from in vitro and animal studies of reproductive toxicity, and registry studies including inadvertent immunization of women who subsequently became pregnant and intentional immunization of pregnant women (many critical health care workers on the front lines) and the safety of breast feeding. There are no signals of effects on menstruation, fertility, fetal development, obstetric or neonatal complications. These are reassuring, but admittedly not as powerful as evidence from appropriate randomized, controlled trials.
RCR QUESTION 7 SETUP: It is undisputed that children are at zero risk for getting or giving COVID-19, meaning becoming infected and transmitting to adults. Not a single case of a child becoming infected with COVID-19 and transmitting to an adult has ever been recorded, worldwide.
RICHD/SCHD Response: We aggressively dispute the “undisputed” premise. Children and adolescents aged 0-18 years constitute 15.9 percent of the documented infections in Scott County since March of 2020. As immunization has reduced infection and illness in the initially vaccinated high risk cohorts, the proportion of infections in children and adolescents has increased somewhat.
Children are indeed less likely to have severe illness, but they do get sick [acute COVID-19, with multisystem inflammatory syndrome in children (MIS-C), a post- COVID-19 inflammatory syndrome, and with “Long COVID”] and they do transmit at rates similar to adults – including to those at high risk for bad outcomes and/or who cannot respond to vaccination optimally. As of 2 June 2021, 366 deaths were reported among children and adolescents 0-18 years of age in the United States. Through March 2021, more than 190,000 children have required hospital admission, many to ICUs. How many are we willing to accept? See attached references as examples. These links are to the webcast of the May 12, 2021,
ACIP and to the National Center for Health Statistics where these syndromes and statistics are discussed. Again, this is a risk-benefit discussion that is evolving in real time.
RCR QUESTION 7: With reference to the third requirement, that the “vaccine(s)” seeking EUA must be unequivocal in demonstrating that the benefits substantially outweigh the risks, please explain what benefits substantially outweigh any and all risks associated with experimentally injecting children and young adults (0-19 years of age), but most especially children 12 and younger who have zero risk from COVID, yet are at higher risk for potential adverse reactions from the injections? Please be specific.
RICHD/SCHD Response: This is incorrect. The EUA criterion from the regulations (i.e., law) is “based on the totality of the evidence”, not “unequivocal” evidence. Attached is the Pfizer-BioNTech letter of authorization if you want more information. All vaccine EUA documents are available online at the FDA website. https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-vaccines
Here is the relevant language from the vaccine EUAs.
“Section 564(b)(1)(C) of the (FD and C)* Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security or the health and security of United States citizens living abroad, and that involves the virus that causes COVID-19. On the basis of such determination, the Secretary of HHS on March 27, 2020, declared that circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID-19 pandemic, pursuant to Section 564 of the Act, subject to terms of any authorization issued under that section...
“...SARS-CoV-2 can cause a serious or life-threatening disease or condition, including severe respiratory illness, to humans infected by this virus.
Based on the totality of scientific evidence available to FDA, it is reasonable to believe that [vaccine name] may be effective in preventing COVID-19, and that, when used under the conditions described in this authorization, the known and potential benefits of [vaccine name] when used to prevent COVID-19 outweigh its known and potential risks; and
There is no adequate, approved, and available alternative to the emergency use of [vaccine name] to prevent COVID-19.” *Emphasis added.
RCR QUESTION 8 SETUP: The Vaccine Adverse Event Reporting System (VAERS) is experiencing an exponential growth in the public's reporting of adverse events from the COVID experimental injections. In the U.S., more than 46,000 adverse effects and 4,400 deaths have been logged in 2021 arising from COVID “vaccines.” The average number of deaths reported to VAERS in a given year is approximately 150. Prior to COVID, a Harvard/CDC collaborative study concluded only 1-10 percent of all adverse events from vaccinations were reported due to a host of weaknesses in the reporting system.
RICHD/SCHD Response: The Harvard study is not relevant. It is about approved vaccines given under routine conditions, not EUA vaccines given during a public health emergency with a concerted effort to enhance reporting by both vaccinees and providers. Further, VAERS and the population-based databases being queried in near real time by FDA and CDC have, to date, found no unexpected safety signals beyond the rapid recognition of TTS associated with the J&J vaccine mentioned previously.
If there is exponential growth of use of a new vaccine, and reporting to VAERS is required and widely encouraged under EUA, would one not expect exponential growth in reports of vaccinees with side reactions? That is exactly what has been seen. Approaching 300,000,000 doses have already been administered to 170,000,000 people as of 3 June 2021. Local health department employees and family are among the 46,000 you cite – with sore arms, fever, and fatigue after Moderna reported to VAERS.
How many deaths are expected in a population of 170,000,000 (predominantly older and with comorbidities) over a period approaching 7 months, independent of COVID-19? The mortality statistics clearly show us that, coincident with declining infection and hospitalization, mortality from COVID and population excess mortality associated with the pandemic are falling far more than any opposite effect one might try to attribute to vaccine injury – if there were a signal of the latter, which there is not.
A more general comment: public health surveillance is almost never able to accrue data on all events of interest. The goal of surveillance is to receive and analyze enough data to recognized and evaluate both anticipated and unanticipated incidents. To be redundant, trends rather than raw case counts are what we find most useful. To insist that “everything” be reported is infeasible and unneeded.
It is apparent to us that “based on the totality of scientific evidence” ...”the known and potential benefits” of vaccination “outweigh its known and potential risks”.
If you are interested in the data, let us suggest that you start with the basics:
https://data.cdc.gov/Case-Surveillance/United-States-COVID-19-Cases-and- Deaths-by-State-o/9mfq-cb36, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/vaers.html, https://www.cdc.gov/coronavirus/2019-ncov/vaccines/reporting-systems.html
RCR QUESTION 8: What are parents' options when children are harmed from these COVID-19 experimental injections ( current adverse reactions such as heart inflammation and blood clotting in younger recipients) if legislated blanket immunity for manufacturers and federal health authorities are unaccountable for liability for harm?
RICHD/SCHD Response: The assertion is incorrect. There is federal compensation for neutrally adjudicated adverse events associated with COVID-19 EUA vaccines that covers children and adults. The program, administered by HRSA, is called the Countermeasures Injury Compensation Program. This is separate from the similar, highly successful, program for licensed vaccines called the Vaccine Injury Compensation program. Again, if you are interested: https://www.hrsa.gov/cicp, https://www.hrsa.gov/vaccine-compensation/about/index.html
Regarding the specific pediatric side effects you cite, the early data suggests their rates are equivalent to that expected in an unvaccinated population (and most likely will be lower than seen after natural infection but stay tuned as a larger systematic experience is accrued.
RCR EDITOR COMMENTARY ON RICHD/SCHD RESPONSES TO QUESTIONS 6, 7, & 8:
Again the SCHD/RICHD misunderstood the questions. While there is much agreement with parts of the response given, the first break-out question focused on whether the four criteria required for including children and young adults (12-18) in approval of emergency use authorization (EUA) for experimental injections has been met? More specifically, what benefits outweigh the risks of experimentally injecting children with new mRNA technology considered gene therapy as opposed to traditional vaccines that mimic the virus itself?
Using the criteria of “totality of evidence” applied to the age cohort of 12-18 favoring emergency use “vaccinations,” this criteria is unequivocally unmet when the risk to this group is considered to be at statistical zero? No medical benefit can overcome zero risk from COVID disease with experimental “vaccinations.” This becomes more true when the cohort is enlarged to include 0-11 year olds. Again, the totality of evidence instead favors non-participation in experimental injections, and is indisputable based on statistical zero risk of disease compared with a) any benefit from experimental mRNA gene therapies and b) the unknown risks of experimental mRNA gene therapies over time, especially without long-term studies.
Review of the CDC's Advisory Committee on Immunization Processes (ACIP) emergency meeting on mRNA vaccinations and Myocarditis for the 12-18 cohort, held on June 23, 2021, indicated a less than rigorous process for continuing with its approval.
The World Health Organization (WHO) announced publicly that it firmly “advised against vaccinating those 18 and younger,” cautioning that there is no perceived benefit for this younger population based on their exponentially low risk of getting or transmitting COVID19. However, this sudden proportionality was short lived.
Two days later, the WHO dialed it back to a mere suggestion. Just in time for ACIP to convene its emergency meeting to evaluate a concerning number of reports from younger cohorts to the Vaccine Adverse Events Reporting System (VAERS), regarding the occurrence of several serious conditions known as Myocarditis and Pericarditis.
For clarification, Myocarditis is inflammation of the heart muscle and can damage the heart permanently depending on the severity of the event. Pericarditis is inflammation of the outer lining of the heart. Both Myocarditis and Pericarditis occur most often in older adults. However, a surge of VAERS reports describe both these conditions, especially the more serious Myocarditis, occurring in a much younger population (12-18) after receiving either Pfizer or Moderna experimental injections, with a larger proportion of these instances in male children and adolescents. Hence ACIP's emergency meeting last week.
It appears that the ACIP work group provided modeling from COVID-NET's pool of data to arrive at their predictions on how children might fare upon receiving the mRNA experimental injections, including estimated beneficial outcomes, such as number of prevented deaths. The work product reflected predictive estimates and depended heavily on “associated” data, such as hospitalizations and previous deaths culled from the COVID-NET surveillance data.
However, an analysis of COVID-NET table(s) of “associated” hospitalizations reveals that of the 376 children admitted, over 319 had at least one serious comorbidity that contributed in large part for their health challenges with or without a positive test for COVID. There were no deaths recorded for this group.
Upon conclusion of a brief slide-show presentation, the crucial risk/benefit balance was not remotely as apparent or reassuring for parents as it was for the ACIP panel due to a lack of public understanding of the inputs and their application underpinning the predictions. This was unfortunate considering ACIP's final recommendations.
ACIP concluded in their evaluation that, while admitting the injections were associative, causing the heart conditions: (1) even if children and adolescents experienced Pericarditis after the first dose, once the condition resolved, they are eligible for the second dose of all injections; (2) had a history of Pericarditis prior to any mRNA injections but had resolved, are eligible for all injections; and (3) had a history of prior Myocarditis unrelated to any mRNA injections but had resolved, are also eligible for all injections. Last one out turns off the lights.
A list of the ACIP committee members, agenda and minutes, and video recording of the June 23 emergency meeting is posted at the CDC ACIP website linked below. The public should listen to ACIP's meeting for themselves to experience the brevity of ACIP's investigative query, especially considering the gravitas of the subject matter.
Meanwhile APIC's YouTube meetings playlist is available for those interested in the process, something parents and grandparents need to familiarize themselves with, because the next cohort up for emergency use authorization approval for experimental injections is children 6 months to 11 years old.
The SCHD/RICHD's observation, that VAERS reports of adverse events will necessarily increase exponentially due to the exponential increase in participants in the mRNA “vaccinations,” is well taken. However, young adults experiencing serious heart-related adverse events from these COVID jabs are estimated at 200 times greater and rising. And while the health authorities conjecture overestimations of events attributed to vaccines, there are reasonable counterarguments (based primarily on a Harvard study of VAERS reporting) that claim the reports of adverse events are seriously underestimated. More time is needed to allow VAERS to sort things out, but it is evident that, as the predominate vaccine injury surveillance system right now, it has a great burden.
As for 590,000 U.S. deaths in 15 months, this total is debatable as strictly COVID-19 deaths, directly or indirectly, upon analysis of the actual reported deaths and accompanying comorbidities, underlying secondary conditions, and other relevant contributing factors. The CDC reduced US COVID mortalities amidst obscuring data by lumping COVID deaths (C) in with Pneumonia and Influenza deaths (P&I) for a new category COVID, Pneumonia & Influenza (CP&I). It is a curious thing to do relative to key critical data in a global pandemic.
SCHD/RICHD resorts to the federal emergency declaration as some overarching justification for considering putting children in harm's way. For the cohorts of 0-11 and 12-18 years old, the risks of getting or transmitting COVID-19 are infinitesimal and no conclusive data exists for “transmission at rates similar to adults.” Meanwhile the risks of being harmed from mRNA experimental injections over time have the potential to be catastrophic. The operative word here is 'potential,' nevertheless it looms large in comparison to the health consequences of highly unlikely COVID-19 infection.s in these groups.
How many children are hospitalized presenting first with illnesses, such as MIS-C, then coincidentally test positive for COVID once admitted? Deaths among children due directly to COVID are extremely rare, as is true for many hospitalizations classified as such. Too many of us have first-hand anecdotal experience with loved ones diagnosed with COVID after being admitted for hospitalization, even though primary illnesses ranging from cancer to heart disease to dementia to a million other conditions, brought them in, initially. Yet COVID is too often listed on admission and discharge papers, ICU admissions and transfers, and death certificates.
Finally, in terms of children dying or requiring hospitalizations: “How many are we willing to accept?” Clearly our answer is zero across the board. Yours is also zero when it comes to the unvaccinated, but just as clearly, you appear to have an acceptable number in mind for those who are?