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My Bad. Long Covid Does Adversely Affect the Memories.

Pandemic Potential of an “Oswald Shooter” Coronavirus

A recent study suggests, about a pathogen, about which early investigators had concluded that “it is not clear whether this correlates with the presence of an infectious virus”[i], incapable, as a validated less than five percent secondary attack rate disease[ii], of either zoonotically evolving or escaping from a laboratory to set off a pandemic, that they had proposed “[t]o establish a novel SARS-CoV-2 human challenge model that enables controlled investigation of pathogenesis, correlates of protection and efficacy testing of forthcoming interventions,” and had “36 volunteers aged 18–29 years without evidence of previous infection or vaccination. . . inoculated with 10 TCID50 of a wild-type virus (SARS-CoV-2/human/GBR/484861/2020) intranasally in an open-label, non-randomized study.”[iii]  According to the study, “[a]t day 28 after inoculation, six of 18 (33%) participants remained qPCR positive in the nose and two of 18 (11%) in the throat, but,

by day 90, all participants were qPCR negative”, but of a total of 36, even after these “[h]ealthy adult volunteers were challenged intranasally with SARS-CoV-2”[iv], only 18 had been infected, at all, with results suggesting, even in duration of illness that some persons, for reasons not explained in this study, appeared to be far more susceptible to infection and outcomes than others.

This finding is significant regarding the infectious dose, a metric for which, even to date, according to the CDC, “[t]he infectious dose of SARS-CoV-2 needed to transmit infection has not been established”^[v], not only because it directly impacts guidance on facial coverings and respiratory protection, but also because, as the researchers admit that their purpose was to determine the correlates of protection for COVID-19, and further admit, limited to a study of the early strain, and having published results so late in the public health crisis, that “[t]his likely will necessitate the further development of the model using variants of concern that have been shown to cause breakthrough infection despite vaccine-induced immunity (such as Delta and Omicron) to permit efficacy testing of novel interventions in that context and further understanding of correlates of protection.”[vi]

It is available knowledge to the general public, in the open source that these COVID-19 countermeasures products had been developed without the prerequisite knowledge of infectious dose, associated with correlates of protection, information described candidly as “buried” in a slide presentation during the White House Briefing while the Food & Drug Administration (FDA), on the same day that the Pfizer products had been approved for private label marketing and licensure[vii].

It is information in the open source environment that, without knowledge of infectious dose, “[d]ata from three ongoing clinical studies were included in the EUA request” for the Moderna product, mRNA-1273-P301, and in which the clinical trials had submitted findings in support of efficacy and safety determinations, using arbitrarily and capriciously selected dosage amounts, of 25ug, 50ug,100ug and 250ug to determine safety, efficacy and immunogenicity, and, hence, could only determine with regard to immune response that “an overall geometric mean fold rise (GMFR)>20-fold in bAB as measured by ELISA and >50-fold in nAb as measured by microneutralization assay at 28 days post-dose 2” had been observed, but not whether such increase would be effective.[viii]

Similarly, in the mere preprint study prior to the FDA approval, researchers had conceded that “[e]arly protection against COVID-19 without robust serum neutralization indicates that neutralizing titers alone do not appear to explain early BNT162b2-mediated protection from COVID-19”, and only speculating that, possibly, “[o]ther immune mechanisms (e.g., innate immune responses, CD4+ or CD8+ T-cell responses, B-cell memory responses, antibody-dependent cytotoxicity) may contribute to protection”[ix], and any subsequent user of that product would, by definition, be a test subject or trial participant.

It is information in the public domain, hidden in open view, that the popular Pfizer product had been subjected, prior to approval, not to an effectiveness test, clinically distinct from an efficacy test[x], but rather only, before approval, a mere preprint of an efficacy test[xi], but for which the company only presented not an effectiveness test, as required for a New Drug Application (NDA), 21 CFR § 314.125, or an Accelerated New Drug Application (ANDA), 21 CFR§ 314.94, a patent defect per se, and “[j]udicial review of agency action. . . is limited to ‘the grounds that the agency invoked when it took the action.’”[xii]

It is easily discernible and discoverable knowledge that “’[i]nformation’ means any knowledge that can be communicated or documentary material, regardless of its physical form or characteristics, that is owned by, produced by or for, or is under the control of the United States Government”, under Part I, Section 1.1(b), Executive Order 12,958, Classified National Security Information, April 17, 1995, and that “’[i]nformation’ means may information or material, regardless of its physical form or characteristics, that is owned by, produced by or for, or is under the control of the United States Government”, under Section 6.1(b), Executive Order No. 12,356, National Security Information, April 2, 1982.

And, it would reasonably follow that such metrics could not, under Executive Order 12,958, be classified unless the government owned the causative biological agent, and, if classified, the novel coronavirus would have had to have been cultivated or manipulated in a laboratory, Myriad Genetics, Inc., 569 U.S., at 576, simple confirmation of which the petitioner in Webb v. Fauci, Civil Action No. 3:21CV432 (E.D.Va. 2021), aff’d Record No. 212394 (4th Cir. 2021), cert. denied Record No. 21-8242 (U.S. 2022), as well as in application for prejudgement relief in Webb v. Fauci, Record No. 21-6868 (U.S. 2022) had sought through a FOIA request, but which statutory right to injunctive relief, 5 U.S.C. § 552(a)(4)(B), found the Trial Court “erect[ing] a novel prudential standing principle in order to avoid reaching the merits of the constitutional claim”[xiii].

And yet, Dr. Fauci, has “repeatedly dismissed concerns that the COVID-19 pandemic began with a lab leak in Wuhan, China”[xiv].

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[i] Report of the WHO-China Joint Mission on Coronavirus Disease 2019 (COVID-19), supra.

[ii] Id.; Ramanan Laxminaraya, Epidemiology and transmission dynamics of COVID-19 in two Indian states, supra.

[iii] Ben Killingsley, et al., Safety, tolerability and viral kinetics during SARS-CoV-2 human challenge in young adults, 28 Nat. Med. pp. 1031–1041, March 31, 2022, https://doi.org/10.1038/s41591-022-01780-9 (citing ClinicalTrials.gov identifier NCT04865237; funder, UK Vaccine Taskforce).

[iv] Id.

[v] Staff, “Scientific Brief: SARS-CoV-2 Transmission,” CDC, May 7, 2021.

[vi] Id.

[vii] Joe Palca, “New Evidence Points To Antibodies As A Reliable Indicator Of Vaccine Protection,” NPR, August 23, 20215 (citing Peter Gilbert, et al.,  Immune correlates analysis of the mRNA-1273 COVID-19 vaccine efficacy clinical trial, 375 Science 6576, pp. 43-50, November 23, 2021, doi: 10.1126/science.abm3425). See also  Florian Krammer, Correlates of protection from SARS-CoV-2 infection, 397 The Lancet, pp. 1421-1423, April 17, 2021 https://doi.org/10.1016/S0140-6736(21)00782-0, Epub. April 9, 2021.

[viii] Marion F. Gruber, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum, “Moderna COVID-19 Vaccine/mRNA-1273: Dosage Forms/Strengths and Route of Administration a 0.5 mL Suspension for intramuscular injection”, December 18, 2020.

[ix] Stephen J. Thomas, et al., Six[-]Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine, MedR_xIV, July 28, 2021, https://doi.org/10.1101/2021.07.28.21261159.

[x] See generally Benjamin B. Lindsey, et al., The efficacy, effectiveness, and immunogenicity of influenza vaccines in Africa: a systematic review, 19 The Lancet 4, pp. E110-E119, April 1, 2019 (published December 12, 2018).

[xi] Stephen J. Thomas, et al., Six[-]Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine, supra.

[xii] Regents of the Univ., 591 U.S., at  ___  (quoting from Michigan v. EPA, 576 U.S., at 743).

[xiii] Elk Grove Newdow, 542 U.S., at 1, abrogated by Lexmark Int’l, Inc., 572 U.S., at 118. (Rehnquist, O’Connor and Thomas dissenting).

[xiv] Josh Christenson, “Fauci sneered at lab leak concerns after pushing paper to disprove theory,” supra.