'Currently, mRNA is considered a gene therapy product by the FDA', as per Moderna’s SEC 10-Q filing for the quarter ending on 30 June 2020

What is done is 'prophylactic' vaccination, and the key question is: are these Covid jabs actually needed as a policy to shield 20% of the population that's (very) susceptible?

Welcome to my spare-time occupation: looking for, reading through, and bringing you seemingly obscure details about the Covid-19 charade masquerading as public health policy [sic(k)].

Here’s the link to the full 10-Q document filed by Moderna for the quarter ending on 30 June 2020, i.e., all things considered, it’s fairly recent; upon second thoughts, it’s also almost ancient history by now.

A brief review of the document reveals the following key insights (pp. numbers are given parentheses; if not stated otherwise, all emphases are mine).

The below excerpt is from p. 68:

As a potential new class of medicines, no mRNA medicines have been approved to date by the FDA or other regulatory agency. Successful discovery and development of mRNA medicines by either us or our strategic collaborators is highly uncertain and depends on numerous factors, many of which are beyond our or their control. We have made and will continue to make a series of business decisions and take calculated risks to advance our development efforts and pipeline, including those related to mRNA technology, delivery technology, and manufacturing processes, which may be shown to be incorrect based on further work by us, our strategic collaborators, or others. Prior to the Phase 3 trial for mRNA-1273 [that would be ‘the Moderna Covid-19 jab’] and that of one other company, there had never been a Phase 3 trial in which mRNA is the primary active ingredient, and there has never been and there may never be a commercialized product in which mRNA is the primary active ingredient. Our mRNA investigational medicines that appear promising in the early phases of development may fail to advance, experience delays in the clinic, experience clinical holds, or fail to reach the market for many reasons…[here follows a list of these reasons]

On p. 69, one may read the following statement:

Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism. In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict.

On p. 72, we may read the following:

There are specific additional risks to certain of our modalities and our programs as a whole. For example, prophylactic vaccines typically require clinical testing in thousands to tens of thousands of healthy volunteers to define an approvable benefit-risk profile. The need to show a high degree of safety and tolerability when dosing healthy individuals could result in rare and even spurious safety findings, negatively impacting a program prior to or after commercial launch. While we believe that certain safety, tolerability, and levels of immunogenicity we have observed in the early-stage clinical trials in our prophylactic vaccine programs are sufficient to initiate additional trials, there can be no assurance that we will observe acceptable safety or efficacy profiles in later-stage trials required for approval of these programs. …In general, several biological steps are required for delivery of mRNA to translate into therapeutically active medicines. These processing steps may differ between individuals or tissues, and this could lead to variable levels of therapeutic protein, variable activity, immunogenicity, or variable distribution to tissues for a therapeutic effect. Gene therapies and mRNA-based medicines may activate one or more immune responses against any and all components of the drug product (e.g., the mRNA or the delivery vehicle, such as an LNP) as well as against the encoded protein, giving rise to potential immune reaction related adverse events. Eliciting an immune response against the encoded protein may impede our ability to achieve a pharmacologic effect upon repeat administration or a side effect. These risks apply to all of our programs, including our systemic secreted therapeutics and systemic intracellular therapeutics modalities

You see, next time someone claims ‘we didn’t know at the time’, you can forward that link.

There’s a lot more in this file, but it all boils down to the following (p. 75, emphasis in the original):

mRNA medicines are a novel approach, and negative perception of the efficacy, safety, or tolerability of any investigational medicines that we develop could adversely affect our ability to conduct our business, advance our investigational medicines, or obtain regulatory approvals.

No shit; there’s also the following statement on p. 76 (again, emphasis in the original):

Some of our investigational medicines are classified as gene therapies by the FDA and the EMA, and the FDA has indicated that our investigational medicines will be reviewed within its Center for Biologics Evaluation and Research, or CBER. Even though our mRNA investigational medicines are designed to have a different mechanism of action from gene therapies, the association of our investigational medicines with gene therapies could result in increased regulatory burdens, impair the reputation of our investigational medicines, or negatively impact our platform or our business.

Just below, there is this (p. 76, my emphasis):

There have been few approvals of gene therapy products in the United States or foreign jurisdictions, and there have been well-reported significant adverse events associated with their testing and use. Gene therapy products have the effect of introducing new DNA and potentially irreversibly changing the DNA in a cell. In contrast, mRNA is highly unlikely to localize to the nucleus, integrate into the DNA, or otherwise make any permanent changes to cell DNA. Consequently, we expect that our investigational medicines will have a different potential side effect profile from gene therapies.

So, let’s check out about the size of the lipid nano particles (LNP) to see if they can get into a vaccinee’s cell nucleus, shall we?

Before we do that, here’s another one from p. 48 (my emphases):

Our prophylactic vaccines modality currently includes eight programs, six of which have entered into clinical trials. Of these programs, we have demonstrated desired pharmacology, in the form of immunogenicity, in the positive Phase 1 clinical trials for the following eight programs: H10N8 vaccine (mRNA-1440), H7N9 vaccine (mRNA-1851), RSV vaccine (mRNA-1777), Chikungunya vaccine (mRNA-1388), human metapneumovirus (hMPV)/ parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653), Zika vaccine (mRNA-1893), CMV vaccine (mRNA-1647) and SARC-CoV-2 (mRNA-1273). We have an ongoing Phase 1 trial for the next generation Zika vaccine (mRNA-1893) and Merck is conducting a Phase 1 trial for an additional RSV vaccine (mRNA-1172). Our SARS-CoV-2 vaccine (mRNA-1273) is described in detail below. In addition to the eight programs being developed, the H10N8 vaccine (mRNA-1440) and Chikungunya vaccine (mRNA-1388) are two public health programs that are not being further developed without government or other funding.

So, before we dive further into the particular rabbit-hole of LNP size, there’s the admittedly much bigger elephant in the room whose name is: ‘prophylactic vaccine’.

Definitions aside, what, then, is the infection rate of Covid-19?

Given the idiosyncrasies of most (western) data, let me provide you with a back-of-the-envelope guesstimate based on Norwegian data. (Why Norway? Well, contrary to, say, the US in particular, Norway does cross-reference and correlate testing, hospitalisation, and infection data, i.e., if you’d get tested for Covid-19 more than once at the same day but at different test sites, you wouldn’t get counted twice. In other words: the data is comparatively free of contamination.)

Just yesterday, Norway’s largest daily Aftenposten ran an article with the headline: ‘Over 400,000 Covid Infections’ (the second part reads: ‘more than half of these occurred in the last quarter’). Given that Norway’s population is slightly less than 6m, that would give us at least an indication that despite its infectiousness, Covid-19 affected (as in: tested positive for) approx. 1 in 30 residents so far.

So—what do we do about the entire ‘prophylactic vaccine’ issue, then?

Here’s what the Norwegian Institute for Public Health (IPH) has to say (via their website; my emphases):

Calculations estimate that one person who is infected with the coronavirus on average infects 2-3 others, while one person with the flu infects 1-2 others. Probably less than 20 percent of those infected with SARS-CoV-2 account for 80 percent of the infection. This indicates that many confirmed patients will not pass on the infection, while a minority will infect many. The infection rate will be lower than 2-3 in Norway both due to low population density and due to implemented infection control measures.

It would appear that ‘prophylactic’ is actually an apt description, for the majority of people hasn’t been affected by Covid-19-the-disease (of course everyone has been affected, in one way or another, by ‘Covid-19’ the social construct, i.e., public health measures).

Hence, we should question government and public health officials about the prophylactic nature of the Covid jabs: significant issues about vaccine efficacy and effectiveness, as well as adverse effects, aside, are these jabs actually needed to protect society from the Covid-19-the-disease?

If the 20 : 80 ratio is factually correct (as far as we can determine it), wouldn’t it make much more sense to identify these 20% of the population that are ‘more’ susceptible to Covid-19-the-disease as opposed to one-size-fits-all policies that fail to take account of, say, age-related risk stratification, lifestyle issues (obesity is a key driver of severe illness of or with Covid-19-the-disease), and co-morbidities?

Again, if you’re in a hole, first stop digging.

Post-script on Covid in Norway

With Omicron now dominant in Norway (as per the IPH’s notice dated 3 Jan. 2022), the most curious aspect thereof appears to be that, contrary to my estimation, the highest share of Omicron isn’t to be found in the Oslo metro area—but in Northern Norway (Troms og Finnmark).

This means that, contrary to the indication of the above-quoted paragraph, it’s not really the population density that matters for the spread of Omicron either: Troms og Finnmark have very low population density, esp. compared to Oslo. Also, ‘implemented infection control measures’ don’t seem to make a dent, either.