Covidistan Annals XXIII: Mückstein missed the Court's deadline, didn't deliver any data; bonus feature--a new paper from Israel on the 4th injection

Spoiler alert: 'vaccine efficacy' against breakthrough infections is 11-30%, but 'only' 80-90% of study participants experienced adverse events, which were 'more common among younger' people

With 18 Feb. 2022 firmly in the rearview mirror, it’s about time to discuss the latest developments in Covidistan. Why, apart from my elder daughter’s birthday, would 18 Feb. be a quite important day?

Well, three weeks ago, on 26 Jan. 2022, Judge Andreas Hauer, currently serving on the Constitutional Court, had transmitted a long list of questions to Health Minister Mückstein, which the latter was ‘asked’ to answer. This not only prompted a sudden and quite unexpected change in the régime’s Covid containment policies, but it is also obvious for everyone with eyes to see and ears to hear that yesterday’s impending deadline led the Committee of Public Safety to announce a staggered revocation of the mandates beginning today and leading up to ‘freedom day’ on 5 March.

Don’t be fooled, though, because the proverbial straw that broke (part of) the population’s back—mandatory injections—will not be abrogated. Yes, there’s been increasing dissent from many quarters in the past two weeks, but so far the régime has been adamant about the law.

Here’s where we are right now

State broadcaster ORF summarised the state of affairs yesterday evening: there will be significant changes to the testing regimen, which means that from 1 April onwards (no joke), no more ‘free’ testing of (largely) asymptomatic people. According to Health Minister Mückstein, both injected and un-injected individuals will be asked to pay for their PCR tests, with prices likely to range between 10-20 € per person and test (pharmacies that perform these tests so far received 25 € per test for this service).

What’s unclear right now is the continuation of the current (or modified) test regime in schools, which has long been one of the main contributors to Covidistan’s insanely high test rates. Meanwhile, in the city-state of Vienna, which is currently running one of the most ‘efficient’ (in terms of insanity) testing regimens—also paid for by the federal gov’t, in the usual way of Covidistan politics—daily analysis of hundreds of thousands of PCR tests appears to be on the verge of ending by 31 March 2022, too.

Also, it would appear that legacy media, however laughably late to that particular party, is finally starting to puncture the much-stitched-up narrative, as exemplified by Der Standard, long one of, if not the, most shrill fearmonger on the faux left, running a brief item on the failure of Israel’s second booster injection experiment (that would be the 4th dose, for those keep count), and doing so a day before Mückstein was due to deliver his answers to the Constitutional Court (my emphases):

Data from Israel suggests limited additional benefits of a fourth dose with respect to (re-) infection with Omicron. Data from healthcare workers who received a fourth injection with a mRNA product [both BioNTech/Pfizer and Moderna] shows restored high levels of antibodies comparable to levels after the booster [the 3rd injection], although breakthrough infections occurred, according to a non-reviewed paper.

Brief Detour: Regev-Yochay et al. 2022 on the 4th Injection

Let’s have a brief look at the paper (Regev-Yochay et al. 2022), entitled ‘4th Dose COVID mRNA Vaccines’ Immunogenicity & Efficacy Against Omicron VOC’, which is available from the medrxiv server, to assess what Der Standard reported, shall we?

The penultimate subordinate clause in the above-quoted news item is the main issue here. In the German original, which reads: ‘allerdings waren Durchbruchsinfektionen verbreitet’ (for my translation, see above). Now, dictionaries typically offer translations such as ‘common’, ‘widespread’, ‘prevalent’, ‘rife’, or even ‘endemic’ for the key term ‘verbreitet’.

As you probably guessed, the paper’s language is less ambivalent that Der Standard’s, whose results section reads as follows (I’ve highlighted the word in question):

Breakthrough infections were common, mostly very mild, yet, with high viral loads. Vaccine efficacy against infection was 30% (95%CI:-9% to 55%) and 11% (95%CI:-43% to +43%) for BNT162b2 and mRNA1273, respectively. Local and systemic adverse reactions were reported in 80% and 40%, respectively.

The entire paragraph is important, esp. as it shows ridiculously low levels of ‘vaccine efficacy’ of 30% and 11% for the Pfizer and Moderna injections, respectively. Remember, the threshold for use is 50%.

Also, read that last sentence again: a fourth injection with the Pfizer product triggered ‘local’ adverse reactions in four out of five study participants, while ‘systemic’ adverse reactions occurred in two out of five study participants.

CONCLUSIONS: The fourth COVID-19 mRNA dose restores antibody titers to peak post-third dose titers. Low efficacy in preventing mild or asymptomatic Omicron infections and the infectious potential of breakthrough cases raise the urgency of next generation vaccine development.

I’ve also highlighted the tell-tale part of the concluding remarks: shouldn’t these injections prevent serious illness, hospitalisation, and death? Why aren’t they looking into these issues?

It gets worse once you go through the full paper (here), which I’ll briefly do to showcase the level of misinformation spread by legacy media.

On methods (p. 3), the authors state this was an ‘open-label, nonrandomized, clinical trial’ consisting of participants ‘with no known history of Sars-Cov-2 infection’. As regards procedures and study period (p. 4), it looks ok-ish in terms of testing and follow-up (before injection, on days 7, 14, and 21), with a ‘final assessment of symptoms and testing either PCR or rapid Ag tests)…performed on day 30’.

Come on, people, this is ridiculous: you only relate a nasopharyngeal swab test before the fourth injection and don’t tell about what kind of testing was done later?

Moving on to immunogenicity and ‘vaccine’ efficacy (all quotes in this paragraph on p. 5; emphases mine), we learn about the primary (‘assessment of in-vitro neutralization of omicron VOC) and secondary end points (‘vaccine efficacy in preventing infection and symptomatic disease compared to three vaccine doses’).

The more one reads, the more absurd this becomes: the ‘control group’ were triple-injected people (this isn’t apples vs. oranges anymore, this is more like oranges vs. blood oranges). The paper continues (p. 5) to state that the study design disregard the severity of ‘infection whether symptomatic or not’, as an important factor; instead, it trial participants were asked to perform weekly assessments whether they developed ‘any potential COVID-19 symptom, including fever, sore throat, headache, myalgia, rhinorrhea, cough or loss of smell or taste’.

Finally, there’s this gem (p. 5): ‘Breakthrough cases were defined only from day 8 (in each arm as well as in the control group), to exclude early infections due to exposure before vaccine is effective.’ So, it’s eight, 14, or 21 days after the injection that (re-) infection counts as a ‘breakthrough’?

Let’s look further to ‘fourth dose safety’ (pp. 6-7, emphases mine), which opens with a bang:

No immediate responses were recorded…No serious adverse events were reported. No hospital admissions were reported. The only unsolicited events reported were ocular redness and pain by two participants who were referred to the ophthalmology emergency room, where they were examined and diagnosed with conjunctivitis, unrelated to vaccination.

This statement was, you know, kinda contradicted by the immediately following paragraph:

Solicited local adverse events (AE) were common, reported by 121 (78.6%, 95%CL: 71.2-84.8%) of BNT162b2 [Pfizer] recipients vs. 99 (82.5%, 95%CL 74.5-88.8%) of mRNA1273 [Moderna] recipients. Among BNT162b2 recipients, local AE were more often reported by younger participants (88% 95%CL 80.6-95.3% compared with 69.6%, 95%CL 59.4-79.7% in >60 years of age). This difference was minor among mRNA1273 recipients. Most AE were reported as mild, and resolved within 1.7 days.

This is the background to the 80% reported AEs cited above, but the really troubling aspect is the ‘local AE were more often reported by younger participants’, as in, like, 90% of the study participants younger than 60 years.

Solicited systemic adverse events were reported by 42.9% (95%CL 35-50.7%) of BNT162b2 recipients and 55.8% (95%CL 46.9%-64.7%) of mRNA1273 recipients. Younger participants reported systemic AE more commonly than older participants for each of the AEs and in both vaccines, but this effect was small and did not reach statistical significance. Systemic adverse events resolved within 1.3 days ± 2.42. The most common adverse event reported was fatigue (27.3%, 95%CL 20.4-35.0% in BNT162b2 and 40.8%, 95%CL 31.9-49.6% in mRNA1273), followed by myalgia and headache. Fever was relatively uncommon, with only 7.1% (95%CL 3.1-11.2%), reported fever above 37.5° C, and slightly less in mRNA1273 recipients.

The paper then moves to immunogenicity (p. 7, my emphases), and declares that contrary to antibody levels ‘restored’ to after the 3rd dose (at least for the period of 14 days post-4th injection), T cell response was bad:

In total, 58 and 56 recipients of BNT162b2 and mRNA1273, respectively, were assessed for T-cell activation on day 1, before receiving the fourth dose. Among BNT162b2 recipients, 53 of the 56 were re-assessed on day 14. The proportion of responders increased from 50% to 60%, yet, the mean number of T cells activated by the spike protein did not change (131±27 to 132±32). Among mRNA1273 recipients, 40 of the 56 were re-assessed on day 14. The proportion of responders increased from 61% to 87% and the average IFNγ activated T cells increased from 72±13 to 203±36.

So, T cell response after a fourth injection with the Pfizer product was…nothing; yes, there was some improvement among the Moderna recipients, but keep in mind that the first eight days after the fourth injection don’t count and the immune reaction was only measured on day 14, which tells you (rocket science ensuing, by subtracting 14-8), well, I suppose ‘something’ about less than week (6 days) after the fourth injection in a grand total of 93 participants (53 of 154 in the Pfizer arm, 40 of the 120 in the Moderna arm) who were selected from the overall total of 274 individuals who participated in the entire study. In other words: this gem of a study—trumpeted by Covidistan de facto state media to shore up support for a mandated fourth injection—is based on essentially six days of data deriving from slightly more than a third (c. 34%) of the participants of a small, underpowered non-randomised study.

In their discussion (pp. 9-10, my emphases), the authors are quite a bit more open about this:

Overall, these data raise the possibility that the fourth dose does not boost immunity but simply restores it to peak levels. It is yet to be observed whether the waning of this fourth dose will be at a similar rate as that observed after the third dose and whether it will differ between the two mRNA vaccine groups.

Two more brief snippets on injection efficacy and the study’s limitations. As regards the former, it is held that

during the study period 25% of the control groups were infected by SARS-CoV-2 and 18-20% of the vaccinated groups had concurrent breakthrough infections, leading to a low vaccine efficacy against infections of 11-30%, with relatively wide confidence intervals. Moreover, most of the infected HCW [healthcare workers], in all groups complained of only negligible symptoms, which in many cases would not have been tested or reported, without the active surveillance. Yet, most of these infected HCW were potentially infectious, with relatively high viral loads. Thus, the major objective for vaccinating HCW was not achieved.

If you’ve made it so far, we can be quite certain that whoever typed that brief news item over at Der Standard didn’t really bother to read the paper (hold that last sentence in the above paragraph in mind for a minute or two). It does beg the questions of asymptomatic transmission, but this is really a function of testing, as the above wording reveals; furthermore, the paper argues against a fourth injection for a specific group of the working population due to lack of efficacy.

I’ll conclude this section with one more (hilarious) statement from the limitations:

Our data provides evidence that an mRNA fourth vaccine dose is immunogenic, safe and somewhat efficacious, apparently more against symptomatic disease.

Rendered into plain English: it appears to help ‘more against symptomatic disease’, because the ‘normal’ symptoms of Omicron are virtually indistinguishable from the background noise of a seasonal cold if it weren’t for the testing. Also, keep the other limitations (esp. the six-day assessment window and the very low T cell response levels) in mind as you ponder the authors’ concluding thought (p. 10, my emphasis):

While mRNA vaccines seem to be highly potent and protective against severe disease, next-generation vaccines may be needed to provide better protection against infection.

And with these issues clarified, we may now return to Covidistan, which I’ll get to in my next post.