Is spike protein harmful ?

Using Lei et al as a reference, the toxic effects of spike resulted from a concentration of 4 mcg/mL on the endothelial cells. A microgram is one-millionth of a gram. If we assume that the plasma concentration of spike and S1 were 100 ng/mL we can conservatively estimate that this concentration is 40,000 times higher than that which was detected in the patient's plasma.

Ah but I hear you protesting- the experts lied! They said no spike circulating- clearly there's spike circulating. Not exactly. For one thing, the data available until this point didn't show evidence of spike circulating, and we have a tendency in shorthand to say that that means there is no spike because we can't prove a negative. All assays have limits of detection (in this case it's labelled). A 10 nM concentration is very small- and yet this is still about 100,000 times more spike than what we find in plasma. This assay is pretty special to be able to find anything reliably at this concentration and I would be skeptical of its accuracy at this level if not for the time points that these things are appearing. Also note that this isn't evidence of spike protein being secreted by the cells that receive the mRNA, which was the key consideration behind such claims and indeed based on the tiny quantities noted, that doesn't appear to be happening. The appearance of intact spike in the plasma of this admittedly small sample is very rare and transient. The authors attribute it to T cell killing of infected cells, which seems plausible (though I would imagine that this would generally occur by an apoptotic pathway which should preserve the contents of the cell as being membrane-bound, although nothing is absolute and given these quantities it could reflect small leaks). My initial guess was that this was from pyroptosis triggered by spike but that doesn't fit with the timing of the appearance of spike protein (it happens too late). Roy Heesbeen suggested that the spike protein may be spontaneously forming virus like particles on the surface of the cells which get released when they concentrate at high levels (I don't know that spike has been shown to do this- but it has been seen with other proteins as he points out). The authors are uncertain about the source of the S1 subunit- I think there's probably a protease on the surface of transfected cells that cleaves spike and that's accounting for this.

So in short, this study is interesting- but it in no way impugns the safety of mRNA vaccines for COVID-19, or mRNA vaccines as a whole. In fact I would take it a step further and say we don't need to know anything about the biology of a pharmaceutical to make judgments about whether or not it's safe. That determination is based on epidemiologic surveillance. To date, the epidemiologic data on mRNA vaccines is exceptional and reassuring: anaphylaxis can occur but is rare and very treatable. Otherwise no events have produced safety signals in these vaccines to date, and outcomes in pregnant patients are reassuring. We have given out hundreds of millions of doses of these vaccines and despite a pharmacovigilance system sensitive enough to detect an adverse event reported in fewer than 1 per million doses, we are seeing no such problems with mRNA vaccines. Papers analyzing the mechanisms of how these vaccines work are valuable because they can be used to guide smarter vaccine design. But they cannot tell us anything definitively about safety. All of this data must be held in context. COVID-19 has killed nearly 600,000 Americans, and the death toll globally is staggering. People are additionally experiencing disabling complications after getting over even seemingly mild cases. Vaccines are the way out.

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Walt told us in an email that the aim of the study was to see if an ultrasensitive detection technology, a single-molecule array, could detect circulating antigen produced by the mRNA vaccine to demonstrate the vaccine is working as designed. 

"We found we could detect extremely low concentrations of S1 (a subunit of spike) in 11 of 13 healthy vaccinated individuals and the full spike in 3 of 13," he said in an email, noting that the technology they used is 1,000 times more sensitive than a typical antigen test, "so we are really detecting minute quantities of the spike and S1 proteins." (Emphasis is his). 

"We found that within a few days of the antigen appearing, the individuals developed antibodies that removed the antigen from the bloodstream," he added. "Our conclusion was that the vaccine is working as intended."  

Walt, a pathology professor, added there is no evidence that the spike protein is a pathogenic protein that causes damage in several tissues. 

"[T]he spike protein from SARS-CoV-2 might be responsible for at least some of the damage that occurs in severe cases of COVID-19," he says, citing a study published in March in Circulation Research. 

The study, in which researchers administered a pseudovirus to hamsters, found the spike protein "alone can damage vascular endothelial cells." But as the authors mention, the use of a pseudovirus is a limitation and "findings need to be confirmed with the SARS-CoV-2 virus" in the future.

https://www.factcheck.org/2021/07/scicheck-covid-19-vaccine-generated-spike-protein-is-safe-contrary-to-viral-claims/

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