Thread by @HowardSteen4

A report has circulated based on VAERS data analysis that about 5% of injectable batches cause v. high ARs while the majority of batches do not. One analyst has suggested this is likely to be a manufacturing process control problem. Base on my own experience of process control ..

I think this could be an explanation. In any manufacturing process designed to yield a certain product quality there is inherent variability in the process output. The statistical variation of the output value is a normally distributed. Background here:
slidetodoc.com/5-quality-and-…

One wants a certain target purity in the product for example. But there will always be variability in this. A process is said to be in control when the spread of the normal distribution is tight and essentially all of the purity values fall within tolerance limits around target.

Statistically that is measured by finding the standard deviation of the process value, sigma. I tried to illustrate this in a sketch. When a process is 'out of control' the average value might still be on target but there will be significant amounts of product outside limits.

As early as Jan 2021 when Dr. V Schmidt-Krüger gave her assessment of the EMA authorisation report for the Pfizer product it was clear that the new process for mass roll out (different to what was used in clinical) had a product purity control problem: open.lbry.com/@shortXXvids:e…

So purity of the m-RNA was not being achieved to the target level. And the manufacturer's own data confirmed this. In a process which is operating 'within limits' you want to have 6 sigma of the variation falling within the upper and lower shipping values - maybe higher for drugs

In the industry I worked in (FMCG) we regularly had to investigate this kind of variation and block & scrap product batches which were OOL (out of limits). I would expect the pharma industry to have high standards about this kind of attention to quality control. Who really knows?

5% of batches being OOL yet being on the market is a truly damning indictment of process control. But this 5% applies not just to Pfizer but all US suppliers. Are they all using the same manufacturing process. Yes, this is actually quite likely because all these processes have to

somehow create large amounts of m-RNA in a bacterial reactor and control the end point purity with RNAse enzymes to remove unwanted DNA. Some processes I have worked on took 5 years or more to optimise for market introduction. It really looks like tis one has still not been ...

optimised at all. Possibly it is simply unsuitable and is a dead end. The science theory of this technology is one thing (and there are many troubling aspects to this) but if the practical manufacturing process execution can't deliver quality it's time to recall all products.