“BASG confirms: In Austria, not a single Pfizer vaccine batch has been tested for quality” was the title of our first article, which emerged from the batch control research. But what about the other so-called vaccines, also called “spikes” by some due to the new mechanism of action?
An attentive reader contacted us and pointed out a contradiction: While our research had shown that not a single batch of Pfizer’s most widely used vaccine in Austria was tested in Austria, the reader found on the website of the responsible Austrian authority, BASG, the information: “AGES reviews COVID 19 vaccine across Europe“. The apparent contradiction arises from the fact that the BASG has “hidden” a note – one has to call it that – in the introduction to the article: “On January 6, 2021, the European Commission approved the second COVID-19 vaccine.” That’s correct, because that’s when Moderna’s vaccine was released conditionally approved. The BASG article mentions neither the manufacturer (Moderna) nor the name of the substance (Spikevax), so the reader must get the impression that Austria is testing all batches (also batches or lots) of all manufacturers. However, this is not the case. Austria checks the Moderna batches, Germany the Biontech-Pfizer batches. In Austria, mainly Biontech-Pfizer is injected. To date, 14.5 million doses of Biontech-Pfizer and 1.6 million doses of Moderna have been administered in Austria. In Germany, these are 124.3 million doses of Biontech-Pfizer and 29.1 million doses (Those).
Batch testing of paramount importance
Even after vaccines have been approved, the individual batches must be released because the quality can vary between batches. The Covid-19 vaccines are new technologies that still only have conditional approval. Accordingly, fluctuations in production are to be expected (see here and here). Whether the tests in the manufacturer’s works are sufficient cannot be transparently verified. Conscientious control and testing when accepting the batches would be all the more important. Incidentally, changes can also occur as a result of storage and transport, but this is apparently not checked at all.
Back to testing and approval: In fact, batch testing in Europe works in a similar way to issuing a passport. As an applicant you can apply for the passport at one of the district authorities or a magistrate. The passport itself is then valid everywhere. Likewise, the manufacturer of a vaccine can contact one of the certified laboratories in the so-called OMCL network and apply for approval. OMCL stands for “official medicines control laboratories”, ie official medical control laboratories. The laboratory tests the substance and releases it with a certificate. The release certificate must then be recognized by all states in the network. There then only an “administrative release” (“administrative batch release”) takes place. Austria, for example, checks the Moderna batches and releases them for all other countries in the network, while only administrative release takes place for the Biontech-Pfizer batches. The OMCL network includes the countries of the EEA area, including Switzerland mutual agreement.
Superficial controls – trust in the manufacturers
But what does such a test look like? Very thin, you can only say that if you expect a detailed assurance of quality. The content of the test is manageable and the testing methodology is secret. The test consists of a part that is done at the manufacturer and a part that is done at the OMCLs. So the official body essentially only takes over that Manufacturer’s test documentation and only checks identity, appearance and salary. Violas are sent from the manufacturer to the testing laboratory for each batch. The laboratory does not take random samples, but trusts that the samples supplied by the manufacturer to be tested correspond to what is contained in all other vials. The identity check means that it is checked whether it is in principle the declared vaccine and not another preparation. Apparently, the check on appearance is carried out by visual inspection, ie we check with the eye whether there is discoloration or obvious soiling. The examination of the content is particularly original, because here it should be about the active ingredient.
Fluctuating quality of active ingredient
The so-called “Pfizer leaks” appeared as early as autumn 2020. Hackers had published the e-mail traffic between Pfizer and the European regulatory authority. Among other things, it emerged from these leaked documents that the quality of the active ingredient fluctuated greatly. That’s why a year ago, the recognized scientific journal “British Medical Journal” (BMJ) set about asking about the active ingredient in the ampoules. But the magazine came across one wall of silence.
The active ingredient in mRNA vaccines is the blueprint for the spike protein of the Wuhan virus. In order for it to be absorbed and read by the cells, it has to get inside the cell. This is done using so-called lipid nanoparticles (LNPs). The mRNA must therefore be inside these LNPs in order to be effective. Now it’s about how much intact mRNA contained in the LNPs at the time of administration. mRNA that is outside of the LNPs is broken down by endogenous enzymes.
Analysis method unsuitable
The suitability of the analysis method presented in the BASG video above can be strongly doubted. A centrifuge is shown and the explanation for this is that one would determine the milligrams per milliliter. How do you intend to find out how much intact mRNA is inside the LNPs by spinning the entire substance vigorously in a centrifuge? The transport has to take place at temperatures well below zero degrees, probably mainly to avoid damage from vibrations. After thawing, the vials may only be handled with extreme caution, otherwise the vaccine will become useless. To check whether there is enough intact active ingredient in the vaccine, you put it in a centrifuge and destroy what you are supposed to be examining.