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2. Conclusions
The available information and data indicate that the ready-to-use mRNA vaccine Comirnaty contains DNA impurities that exceed the permitted limit value by several hundred times and, in some cases, even more than 500 times, and that this went unnoticed because the DNA quantification carried out as part of batch testing only at the active substance level appears to be methodologically inadequate when using qPCR, as explained above. Because of the conditions during the production of the mRNA active substance of Comirnaty, the applied qPCR is designed so that a massive under-detection of DNA impurities appears to be the result.
The available information and data indicate that the ready-to-use mRNA vaccine Comirnaty contains DNA impurities that exceed the permitted limit value by several hundred times and, in some cases, even more than 500 times, and that this went unnoticed because the DNA quantification carried out as part of batch testing only at the active substance level appears to be methodologically inadequate when using qPCR, as explained above. Because of the conditions during the production of the mRNA active substance of Comirnaty, the applied qPCR is designed so that a massive under-detection of DNA impurities appears to be the result.
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