Berlin: (hib/PK) In its answer (20/10958) to a minor question (20/10832) from the AfD parliamentary group, the federal government explains the limit value for DNA contamination in corona vaccines. In principle, medicines should contain the lowest possible amount of impurities. If scientifically recognized, limit values for impurities in medicines such as vaccines are set in relevant guidelines or specifications in the pharmacopoeia, the answer says.
Since in the present case (Comirnaty) there are no relevant specifications regarding a limit value for residual plasmid DNA that must be adhered to, this had to be determined using study data.
According to the information, the limit of ten nanograms of residual plasmid DNA per dose of the Covid-19 vaccine was not determined solely through toxicological studies in animals. Rather, the investigations found that no specific safety risk could be observed even after repeated administration of the vaccine with an amount of residual plasmid DNA known from test results.