Each dose of Pfizer bivalent vaccine contains 0.03 milligrams of mRNA.
Therefore each dose should contain no more than 10 nanograms of DNA (0.03 x 330).
This is the limit recognised by the Australian Therapeutic Goods Administration (TGA), being guided by earlier discussion on the topic by the WHO and EMA, wheer the latter two suggested the limit of not more than 10 nanograms of DNA per dose.
Note, in the WHO study group paper above, though 10 nanograms per dose had been raised, the WHO ultimately decided against setting a DNA limit due to what it saw as evolving testing methods - in short, they appear to have bent to the wishes of pharma to have no limit stated.
A paper by Hess et al (2012) on the issue of residual DNA summarised the situation:
‘.. the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human vaccines together with compliance to GCCP (Good Cell Culture Practice) are discussed. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs.’
See: Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines
But, up to 35% of the total nucleic acids in the Pfizer bivalent vaccine is DNA, meaning 0.0105 milligrams is DNA (0.35 x 0.03), which is equivalent to 10,500 nanograms of DNA per dose.
10,500 nanograms of DNA is over 1,000 x above the acceptable DNA limit, or a 104,900% increase over the acceptable limit.
Each dose of the Moderna bivalent vaccine contains 0.1 milligrams of mRNA.
Therefore each dose should (per ealier suggestions) contain no more than 33 nanograms of DNA (0.1 x 330), despite already being 3 times over the historically accepted Australian limit.
But, up to 35% of the total nucleic acids in the Moderna vaccine is DNA, meaning 0.035 milligrams is DNA (0.35 x 0.1), which is equivalent to 35,000 nanograms of DNA per dose.
35,000 nanograms of DNA is over 3,500 x above the Australian acceptable DNA limit, or a 349,900% increase above the historically accepted Australian limit.
for the Pfizer Monovalent vaccine .. this article
Instead of DNA contamination at or below 330 nanograms of DNA per 1 milligram of mRNA, 5,940-23,100 nanograms of DNA per 1 milligram of mRNA was discovered (18-70 fold higher).
This represents 1,700% up to 6,900% increases above the accepted limit of DNA contamination.
One Pfizer vial has that 72bp repeat in one of the vectors but not the other.
on the issue of contamination limits and how the EMA limit of 330 ng DNA per 1 mg of RNA was arrived at ..
The European Medicine Agency (EMA) has stipulated that DNA should not amount to more than 330 nanograms of DNA per milligram of mRNA.
EMA page 74: Rapporteur Rolling Review critical assessment report
https://mega.nz/file/tQgzBYIS#KZLmkCVKJljv2IotP8hnQNXPhEj-sZYos2mSv8o7fYE
Each dose of Pfizer bivalent vaccine contains 0.03 milligrams of mRNA.
Therefore each dose should contain no more than 10 nanograms of DNA (0.03 x 330).
This is the limit recognised by the Australian Therapeutic Goods Administration (TGA), being guided by earlier discussion on the topic by the WHO and EMA, wheer the latter two suggested the limit of not more than 10 nanograms of DNA per dose.
TGA page 11: https://www.tga.gov.au/sites/default/files/pm-argpm-guidance-18.pdf
WHO page 18: https://www.who.int/publications/m/item/who-study-group-on-cell-substrates-for-production-of-biologicals
EMA page 3 of 4: https://www.ema.europa.eu/en/documents/scientific-guideline/position-statement-use-tumourigenic-cells-human-origin-production-biological-biotechnological_en.pdf
Yang, 2013: Establishing Acceptable Limits of Residual DNA:
https://www.corrispondenzaromana.it/wp-content/uploads/2021/03/3_Establishing_acceptable_limits_of_DNA.pdf
Note, in the WHO study group paper above, though 10 nanograms per dose had been raised, the WHO ultimately decided against setting a DNA limit due to what it saw as evolving testing methods - in short, they appear to have bent to the wishes of pharma to have no limit stated.
A paper by Hess et al (2012) on the issue of residual DNA summarised the situation:
‘.. the safety challenges and almost arbitrary risk-based classification of cell substrates used in the production of human vaccines together with compliance to GCCP (Good Cell Culture Practice) are discussed. Even though there has been tremendous progress in the last few years, reflected mainly by revisions and updates to regulatory guidance documents, there still is still no consensus between regulators nor significant harmonisation of the guidance documents or monographs.’
See: Regulatory, biosafety and safety challenges for novel cells as substrates for human vaccines
https://www.sciencedirect.com/science/article/pii/S0264410X12001806
returning ..
But, up to 35% of the total nucleic acids in the Pfizer bivalent vaccine is DNA, meaning 0.0105 milligrams is DNA (0.35 x 0.03), which is equivalent to 10,500 nanograms of DNA per dose.
10,500 nanograms of DNA is over 1,000 x above the acceptable DNA limit, or a 104,900% increase over the acceptable limit.
Each dose of the Moderna bivalent vaccine contains 0.1 milligrams of mRNA.
Therefore each dose should (per ealier suggestions) contain no more than 33 nanograms of DNA (0.1 x 330), despite already being 3 times over the historically accepted Australian limit.
But, up to 35% of the total nucleic acids in the Moderna vaccine is DNA, meaning 0.035 milligrams is DNA (0.35 x 0.1), which is equivalent to 35,000 nanograms of DNA per dose.
35,000 nanograms of DNA is over 3,500 x above the Australian acceptable DNA limit, or a 349,900% increase above the historically accepted Australian limit.
for the Pfizer Monovalent vaccine .. this article
Instead of DNA contamination at or below 330 nanograms of DNA per 1 milligram of mRNA, 5,940-23,100 nanograms of DNA per 1 milligram of mRNA was discovered (18-70 fold higher).
This represents 1,700% up to 6,900% increases above the accepted limit of DNA contamination.
further ..
Each dose of the children’s formulation contains 10 micrograms of mRNA, which equals 0.01 milligrams. (The adult dose contains 30 micrograms)
Therefore the vials examined by Kevin contained between 59 and 231 nanograms of DNA (0.01 x 5,940 & 23,100) per 0.01 mg dose.
Recall the suggested limit stated above, that no more than 10 nanograms of DNA should be found in any one dose.
Note 0.01 milligrams equals 10,000 nanograms.
Therefore DNA contamination in the vials ranged between 0.6 to 2.3%.
Such DNA contamination should not have exceeded 0.1% for a 0.01 mg children's dose.
These DNA contamination levels are 23 x (times) above, or 22 fold higher, or evidence a 2,200% increase over Australian stated limits.