This is not a "against the vacine report". It is actually a "in favor of". To understand why you have read around this part. It basically says that it becomes undetectable after 24 hours.
The vast majority of people will take this at its face value and say: "This proves it is safe". And ignore the risk of the concentration not receding or even "why is this concentration safe?". It appears there is no deeper study of why the mRNA recedes, and consequently why it would not. They saw receding and were satisfied to test on other people.
The whole paragraph summary would be.
Concentration of the mRNA were found in all body.
Peak concentration before 24 hours.
Biggest concentration on: injection site, immune system, spleen and eyes.
Lower concentration on: everywhere apart from kidney.
Concentration falls to its half every 4 hours. Which makes the concentration undetectable in 24 hours. Undetectable is different from zero; and it is different from safe.
After the first 24 hours, mRNA was detected only on immune system, muscles (probably around injection site), spleen and brain.
The concentrations found in the spleen were considered safe based on studies on rats.
There are no studies about absorption, metabolism, and excretion of the mRNA.
This is the "happy path".
If the concentration does now recede, nobody know what can happen (maybe we do know now).
Complete text:
"Concentrations of mRNA-1647 were quantifiable in the majority of tissues examined at the first time point collected (2 hours post-dose) and peak concentrations were reached between 2- and 24-hours post-dose in tissues with exposures above that of plasma.
Besides injection site [muscle] and lymph nodes [proximal and distal], increased mRNA concentrations (compared to plasma levels) were found in the spleen and eye.
Both tissues were examined in the frame of the toxicological studies conducted with mRNA-1273 final vaccine formulation.
Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis and also brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although to very low levels (2-4% of the plasma level). Liver distribution of mRNA-1647 is also evident in this study, consistent with the literature reports that liver is a common target organ of LNPs.
Assessment reportEMA/15689/2021Pa ge 48/169The T1/2 of mRNA-1647 was reliably estimated in muscle (site of injection), proximal popliteal and axillary distal lymph nodes and spleen with average T1/2 values for all vaccine components of 14.9, 34.8, 31.1 and 63.0 hours, respectively. mRNA-1647 was rapidly cleared from plasma during the first 24 hours with the T1/2 estimated in a range of 2.7 - 3.8 hours. The mean concentrations of all vaccine components became undetectable after 24 hours, except for gH, which was detectable up to the last time point of 120 hours but which was also detectable in 2 pre-dose plasma samples. The mRNA constructs were not measurable after maximum 3 days in tissues other than the muscle, lymph nodes, and spleen (~25 hours in brain).
Reference with regards to the mRNA biodistribution is made to the respective adverse findings observed in rat spleens in toxicological studies. No adverse findings were detected in the ophthalmological examinations or the brain/CNS.No dedicated studies on absorption, metabolism, and excretion for mRNA-1273 have been submitted. This is generally acceptable with regards to the nature of the vaccine product."
This is not a "against the vacine report". It is actually a "in favor of". To understand why you have read around this part. It basically says that it becomes undetectable after 24 hours.
The vast majority of people will take this at its face value and say: "This proves it is safe". And ignore the risk of the concentration not receding or even "why is this concentration safe?". It appears there is no deeper study of why the mRNA recedes, and consequently why it would not. They saw receding and were satisfied to test on other people.
The whole paragraph summary would be.
Concentration of the mRNA were found in all body.
Peak concentration before 24 hours.
Biggest concentration on: injection site, immune system, spleen and eyes.
Lower concentration on: everywhere apart from kidney.
Concentration falls to its half every 4 hours. Which makes the concentration undetectable in 24 hours. Undetectable is different from zero; and it is different from safe.
After the first 24 hours, mRNA was detected only on immune system, muscles (probably around injection site), spleen and brain.
The concentrations found in the spleen were considered safe based on studies on rats.
There are no studies about absorption, metabolism, and excretion of the mRNA.
This is the "happy path".
If the concentration does now recede, nobody know what can happen (maybe we do know now).
Complete text:
"Concentrations of mRNA-1647 were quantifiable in the majority of tissues examined at the first time point collected (2 hours post-dose) and peak concentrations were reached between 2- and 24-hours post-dose in tissues with exposures above that of plasma.
Besides injection site [muscle] and lymph nodes [proximal and distal], increased mRNA concentrations (compared to plasma levels) were found in the spleen and eye.
Both tissues were examined in the frame of the toxicological studies conducted with mRNA-1273 final vaccine formulation.
Low levels of mRNA could be detected in all examined tissues except the kidney. This included heart, lung, testis and also brain tissues, indicating that the mRNA/LNP platform crossed the blood/brain barrier, although to very low levels (2-4% of the plasma level). Liver distribution of mRNA-1647 is also evident in this study, consistent with the literature reports that liver is a common target organ of LNPs.
Assessment reportEMA/15689/2021Pa ge 48/169The T1/2 of mRNA-1647 was reliably estimated in muscle (site of injection), proximal popliteal and axillary distal lymph nodes and spleen with average T1/2 values for all vaccine components of 14.9, 34.8, 31.1 and 63.0 hours, respectively. mRNA-1647 was rapidly cleared from plasma during the first 24 hours with the T1/2 estimated in a range of 2.7 - 3.8 hours. The mean concentrations of all vaccine components became undetectable after 24 hours, except for gH, which was detectable up to the last time point of 120 hours but which was also detectable in 2 pre-dose plasma samples. The mRNA constructs were not measurable after maximum 3 days in tissues other than the muscle, lymph nodes, and spleen (~25 hours in brain).
Reference with regards to the mRNA biodistribution is made to the respective adverse findings observed in rat spleens in toxicological studies. No adverse findings were detected in the ophthalmological examinations or the brain/CNS.No dedicated studies on absorption, metabolism, and excretion for mRNA-1273 have been submitted. This is generally acceptable with regards to the nature of the vaccine product."