We publish a report on the analysis of metals present in Infanrix Hexa, Hexyon, Priorix Tetra and Gardasil vaccines 9.
The results let us state that with regard to the presence of aluminum we have not found non-compliance for the Infanrix Hexa, Hexyon and Gardasil 9 vaccines. As for the Priorix Tetra vaccine we have to mention that we found, 0.8 μg/dose (500 μg), that even if little shouldn’t be there.
Metal analysis by ICP-MS
ICP-MS : Inductively Coupled Plasma - Mass Spectrometry
ICP-MS is the most sensitive atomic spectroscopy technique and is therefore suitable for the qualitative and quantitative analysis of trace elements and the simultaneous determination of about 30 elements in a single turn.
In inductively coupled plasma – mass spectrometry or ICP-MS, ions produced in argon plasma are injected into the MS where they are separated based on their mass/charge ratio. This procedure is the ideal solution for the analysis of metals at concentrations as low as parts per trillion.
Plasma is an electrically neutral gas with a certain percentage of ionization (~5%). The sun, lightnings and aurora borealis are examples of plasma in nature. The energy that maintains an analytical plasma derives from an electric or magnetic field; they do not “burn” the sample. Most analytical plasmas work with argon or helium, which makes combustion impossible. Plasmas are characterized by high temperature (typically in the range 600-8000 K) and by high ionic and electronic density.
Infanrix Hexa - Batch A21CD072D |
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| Metal | Unit of measure | Results | |
| Aluminum | mg/Kg | 1447 ± 260** |
Equal to 723,5 μg ± 130 μg / dose |
| Other metals | mg/Kg | <0.3* | |
Hexyon - Batch P3B412V |
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| Metal | Unit of measure | Results | |
| Aluminum | mg/Kg | 1092 ± 197** |
Equal to 546 μg ± 98.5 μg / dose |
| Other metals | mg/Kg | <0.3* | |
Priorix Tetra - Batch A71CB243A |
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| Metal | Unit of measure | Results | |
| Aluminum | mg/Kg |
1.6 ± |
Equal to 0.8 μg ± 0.15 μg / dose |
| Other metals | mg/Kg | <0.3* | |
Gardasil 9 - Batch R013092 |
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| Metal | Unit of measure | Results | |
| Aluminum | mg/Kg | 832 ± 150** |
Equal to 416 μg ± 75 μg / dose |
| Other metals | mg/Kg | <0.3* | |
* Detection limit of (300 ng/g)
** Measurement error (deviation from the mean)
Supplementary notes
Beyond aluminum we have researched Afnio, Antimony, Arsenic, Barium, Bismuth, Cadmium, Chromium, Gallium, Indium, Iridium, Yttrium, Lanthanum, Mercury, Nickel, Palladium, Lead, Platinum, Copper, Rhodium, Ruthenium, Scandium, Tin, Strontium, Tantalum, Thallium, Tungsten, Vanadium and all were below the detedtion limit of 300 ng/g. We will analyze by a more sensitive technology only the metals that have given a clear signal.
Download: CORVELVA-Metal-analysis-by-ICP-MS.pdf
Translated by team CLiVa - www.clivatoscana.com
