Petitioners Demand FDA Address Inconsistent Labeling of Childhood Vaccines That Contain Aluminum
Two formal petitions were filed with the U.S. Food and Drug Administration (FDA) on May 4 and on May 6, to demand the agency do its job and assure that vaccine manufacturers are disclosing accurate information regarding the amount of aluminum adjuvant in their childhood vaccines.
The petitions follow on the heels of a recently published study showing that numerous childhood vaccines have far more or far less aluminum adjuvant than listed on their FDA- approved product labels.The study, published in the Journal of Trace Elements in Medicine and Biology, requires the FDA’s and all parents’ urgent attention.
A team of aluminum experts at Keele University — led by Christopher Exley, a professor of bioinorganic chemistry for the last 29 years and author of more than200 published peer-reviewed articles regarding aluminum — has found that six childhood vaccines contain a statistically significant greater quantity of aluminum adjuvant than is provided for on these products’ labeling. The six vaccines arePentacel, Havrix, Adacel, Pedvax, Prevnar 13 and Vaqta.
According to the study, four childhood vaccines — Infanrix, Kinrix, Pediarix and Synflorix — contain a statistically significant lower quantity of aluminum adjuvant than is provided for on the product labeling.
These deviations from the products’ labels are extremely concerning, according to Exley Doses with more than the approved amount of aluminum adjuvant raise serious safety concerns, and doses with less than the approved amount raise questions regarding efficacy.
Indeed, aluminum adjuvant is a known cytotoxic and neurotoxic substance used to induce autoimmunity in lab animals, and which numerous peer-reviewed publications implicate in various autoimmune conditions.
These deviations also render the products and manufacturers non-compliant with various federal statutes and regulations, requiring immediate action from the FDA.
The petitions demand the FDA immediately and publicly release documentation sufficient to establish that the aluminum content in each vaccine at issue is consistent with the amount provided in its labeling. The petitions also ask the FDA to pause distribution of the vaccines at issue until it has done so.
Although Informed Consent Action Network’s legal team has been focusing on COVID-19 and related issues, transparency regarding childhood vaccines remains a top priority for the organization — nothing can be more important than the safety of vaccines injected into babies.
If you would like to provide the FDA a comment about the petitions addressing aluminum levels in childhood vaccines, you can do so here and here. Comments are due May 17.
Originally published by Informed Consent Action Network.
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