FORMAL PETITIONS SUBMITTED TO THE FDA TO ASSURE CONSISTENT LEVELS OF ALUMINUM ADJUVANT IN CHILDHOOD VACCINES AFTER A METHODICAL STUDY FINDS WIDE DEVIATIONS FROM THE APPROVED QUANTITIES
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 label, two formal petitions were filed with the FDA on May 4, 2021 and on May 6, 2021 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.
A study, just 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 with over 200 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 (Pentacel, Havrix, Adacel, Pedvax, Prevnar 13, and Vaqta) while four childhood vaccines contain a statistically significant lower quantity of aluminum adjuvant than is provided for on the labeling for these products (Infanrix, Kinrix, Pediarix, and Synflorix).
These deviations from the products’ labels are extremely concerning. 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 not in compliance with various federal statutes and regulations, requiring immediate action from the FDA.
The Petitions therefore demand that 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 and that the FDA pause distribution of the vaccines at issue until it has done so.
Although ICAN’s legal team has been focusing on COVID-19 and related issues, their eye is never off the ball and transparency regarding childhood vaccines remains a top priority. Nothing can be more important than the safety of vaccines injected into babies.
If you would like to provide the FDA a comment regarding the petitions filed regarding aluminum levels in childhood vaccines, you can do so here and here.