FDA Still Cannot Confirm Level of Aluminum Adjuvant in Vaccines Injected Into Babies

Six months have passed since the FDA received two petitions demanding that the agency assure that vaccine manufacturers are disclosing accurate information regarding the amount of aluminum adjuvant in their childhood vaccines.  The FDA’s response after half a year is that they “have not been able to complete [their] final responses at this time.”

 

After a study, published in the Journal of Trace Elements in Medicine and Biology, showed that numerous childhood vaccines have far more or far less aluminum adjuvant than listed on their FDA approved product label, ICAN submitted a petition to the FDA with an extremely reasonable demand:

 

that FDA publicly release documentation sufficient to establish that the aluminum content in certain vaccines is consistent with the amount stated in its labeling and, if unable to do so, pause distribution of those vaccines until the Agency has confirmed and publicly released documentation sufficient to establish that the aluminum content in the vaccines is consistent with the amount stated in its labeling.

 

This is apparently not a simple, straight-forward request for the FDA.  One would think that the agency tasked with overseeing the safety of vaccines – products injected into children – would easily be able to provide proof that what is in the vaccines is what is supposed to be in the vaccines.

 

Evidence that parents can trust the label should be readily available and willingly disclosed.  Instead, the FDA states that they “will respond to [the] petition as soon as we have reached a decision on [the] request.”  This is an incredible response given that the decision was to either produce proof that the aluminum content in the vaccines is consistent with its label, or stop distributing them until the FDA can confirm this is true.  Plainly, they cannot confirm the aluminum adjuvant in the vaccine matches the approved label.

 

What prompted this request?  It was the finding of 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 – 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.

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