FDA Emails Show that Agency Could Not Address Serious Safety Gaps in Clinical Trials of Childhood Vaccines

ICAN, through the efforts of its attorneys, obtained internal FDA emails showing that it carefully reviewed and considered its responses to ICAN’s claims regarding the clinical trials relied upon to license childhood vaccines.  Among other things, ICAN demanded an explanation for the fact that these clinical trials had too few children in the study, only reviewed safety for days or weeks, and virtually none of them included a placebo control.

Tellingly, when presented with information on just how little scientific study vaccines undergo before being recommended for injection into babies, Maureen Hess, the FDA’s Special Assistant for Communication, admitted that she wondered to herself “how could this be.”

Despite that, the FDA’s incredible response was to lie and claim many of the vaccines did undergo placebo control studies even though the FDA’s own licensure documents for each childhood vaccine show otherwise! Its response similarly failed to show proof that the safety periods exceeded mere days or weeks or that the studies were otherwise not underpowered (meaning, involved too few children).

Here are the emails just obtained showing the FDA’s careful attention in responding to ICAN’s letter to HHS.  You can read the entire exchange with the HHS, including FDA’s contributions,  here. Note that for all of its internal debate and collaboration formulating an answer, this equivocal response is the best it could muster to support the over 70 doses of vaccines given to babies and children.  It should deeply trouble all Americans, whatever their views on vaccines: