FDA ILLEGALLY AND UNETHICALLY AUTHORIZES PFIZER VACCINE FOR 5- TO 11-YEAR-OLD CHILDREN

It is illegal and unethical because there is no COVID-19 emergency as it relates to children ages 5-11, the clinical trials are inadequate, the harms exceed the risks, and Pfizer failed to properly document at least one serious injury to a child in its clinical trial.

None of these facts got in the way of the Vaccines and Related Biological Products Advisory Committee’s (VRBPAC) vote to recommend that emergency use authorization (EUA) be granted for Pfizer’s COVID-19 vaccine for children ages 5-11, nor in the FDA’s way of granting the authorization, nor in Advisory Committee on Immunization Practices (ACIP) or the CDC’s way of recommending the vaccine.

Aghast at the complete dismissal of the relevant science and data, ICAN sent a letter to 15 United States Representatives explaining how the EUA granted for Pfizer’s COVID-19 vaccine in children is illegal as (i) there is no emergency for children; (ii) the known benefits do not outweigh the risks; and (iii) it is destructive to liberty, especially in light of the fact that Pfizer has been granted complete immunity from liability.

The FDA advisory committee, VRBPAC, was given all of this information prior to its recommendation of authorization via a public comment submitted by ICAN, which  outlined the lack of safety data for this vaccine in children due to inadequate clinical trials.  ICAN’s attorneys also submitted a letter to the same committee which highlighted the story of Maddie de Garay, a child who was severely injured in Pfizer’s vaccine clinical trial.

ICAN’s plea, and that of the de Garay’s, has fallen on deaf ears, as VRBPAC voted 17-0 to authorize two doses of Pfizer’s COVID-19 vaccine for children ages 5-11.  Shortly thereafter, and not surprisingly, the FDA took VRBPAC’s recommendation and authorized the EUA.  The CDC has now recommended the vaccine for use in this age group.

Therefore, ICAN has now asked the U.S. representatives to “stand with Americans that reject letting the government decide what medical procedures they must engage in to participate in civil society.”

ICAN will continue to call federal agencies out for ignoring the science and will work to stand up for your rights.  We will keep you updated along the way.

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