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FDA Illegally Authorizes Pfizer Vaccine for 5-11 Year Old Children
Does the FDA know they are safe? No. Can you sue for harm? No. Is there an emergency for children? No. Can you always say "no" to this product? No. Is that dystopian? Yes.
If the FDA wants to authorize the Pfizer vaccine for 5 to 11 year old children without sufficient safety information … fine. Ignore government data reflecting that the risks outweigh the benefits … fine. Ignore serious injuries to children in their clinical trials … fine. Grant the emergency use authorization illegally because there is no emergency for children … fine. Even grant complete financial immunity to Pfizer for any injuries to these children … fine.
But to do these things knowing that this product will be mandated by law to numerous children across the country is insidious and shameful. On behalf of ICAN, my firm sent a letter to fifteen members of Congress that have taken a stance defending individual rights. Here is the introduction and, if you like what you are reading, click on the document image below to read more.
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On behalf of the Informed Consent Action Network (“ICAN”), we write to you because of your stance defending individual and civil rights. If individual and civil rights do not include being able to choose, without government coercion, what is put on or in our bodies, then they are illusory. It means these rights can evaporate at the whim of any public health official’s opinion or agenda driven study.
In that vein, no child should be mandated to receive a COVID-19 vaccine, especially where there were serious legal and ethical breaches which occurred as part of the emergency use authorization (“EUA”) of Pfizer’s COVID-19 vaccine (the “Pfizer vaccine” or “product”) for children ages 5 through 11 (“children”).
The legal authority for the Food and Drug Administration (“FDA”) to issue an EUA for children for this product is lacking, including because there is no medical emergency for children… (Infra § I.) It is also improper to issue an EUA for children when the data does not demonstrate that the known benefits outweigh the known risks... (Infra § II.) The foregoing issues are compounded by the fact that federal health authorities have given financial immunity to Pfizer for injuries caused by this product, including if it engages in willful misconduct, despite a history of such conduct by Pfizer. (Infra § III.)
The FDA makes mistakes in authorizing and licensing products. It happens. But typically, the public is not coerced to receive the product. With this product, however, schools across the country are mandating this product based on the issuance of this EUA. This brings into sharp focus precisely why civil and individual rights should never be contingent upon a medical procedure. This right is the last and final backstop to the dangerous authoritarianism that results when we permit the government to decide what must be injected or placed into or onto our bodies.
Whatever your views are on the COVID-19 vaccine itself, we trust you will stand with Americans that reject letting the government decide what medical procedures they must engage in to participate in civil society.
I. EUA for Pfizer’s Vaccine is Illegal Because There is No Emergency
Congress passed the law granting the FDA the authority to issue EUAs after the United States experienced September 11, 2001, and subsequent acts of terror, including envelopes with anthrax that were sent through the U.S. Postal Service. To create a legal route to distribute an unlicensed and therefore, experimental, medical product in the event of bioterrorism, or a similar emergency . . . .