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Children’s Health Defense Sues the Food and Drug Administration over its Licensure of Pfizer’s Comirnaty Vaccine

Washington, DC, Sept. 07, 2021 (GLOBE NEWSWIRE) — Last week, Children’s Health Defense (CHD) filed suit in Tennessee federal court against the U.S. Food and Drug Administration (FDA) and its acting director Janet Woodcock for their deceptive, rushed licensure of Pfizer’s Comirnaty vaccine. CHD argues that the licensure was a classic “bait and switch,” allowing Pfizer, the Administration, the military and employers to exhort people to take “licensed” vaccines when in fact the vaccines available continue to be the Pfizer-BioNTech Emergency Use Authorization (EUA) vaccines.

The lawsuit alleges that the FDA’s actions are arbitrary and capricious. Under federal law, if the FDA licenses a product for the same precise purpose as an existing emergency use authorization product, it must withdraw the EUA. Yet here, the FDA is allowing Pfizer to have “interchangeable” vaccines, Comirnaty and Pfizer-BioNTech, on the market at the same time for the same indication of people aged 16 and up, while suggesting that the vaccines are “legally distinct.” CHD asserts that the FDA has violated the law.

CHD is following up on the Citizen Petition that Robert F. Kennedy, Jr. and Meryl Nass, M.D. submitted on behalf of CHD on May 16, 2021, which garnered over 30,000 public comments. On August 23, 2021, the same day that it licensed the Pfizer Comirnaty vaccine, the FDA responded to CHD’s petition. This licensure and FDA response cleared the administrative path for CHD to file suit. Attorneys Robert F. Barnes and Derek Jordan of Barnes Law are the lead attorneys along with Robert F. Kennedy, Jr. and other counsel for CHD.

“The FDA must justify its actions in open court,” said Mary Holland, CHD President and General Counsel. “The language of its licensure is nearly incomprehensible, and the result of licensed and unlicensed vaccines for the same indication is arbitrary.”

CONTACT: Rita Shreffler Children's Health Defense 202-599-1461 [email protected]