Excerpts from RFK Jr. et al’s petitions to ban COVID-19, Polio, and Hepatitis B vaccines (2021, 2022, 2020)

ALT text copy and pasted from images, with minimal editing. Sorry if there are any mistakes; I’m half awake and horrified. (I do not endorse any of this!!)

Editing to add that, upon reflection, I do think I’ve heard about these before. There are just so many recent horrors now that it’s hard to keep them straight

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Children’s Health Defense

May 16, 2021

Division of Dockets Management
Department of Health and Human Services
Food and Drug Administration
Acting Commissioner Janet Woodcock, M.D.
5630 Fishers Lane, Room 1061
Rockville, MD 20852

Dear Acting Commissioner Woodcock:

Enclosed is a Citizen Petition filed on behalf of Children’s Health Defense by Meryl Nass, M.D., Scientific Advisory Board member, and Robert F. Kennedy, Jr., Board Chair and Chief Litigation Counsel, requesting that the FDA revoke Emergency Use Authorizations for existing COVID vaccines and refrain from approving and licensing them.

Dr. Nass and Mr. Kennedy look forward to your timely review of this petition. They are available to answer questions and to provide any additional relevant information.

Sincerely yours,

Mary Holland
President and General Counsel
(845) 445-7807
mary.holland@childrenshealthdefense.org

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This is the cover letter for a petition filed by Children’s Health Defense, which was chaired by RFK Jr. from 2015 to 2023 according to Wikipedia (citing an AP article ).

There’s an article about the petition here, from January 17, 2025:

RFK Jr. petitioned FDA in 2021 to revoke authorization of all COVID vaccines

RFK Jr. petitioned the FDA in 2021 to revoke authorization of all COVID vaccines.

PDFs of the petition are available from multiple sources:

https://downloads.regulations.gov/FDA-2021-P-0460-0001/attachment_1.pdf

https://static01.nyt.com/newsgraphics/documenttools/b3ab45ec074c9eff/c583e080-full.pdf

childrenshealthdefense.org/wp-content/uploads/FDA-2021-P-0460-0001_attachment_1.pdf

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CITIZEN PETITION

This petition is being submitted pursuant to 21 C.F.R. § 10.30 and related relevant provisions of the Federal Food, Drug, and Cosmetic Act and Public Health Service Act, the Public Health and Welfare at, inter alia, 42 U.S.C. § 262(a)(2)(A)-(C), 42 U.S.C. § 262), and 42 U.S.C. § 300aa-10 et seq., to request that the Commissioner of Food and Drugs (the “Commissioner”) withdraw or suspend the approval granted by the Food and Drug Administration (“FDA”) for IPOL for infants and toddlers until a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product as required pursuant to applicable federal statutes and regulations for licensing this product. See, e.g., 21 U.S.C. § 393 (The FDA “shall promote the public health by ... reviewing clinical research and taking appropriate action ... [to] protect the public health by ensuring that .... drugs are safe and effective.”)

The clinical trials relied upon to license this product did not include a control group and only assessed safety for up to three days after injection. These trials therefore did not comply with the applicable federal statutory and regulatory requirements necessary to prove the product was “safe” prior to licensure. The FDA therefore must either withdraw or suspend the approval of this product until an appropriate clinical trial, as required by law, is conducted to determine its safety.

Furthermore, the product label for IPOL should be amended to note that this product does not prevent infection and transmission.

A. ACTION REQUESTED

1. Petitioner requests that the FDA withdraw or suspend the approval for IPOL for infants, toddlers, and children until a properly controlled and properly powered double-blind trial of sufficient duration is conducted to assess the safety of this product.

2. Petitioner further requests that the FDA amend the product label for IPOL to note that: “IPOL does not prevent intestinal infection and therefore does not prevent poliovirus transmission.”

B. STATEMENT OF GROUNDS

3. IPOL is a vaccine for poliomyelitis. The Centers for Disease Control and

Prevention (“CDC”) Recommended Child and Adolescent Immunization Schedule recommends universal vaccination of all infants and children with inactivated polio vaccine (“IPV”) with a 4-dose series administered at 2-months, 4-months, 6-months, and 4-years of age.¹ The only standalone vaccine for poliomyelitis used in the United States is Poliovirus Vaccine Inactivated

¹ See https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html#note-polio (last visited August 23, 2022).

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This is from another petition filed by the law firm Siri & Glimstad on the behalf of the Informed Consent Action Network (ICAN), presumably on August 23, 2022 (based on the footnotes citing URLs and the PDF URL below).

Paywalled article from December 13, 2024 (updated December 15, 2024):

Kennedy’s Lawyer Has Asked the F.D.A. to Revoke Approval of the Polio Vaccine (Published 2024)

Aaron Siri, who specializes in vaccine lawsuits, has been at Robert F. Kennedy Jr.’s side reviewing candidates for top jobs at the Department of Health and Human Services.

Paywall-free article from December 13, 2024 that cites the above:

RFK Jr.'s lawyer and top ally asked FDA to revoke approval of a polio vaccine

Robert F. Kennedy Jr.'s personal attorney previously petitioned the Food and Drug Administration to revoke its approval of a polio vaccine.

NBC News article about RFK Jr. and ICAN from December 23, 2024, which gets embedded on Leaflet as a video (see link for text):

PDFs of the full petition:

https://downloads.regulations.gov/FDA-2022-P-1998-0001/attachment_1.pdf

icandecide.org/wp-content/uploads/2023/05/Petition-IPOL-2022-08-23.pdf

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regulatory requirements necessary to prove they were “safe” prior to licensure. See, e.g., 21 U.S.C. § 393 (The FDA “shall promote the public health by ... reviewing clinical research and taking appropriate action ... [to] protect the public health by ensuring that .... drugs are safe and effective.”). Consequently, the FDA must either withdraw or suspend the approval of these products until an appropriate clinical trial is conducted, as required by law, to determine their safety for licensure.

A. Action Requested

1. That the FDA withdraw or suspend the approval for Engerix-B and Recombivax HB for infants² and toddlers until a double-blind placebo-controlled trial of sufficient duration³ is conducted to assess the safety of these products.

B. Statement of Grounds

2. The Centers for Disease Control and Prevention (“CDC”) Recommended Child and Adolescent Immunization Schedule recommends universal vaccination of all infants with a Hepatitis B vaccine at birth, 1-month of age, and 6-months of age.⁴ There are only two Hepatitis B vaccines licensed for administration to newborns: Engerix-B and Recombivax HB.

3. The Informed Consent Action Network (“ICAN”) is a non-profit organization that advocates for informed consent and disseminates information necessary for same with regard to all medical interventions. In 2017, a supporter of ICAN advised the organization that the clinical trial relied upon by the FDA to license each of the two Hepatitis-B vaccines on the market only reviewed safety for a few days after injection. ICAN found this claim incredible. It assumed the claim was likely false.

4. Indeed, the importance of capturing all potential health issues for a material duration during a clinical trial is reflected in the trials of, for example, the drugs Enbrel⁵, Lipitor⁶, and Botox⁷, which had safety review periods of 6.6 years, 4.8 years and 51 weeks respectively, each with a placebo control group. As another example, the weight loss drug Belviq, indicated only for adult use, was safety tested in a placebo-controlled trial for two years before being licensed by the FDA.⁸

² Id.

﻿³ As discussed below, safety should be assessed until the infants and toddlers are at least six years of age so that the rates of autoimmune and neurological disorders, many of which are not diagnosed until childhood, can be assessed.

⁴ See htt ps://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html#note-hepb (l ast visited Sept. 3, 2020).

⁵ https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/1037955503lbl.pdf (last visited Sept. 3, 2020).

⁶ https://www.accessdata.fda.gov/drugsatfda_docs/label/2009/020702s056lbl.pdf (last visited Sept. 3, 2020).

⁷ https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/103000s5302Ibl.pdf (last visited Sept. 3, 2020).

⁸ https://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022529lbl.pdf (last visited Sept. 3, 2020). In February 2020 the drug was voluntarily removed from the US market at the request of the FDA due to emerging data showing that people who had taken the drug as part of a large clinical trial had an increased occurrence of cancer five years later. See also https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-

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The last footnote

The last sentence of the last footnote in its entirety:

See also https://www.fda.gov/drugs/drug-safety-and-availability/fda-requests-withdrawal-weight-loss-drug-belviq-belviq-xr-lorcaserin-market (last visited Sept. 3, 2020); https://www.health.harvard.edu/blog/weight-loss-drug-belviq-recalled-2020040919439 (last visited Sept. 3, 2020).

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This is another petition filed by Siri & Glimstad on September 4, 2020, again on ICAN’s behalf. The articles linked for the previous image also mention this petition against the Hepatitis B vaccine.