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August 1, 2023 4:30 pm

After members of Congress sent an urgent letter to VRBPAC, FDA’s vaccine advisory committee, raising critical questions regarding the safety of COVID-19 vaccines for infants and children, ICAN’s attor... View MoreAfter members of Congress sent an urgent letter to VRBPAC, FDA’s vaccine advisory committee, raising critical questions regarding the safety of COVID-19 vaccines for infants and children, ICAN’s attorneys submitted FOIA requests which revealed that none of the lead members of VRBPAC bothered to even discuss the letter, let alone reply to Congress. On June 7, 2022, 18 members of congress sent a 5-page letter to the FDA Commissioner and VRBPAC prior to its June 14, 2022 meeting where the committee was to discuss authorization of COVID-19 vaccines in infants and children. The letter posed 19 crucial questions, including: “Why has the FDA recently lowered the efficacy bar for COVID vaccines for youngest children?” “If approved and widely used among children ... how many lives does the FDA estimate will be saved in this age group over the next year?” “Given the injuries reported in the FDA’s own VAERS, system, how will the FDA evaluate potential tradeoffs of serious vaccine injuries versus serious COVID outcomes?” Given the serious nature of the letter and its authors, and that it’s not often VRBPAC receives letters of this importance from Congress, ICAN’s attorneys submitted FOIA requests to determine whether VRBPAC’s Chairman and/or top committee members held any meetings, exchanged any emails, or had any discussions in response to this probing letter. The response to the FOIA request was as disheartening as it was unsurprising. Neither Dr. Amanda Cohn, one of the lead members of VRBPAC, nor the Chairwomen herself, Dr. Ana El Sahly, exchanged any communications about the letter. Evidently, these VRBPAC members feel free to entirely disregard legitimate questions from another branch of government. So much for checks and balances. While the response to the request for Dr. Sahly’s communications stated simply, “No records were found responsive to your request,” Dr. Cohn’s emails indicated the only discussion of the letter was a message from an FDA management director to several higher-ups stating that, “FDA will use its standard process for responding to letters from Members of Congress” – which, we know from experience, means that little attention will be given to the letter as the FDA hopes it will “just go away.” ICAN still has numerous requests pending for the communications of other VRBPAC members, as well as Commissioner Califf, and we will be sure to bring you any updates. See below for ICAN’s other recent legal wins and tussles with VRBPAC: ICAN’S ATTORNEYS SCORE ANOTHER MAJOR WIN AGAINST FDA WITH PFIZER AND MODERNA COVID-19 VACCINE DOCUMENTS ICAN’S MONUMENTAL MISSISSIPPI WIN FDA ASSIGNED PFIZER’S COVID VACCINE A LICENSE NUMBER MONTHS PRIOR TO ACTUALLY LICENSING IT FDA’S ADVISORY COMMITTEE IGNORES MEMBER’S CONFLICT OF INTEREST AND ALLOWS HIM TO ATTEND MEETINGS AND VOTE FDA PERPETUATES FAILED STRATEGY IN LATEST VRBPAC MEETING ON FLU SHOTS https://icandecide.org/press-release/ican-uncovers-fda-vaccine-advisory-committee-ignoring-pointed-questions-from-congress/ Employment Opportunity: A law firm that regularly represents ICAN has an opening for attorneys with experience in any of the following areas: (i) litigation and/or civil rights, (ii) employment rights, (iii) class action, (iv) vaccine injury, (v) medial board hearings, (vi) immigration, and (vii) toxic torts. If interested, please send a resume, a short cover letter, and 2-4 writing samples to jenna@icandecide.org.

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ICAN Uncovers FDA Vaccine Advisory Committee Ignoring Pointed Questions from Congress - ICAN - Informed Consent Action Network

icandecide.org

After members of Congress sent an urgent letter to VRBPAC, FDA’s vaccine advisory committee, raising critical questions regarding the safety of COVID-19 vaccines for infants and children, ICAN’s a

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Erika Blas shared...

July 12, 2023 11:11 am

#ICAN #Petition #FDA #IPOL #SanofiPasteur #PolioVaccine #Babies #Children #ClinicalTrials #CDC #FOIA #Polio

Homestead Magazine

In August 2022, ICAN’s attorneys filed a formal petition demanding that FDA suspend or withdraw approval of IPOL, Sanofi Pasteur’s inactivated polio vaccine for babies and children, until appropriate ... View MoreIn August 2022, ICAN’s attorneys filed a formal petition demanding that FDA suspend or withdraw approval of IPOL, Sanofi Pasteur’s inactivated polio vaccine for babies and children, until appropriate clinical trials are undertaken. The petition is simple and straightforward, and requests that, until the safety of IPOL is demonstrated with a properly powered, double blind, placebo-controlled study (that lasts beyond three days), the vaccine should be withdrawn or suspended from the market and, if reintroduced, its label amended to note that IPOL does not prevent infection or transmission. Despite this simple request, it was not until six months later that ICAN finally received a response – required by law – from Dr. Peter Marks, Director of FDA’s Center for Biologics Evaluation and Research, who oversees vaccine approval. Like his previous responses to ICAN’s citizen petitions, this one was as inane as ever. He wrote simply to state that FDA had “not yet reached a resolution because [the petition] raises issues requiring further review and analysis by agency officials.” Further review and analysis! Effectively, what the FDA is really saying is that despite the passage of six months, it cannot yet figure out how to rebut ICAN’s claim that three days of safety review in the clinical trial was insufficient. While the agency drags it feet “reviewing and analyzing” this plainly improperly clinical trialed vaccine, the CDC continues to recommend it be injected into every baby three times during the first six months of life. What the FDA should do is immediately withdraw this product from the market until a proper clinical trial that actually proves it is safe and effective, as required by law, is conducted. As longtime ICAN supporters may recall, ICAN first began investigating IPOL back in 2017 when it was brought to our attention that IPOL’s clinical trials for babies and children did not include a placebo control group and only assessed safety for three days after injection, as set forth plainly in the IPOL package insert. To verify this data, ICAN’s attorneys submitted a FOIA request seeking all of the clinical trial data that FDA relied upon to conclude that this vaccine was “safe and effective” when it approved IPOL back in 1990. Incredibly, upon receiving the studies, ICAN confirmed once and for all that none of them demonstrated that IPOL was “safe” prior to licensure and, therefore, neither the product nor FDA approval complied with the applicable federal statutory and regulatory requirements. It was for that reason that ICAN’s attorneys filed the formal petition mentioned above, which you can read in its entirety here. But despite the urgency of a potentially dangerous vaccine remaining on the market, FDA is – yet again – failing to act. You can rest assured, however, that this is only the beginning of a renewed effort by ICAN’s attorneys to investigate FDA’s knowledge and promotion of polio vaccines. Stay tuned for more on that front soon. In the meantime, you can still submit a comment in support of ICAN’s petition, by clicking the blue “Comment” button at the link here. You can read more about ICAN’s citizen petitions at the links below: FDA DOUBLES DOWN ON JUNK SCIENCE IN RESPONSE TO ICAN PETITION TO REVOKE USE OF COVID-19 VACCINES IN CHILDREN NEW CHALLENGE TO FDA ON 12-15-YEAR-OLD COVID INJECTIONS EMERGENCY PETITION TO HALT CLINICAL TRIAL OF MODERNA AND NIH’S COVID-19 VACCINE UNLESS ALL ADVERSE REACTIONS ARE TRACKED PETITION FILED REGARDING IMPROPER AMOUNTS OF ALUMINUM ADJUVANT IN CHILDHOOD VACCINES ICAN FILES FORMAL PETITION DEMANDING THAT THE FDA WITHDRAW ITS LICENSURE OF HEPATITIS B VACCINES https://icandecide.org/press-release/fda-continues-to-avoid-icans-petition-to-suspend-the-ipol-polio-vaccine-for-children/ Employment Opportunity: A law firm that regularly represents ICAN has an opening for attorneys with experience in any of the following areas: (i) litigation and/or civil rights, (ii) employment rights, (iii) class action, (iv) vaccine injury, (v) medial board hearings, (vi) immigration, and (vii) toxic torts. If interested, please send a resume, a short cover letter, and 2-4 writing samples to jenna@icandecide.org.

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FDA Continues to Avoid ICAN’s Petition to Suspend The IPOL Polio Vaccine for Children - ICAN - Informed Consent Action Network

icandecide.org

The FDA continues to avoid an ICAN petition to suspend the use of Sanofi-Pasteur's IPOL polio vaccine for use in babies and children

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Homestead Magazine

August 31, 2021 8:51 pm

ANATOMY OF A HIT PIECE In the wake of another hit piece on Del, we’re sharing a behind-the-scenes look at how Business Insider reporter, Tom Porter, gathered information for his article. How much due ... View More

ANATOMY OF A HIT PIECE

thehighwire.com

A behind-the-scenes look at how Business Insider writer, Tom Porter, sought information for his article, exposing the anatomy of a hit piece.

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Homestead Magazine

October 4, 2020 12:27 am

A DEBATE WORTH WATCHING FDA Acts On Mercury Fillings; Florida Open!; Moms On Masks; Doctor Arrested In UK Speaks Out; ICAN Sues Again! #AtlasSmackdown #Fauci #MaskMandates #UnmaskOurKids #MomsOnMasks ... View More

A DEBATE WORTH WATCHING - The Highwire

thehighwire.com

FDA Acts On Mercury Fillings; Florida Open!; Moms On Masks; Doctor Arrested In UK Speaks Out; ICAN Sues Again! #AtlasSmackdown #Fauci #MaskMandates #UnmaskOurKids #MomsOnMasks #UKProtests #FreeHeiko #

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Homestead Magazine

August 13, 2020 1:42 pm

A few weeks ago, the Informed Consent Action Network filed a formal petition with the FDA, with safety demands regarding the design of COVID-19 vaccine trials. The FDA shortly thereafter issued guidan... View More

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ICAN PETITION FORCES FDA TOWARDS SAFER VACCINE TRIALS

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