Overrule the FDA and the CDC

We want the White House to stop pushing harmful experimental shots on Americans, especially our youngest, as part of a perpetual COVID policy.

You answered our call to email the decision-makers on the shot for kids – VRBPAC, ACIP, and the CDC and FDA Directors – by sending 220,000 personalized emails!

Let’s keep the momentum going to protect our kids from these harmful shots. The White House shows no signs of stopping the runaway train of COVID shots, so we need our governors to do their jobs to protect health freedom and stand up against the recommendations from the CDC and FDA.

 The state of Florida Department of Health is leading the way by recommending against COVID shots for healthy kids. (If you live in FL, you can send Governor DeSantis a thank you here!) The country of Sweden has recommended against COVID shots for kids 5-11, concluding the benefits did not outweigh the risks.[i]

Even the World Health Organization stated, in June 2021, “Children should not be vaccinated for the moment,” as there wasn’t enough evidence to clearly understand the risks or benefits.[ii] In contrast, by June 2021 the U.S. had authorized and recommended the shot for kids as young as 12.

States can and should follow Florida’s lead by overriding the ability of FDA and CDC to make decisions for our kids!

Pfizer may have delayed its rolling EUA application for their mRNA COVID shot for kids under 5, but it is not off the table. White House officials stand at the ready for approval and shots rollout once the data is submitted. In the meantime, Moderna recently announced it’s ready to submit for approval in this age group, as well. It’s only a matter of time before the FDA and the CDC decide whether to authorize and recommend the shots for our babies and toddlers.

The COVID shots are currently immune from liability for injury or death as a “covered countermeasure” under the PREP Act. Once that expires, companies could enjoy permanent protection from liability if the shots are put on the CDC’s Childhood Vaccine Schedule. We cannot let that happen to our children! On that front, the state of Washington is leading the way. Its Board of Health decided against adding the COVID shot to the list of required immunizations for kids in K-12.[iii]

Healthy children do not need a COVID shot. It is estimated that 40% or more kids have natural immunity and their survival rate is over 99%. A massive amount of data shows serious harms from the shot: the most well-known being myocarditis in our young children. Yet the federal government keeps authorizing and recommending the COVID shot for kids younger and younger and is poised to start injecting infants and toddlers.

The federal government should not be making this decision for our families! The decision to make shots the central part of COVID policy has a checkered history. People who spoke out against the shots have been filtered out of the decision-making process. If we want to follow the science, we must follow the resignations and retirements that have exploded among our top vaccine officials and experts since 2020.

Here is what we have seen in the executive branch over the last two years as the White House pushed the plan to “vaccinate America”:

• In May 2020, amidst the most devastating pandemic seen for generations, global health expert Rear Adm. R. Timothy Zeimer retired after 50 years in government service. His departure was called “deeply alarming,” and “abrupt.”[iv] Despite being known as “one of the most quietly effective leaders in public health,”[v] he was reorganized out of his position as senior director for global health security at the National Security Council in 2018. He then worked for USAID until he announced a sudden, swift, and unexpected retirement.[vi]
• BARDA (Biomedical Advanced Research and Development Authority) Director Rick Bright suddenly left his role directing the agency that led countermeasures for a position at NIH[vii] and then left government entirely in October 2020. He became a whistleblower but his warnings about the need for early and strategic actions to prevent a devastating coronavirus pandemic went unheeded. He also stated that treatments such as hydroxychloroquine would be effective to save lives and quell the pandemic in its early days.[viii] (That’s quite a significant claim from the person heading an office funding COVID vaccine research!) BARDA is an office of the Assistant Secretary for Preparedness and Response (ASPR) in HHS. Bright worked under four presidents in different roles at the CDC, NIH, and ASPR. After leaving government, he joined the Rockefeller Institute as Senior Vice President of Pandemic Prevention and Response.[ix]
• The top vaccine experts at the FDA’s Office of Vaccines Research and Review, in CBER, Director Marion Gruber and Deputy Phil Krause, left the FDA in October 2021 and came out publicly against boosters by publishing a viewpoint article in the Lancet against the need.[x] [xi] Their retirements were unexpected and came at a critical time. Marion Gruber had been at the FDA for three decades and had been in charge of oversight of EUA submissions, until the FDA determined a “new plan” to expedite the EUA process and instead put Peter Marks, director of biologics center at the FDA, in charge in July 2021.[xii]
• Janet Woodcock was left in charge of the FDA despite massive opposition to her management of the FDA around the nation’s opioid crisis.[xiii] Despite pushback from lawmakers and advocacy groups, President Biden took 11 months to nominate a replacement: Robert Califf. The confirmation hearings and subsequent time Califf has to divests stocks that would pose a conflict of interest for him put the timing of his taking the helm of the FDA interestingly aligned with COVID policies shifting from pandemic to “new normal.”
• John Mascola, director of NIAID’s vaccine research center at NIH and Moderna COVID shot collaborator and advisor for Operation Warp Speed,[xiv] announced his retirement at the end of March 2022.[xv]
• White House COVID-19 Task Force Coordinator Jeff Zeintz and his Deputy Natalie Quillen are leaving in April 2022 now that COVID policy is shifting. Ashish Jha, dean of the Brown University School of Public Health will take the post. White House press secretary Jen Psaki said Thursday that the transition reflected the changing circumstances in the pandemic response. “Jeff Zients’ superpower is that he is an operational and managerial guru,” she said, “while Jha is a respected public health communicator.”[xvi]
• Jen Psaki, who joined the White House as press secretary in January 2021 and was critical in conveying the messaging of COVID policy, is also leaving the administration with a tide of others as COVID policy shifts. She was recruited by network news and is in discussions with MSNBC to host a show.[xvii]

We have also seen the White House pushing shots and boosters to “vaccinate America” before there was any evidence of safety or efficacy. Acting FDA Director Janet Woodcock, and CDC Director Rochelle Walensky have completely bypassed or ignored advice from VRBPAC and ACIP – the committees created to advise them on safety, efficacy, and risk-benefit analysis – when it came to key decisions about authorization or recommendations.

• Before the FDA even had data to analyze on boosters, the Biden administration promised Americans free boosters by September 20, 2021.[xviii] The White House pre-purchased millions of shots.[xix] Unfortunately for the administration, when VRBPAC met on September 17, 2021, the group overwhelmingly voted against boosters for all Americans.[xx] Instead, boosters for people 65 years and older were voted to be authorized, along with boosters for those who were “high risk,” at the impromptu prompting of FDA CBER Director Peter Marks, without a definition of what “high risk” meant. When the Advisory Committee on Immunization Practices met, they declined to recommend for all “high risk” people, finding the group so broad as to essentially encompass anyone. CDC Director Rochelle Walensky overruled their decision to recommend boosters for 18+ who were “high risk” due to occupational or community exposure.[xxi]
• FDA subsequently left VRBPAC out of the decision to expand Pfizer’s EUA for COVID shots to the 12–15-year-old age group, in May 2021.[xxii] This decision left a sour taste for many in the public. When the next decision to expand the EUA to younger ages 5-11 came around in October 2021, VRBPAC was included. But although members doubted the safety or efficacy of a COVID shot for kids 5-11, they still voted to expand EUA authorization to that age group.[xxiii]
• VRBPAC was not consulted when the FDA chose to expand Pfizer’s EUA to include boosters for kids ages 16+ in December 2021, and then kids 12+ in January 2022. This is not surprising given their first vote on boosters, and a quote from one panel member, Dr. Paul Offit, after the rejection of boosters for all adults that he “would really have trouble supporting [boosters] for anyone of greater than or equal to 16.”[xxiv]
• In February 2022, the White House asked Pfizer to submit a rolling EUA application for the COVID shot for our youngest kids, ages 6 months to 4 years old, without having adequate data. After a huge outcry, including doubts from VRBPAC that there would be enough data to make a decision, Pfizer announced it needed more time and the decision was delayed.[xxv]
• In April 2022, the FDA authorized second COVID boosters for adults 50 years and older — some immunocompromised – without any input from VRBPAC.[xxvi] As the Wall Street Journal reported, “Some of the agency’s own experts disagree with the decision, but the agency simply ignored that.”[xxvii] The same day, the CDC recommended the same, without any input from its advisory committee, ACIP.[xxviii]

Also of note, the CFOs for Pfizer and Moderna both announced their retirements in April 2022 and were replaced by their respective companies on the same day.[xxix]

How can parents trust the recommendation of an administration when they ignore all advice and warnings against their agenda to vaccinate America?

Here is what we see when we follow the science: (hat tip to Dr. Toby Rogers on Substack—check out his page for links to the science!)

1. There is no emergency for kids under 5.
2. The COVID shots do not work well in kids under 5.
3. Harms from COVID shots are catastrophic in kids!

It is time for us to take back the narrative about the COVID shots for kids. Urge your governor to tell the public health department to follow Florida’s lead and stop accepting the CDC and FDA lies about safety and efficacy of the COVID shots for kids.

[i] https://www.reuters.com/world/europe/sweden-decides-against-recommending-COVID-vaccines-kids-aged-5-12-2022-01-27/

[ii] https://web.archive.org/web/20210621183016/https://www.who.int/emergencies/diseases/novel-coronavirus-2019/COVID-19-vaccines/advice

[iii] https://www.valleyrecord.com/northwest/health-board-decides-against-COVID-vaccine-requirement-for-students/

[iv] https://www.huffpost.com/entry/tim-ziemer-global-health-security-leaves_n_5af37dfbe4b0859d11d02290

[v] https://www.nytimes.com/2014/10/21/science/a-quiet-approach-to-bringing-down-malaria.html?_r=0

[vi] https://www.politico.com/news/2020/05/05/top-pandemic-expert-leaves-trump-administration-237612

[vii] https://xconomy.com/national/2020/04/21/barda-director-rick-bright-moves-to-nih-to-head-COVID-19-testing-rd/

[viii] https://www.biospace.com/article/rick-bright-trump-admin-vaccine-expert-and-whistleblower-resigns/

[ix] https://www.rockefellerfoundation.org/profile/dr-rick-bright/

[x] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(21)02046-8/fulltext

[xi] https://endpts.com/breaking-in-a-major-blow-to-vaccine-efforts-senior-fda-leaders-stepping-down-report/

[xii] https://www.statnews.com/2021/07/30/fda-under-pressure-plans-sprint-to-accelerate-review-of-pfizers-COVID-19-vaccine-for-full-approval/

[xiii] https://www.theguardian.com/us-news/2021/jan/28/fda-janet-woodcock-opioids-biden

[xiv] https://www.wired.com/story/the-nihs-top-vaccine-maker-wants-warp-speed-to-be-the-new-normal/

[xv] fiercebiotech.com/biotech/john-mascola-director-niaids-vaccine-research-center-resign-end-march

[xvi] https://www.everythinglubbock.com/news/health/coronavirus/biden-COVID-coordinators-leaving-in-april-jha-to-take-over/

[xvii] https://www.axios.com/jen-psaki-leaving-white-house-msnbc-a75bdbc6-4c6b-43f9-b406-e104ea3b88e9.html

[xviii] https://www.whitehouse.gov/briefing-room/statements-releases/2021/08/18/fact-sheet-president-biden-to-announce-new-actions-to-protect-americans-from-COVID-19-and-help-state-and-local-leaders-fight-the-virus/

[xix] https://www.whitehouse.gov/briefing-room/speeches-remarks/2021/08/18/remarks-by-president-biden-on-fighting-the-COVID-19-pandemic-2/

[xx] https://www.msn.com/en-us/health/medical/tensions-rise-as-fda-advisory-panel-weighs-evidence-on-pfizer-booster/ar-AAOyEf9

[xxi] https://www.statnews.com/2021/10/07/cdc-director-defends-decision-to-overrule-expert-panel-on-COVID-booster-shots-for-health-workers/

[xxii] https://www.raps.org/news-and-articles/news-articles/2021/5/vrbpac-to-meet-next-month-on-COVID-vaccines-in-chi

[xxiii] https://www.youtube.com/watch?v=laaL0_xKmmA&t=26398s

[xxiv] https://www.msn.com/en-us/health/medical/tensions-rise-as-fda-advisory-panel-weighs-evidence-on-pfizer-booster/ar-AAOyEf9

[xxv] https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-provide-update-rolling-submission

[xxvi] https://www.fda.gov/news-events/press-announcements/coronavirus-COVID-19-update-fda-authorizes-second-booster-dose-two-COVID-19-vaccines-older-and

[xxvii] https://www.wsj.com/articles/fda-shuts-out-its-own-experts-in-authorizing-another-booster-COVID-vaccine-pandemic-science-11649016728?mod=Searchresults_pos1&page=1

[xxviii] https://www.cdc.gov/media/releases/2022/s0328-COVID-19-boosters.html

[xxix] https://endpts.com/hours-after-pfizer-moderna-names-its-own-new-cfo-with-dental-healthcare-and-auto-chops/