Urgent call to action! We have 26 days to convince the FDA to reject the Pfizer mRNA shot in kids under 5. Let’s go!!!!!
by Toby Rogers March 22, 2022
On February 10, we achieved a remarkable victory — Pfizer was forced to withdraw its Emergency Use Authorization application to inject kids 6 months to four years old because the data was so terrible. But it was a temporary reprieve. Even though Pfizer’s clinical trials of the genetically modified mRNA shot have already failed twice in this age group, Pfizer is planning to submit another application for Emergency Use Authorization in early April — just under 26 days from now.
This is one of the last battles in this phase of the war. There are 18 million children under five who are potentially impacted by this decision. But Pfizer’s real goal is to achieve permanent liability protection. Currently, Pfizer shots are authorized for emergency use and given liability protection under the PREP Act. Emergency use authorization expires, usually after a year, so Pfizer has to apply for full approval — which is not difficult because they control the FDA. As long as the PREP Act is in force, the Pfizer shot has liability protection as a “covered countermeasure.” But the liability protections under the PREP Act are schedule to expire October 1, 2024. However, if Pfizer can get the mRNA shot added to the childhood vaccine schedule, then it will enjoy permanent liability protection under the 1986 National Childhood Vaccine Injury Act. So that’s what this fight is all about.
We absolutely must find a way to defeat the upcoming Pfizer EUA application in kids 6 months to 4 years old.
So here’s the plan. I and a group of allies are going to put out a call to action once a week from now until the FDA meets to consider this application. Each week we are going to focus on a different pillar of the corrupt system. We need you to dedicate one hour a week to sending out 25 emails, making 25 calls, send 25 letters, or sending 25 faxes. It seems like a big ask until you realize that the alternative is to live under Pharma tyranny for the rest of our lives. The momentum is on our side, the data is on our side, every day more politicians come over to our side, we are the majority, this is our moment, we must embrace our responsibility to stop this insanity.
Many of you have participated in my calls to action before (THANK YOU!!!) What’s new or different about this call to action? I’ve got much better talking points. There is a new FDA Commissioner, Robert Califf, who we need to educate about these matters. We are reaching deeper inside the bureaucracy to educate some of the staffers who write the reports that are part of the evaluation process. And there are several new members of the Vaccines and Related Biological Products Advisory Committee who need to hear from us as well.
Talking Points
Feel free to compose your own message or share your story with the federal officials listed below. Alternatively you can copy and paste these talking points into your message.
Subject line: please REJECT the Pfizer EUA application to inject mRNA into kids 6 months to 4 years old when it returns in April
1. There is no Covid emergency for children under five years old.
Children have a 99.995% recovery rate and a body of medical literature indicates that almost zero healthy children under five years old have died from Covid.
• A large study conducted in Germany showed zero deaths for children under 5 and a case fatality rate of three out of a million in children without comorbidities.
•A Johns Hopkins study monitoring 48,000 children diagnosed with Covid showed a zero mortality rate in children under 18 without comorbidities.
•A study in Nature demonstrated that children under 18 with no comorbidities have virtually no risk of death.
2. The Pfizer mRNA shot does not work very well in kids.
The Pfizer clinical trial in kids 6 months to four years old failed in December 2021 and failed again in February 2022. Adding a third dose is not going to solve the underlying problems with this shot in this age group.
The FDA and CDC claimed that the Pfizer shot was 90% effective in kids 5 to 11. Recently released data show that it was only 12% effective against the Omicron variant. So all of the FDA and CDC risk benefit calculations were wrong.
By contrast, there are more than 1,500 studies in connection with about twenty off-the-shelf medicines that are safe and effective. Prophylaxis and early treatment with these medicines offer a better alternative than risky mRNA shots.
3. The harms from the Pfizer mRNA shot in children are catastrophic.
There are now 43,760 VAERS reports of adverse events in children following Covid shots. These reports likely understate harms by a factor of 41 to 100.
There are troubling reports of fatalities in children following Covid shots:
https://openvaers.com/covid-data/child-reports/1975356
https://openvaers.com/covid-data/child-reports/2109625
https://openvaers.com/covid-data/child-reports/2152560
https://www.icandecide.org/ican_press/report-of-toddlers-death-disappears-from-vaers-and-cdc-has-no-records-as-to-why/
Everyone knows that FDA authorization = CDC adding it to the childhood schedule = liability protection forever = mandates = widespread iatrogenic injury.
You have a professional and moral obligation to reject Pfizer’s EUA application for kids 6 months to 4 years old.
People to contact:
Please reach out and find a way to awaken the moral core of these 25 people:
Rochelle Walensky
Director, Centers for Disease Control and Prevention
Roybal Building 21, Rm 12000
1600 Clifton Rd
Atlanta, GA 30333
phone: (404) 639-7000
Aux7@cdc.gov
https://twitter.com/CDCDirector
Xavier Becerra
Secretary, Health & Human Services
200 Independence Avenue S.W.
Washington, D.C. 20201
c/o Sean McCluskie
sean.mccluskie@hhs.gov
https://twitter.com/XavierBecerra
Robert Califf
FDA Commissioner
Food and Drug Administration
Mail stop: HF-1
10903 New Hampshire Ave.
Silver Spring MD 20993-0002
phone: (301) 796-5400
fax: (301) 847-8752
commissioner@fda.hhs.gov
https://twitter.com/DrCaliff_FDA
Actual office address:
Robert Califf:
FDA Commissioner
Food and Drug Administration
Parklawn Building
12420 Parklawn Drive
Rockville, Maryland, 20852
Ashish K. Jha, MD, MPH
White House Covid Czar
Brown University School of Public Health
121 South Main Street
Providence RI 02903
DeanofPublicHealth@brown.edu
https://twitter.com/ashishkjha
Peter Marks
Director, Center for Biologics Evaluation and Research
FDA, Mail stop: HFM-2
10903 New Hampshire Ave., WO71-7232
Silver Spring MD 20993-0002
phone: (240) 402-8116
fax: (301) 595-1310
Peter.Marks@fda.hhs.gov
Hong Yang
Biologist, FDA/CBER/OBE
Building WO71, Room 5338
Mail stop: HFM-210
Silver Spring MD 20993-0002
phone: (240) 402-8836
fax: (301) 595-1240
Hong.Yang@fda.hhs.gov
Richard Forshee
Associate Director, FDA/CBER/OBE
Building, WO71, Room 5342
Silver Spring MD 20993-0002
phone: (240) 402-8631
fax: (301) 595-1240
Richard.Forshee@fda.hhs.gov
Hui-Lee Wong
Associate Director for Innovation and Development,
Office of Biostatistics and Epidemiology,
Center for Biologics Evaluation and Research
White Oak Building 71, Room 5222
Silver Spring MD 20993-0002
phone: (240) 402-0473
Huilee.Wong@fda.hhs.gov
Leslie Ball
Office of Vaccines Research and Review
Division of Vaccines and Related Products Applications,
Center for Biologics Evaluation and Research
Building WO22, Room 6156
Silver Spring MD 20993-0002
phone: (301) 796-3399
Leslie.Ball@fda.hhs.gov
Doran L. Fink
Deputy Director – Clinical,
Division of Vaccines and Related Products Applications
Office of Vaccines Research and Review, CBER
Mail stop HFM-475
Building WO71, Room 3314
Silver Spring MD 20993-0002
phone: (301) 796-1159
Doran.Fink@fda.hhs.gov
Hana El Sahly, M.D., Chair VRBPAC
Associate Professor
Department of Molecular Virology and Microbiology
Department of Medicine
Section of Infectious Diseases
Baylor College of Medicine
Houston, TX 77030
713-798-2058
hanae@bcm.edu
Paula Annunziato, M.D.
Vice President and Therapeutic Area Head
Vaccines Clinical Research
Merck
North Wales, PA 19454
paula.annunziato@merck.com
Adam C. Berger, Ph.D.
Director, Division of Clinical and Healthcare Research Policy
Office of Science Policy
Office of the Director
National Instituters of Health
6705 Rockledge Drive, Suite 630
Bethesda, MD 20892
(301) 827-9676
adam.berger@nih.gov
Henry H. Bernstein, D.O.
Professor of Pediatrics
Zucker School of Medicine at Hofstra/Northwell
Department of Pediatrics
Cohen Children’s Medical Center
New Hyde Park, NY 11042
phone: (516) 838-6415 (office)
fax: (516) 465-5399
hbernstein@northwell.edu
Captain Amanda Cohn
Chief Medical Officer
National Center for Immunizations and Respiratory Diseases
Centers for Disease Control and Prevention
1600 Clifton Rd
Atlanta, GA 30333 MS C-09
phone: (404) 639-6039
fax: (404) 315-4679
acohn@cdc.gov
anc0@cdc.gov
Holly Janes, Ph.D.
Fred Hutchinson Cancer Research Center •
Vaccine and Infectious Disease Division
1100 Fairview Avenue North,
M2-C200
P.O. Box 19024
Seattle, Washington 98109 U.S.A.
phone: (206) 667.6353
hjanes@fredhutch.org
Hayley Gans, M.D.
Professor of Pediatrics
Department of Pediatrics
Stanford University Medical Center
Stanford, CA 94305
phone: (650) 723-5682
fax: (650) 725-8040
hgans@stanford.edu
David Kim, M.D.
CAPT, U.S. Public Health Services
Office of Infectious Disease and HIV/AIDS Policy
Office of the Assistant Secretary for Health
U.S. Department of Health and Human Services
330 C Street SW, Suite L600
Washington, DC 20024
phone: (202) 795-7636
david.kim@hhs.gov
Arnold Monto, M.D.
Professor Emeritus
Department of Epidemiology
University of Michigan School of Public Health
Ann Arbor, MI 48109
phone: (734) 764-5453
fax: (734) 764-3192
asmonto@umich.edu
Paul Offit, M.D.
Professor of Pediatrics
Division of Infectious Diseases
Abramson Research Building
The Children’s Hospital of Philadelphia
Philadelphia, PA 19104
phone: (215) 590-2020
offit@chop.edu
https://twitter.com/DrPaulOffit
Steven Pergam, M.D.
Medical Director
Infection Prevention
Seattle Cancer Care Alliance
Seattle, WA 98109
phone: (206) 667-7126
spergam@fredhutch.org
https://twitter.com/PergamIC
Jay Portnoy, M.D.
Director, Division of Allergy, Asthma & Immunology
Children’s Mercy Hospitals & Clinics
2401 Gillham Road
Kansas City, MO 64108
phone: (816) 960-8885
fax: (816) 960-8888
Jportnoy@cmh.edu
Eric Rubin, M.D., Ph.D.
Editor-in-Chief
New England Journal of Medicine
Adjunct Professor
Harvard TH Chan School of Public Health
665 Huntington Ave
Building 1, Room 811
Boston, MA 02115
phone: (617) 432-3335
erubin@hsph.harvard.edu
erubin@nejm.org
Andrea Shane, M.D.
Professor of Pediatrics
Emory University School of Medicine
2015 Uppergate Drive NE, Rm. 504A
Atlanta, GA 30322
phone: (404) 727-9880 (direct)
(404) 727-5642 (main)
fax: (404) 727-8249
ashane@emory.edu
Geeta K. Swamy, M.D.
Senior Associate Dean
Vice Chair for Research & Faculty Development
Associate Professor, Department of Obstetrics & Gynecology
Division of Maternal-Fetal Medicine
Duke University
Box 3967 Med Ctr,
Durham, NC 27710
phone: (919) 681-5220
swamy002@mc.duke.edu
Please be respectful and courteous. The fate of our nation is at stake. Let’s GOOOOOOOOO! ?