Urgent Call to Action: FDA announces FOUR meetings in June to push through Novavax in adults, Moderna in kids 0-17, and Pfizer in kids under 5

The blitzkrieg culminates with a "Future Framework" that will automatically deem all reformulated Covid-19 shots as "safe and effective" WITHOUT further clinical trials. The FDA must be stopped!

[Updated May 25, 2022]

I. FDA goes full Shock & Awe in the attempt to get several toxic shots authorized in quick succession

The FDA is going to hold FOUR meetings of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) in June. FOUR! The schedule is as follows:

June 7, Novavax in adults 
June 14, Moderna in adolescents (delayed for a year because of myocarditis concerns)
June 15, Moderna in kids <6, Pfizer in kids <5
June 28, “Future Framework” for Covid-19 shots

This is very troubling. It means that the FDA is shifting into Shock & Awe military strategy to try to push through five authorizations in quick succession — so that the public does not have time to think and react. This is not the proper way to do science, it is an attack on democracy, and if they succeed, the FDA will kill and injure millions of American for years to come.

Let’s talk about what we know about each of these shots and then talk about what we can do to stop the FDA from destroying our country.

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II. Novavax is useless and terrible

Novavax is a protein subunit vaccine. Fellow Substacker Robyn Chuter has done the best deep dive that I’ve seen on Novavax:

Novavax - hope or hype?

Robyn reviewed 3 Novavax clinical trials and the results are always terrible:

• No reductions in hospitalizations.
• No reductions in deaths.
• Tiny absolute risk reduction for a couple months (and then, after six months, the control group gets injected too so there is no long term data).
• Significant risk of adverse events in the vaccinated group.

This is not a surprise. The SARS-CoV-2 virus was never a good candidate for a vaccine (in the same way that HIV and the common cold have never had a successful vaccine in spite of decades of efforts). Recombinant proteins are not safer nor more effective than mRNA — they just fails in different ways. Novavax also uses a proprietary new adjuvant, “Matrix M”, that is not well studied.

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III. Moderna mRNA shots in adolescents and kids are useless and terrible

A few days ago, I did a deep dive into the problems with the Moderna mRNA shot in kids. To summarize briefly:

• The Moderna application to inject adolescents has been held up since June 2021, because the Moderna shot increases the risk of myocarditis.

• Finland, Sweden, Denmark, and Norway have all suspended the use of the Moderna mRNA shot in teenagers because it leads to myocarditis. Finland and Sweden even suspended its use in men under 30 years old.

• We have no data from the Moderna clinical trial in kids younger than 12 other than selective leaks to the NY Times. But we know that even with Moderna rigging the trials, the shot made no difference on clinically significant outcomes including infection, hospitalization, ICU visits, or death.

However the Moderna shot did cause fevers in 15% to 17% of kids and fevers over 104 degrees in 0.2% of kids (which, if you multiply that by the 18 million kids they want to inject = 36,000 kids with potentially permanent neurological injury from a shot that provides no benefit).

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IV. Pfizer mRNA shots in kids under 5 are useless and terrible

I’ve done several articles on the dangers of Pfizer mRNA shots in kids under 5. To summarize briefly:

• There is no Covid emergency for children under five years old. The CDC’s own research shows that 74.2% of kids 0-11 already had natural immunity. That was as of February 2022 — by now the number is probably closer to 100%.

• 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. A study by the NY State Department of Health shows that against the Omicron variant, after one month the Pfizer shot was only 12% effective in kids 5 to 11. After 6 weeks, vaccine effectiveness was a shocking MINUS 41% (vaccinated children were significantly more likely to catch Covid than the unvaccinated).

• The harms from the Pfizer mRNA shot in children are catastrophic. There are now 47,736 VAERS reports of adverse events in children following Covid-19 shots. These reports likely understate harms by a factor of 41 to 100. There are numerous reports of fatalities in children following Covid-19 shots (including reports that mysteriously disappear).

For those who want more details, Michael Palmer, MD; Sucharit Bhakdi, MD; and Wolfgang Wodarg, MD produced a 50 page guide, “On the use of the Pfizer and the Moderna COVID-19 mRNA vaccines in children and adolescents.”

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V. The FDA’s proposed “Future Framework” for Covid-19 Vaccines is the worst idea in the history of public health

The “Future Framework” is how the FDA plans to rig the process in perpetuity. The “Future Framework” will take the" “flu strain selection process” that is used every year — and apply it to future (reformulated) Covid-19 shots.

Manufacturers love this because then all future Covid-19 shots will be deemed automatically “safe and effective” WITHOUT FURTHER CLINICAL TRIALS because they are “biologically similar” to existing Covid-19 shots.

This approach does not work with the flu shot (last year the flu shot was somewhere between 0% and 14% effective) and it will not work with Covid-19 shots either.

Moderna is already signaling that they want to manufacture a Covid-19 shot with Wuhan and Beta strains — even though neither strain is still in widespread circulation.

If the “Future Framework” is approved, there will be no future clinical trial data submitted to the FDA in connection with Covid-19 shots in perpetuity. 

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VI. What is to be done. Talking points.

Sharing your own story is always powerful. Or if you wish you can copy and paste these:

1. The FDA must revoke the existing authorizations for Moderna, Pfizer, and J&J Covid-19 shots and withdraw them from the market immediately. SARS-CoV-2 was never a good candidate for a vaccine. These shots do not stop infection, transmission, hospitalization, nor death. They appear to have negative efficacy and are driving the evolution of variants that evade vaccines. The pandemic will never stop as long as the FDA and CDC are promoting shots that lack sterilizing immunity.

2. The FDA and CDC must pivot to therapeutics. This was always the answer. The CDC’s own research showed that chloroquine is safe and effective for prophylaxis and early treatment of SARS coronaviruses (hydroxychloroquine is even safer than chloroquine). The best frontline doctors have found that ivermectin is a life saver if used early. About twenty off-the-shelf treatments are more effective than vaccines. Get these safe and effective medicines to people who need them and let doctors be doctors again and treat patients based on their own best clinical judgment.

3. Vaccine safety assessments must be based on actual science. That means:
• Large (50,000+ person) double blind randomized controlled trials with inert saline placebos conducted by an independent third party.
• Safety and efficacy studies for two years prior to any application followed by 20 years of follow up (with the control group intact).
• Greater than 90% efficacy with less than 1% Grade 3 Adverse Events.
• Proper monitoring for carcinogenesis, mutagenesis, and impairment of fertility.

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VII. What is to be done. Whom to contact:

Please reach out and find a way to awaken the moral core of these 36 people:

You can use the talking points from above or share your own story and insights.

Political appointees:

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

Ashish K. Jha, MD, MPH
COVID-19 Response Coordinator
The White House
1600 Pennsylvania Avenue, N.W.
Washington, DC 20500
DeanofPublicHealth@brown.edu
https://twitter.com/AshishKJha46

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

FDA staff:

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

VRBPAC Members:

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

Temporary VRBPAC members (but their votes count just the same):

A. Oveta Fuller, Ph.D.
Associate Professor of Microbiology and Immunology,
University of Michigan Medical School
Ann Arbor, MI 48109
phone: (734) 647-3830
fullerao@umich.edu

Randy Hawkins, M.D.
Charles Drew University
1731 E. 120th St.
Los Angeles, CA 90059
(323) 563-4800
RandyHawkins@cdrewu.edu

James Hildreth, Sr., Ph.D., M.D.
Professor
Department of Internal Medicine
School of Medicine
President and Chief Executive Officer
Meharry Medical College
Nashville, TN 37205
officeofthepresident@mmc.edu

Jeannette Lee, Ph.D.
Professor Department of Biostatistics
University of Arkansas for Medical Sciences
Little Rock, AR 72701
phone: (501) 526-6712
JYLee@uams.edu

Ofer Levy, M.D., Ph.D.
Staff Physician & Principal Investigator
Director, Precision Vaccines Program
Division of Infectious Diseases
Boston Children’s Hospital
Professor,
Harvard Medical School Associate Member
phone: (617) 919-2900
fax: (617) 730-0254
ofer.levy@childrens.harvard.edu

Wayne Marasco
Dana-Farber Cancer Institute
450 Brookline Avenue
Jimmy Fund 824
Boston, MA 02215
Phone: (617) 632-2153
fax: (617) 632-3889
wayne_marasco@dfci.harvard.edu

H. Cody Meissner, M.D.
Professor of Pediatrics
Tufts University School of Medicine
Director, Pediatric Infectious Disease
Tufts Medical Center
Boston, MA 02111
phone: (617) 636-5227
fax: (617) 636-4300
cmeissner@tuftsmedicalcenter.org

Michael Nelson, M.D., Ph.D.
Professor of Medicine
Asthma, Allergy and Immunology Division
UVA Division of Asthma, Allergy & Immunology
PO Box 801355
Charlottesville, VA 22908
phone: (434) 297-8399
fax: (434) 924-5779
mrn8d@virginia.edu

Stanley Perlman, M.D., Ph.D.
Professor of Pediatrics
University of Iowa
3-712 Bowen Science Building (BSB)
51 Newton Rd
Iowa City, IA 52242
phone: (319) 335-8549
stanley-perlman@uiowa.edu

Mark Sawyer, M.D.
Professor of Clinical Pediatrics
8110 Birmingham Way
Bldg. 28, 1st Floor
San Diego, CA 92123
phone: (858) 966-7785
fax: (858) 966-8658
mhsawyer@ucsd.edu

Melinda Wharton, M.D., MPH
Associate Director for Vaccine Policy
National Center for Immunization and Respiratory Diseases,
Centers for Disease Control and Prevention,
1600 Clifton Road, Mailstop E05,
Atlanta, GA 30333
phone: (404) 639.8755
fax: (404) 639.8626
mew2@cdc.gov

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I know that we’re all weary. We’ve been battling Pharma fascism for the last two years and battling against the FDA every day for the last few months. I imagine it’ll take about an hour to call or write to all 36 people on this list. It’s a heavy lift. But that’s the price of liberty. This is what it’s going to take to save our Republic. So let’s fire up our computers and get out our phones and generate the largest response in the history of the movement. Let’s make history together! 🙌

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Blessings to the warriors! 🙌

Prayers for everyone working to build a better world free of Pharma tyranny. 🙏

In the comments, please let me know how you go with contacting these people and if I need to make any corrections.

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