The Vaccines and Related Biological Products Advisory Committee is meeting on December 17, 2020 to discuss Emergency Use Authorization (EAU) of the Moderna COVID-19 vaccine in individuals 18 years and older.
The general public has until tomorrow, December 16, 2020 at 11:59 p.m. Eastern Time to submit their comments to the U.S. Food and Drug Administration (FDA). Interested persons may present data, information, or views, orally or in writing.
The odds are that FDA will approve Moderna’s vaccine, since they gave emergency use authorization for Pfizer’s COVID-19 vaccine last week, and both vaccines use messenger RNA (mRNA) technology.
But it’s still important to put people’s objections in front of the agency. Both Pfizer and Moderna’s fast-tracked vaccines are associated with many problems, even in the very short time frame that they have been tested. And there is no way to know if a vaccine is safe unless you wait at least 1 year to monitor side effects of those in who participate in clinical trials – and properly report all the side effects. But that’s not happening with the COVID vaccines.
Please take the time today to submit your public comment to the FDA.
Submit your public comments to the FDA by Wednesday, December 16, 2020 at 11:59 p.m.
Use the FDA’s electronic filing system at
(Note that your comment will be made public if filing electronically.)
Click here for more information and detailed instructions: https://www.fda.gov/advisory-committees/advisory-committee-calendar/vaccines-and-related-biological-products-advisory-committee-december-17-2020-meeting-announcement
Even if you only have time to write a few sentences, that is still helpful! Here are some ideas to help you write your comment:
- If you or a family member have had a vaccine reaction, share that information – they need to be reminded that vaccine injuries are real and happen even with vaccine that have gone through the full normal process (unlike these fast-tracked vaccines!)
- If you or a family member are at higher risk for vaccine reactions (for example, you have an autoimmune condition, allergies, leaky gut, etc.), talk about that issue and point out the need to look at the risks posed to different people, not just approve by age.
- Share the things you are doing to prevent illness, such as a healthy diet, that don’t carry the risks of experimental vaccines.
- You can also look through the document submitted by Moderna and point out the problems you see with approving the vaccine based on this record. The document is posted at Vaccines and Related Biological Products Advisory Committee December 17, 2020 Meeting Briefing Document- Sponsor (fda.gov) (Their claims about safety start at page 56 of the document)
WAPF is submitting comments that cover the following points:
- Vaccine manufacturers claim that Covid-19 vaccines are 95 percent “effective,” but the FDA is allowing companies to define effectiveness as “prevention of mild symptoms.” The studies are not designed to detect a reduction in outcomes such as severe illness, hospitalization or death.1,2 For individuals who develop severe symptoms, the vaccine is not a remedy. Instead, nutritional and oxidative support can help keep the illness from going into “overdrive.”3
- Participants in every Covid-19 vaccine trial have reported adverse reactions including high fever, chills, muscle pains and headaches.4-6 Some have even reported severe reactions that required hospitalization and invasive treatment. According to the FDA, potential long-term effects may include Guillain-Barré syndrome, brain swelling, muscle weakness and paralysis, convulsions and seizures, stroke, narcolepsy, shock, heart attack, autoimmune disease, arthritis and joint pain, multisystem inflammatory syndrome in children, and death.7 Some UK health workers have experienced anaphylactic shock after receiving one dose of Pfizer’s EAU approved vaccine.8
- 20 percent of Moderna’s mRNA-1273 vaccine recipients in the Phase 1 trial high dose cohort suffered Grade 3 Adverse Reactions; Grade 3 reactions, according to the FDA, are serious enough that they prevent daily activity and require medical intervention.[i]
- An FDA Pfizer briefing paper published December 10, 2020 revealed 43 percent more cases of Covid-19 in the vaccinated group than in the placebo group.9
- Covid-19 vaccine manufacturers will be protected from all liability—if you are injured, you cannot sue.10 Manufacturers will have complete indemnity even though all previous attempts at creating coronavirus vaccines caused harm and never advanced to regulatory approval.11
- Dr. Anthony Fauci of the National Institutes of Health acknowledges that the vaccines may prevent symptoms but will not block spread of the virus, so vaccine recipients will still need to wear masks, practice social distancing and avoid crowds.12,13
- According to the CDC’s current best estimate, the “infection fatality rate” (IFR) for Covid-19 is less than 1 percent for people age 69 and younger, including a .003 percent IFR for children and adolescents.14
- Two prominent doctors, including the ex-head of Pfizer’s respiratory research, warn that Covid-19 vaccines contain a spike protein called syncytin-1, vital for the formation of the placenta.15 If the vaccine triggers an immune response to this protein, then female infertility, miscarriage or birth defects could result.
- Doshi P. Will covid-19 vaccines save lives? Current trials aren’t designed to tell us. BMJ. 2020;371:m4037. https://www.bmj.com/content/371/bmj.m4037.
- Haseltine WA. Covid-19 vaccine protocols reveal that trials are designed to succeed. Forbes, September 23, 2020. https://www.forbes.com/sites/williamhaseltine/2020/09/23/covid-19-vaccine-protocols-reveal-that-trials-are-designed-to-succeed/?sh=5da0663d5247.
- Brownstein D, Ng R, Rowen R et al. A novel approach to treating COVID-19 using nutritional and oxidative therapies. Science, Public Health Policy, and the Law. 2020;2:4-22. https://ozonewithoutborders.ngo/wp-content/uploads/2020/07/Novel-Approach-to-Covid-19.pdfUS COVID-19 VAC EUA FDA PUBLIC COMMENT.doc.
- Jackson LA, Anderson EJ, Rouphael NG et al. An mRNA vaccine against SARS-CoV-2 – preliminary report. New England Journal of Medicine. 2020;383(20):1920-1931. https://www.nejm.org/doi/full/10.1056/NEJMoa2022483.
- Allen A, Szabo L. NIH “very concerned” about serious side effect in coronavirus vaccine trial. Scientific American, September 15, 2020. https://www.scientificamerican.com/article/nih-very-concerned-about-serious-side-effect-in-coronavirus-vaccine-trial/.
- Mayer A. Leading COVID vaccine candidates plagued by safety concerns. The Defender, November 13, 2020. https://childrenshealthdefense.org/defender/covid-vaccine-candidates-safety-concerns/?itm_term=home. .
- U.S. Food and Drug Administration. Vaccines and Related Biological Products Advisory Committee, October 22, 2020 Meeting Presentation, slide #16. https://www.greenmedinfo.com/blog/covid-19-vaccine-bombshell-fda-documents-reveal-death-21-serious-conditions-possi1.
- Reals T. U.K. warns against giving Pfizer vaccine to people prone to severe allergic reactions. CBS News, December 9, 2020. https://www.cbsnews.com/amp/news/covid-vaccine-pfizer-shot-uk-warning-people-with-history-of-significant-allergic-reactions/#app.
- https://www.fda.gov/media/144245/download, page 42.
- Public Readiness and Emergency Preparedness Act. COVID-19 PREP Act Declarations. https://www.phe.gov/Preparedness/legal/prepact/Pages/default.aspx.
- Lyons-Weiler J. Pathogenic priming likely contributes to serious and critical illness and mortality in COVID-19 via autoimmunity. Journal of Translational Autoimmunity. 2020;3:100051. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7142689/.
- Khemlani A. Fauci: Early COVID-19 vaccines will only prevent symptoms, not block the virus. Yahoo! Finance, October 26, 2020. https://finance.yahoo.com/news/fauci-vaccines-will-only-prevent-symptoms-not-block-the-virus-195051568.html.
- Scipioni J. Dr. Fauci says masks, social distancing will still be needed after a Covid-19 vaccine—here’s why. CNBC, November 16, 2020. https://www.cnbc.com/2020/11/16/fauci-why-still-need-masks-social-distancing-after-covid-19-vaccine.html.
- Centers for Disease Control and Prevention. COVID-19 pandemic planning scenarios. Updated September 10, 2020. https://www.cdc.gov/coronavirus/2019-ncov/hcp/planning-scenarios.html.
- Petition/motion for administrative/regulatory action regarding confirmation of efficacy end points and use of data in connection with the following clinical trials. Dr. Wolfgang Wodarg and Dr. Michael Yeadon, petitioners. Filed with European Medicines Agency, December 1, 2020. https://healthimpactnews.com/wp-content/uploads/sites/2/2020/12/Wodarg_Yeadon_EMA_Petition_Pfizer_Trial_FINAL_01DEC2020_EN_unsigned_with_Exhibits.pdf.
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