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.
[i] https://childrenshealthdefense.org/news/vaccine-trial-catastrophe-moderna-vaccine-has-20-serious-injury-rate-in-high-dose-group/🖨️ Print post
DOROTHY FREE says
As much as I want to trust that the new vaccines coming out for Covid-19 are safe and effective, I do not trust the new C-19 vaccines coming out. Under normal circumstances, vaccines take about ten years to test for safety and efficacy. I do not plan to take the vaccine, nor does my family, no matter what the government or government/health departments tell us. The vaccines are a huge risk to every person. The unknowns are infinite. I’d rather get the virus than take the shot. As much as the media and government wants us to fear Covid 19, most of the people dying from it would have died from some other cause, had C 19 not been around. I do not want to be forced or coerced to get a vaccine that has not been tested or held to the usual standards for health and safety. Until the vaccine is guaranteed to be 100% safe and effective, please do not authorize the vaccines and please do not force people to submit to the vaccinations.
No long term studies have been done. What are the changes in the body with this vaccine???
Jan Dederick says
I will not take the covid vaccine, as it has not been tested adequately,
and it utilizes an experimental technology, effectively making us human guinea pigs. The risk of damage by the vaccine is far greater than the risk of contracting covid-19.
MARYANN MILLER says
I am 68 years old and to my knowledge have only had the small pox vaccine and possibly 2 at the most Tetanus shot. I will not take a shot to compromise my immune system. I take Vitamin D3-K, Vitamin C, cod liver oil, and since Covid have been taking Zinc. I have my Vitamin D levels check annually. I faithfully exercise daily.
I have 2 nieces ages 27 and 22 who are autistic and a granddaughter age 10 who is austistic. They have all had the required shots which I highly suspect are autistic due to shots.
I will not take the shot for Covid 19 .
Ellen Rixford says
Under no circumstances will I allow this vaccine to be given to me. It is poison, will have devastating effects, and it is a no- liability Product. I would defend myself to the extent of my ability, leave my home, and do my utmost to prevent this vaccine being given to others. The Covid vaccine is a treasonous act against all citizens. The creators of the Covid hoax are guilty of mass murder, and should go to jail for life.
Pat Howe says
I have two comments. First I want to know why so many people were allowed to die in and by the current health care system when other efficacious methods and treatments are available for infectious diseases. These other paths might have slowed the whole process down, and minimized or prevented suffering and death until issues around the vaccines could be resolved.
Second, I want to see safety studies, which currently have not been done.
As a front line worker, I have a qualified health care professional who helped me design a protocol, (including Weston A. Price nutrition),
Using supplements and a nebulizer to Keep my immune system in good condition.
At present I don’t plan on taking the vaccines.
Thanks for the opportunity to comment.
Isles of toxic, health destroying garbage, aka edible items, fill our supermarkets. You spent tons of money developing vaccines instead of helping farmers produce, clean, healthy foods; and instead of educating the public about health enhancing nutrition. It’s not too late. Change your course: Do not approve the distribution of chemical vaccines that don’t belong in our bodies! Instead support real food production and nutrition curriculum in all schools, K-12 plus colleges and universities.
Martha Crawford says
I am a 75 yr old grandmother with multiple co- morbidies. I have not seen my children in 10 months. I will take the vaccine, since it is my only option to have a normal remainder of my life. It may be a risk, but I am willing to take it. I however feel that no one should be forced to take the vaccine.
Beth Hoxie says
I will not be vaccinated. I follow the Weston Price diet guidelines, take B,C,D,E,K2, zinc,selenium, iodine, have quercitin on hand, use herbs, am prepared to nebulize and insufflate with ozone, and much more. I see Dr Ng (Dr. Brownstein) who set me up with the protocol maybe 15 years ago so when I got it in March, I was prepared to get through it, at 68 years old with treated high blood pressure and being overweight. I would rather die than risk my body to be compromised the rest of my life.
Richard Noegel says
In its statement to the FDA, WAPF might point out that, according to the Universal Declaration of Human Rights and Bioethics ( http://portal.unesco.org/en/ev.php-URL_ID=31058&URL_DO=DO_TOPIC&URL_SECTION=201.html ), dated 19 October 2005, especially Article VI (“Consent”), it is unacceptable to oblige any person to submit to any sort of medical intervention, or to sanction such persons as refuse an “intervention,” including “vaccinations,” and, according to the Declaration, such interventions without consent are violations of human rights–universally.
And although Congress has granted blanket immunity from lawsuits to vaccine manufacturers, there is no such immunity for anybody who might forcibly inject any person without that person’s consent. Therefore, any person who injects another person against that person’s will and without that person’s express, written consent, most certainly can be sued successfully. The “medical community” should be told this immediately and often.
Lauren Ayers says
Since I was “late” I used a different Contact Us form to reach the FDA:
I heard about this issue from a friend and she told me I had until 11:59 pm today. She didn’t happen to mention that YOUR deadline is ll:59 EASTERN TIME.
What possible difference could it make for us in this vast country who do NOT live in YOUR time zone to post our comment by 11:59 OUR time???
That is bias against any American who lives west of the Eastern Time Zone!
Please add my comment to the file, I AM SENDING IT IN ON TIME for my state. It would have been longer, with citations, if the system were fair.
Many professionals who have been questioning the accuracy of the data point to the fact that the total death rate (i.e. deaths from all causes) has not gone up by more than a smidgen. We know that the directives from the CDC and other agencies tell medical personnel to find any possible way to label a death as COVID or COVID-related. Rumor was that a man who died in an accident was labeled a COVID death.
Plus, the COVID tests are notoriously prone to both false negatives and false positives, so often the “diagnosis” is based on the fact that the patient was in the vicinity of someone who had COVID in the past 30 days (although how we know they had COVID is, again, questionable). The unhelpful incentive is there because hospitals actually get $11,000 for COVID cases (and if the patient goes on a ventilator, they get another $22,000).
Our tax dollars (and massively larger national COVID debt) are paying for the research on the tests and the purchase of the masks and other protective gear, and for the vaccines themselves. The vaccine companies have no legal liability for harm or deaths from the vaccines. This adds up to an ideal way to make money, for them. And a sad and terrible way for taxpayers who can’t work to lose savings, jobs, homes, businesses, and education.
Dr. Fauci mentioned that he takes 1000 IU of D and 1 gram of vitamin C every day,  but does he encourage the nation to use these proven, cheap, and safe preventative measure??