Dear Subscriber,
I am coming to the belief that what our world/planet is going through is diabolical spiritual warfare. I am sticking my neck out here, but that is the only way I can make any sense out of COVID, the ripping apart of the fabric of society over sex. I seem to recall that other civilizations lost to history were ripped apart by authoritarianism, religion, sex and more. I recently saw a video by one Jonathan Cahn who brings forth the historical dark spirit forces which are bespoken of in the Bible and ancient pagan civilizations. His book is called Return of the Gods. Well, the gods he discusses are spirits of evil, and he connects dots with names, words, root words, names of months, gods, cults, practices, and more of ancient antiquity to the seeming craziness we have faced in the past 2 years from the sexual madness of mutilating children, to child trafficking, pedophilia, and more. Well, without getting into the dark, dark spirituality of the former, we have all lived through an exemplar of evil with COVID, the lives, the beguiling, and the sacrifice of the lives on tens of thousands of us in our nation alone.
I have a concrete example for you right in my own field – the mass madness over the COVID vaccine which, like a hot knife in butter, ripped through our society. Our leaders and media prevailed in terrorizing our society between the vaccinated and not vaccinated. That has happened in our schools in the past decade, but now it morphed into the entire adult population. The unvaxxed were blamed for the pandemic. “Pandemic of the unvaccinated”. Many unvaccinated were forbidden to visit their vaccinated parents, children, or grandchildren. The guidelines came right from the highest realms of government and world leaders. You could not enter a theater, board a plane, enter a building, etc, without your vaccine card, as if that was evidence that you made the world safer with your vax.
Well, today I received a copy of a letter sent by the FDA to an organization that sought to get the FDA to come clean on product labeling. Here is the first page of the FDA response which details the requested “truth in advertising:
RE: Citizen Petition (Docket Number: FDA-2023-P-0360)
Dear CAALM:
This letter responds to the citizen petition (the Petition) dated January 31, 2023 that you (Petitioner) submitted to the Food and Drug Administration (FDA, the Agency, we) requesting that FDA “require that the sponsors of Comirnaty, Spikevax, Pfizer-BioNTech COVID-19 Vaccine, and Moderna COVID-19 Vaccine (collectively, ‘Pfizer and Moderna COVID-19 vaccines’) amend current product labeling”1 “for all authorized or approved indications and populations”2 to:
“1. Add language clarifying that phase III trials were not designed to determine and failed to provide substantial evidence of vaccine efficacy against SARS-CoV-2 transmission or death.
2. Add language clarifying that the immunobridging surrogate endpoint used in multiple authorized indications has not been validated to predict clinical efficacy.
3. Add safety and efficacy results data from manufacturer randomized trials of current bivalent boosters that reported results after EUA was granted.
4. Add a clear statement that FDA authorized a new Pfizer vaccine formulation containing Tris buffer without requiring clinical studies to evaluate efficacy, safety or bioequivalence to the formulation containing phosphate buffer.
5. Add a clear statement disclosing that a Pfizer phase III randomized trial in pregnant women (NCT04754594) was completed as of July 2022 but there have been no results reported.
6. Add a clear statement that Pfizer vaccine efficacy wanes after 2 months following dose 2 according to the Pfizer phase III randomized trial.
7. The following adverse event types should be added to the Adverse Reactions section of labeling:
a. multisystem inflammatory syndrome (MIS) in children; b. pulmonary embolism;
Now I want you to read the most important lines in the 33-page FDA reply. I have bolded the key information for your convenience:
“””It is important to note that FDA’s authorization and licensure standards for vaccines do not require demonstration of the prevention of infection or transmission. A vaccine can meet the licensure standard if the vaccine’s benefits of protecting against disease outweigh the vaccine’s risks for the licensed use. There is no requirement that the vaccine also prevents infection with the pathogen that can cause the disease or transmission of that pathogen to others.48 Similarly, a vaccine can meet the EUA standard without any evidence that the vaccine prevents infection or transmission. To that end, there is no requirement that the clinical trials supporting a vaccine’s licensure or authorization be designed to determine whether the vaccine prevents infection of a pathogen or transmission of that pathogen to others. In addition, with respect to the discussion of clinical studies in prescription drug section of labeling must discuss those clinical studies that facilitate an understanding of how to use the drug safely and effectively.49 50
After undergoing a rigorous and comprehensive scientific and regulatory process to demonstrate that the relevant statutory and regulatory requirements are satisfied, the Pfizer and Moderna COVID-19 vaccines have been licensed or authorized for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2. This is directly stated in the relevant labeling for each product – in the Indications and Usage section of the Prescribing Information for the approved products, and on the first page of the healthcare provider and recipient Fact Sheets for the authorized products.51 The vaccines are not licensed or authorized for prevention of infection with the SARS-Co-V-2 virus or for prevention of transmission of the virus, nor were the clinical trials supporting the approvals and authorizations designed to assess whether the vaccines prevent infection or transmission of the virus. In the clinical trials supporting the initial authorization of the vaccines, the primary efficacy endpoint was incidence of COVID-19, i.e. incidence of the disease caused by the SARS-CoV-2 virus. Specifically, for the Pfizer-BioNTech COVID-19 Vaccine, the primary efficacy endpoint was incidence of COVID-19 among participants without evidence of SARS-CoV-2 infection before or during the 2-dose vaccination regimen,52 and for the Moderna COVID-19 Vaccine the primary efficacy endpoint was the reduction of incidence of COVID-19 among participants without evidence of SARS-CoV-2 infection before the first dose of vaccine in the period after 14 days post-dose 2.53
These studies are accurately described in the authorized and approved labeling for the Pfizer and Moderna COVID-19 vaccines. For example, Table 24 in the most current Fact Sheet for healthcare providers administering the Pfizer-BioNTech COVID-19 Vaccine, Bivalent54 presents this vaccine efficacy information, describing data about the first COVID-19 occurrence from 7 days after dose 2. As another example, Table 3 in the Spikevax Prescribing Information presents efficacy of the vaccine against COVID-19 in participants 18 years of age and older starting 14 days after dose 2.
The Petition’s assertion that there is a “widespread (but inaccurate) notion that efficacy against infection and transmission have been established by substantial evidence” is supported only by references to selected statements by U.S government officials suggesting that vaccination against COVID-19 may prevent infection or transmission, as well as one statement from Pfizer and one from Moderna. Your Petition also does not account for countervailing statements made by some of these officials. For example, Dr. Fauci has stated that the vaccines were not developed to protect against infection,55 and Dr. Walensky has stated that high viral loads in vaccinated individuals “suggest an increased risk of transmission[.]”56 In responding to your Petition, we are not agreeing or disagreeing with any of the statements that are selected in the Petition. Rather, we are observing that the statements referenced by the Petition do not demonstrate a commonly held belief that the clinical trials provided substantial evidence of efficacy against SARS-CoV-2 transmission. We are not convinced that there is any widespread misconception about this.””
45 https://www.fda.gov/media/153409/download#page=16
46 http://web.archive.org/web/20230107040800/https:/www.makeityourvaccine.com/faqs.
47 The Petition also points to the Warnings and Precautions section of the Tamiflu labeling, which includes a statement that: “Serious bacterial infections may begin with influenza-like symptoms or may coexist with or occur as complications during the course of influenza. TAMIFLU has not been shown to prevent such complications.” However, the Petition has not demonstrated that the considerations that led to this statement being added to the Tamiflu labeling are applicable to the labeling for the Pfizer and Moderna COVID-19 vaccines. Just because a “has not been shown” statement is included in the Tamiflu labeling does not mean that such a statement must be added to the labeling for the Pfizer and Moderna COVID-19 vaccines.
48 We note that a vaccine does not need to be 100% effective in preventing the target disease in order to meet the licensure standard. It is expected that some vaccinated individuals will contract the target disease despite having been vaccinated against it. No FDA licensed or authorized vaccine is 100% effective in preventing disease, but scientific data has nevertheless demonstrated that vaccinations have been a very effective approach to protecting the public's health in the U.S. (See FDA, Vaccine Safety Questions and Answers, last updated March 2018, https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/vaccine-safety-questions-and-answers.)
49 21 CFR 201.57(c)(15)).
50 Although the labeling for EUA products is not subject to the regulation in 21 CFR 201.57, the Petition makes the same request and same arguments with respect to the approved labeling and the EUA labeling for these COVID-19 vaccines. Because of this, and because it would be appropriate for this this type of labeling information to be consistent across labeling for these EUA and BLA COVID-19 vaccine products, we evaluate the requested labeling revision to the approved labeling and the EUA labeling for these products under the same analysis.
51 The Package Inserts for the licensed vaccines are available at the following website links: for Spikevax- https://www.fda.gov/media/155675/download, for Comirnaty https://www.fda.gov/media/151707/download, and https://www.fda.gov/media/154834/download. The authorized Fact Sheets are available on FDA’s website for each authorized vaccine.
52 See FDA, Pfizer-BioNTech COVID-19 Vaccine, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum, (Dec. 11, 2020), available at https://www.fda.gov/media/144416/download.
53 FDA, Moderna COVID-19 Vaccine, Emergency Use Authorization (EUA) for an Unapproved Product Review Memorandum, (Dec. 18, 2020), available at https://www.fda.gov/media/144673/download.
54 This fact sheet is entitled, Fact Sheet for Healthcare Providers Administering Vaccine: Emergency Use Authorization of Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5).
55 See Sarah Jacoby, “Early COVID-19 Vaccines May Prevent Symptoms but not the Infection, Dr. Fauci Says,” Self, Oct. 29, 2020, available at https://www.self.com/story/early-covid-19-vaccines-prevent-symptoms (quoting Dr. Fauci as stating ….
56CDC, Statement from CDC Director Rochelle P. Walensky, MD, MPH on Today’s MMWR, (July30,2021), https://www.cdc.gov/media/releases/2021/s0730-mmwr-covid-19.html.
Rowen note: I have good command of the English language, but I must admit, I am mystified by the gobbly-gook of this response. I took the liberty to bold what I thought is most important. There was no requirement that the vaccine prevent infection in the recipient, or, that the vaccine would prevent the recipient from spreading the disease! Hello!!!!!!
Then what is the vaccine for? Am I to presume it is only to moderate the severity of the disease if you contract it? If this is what the end points of the study were for, why did we destroy the economy, destroy business, close schools, destroy family gatherings, church gatherings, travel, and create mass hysteria over the unvaxxed? Why are those going to universities being blacklisted if not vaxxed? Why have so many good people been blacklisted or otherwise been deplatformed on social media? The vaccine is not protecting anyone else! Perhaps the Substack community can help me here.
More than a year ago, I wrote that I saw this event as an EVIL which arrived and took off the mask it was hiding behind, and announcing to us all, “I AM HERE! NOW, WHAT ARE YOU GOING TO DO ABOUT IT?”
Yes, I believe we are in the midst of spiritual warfare, something that was not part of my religious upbringing, but one, that to me, is now clearly evident, and which proves to me the existence of God. And, that we must turn to the Creator for the answers and salvation we seek, rather than continue to permit the evil force to beguile us to the point of us perpetrating the evil on ourselves and on each other. I do suggest Jonathan Kahn’s video or his book for a wider perspective on the widespread spiritual evil in our midst with his connection of dots that is simply amazing.
In response to several requests, I will be writing some materials on ozone therapy for general information, vaccine injury and long haul in the next weeks, which will appear in the Premium section. Thank you for your support!
To Your Excellent Health,
Robert Jay Rowen, MD
PS The FDA denied virtually the entire request for truth in labeling with this conclusion:
“”IV . CONCLUSION
We grant the request regarding describing certain data related to the Pfizer-BioNTech COVID- 19 Vaccine, Bivalent. For the reasons given above, FDA denies all other requests.””
Thank you for featuring our petition and the FDA's response to it. We thought improved and updated labeling for the C-19 injections a reasonable ask. Obviously, the FDA did not. Yes, the FDA's response is a circular, vapid, condescending, and contradictory mess. It is a prime example of both doublethink and newspeak. Orwell paints both as evil. We are looking at ways to respond. This 'conversation' is not yet over. Peace...
So the FDA is saying that their approval will be given for a vaccine that doesn't work in any way. Then why have the FDA? I clearly remember televison ads repeatedly stating that the vaccines will protect you and others and are safe and effective. If that isn't false advertising, I don't know what is.