Thank you Dr. Malone for this revealing photo.
I’ve been doing a deep dive into the FDA approval of the Pfizer BioNTech “vaccine” and have some important information to share that you might be unaware of. It appears that the public health agencies have done a bit of a bait and switch on us. Most people believe that the Pfizer vaccine has in fact been fully approved for Covid but it appears that the approval went to their EU based vaccine called Comirnaty. The Pfizer BioNTech injection, which is the only Pfizer vaccine that is available in the U.S., is still under EUA. Despite the fact that they state that the material inside the vials are identical, they hold legal differences.
The confusion stems from this section of the FDA's Comirnaty Vaccine Information for Recipients and Caregivers sheet:
"[1] The licensed vaccine has the same formulation as the EUA-authorized vaccine and the products can be used interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns. The products are legally distinct with certain differences that do not impact safety or effectiveness."
I find this extremely disturbing. Why do you suppose after over year, the FDA has failed to fully approve their U.S. distributed BioNTech “vaccine”? No one is even asking that question because we’ve all been led to believe that the vaccine was in fact FDA approved. The same applies to the jabs that they’re giving to children, which is still operating under an EUA. Remember, an emergency use authorization is available during an “emergency”, before sufficient safety and efficacy data can be determined.
“The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against chemical, biological, radiological, and nuclear (CBRN) threats including infectious diseases, by facilitating the availability and use of medical countermeasures (MCMs) needed during public health emergencies.
Under section 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), when the Secretary of HHS declares that an emergency use authorization is appropriate, FDA may authorize unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when certain criteria are met, including there are no adequate, approved, and available alternatives. The HHS declaration to support such use must be based on one of four types of determinations of threats or potential threats by the Secretary of HHS, Homeland Security, or Defense.”
When I googled “is the Pfizer BioNTech vaccine FDA approved”, here’s what I got:
“FDA has now granted full approval for Pfizer-BioNTech (COMIRNATY) COVID-19 Vaccineexternal icon for people aged 16 years and older and for Moderna (Spikevax) COVID-19 Vaccine for people ages 18 years and older. Before granting approval, FDA reviewed evidence that built on the data and information submitted to support the EUA. This included preclinical and clinical trial data and information, as well as details of the manufacturing process, vaccine testing results to ensure vaccine quality, and inspections of the sites where the vaccine is made. These vaccines were found to meet the high standards for safety, effectiveness, and manufacturing quality FDA requires of an approved product.”
Here’s what we know. The use of an EUA is appropriate when there’s an “emergency”. Today however, there is NO emergency regarding Covid-19, which has become endemic. Dr. Fauci went on record to state that the U.S. is “out of the pandemic phase” of Covid. Regarding children however, there has never been an emergency for healthy children, who have less than a .01% chance of death from Covid. We also know that there are safe, effective, evidence based FDA approved medicines, which can legally be used off-label, to prevent and treat Covid-19. We saw direct evidence of this in Uttar Pradesh, India, where they successfully eradicated the Delta variant from their region within 2 months last spring, after the mass delivery of “home health kits”. which included 12 mg. of ivermectin. With a population of over 230 million people, this observational trial cannot be ignored. Today, over 81 international trials on ivermectin have been completed, the vast majority of which showing significantly positive outcomes for all phases of Covid. This is no longer even debatable.
Now I’m no attorney but it seems to me that our public health agencies, the FDA, the CDC, HHS and the NIH are deliberately participating in medical/scientific fraud. What we can do about it however, remains to be seen. There are numerous legal actions that have been initiated which include the WHO. They refused to confirm the presence of ivermectin in the home medicine kits that they helped to distribute. The contents of those medicine kits should have been disseminated to every country around the world but thanks to the WHO, that didn’t happen. The Bar Association of India has sanctioned them for their interference in this matter and subsequently charged them with Crimes Against Humanity.
An area of concern that hasn’t received sufficient attention relates to the safety of these spikeshots. When looking into their safety monitoring system, here’s what I got from the CDC website:
“Hundreds of millions of people in the United States have safely received Covid-19 vaccinations. These vaccines have undergone the most intensive safety monitoring in U.S. history that includes both established and new safety monitoring systems. Results from monitoring show that while some people don’t have side effects after getting a COVID-19 vaccine, many people have mild side effects, like pain or swelling at the injection site, headache, chills, or fever. These reactions are normal signs that your body is building protection. COVID-19 vaccines are effective at protecting you from getting sick. CDC recommends everyone ages 5 years and older get a COVID-19 vaccination as soon as possible.”
If only that were true. So the CDC doesn’t think that over 1 million adverse effects are meaningful AND they believe these dangerous spikeshots are “effective at protecting you from getting sick.” We KNOW that these vaccines do NOT prevent infection OR transmission of Covid.
The good news is that many states are finally waking up to the truth. Many bills are working their way through state boards that are allowing the use of ivermectin to treat Covid-19. Perhaps the best news yet is that the state of Tennessee has passed a law that allows ivermectin to be purchased without a prescription at local pharmacies. How about that my friends! Amazing things can happen. We saw in New York, Attorney General Lattica James walked back her initial position on preventing any physician from even prescribing ivermectin for Covid, to a determination that New York State would NOT interfere in the doctor/patient relationship, thus allowing NY State licensed physicians to prescribe ivermectin for Covid-19. Did I somehow miss seeing that story in the N.Y Times? Perhaps they didn’t think this news was “fit to print”!
A recent article in Trial Site News has revealed an extremely disturbing report. They have done a remarkable job over the last 2 years, shining a light on what our public health agencies have been doing to interfere in the treatment of Covid-19.
“The U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) ‘altered’ COVID-19 guidance in response to political pressure and in fact, reports are out that the one-time trustworthy apex federal health agencies ‘suppressed’ findings associated with SARS-CoV-2 in a new bombshell report associated with investigators from the Government Accountability Office (GAO). Apparently, GAO investigators probed for such actions conducting a series of interviews with managers and higher-up officials employed with the agencies. Now, evidence mounts for what Trial Site News has been reporting on for a couple of years now: ‘political interference’ associated with scientific reports and possibly even tampered with study results to skew or bias the results.” You can review their exposee here.
Where do we go from here? I wish I had answers for that. I know that the brave physicians at the FLCCC continue to fight the good fight, traveling around the country and the world, giving talks, participating in round table discussions, doing everything imaginable to get the truth out. No one needs to die any longer from Covid. With safe, effective, evidence based treatments, started at the initial signs of infection, Omicron will cause a day or two of a cold. We all should be celebrating the end of this 2 year nightmare but unfortunately, we’re still having to fight the good fight. If you’ve got any great ideas or strategies, or know someone personally in MSM, please share that information with me so I can be sure that the science and information gets to trusted physicians who can pursue creative solutions.
> Why do you suppose after a year+, the FDA has failed to fully approve their U.S. distributed BioNTech “vaccine”?
Because Pfizer doesn't the liability of a "fully approved" vaccine that doesn't have the liability protection afforded by the National Childhood Vaccine Injury Act fo 1986.
Those of us who've been paying attention have known about the "legally distinct" deception since last August, when Comirnaty was "fully approved".
First, I found out, Pfizer is waiting with Comirnaty for Pfizer shot to be approved for all kids and be placed on the mandatory vaccination schedule. This will give a liability shield, which currently EUA gives. Second, I remember reading somewhere that the EUA Pfizer got is not quite the EUA normally given. Unfortunately, I cannot recall the details but I suppose one should be able to find that out.