In a new interview with German attorney Reiner Fuellmich, biotech analyst and med-legal advisor Karen Kingston explains—in great detail—how Pfizer has broken the law by trying to maintain its Emergency Use Authorization (EUA) liability shield while also producing an FDA-approved COVID-19 “vaccine.”
In a new interview with German attorney Reiner Fuellmich—who, along with the rest of his Corona Investigative Committee is trying to glean what’s really going on with COVID-19 by speaking with experts in various fields—biotech analyst and med-legal advisor Karen Kingston explains how pharma giant Pfizer broke the law multiple times while marketing its COMIRNATY COVID-19 “vaccine.” Specifically by attempting to maintain its Emergency Use Authorization (EUA) liability shield, while simultaneously producing FDA-approved lots (or batches) of its “vaccine,” which Kingston says were likely made for the U.S. military in order to “wipe them out.”
In the interview—immediately above—Kingston, a former Pfizer sales representative for the Northwest region of New York and self-described “hummingbird on speed,” flies through a presentation showing exactly how the pharma giant attempted to have its cake and eat it too, so to speak, in its production and marketing of its COVID-19 injections. Critically, Kingston notes that once a company has gone through an Initial New Drug (or IND) application process, it no longer enjoys legal immunity against adverse events under an Emergency Use Authorization. She then goes on to show that, by producing COMIRNATY “vaccine” lots, the company broke this so-called “immunity shield” provided by the EUA, opening itself up to lawsuits from recipients harmed by the injections.
HOW HAS PFIZER PRODUCED FDA-APPROVED COMIRNATY EVEN THOUGH IT SAID IT DIDN’T?
Kingston notes Pfizer filed a New Drug Application (NDA)—also referred to as a Biological License Application (BLA)—with the Food and Drug Administration (FDA) in May of 2021 and then had it approved on August 23, of 2021. Kingston points out “it’s very important [to note] this [“vaccine”] was approved by the FDA; they issued NDC codes [National Drug Codes], they recalled those NDC codes, and issued new NDC codes [for COMIRNATY] and manufactured [it] in the United States.”
This is important to note, Kingston says, because if a company wants an EUA product, it must go through the IND process, and the NDA process. “If you’re going to use a drug for more than six months, you must go through the IND/NDA process, and once you do that, you do not have [legal] immunity under the EUA for the indication you got approval for.” Kingston adds that “you don’t have immunity for any of those participants in any of the trials that were in the [Initial New Drug application process], including the babies and toddlers that just went through [it].”
Kingston goes on to look at the contract that Pfizer has with the Department of Defense (DoD)—immediately above—showing specifically that the DoD designates Pfizer as “basically the IRB, [or] the Independent Review Board.” The biotech analyst goes on to note that BioNTech—a German biotech company based in Mainz that develops and manufactures active immunotherapies—is designated as the “regulatory sponsor,” which means “they are the applicant in the United States for FDA approval.” Kingston adds that, in the contract with the DoD, BioNTech is also designated as the manufacturer of the COVID-19 “vaccines.”
When Fuellmich asks how it’s possible that BioNTech can be both a manufacturer and “independent” regulator of a product, Kingston says it’s normally “grossly illegal,” but allowable under an EUA.
Regardless of that would-be violation, Kingston notes that Dr. Anthony Fauci said on August 8, 2021 that once the “vaccines” got FDA approval then mandates would be inevitable—so the date for approval was moved up from 2025 to August 23, 2021.
Kingston notes Pfizer literally cannot say it didn’t go through an IND for its COVID-19 “vaccine” because on August 23, 2021 it was approved by the FDA (see excerpt from letter immediately above). Kingston adds the BLA approval is signed by Marion Gruber and Mary Malarkey. Those two members of the FDA both resigned on the exact same day (sometime after the approval) Kingston adds.
In the original application submitted in May of 2021, Kingston points out the PDUFA (or Prescription Drug User Fee Act) date is January 16, 2022. Pfizer paid “about three million dollars” to have the FDA approve their COVID-19 “vaccine” Kingston says. Kingston notes the original timeline for approval for Pfizer’s “vaccine” was 2025. (PDUFA was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products.)
Kingston says that the NIH then, on September 13, 2021, issued the BLA lot numbers that are associated with the EUA product from August 23rd. Then, Pfizer/BioNTech, along with the NIH, put out a press release saying that “At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution.”
Kingston notes, however, that in December of 2021, Pfizer did produce FDA-approved COMIRNATY lots of “vaccine”—each with a BLA number. Kingston shows how the pharma giant specifically produced lots on December 22, 2021, as well as on August 23, 2021. (COMIRNATY lots were also produced on May 18, 2022, as of this writing.)
Kingston notes in clear terms that once Pfizer and BioNTech have “FDA approval, and they manufacture an FDA-approved product, that proves that they have a product that went through the Initial New Drug Application process, which must adhere to the Food and Drug Consumer Protection Act, and all of the codes to bring a product safely to market. It is not shielded under the EUA; there are separate laws.” Kingston adds that “this is the one loophole that they broke because Fauci pushed the approval. They were not supposed to approve this until 2025—that’s the original plan… .”
When Fuellmich asks Kingston why Pfizer and BioNTech would want to lose their EUA liability shield in exchange for producing approved COMIRNATY lots, the biotech analyst responds that only President Biden can issue an order “to have the military injected for an experimental product.” And because those in charge didn’t want that, the lots of approved COMIRNATY were “probably manufactured for our military… to wipe them out.”
Kingston adds that on top of the FDA record of COMIRNATY having been manufactured, the BLA approval for COMIRNATY also states that:
“[T]he Applicant [BioNTech in partnership with Pfizer] submitted information listing which lots they considered to be manufactured according to the BLA. To address the issue of these lots not bearing the vial label associated with BLA approval, CBER worked with the Applicant to develop a Dear HCP letter to be included with lots considered by CBER to be BLA-compliant. This letter explained that some lots labeled for EUA use were also considered BLA-compliant and refers HCP to a website for additional information. CBER requested and the Applicant agreed that only EUA-labeled lots that had also undergone CBER lot release according to the BLA would be considered BLA-compliant and listed at the website included in the Dear HCP letter.”
Clearly, BioNTech, in partnership with Pfizer, manufactured lots that were BLA-compliant. This is critical because BLA compliant literally means those lots had “full approval” from the FDA. Per Harvard Law’s Bill of Health blog:
“A Biologics License Application, or BLA, is FDA’s standard “full approval” mechanism for biological products, including therapeutics and vaccines. A company seeking a BLA for its product must demonstrate that the product is “safe, pure, and potent,” which generally means completing robust, well-controlled clinical trials. A company receiving a BLA for their product can introduce the product into interstate commerce and market it for its approved uses. A BLA also has no defined end date — assuming no significant problems emerge, the product can stay on the market indefinitely.
“By contrast, an Emergency Use Authorization, or EUA, is just that — an authorization to distribute an otherwise unapproved product (or an approved product for an unapproved use) during an emergency formally declared by the Secretary of Health & Human Services. Both the substantive and procedural rules surrounding an EUA differ from those surrounding a BLA (or the BLA counterpart for small-molecule drugs, a New Drug Application or NDA). Substantively, the standard for granting an EUA is whether, “based on the totality of scientific evidence available,” “it is reasonable to believe that the product may be effective” and that the “known and potential benefits… outweigh the known and potential risks.” Procedurally, an EUA lasts only as long as the underlying emergency. Further, the FDA may “revise or revoke” an EUA if the substantive evidence for granting it no longer exists.”
Kingston also notes the NIH posted the FDA-approved COMIRNATY lots produced on December 22, 2021 to Daily Med. (Immediately below.)
Kingston goes on to note that the COMIRNATY product on Daily Med contains “tris” and sucrose. Kingston notes Tromethamine, which is a listed ingredient, is tris. The list of ingredients also contains Tromethamine Hydrochloride, which is tram. So COMIRNATY does indeed contain tris and tram. Because these lots contain these molecules, Kingston says, it’s irrefutable that they are COMIRNATY.
NOTE: It is unclear why Kingston says that COMIRNATY is the only “vaccine” formulation to have tris, tram, and sucrose. The CDC says both Pfizer-BioNTech “vaccines” use tris, tram, and sucrose. Although even the NIH still delineates between FDA-approved COMIRNATY and EUA BNT162b2.
Kingston also notes the drug label information for COMIRNATY made available on December 22, 2021 (and other dates) indicates it was both manufactured and “analyzed” (quality controlled) by BioNTech. Kingston also points out that Wyeth Pharmaceuticals, a subsidiary of Pfizer, manufactured COMIRNATY and is indeed located in the U.S. (Again, Kingston aims to establish here that Pfizer did indeed manufacture FDA-approved COMIRNATY in the U.S.)
Kingston also invites people to note that COMIRNATY, per the NIH’s own website (excerpted immediately below), “has not been evaluated for the potential to cause carcinogenicity, genotoxicity, or impairment of male fertility.” The biotech analyst notes this absence of evaluation violates section 312.4 of the Consumer Drug Protection Act “because you cannot inject a population that can cause harm to men and women of childbearing age that may affect their fertility or cause genetic mutations; it’s a major violation.” (Writer’s note: I was unable to find this statutory law.)
Kingston goes on to show a slide from a BioNTech presentation showing Pfizer/BioNTech “vaccine” manufacturing plants in the United States. (No link is provided for the BioNTech presentation; the slide presented by Kingston is immediately below.)
Critically, Kingston claims—at the 9:30 mark—that she pulled the COMIRNATY lots mentioned in the “Dear Healthcare” letter referenced in the BLA and found “over 41 deaths and… about 600 serious adverse events” as of December of 2021.
HOW IS COMIRNATY DIFFERENT FROM THE EUA PRODUCTS?
After outlining how Pfizer and BioNTech did, in fact, produce FDA-approved COMIRNATY lots of “vaccine,” therefore breaking any liability shield offered to the companies under an Emergency Use Authorization, Kingston goes on to discuss how COMIRNATY is different from the EUA product. For one, Kingston points out, it says in the FDA’s Summary Basis for Regulatory Action for COMIRNATY that “The mRNA in COMIRNATY is a single-stranded, 5’-capped mRNA encoding the full-length SARS-CoV-2 spike glycoprotein derived from the Wuhan-Hu-1 isolate (GenBank MN908947.3 and GenBank QHD43416.1)… [and] The antigen-coding RNA sequence is codon-optimized and contains two proline mutations… which [ensure] an antigenically optimal trimerized pre-fusion confirmation (S-2P).”
Kingston says it’s also important to note that the FDA’s Summary states COMIRNATY’s “RNA also contains common structural elements, including 5’-cap, 5’-UTR, 3’-UTR, and poly(A) tail, all of which are designed for mediating high RNA stability and translation efficiency.” The biotech analyst says this is critical because while authorities call Pfizer/BioNTech’s injection a “vaccine,” if one looks at the FDA’s Design and Analysis of Shedding Studies for Virus or Bacteria-Based Gene Therapy and Oncolytic Products, the agency notes that “Gene therapy products are all products that mediate their effects by transcription and/or translation of transferred genetic material and/or by integrating into the host genome and that are administered as nucleic acids [which would be the spike proteins in the instance of the Pfizer “vaccines”], viruses, or genetically engineered microorganisms. The products may be used to modify cells in vivo or transferred to cells ex vivo before administration to the recipient.”
Kingston says all of this to make it clear that according to the FDA’s and Department of Health and Human Services’ (HHS) own definition, Pfizer’s COVID-19 “vaccine” is actually a gene therapy.
“What’s most important about these gene therapies,” Kingston says, “is that they all have a very high risk for shedding. She adds that this means that “once you inject someone with a viral gene therapy and they produce that virus and the spike proteins in their bodies, they’re very likely to infect other people,”
“This is why everybody’s gotten COVID at this point,” Kingston adds. “Because everybody’s gotten injected with it.”
Next, Kingston notes how COMIRNATY is—evidently—“a gene therapy that produces a spike protein” and that in 2014 the FDA put out a presentation “The immunogenicity of therapeutic proteins- what you don’t know can hurt YOU and the patient,” in which scientists discussed the immunogenicity (or self-harming immune reaction) from therapeutic proteins—such as the spike protein in the case of Pfizer’s “vaccine.” Kingston also cites a 2015 press release from an FDA scientist—linked immediately below—which notes: “A major problem with protein-based therapeutics is their immunogenicity, that is, their tendency to trigger an unwanted immune response against themselves… Such antibodies can cause complications that can be life threatening.”
Referencing the BLA again, Kingston notes that the FDA states “repeat dose toxicity evaluations were conducted on COMIRNATY and a similar vaccine termed BNT162b2…” and that the two so-called vaccines “have identical amino acid sequences of the encoded antigens but COMIRNATY includes the presence of optimized codons to improve antigen expression.”
What are those optimized codons? Kingston speculates on one possibility. She highlights a study in which scientists in Philadelphia took 38 samples from people who had mild to moderate COVID in early 2020, and those who had severe COVID-19 from the same period. In those who had severe COVID, the scientists didn’t identify SARS-COV-2. Instead, they went looking for toxins—they said it looked like people had been poisoned—and they found an optimized, trimerized spike protein consisting of: venom from the krait snake, synthetically re-created; the rabies virus; an aggressive gram-positive bacteria called Staphylococcal enterotoxin B, and the HIV glyco-protein. I.e. the scientists had identified the “trimeric” protein.
Kingston notes that the holders of a patent for S-2P spike proteins filed in 2017—immediately below— include Barney Graham at the NIAID and Jason McLellan at Moderna. She invites people to look at the S-2P spike proteins patented by Graham and McLellan, which likely make up the S-2P proline mutations in the COMIRNATY formulation; she notes that S-2P spike proteins—which can be coded independently of the mRNA for the original Wuhan spike protein in the formulations for the “vaccines”—cause a range of severe conditions, including severe gastroenteritis, diarrhea, etc.
“What they did was they took SARS-CoV-2 virus, they infected cells outside the body, they produced the WIV [Wuhan Institute of Virology] spike protein, and then they added the 20 amino acids—the two prolines—which are the synthetically created bioweapons from venom and rabies,” Kingston says.
Kingston goes on to note a 2016 paper published in PNAS by Ralph Baric, et al., in which scientists worked on “constructing chimeric and full-length zoonotic coronaviruses to evaluate emergence potential.“ Kingston notes at one point that the authors write: “Focusing on the severe acute respiratory syndrome (SARS)-like viruses, the results indicate that the WIV1-coronavirus (CoV) cluster has the ability to directly infect and may undergo limited transmission in human populations. However, in vivo attenuation suggests additional adaptation is required for epidemic disease.”
The scientists were stating openly that the “[The WIV1 coronavirus cooked up by Baric et al] needed further weaponization,” Kingston translates into plain English.
INDICATIONS SARS-COV-2 IS THE WEAPONIZED SPIKE PROTEIN IN LIPID NANOPARTICLES AND IS BEING INTENTIONALLY SPRAYED VIA AEROSOLS
Adding on to the 2016 paper in which Ralph Baric et al. (in effect) opine on how they were unable to make an epidemic disease-causing agent with a natural spread of their chimeric viruses, Kingston presents a paper from December 8, 2020 published in the journal Immunity, Inflammation and Disease, in which the authors looked at 222 frontline healthcare workers in Wuhan. The researchers found “no nosocomial infection of SARS-CoV-2” among the cohort of healthcare workers. The healthcare workers also consistently tested negative for SARS-CoV-2 antibodies and had no typical chest CT scan for COVID-19 either. All of their throat swabs were negative the entire time the healthcare workers were at ground zero, on the frontline.
This evidence, Kingston says, “means the original SARS-CoV-2 virus… once it infects somebody, they cannot infect another person; there is no human-to-human transmission. How were the people infected? They were infected because the virus was encapsulated in a lipid nanoparticle and it was put in something that they ate, something that was an aerosol application, or something that was put on their skin, per the EcoHealth Alliance pitch to DARPA.”
Kingston specifically references the report immediately above, in which EcoHealth Alliance—with Principal Investigator (PI) Peter Daszak—proposes Project DEFUSE. In their proposal—which ostensibly has the goal of identifying and modeling “spillover risk”—Daszak et al. explain how they aim to “assess delivery vehicles” of “reconstruct[ed] and characterize[d] spike trimers” in “transdermally applied nanoparticles,” “sticky edible gels that bats mutually groom and consume,” and “aerosolization via prototype sprayers.”
Daszak—and Ralph Baric—et al. go on to say that they have “extensive preliminary data on these techniques… including vaccinating bats against rabies in the lab [and] successful delivery, consumption and spread in wild vampire bats.”
Kingston goes on to say that Patient Zero in the U.S. was a 31-year-old man from Wuhan who went to the King’s County nursing home in Washington State to visit his mother. Kingston speculates the man may have sprayed down the nursing home with the poisonous aerosols; or perhaps put them in something they were eating.
Likewise, Kingston notes Patient Zero in Italy was also from Wuhan—a fashionista—around the age of 25. Apparently the young woman from Wuhan went to Lombardy in Italy for fashion shows. She also, Kingston says, was the source of another major attack. As for New York City? Kingston says the subway system would’ve been an easy target.
Incidentally or not, The Daily Mail reports the woman who served as patient zero in Italy—who is still unidentified—was indeed 25 years old, although the news outlet claims the hospital that treated her says she was Italian. An NPR report from January 22, 2020 claimed that “The first U.S. patient is a man in his 30s who had spent several months traveling in Wuhan, China… . On January 15, the patient took an indirect flight back to Washington, where he lives just north of Seattle. The next day, he fell ill and went to a nearby clinic.”
The biotech analyst notes yet another study evincing her theory of how COVID-19 spreads, “Absence of nosocomial transmission of coronavirus disease 2019 (COVID-19) due to SARS-CoV-2 in the prepandemic phase in Hong Kong,” which was published in the American Journal of Infection Control on May 24, 2020. The results of the study stated, in part, that:
“Up to day 72 of the epidemic, 130 (0.40%) of 32,443 patients being screened confirmed to have SARS-CoV-2 by reverse transcription polymerase chain reaction. Compared with SARS outbreak in 2003, the SARS-CoV-2 case load constituted 8.9% (130 SARS-CoV-2/1458 SARS-CoV) of SARS-CoV infected cases at day 72 of the outbreak. The incidences of nosocomial acquisition of SARS-CoV per 1,000 SARS-patient-day and per 100 SARS-patient-admission were 7.9 and 16.9, respectively, which were significantly higher than the corresponding incidences of SARS-CoV-2 (zero infection, P <.001).“
“So [with] MERS and the original SARS-CoV-1 virus, there was human-to-human transmission in the hospitals,” Kingston says. “There was no such transmission with the original virus in over 32,000 patients who were hospitalized in Hong Kong.”
Regarding the COVID-19 outbreaks in the nursing homes, Kingston makes the—apparently completely unsubstantiated claim—that Governor Cuomo sent sick, elderly patients into nursing homes “more than likely so he could send someone in there and use [Enviro-Mist] to infect the nursing home and make it appear like this was infectious.” Kingston says that Enviro-Mist, an aerosolized disinfectant that’s sprayed in laboratories, schools, etc. could’ve been used to spread LNPs with the stabilized, weaponized spike proteins. (As Kingston notes, Enviro-Mist is funded by DARPA—as well as the British Ministry of Defense.)
NOTE: Although Kingston’s claims about Enviro-Mist may be true, many governors, perhaps the vast majority of them, sent elderly who tested positive for COVID-19 back into the nursing homes. They were all following the Centers for Medicaid and Medicare Services (CMS) guidelines, which were ultimately orders from the CDC.
Kingston goes on to discuss the first autopsy in the peer-reviewed journal International Journal of Infectious Diseases of a “vaccinated” person’s body. (Likely the COMIRNATY formulation of the vaccine, according to Kingston.) Unlike with SARS-CoV-2, which disintegrates in the body, Kingston notes the spike proteins were found everywhere in the 86-year-old man; including in his brain; in his throat; in his tongue; in his lungs; in his heart (his myocardium); and in his kidneys.
Indeed, the authors of the paper write in their abstract that:
“A previously symptomless 86-year-old man received the first dose of the BNT162b2 mRNA COVID-19 vaccine. He died 4 weeks later from acute renal and respiratory failure. Although he did not present with any COVID-19-specific symptoms, he tested positive for SARS-CoV-2 before he died. Spike protein (S1) antigen-binding showed significant levels for immunoglobulin (Ig) G, while nucleocapsid IgG/IgM was not elicited. Acute bronchopneumonia and tubular failure were assigned as the cause of death at autopsy; however, we did not observe any characteristic morphological features of COVID-19. Postmortem molecular mapping by real-time polymerase chain reaction revealed relevant SARS-CoV-2 cycle threshold values in all organs examined (oropharynx, olfactory mucosa, trachea, lungs, heart, kidney and cerebrum) except for the liver and olfactory bulb. These results might suggest that the first vaccination induces immunogenicity but not sterile immunity.”
Later on in the interview (around minute 49:00) Kingston adds that the toxins amended to the original Wuhan spike protein in the COMIRNATY “vaccine” cause Rouleaux; i.e. the blood clotting that’s now occurring in “vaccinated” people’s bodies.
To emphasize the claim that Pfizer must’ve known from the get-go that its “vaccine” would cause birth defects, Kingston brings up Capoten, an ACE1 inhibitor that has a contraindication because it works along the angiotensin renin pathway, which contains ACE1 and ACE2 receptors. “Where does the spike protein bind?” Kingston asks. (The answer being with ACE2 receptors.) Kingston notes “you cannot give” Capoten to pregnant women. Due to this known issue with Capoten, Kingston deduces the FDA must’ve known that the COVID-19 “vaccines” were contraindicated for pregnant women.
WHY THE FDA APPROVAL AND CONTINUING EUA FOR THE COVID ‘VACCINES’ ARE ‘CRIMINAL’
“Not only does COMIRNATY… not prevent the respiratory [illness] caused by SARS-CoV-2, the vaccine causes it,” Kingston says. To evince her claim Kingston shows an FDA briefing document from September 17, 2021, in which the FDA notes clearly that “the post hoc analysis [for Pfizer’s COVID-19 vaccine] appears to indicate that the incidence of SARS-CoV-2 during the analysis period among 18,727 study participants originally randomized to BNT162b2 (mean of 9.8 months post-Dose 2 at the beginning of the analysis period) was 70.3 cases per 1,000 person-years, compared with an incidence of 51.6 cases per 1,000 person-years among 17,748 study participants originally randomized to placebo and crossed over to BNT162b2 (mean of 4.7 months post-Dose 2 at the beginning of the analysis period).” The briefing goes on to say that “An additional analysis appears to indicate that incidence of COVID-19 generally increased in each group of study participants with increasing time post-Dose 2 at the start of the analysis period.”
OTHER TERRORS AND HORRIFYING REALITIES
“There’s over 10,000 SARS-CoV-2 weaponized bat viruses in the EcoHealth Alliance database as of 2016,” Kingston says. “That number is probably upwards of 100,000 right now.” She adds the “the next-generation sequencing” of the viruses is being done by Twist Bioscience; a company that claims to provide “synthetic DNA tools” for customers in medicine, agriculture, industrial chemicals, and data storage.
Kingston notes Twist has its largest manufacturing facility in Beijing, China, and receives funding from the NIH.
The biotech analyst then briefly touches on the experiments Pfizer conducted on children with its COVID-19 “vaccine,” noting “many of the children had very severe epileptic seizures… having more than six or twelve [of them] a day.” Kingston adds that “[Pfizer/BioNTech, the FDA, et al.] have permanently damaged these children.“
Kingston also briefly outlines the clinical trial Pfizer performed on children, noting there were 598 children in the placebo cohort; around week 8, 344 “got injected with the three-dose series [of Pfizer “vaccine”]” and “only one child made it to one week post dose-three.” According to Kingston, the Independent Review Board for the trials—which is Pfizer—does not have to disclose why all of those children pulled out of the study; nor has it.
Pfizer and the FDA even looked at the VAERS (Vaccine Adverse Event Reporting System) database “and they noted that children became severely ill after breastfeeding with a mother that was vaccinated—their mother,” Kingston says. “One five-month-old baby died from thrombosis/thrombocytopenia,” Kingston adds, noting that “I can tell you blood clotting is very painful in adults [so] that baby died a very painful death while the mother thought she was feeding him.”
Feature image: OVAL Media
Related News
