Updated: Aug 25, 2021
Update: Many readers are writing in to state FDA letter does NOT constitute full use authorization.. Videos and articles have surfaced stating the approval violates existing FDA standards for full FDA licensure of pharmaceuticals. This article sheds some clarification on the manipulations involved in current FDA Pfizer approval:
The determination of legal standing of current approval is beyond the expertise of this blog, however, relevant information related to this topic will be included in future posts.
*Note: Important physician whistle blower video included in this blog.
Emergency Update 8/23/2021: Democratic Congressman Richie Torres has introduced bill to stop unvaccinated individuals (not limited to Covid-19) from airline travel on domestic flights and added to no fly lists. This follows DHS 'terror alerts' smearing and misrepresenting citizens with evidence based, legitimate, concerns as potential terrorist threats, a framing which justifies draconian civil and human rights violations including banning individuals from access to travel. Contact information for the Congressman may be found here.
FDA has moved to violate every tenet of evidence based science and medical ethical and granted full authorization for Pfizer Biontech Covid-19 vaccine against vaccine trial and public health organization data clearly documenting harm outweighs benefit.
The approval is to PREVENT Covid-19 'disease'. Covid-19 vaccines do not prevent transmission of disease, EUA approved to suppress symptoms based on trial data which monitored for mild symptom suppression NOT prevention of serious health outcomes.
Per approval letter:
"Under this license, you are authorized to manufacture the product, COVID-19 Vaccine, mRNA, which is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older"
Sars CoV2 testing is non specific to virus and peer review has deemed the central test 'useless' for detection of virus. Multiple countries have ruled against mandates due to use of RT PCR testing unsuitable for diagnosis of Covid-19 infections.
Full approval letter defers finished trials for pediatric group to 2024 & NO trials studies are completed per the letter. No trial will be complete for another 18 months.
FDA Moving to Give Full Approval to Pfizer Vaccination Despite Clinical Trial Period Not Scheduled to End for Another 18 Months, No Public Comment Period Allowed. Act of Public Fraud.
The FDA is headed by Janet Woodcraft, the woman who approved Oxycontin. Twenty eight group petitioned the government to stop Woodcraft's appointment due to her dangerous history and failures with the Opioid drug crisis.
“In its opioid decision-making, Dr Woodcock, and the division she supervised, consistently put the interests of opioid manufacturers ahead of public health, often overruling its own scientific advisors and ignoring the pleas of public health groups, state Attorneys General, and outraged victims of the opioid crisis,” the letter said.
She has a long and corrupt history of approving unsafe drugs and acting to place profit of pharmaceutical agencies over health and well being of citizens with extensive direct source links to her past approval and history HERE.
65% of FDA Funding Comes Directly from Pharmaceutical Companies:
75% of Pharmaceutical Drug Review is financed by Biopharmaceutical Industry as documented here. This means the drug companies PAY for the process of reviewing their own products.
Public health organization and trial data clearly document Pfizer Covid-19 mRNA inoculations do not work and induce significantly greater harms than individuals experience with a positive test diagnosis of Covid-19 attributed infection. Recent Israel study found only 39% 'effectiveness' rate, for Pfizer Covid-19 vaccines, significantly lower than required to maintain FDA Emergency Use Authorization.
Per The British Medical Journal:
“It is already concerning that full approval is being based on 6 months’ worth of data despite the clinical trials designed for two years,” she said. “There is no control group after Pfizer offered the product to placebo participants before the trials were completed.
“Full approval of covid-19 vaccines must be done in an open public forum for all to see. It could set a precedent of lowered standards for future vaccine approvals.”
Over 9,000 deaths, 12,000 permanent disabilities and 326,000 injuries have been reported to CDC VAERS in association with Covid-19 Pfizer Inoculation in the United States. VAERS is estimated to capture only 1% of injury and FDA admitted mass inoculation program launched without adequate safety screening in place. 83% of VAERS reports are generated by mandated health care provider, pharmaceutical company and state reporting agencies.
In Europe, over 833 thousand injuries and 10,616 deaths have been reported to Eudravigilance official system in association with Pfizer Covid-19 vaccinations:
In 1976, Swine Flu vaccines were pulled from market after 53 associated (not proven) deaths were associated with the vaccinations
In 2021, amidst on gong investigations into kidney disorders, myocarditis, blood clotting, skin and neurological disorders and new safety risk popping up nearly every week, the FDA wants to give final approval 18 months before preliminary trials are even complete.
Worse, the government wants to make receipt of these unnecessary, ineffective, and harmful drugs a condition to function and maintain access to society. In France, vaccination passports have already been implement despite mass protests and civil disobedience to the policy.
Pfizer is estimated to receive 33 billion dollars in profit for Covid-19 inoculation currently under global investigative for multiple serious health risks.
The TRUE Story of Pfizer Covid-19 mRNA Inoculations (they are NOT vaccines):
Pfizer Covid-19 mRNA inoculations do not provide any health benefit, and induce significant & widespread harms per the vaccine trial, research, and public health organization data. They do NOT stop transmission of disease thus are utterly useless as a public health intervention.
Risk/Benefit analysis destroys ANY rationale for administration of Pfizer Covid-19 mRNA gene line editing drugs. This simple analysis has NEVER been presented to the public.
Indeed, the media continually repeats public health official statements that are actively DISPROVEN by vaccine trial and public health organization data.
This analysis will be done without correcting for the severe and extreme flaws with Sars CoV2 testing methods which render all data and research utilizing this testing as fatally corrupted and invalid to inform public health policy decisions. If you are unfamiliar with the significant Covid-19 attribution and testing problems, please review HERE and HERE for full substantive documentation on the issue. No Covid-19 vaccine research has ANY clinical validity due to use of RT PCR testing methods expert panel peer review has deemed USELESS for detection of Sars CoV-2 , virus attributed to cause symptoms of Covid-19.
Risk: Covid-19 Attributed Infection:
Based on CDC Covid-19 Survival Scenario, individuals with an attributed Covid-19 infection have overall survival rating of 99.95%.
Up to 86% of individuals with a positive PCR test for Sars CoV2 will experience no core symptoms of Covid-19 infections, and majority present asymptomatically. This is due to faulty testing and attribution methods, not asymptomatic infection as documented HERE.
Of the 14% of individuals who experience symptoms with a RT PCR test for Sars CoV2 test, 98% are mild.
Covid-19 attributed illness presents with very low mortality, symptom presentation rate, and severe symptom presentation rate.
The numbers clearly demonstrate there was NEVER any public health emergency to justify Emergency Investigative Use mRNA technology drugs and adenovector virus inoculations
(Moderna could not get past regular safety trials)
First, what is the purpose of the Pfizer Covid-19 inoculation? The intended use?
The drug was approved for symptom suppression of Covid-19 infections and this was clearly articulated by Dr Anthony Fauci last year:
"Dr. Anthony Fauci explained in an interview that the actual goal of the early COVID-19 vaccines isn’t even to block infections, a detail that people should be aware of even before considering whether to get a vaccine or which vaccine to go for. Instead, scientists are aiming to prevent severe COVID-19 cases or stop symptoms altogether. The virus would still gain entry into the human body, but vaccines will stop it from replicating and prevent symptoms, including life-threatening complications".
Dr Fauci's claim of suppression of life threatening complications with administration of Covid-19 vaccines were not based on real world evidence as trials only monitored for mild outcomes. The media has repeated this claim ad nauseam with NO real world evidence to back the statement:
According to analysis of trials by Peter Doshi in the British Medical Journal, the trial analyzed for majority mild outcomes and approval for Covid-19 vaccines was based on less these events:
"Peter Hotez, dean of the National School of Tropical Medicine at Baylor College of Medicine in Houston, said, “Ideally, you want an antiviral vaccine to do two things . . . first, reduce the likelihood you will get severely ill and go to the hospital, and two, prevent infection and therefore interrupt disease transmission.”7
Yet the current phase III trials are not actually set up to prove either (table 1). None of the trials currently under way are designed to detect a reduction in any serious outcome such as hospital admissions, use of intensive care, or deaths. Nor are the vaccines being studied to determine whether they can interrupt transmission of the virus".
"In all the ongoing phase III trials for which details have been released, laboratory confirmed infections even with only mild symptoms qualify as meeting the primary endpoint definition.9101112 In Pfizer and Moderna’s trials, for example, people with only a cough and positive laboratory test would bring those trials one event closer to their completion. (If AstraZeneca’s ongoing UK trial is designed similarly to its “paused” US trial for which the company has released details, a cough and fever with positive PCR test would suffice.)
Part of the reason may be numbers. Severe illness requiring hospital admission, which happens in only a small fraction of symptomatic covid-19 cases, would be unlikely to occur in significant numbers in trials"
G0t that? Covid-19 attributed infections present with such mild symptoms in nearly all cases, the vaccine trials could not FIND enough trial subjects to monitor for severe outcomes.
The logical question then is WHY did America spend hundreds of billions of dollars for Covid-19 infection that posed no significant public health threat?
Hospitalization Rates with attributed Sars CoV2 Infection, 3.4% (out of attributed infections presenting with symptoms, this number does not refer to a entire population risk as misrepresented by media):
(hospitalizations attributed through positive test for Sars CoV2 NOT reason for actual admission, this number would plummet if actual reason for admission was standard - full Covid-19 case, hospitalization, and mortality standards may be verified HERE)
Data published by the US Centers for Disease Control and Prevention in late April reported a symptomatic case hospitalization ratio of 3.4% overall, varying from 1.7% in 0-49 year olds and 4.5% in 50-64 year olds to 7.4% in those 65 and over.13 Because most people with symptomatic covid-19 experience only mild symptoms,14 even trials involving 30 000 or more patients would turn up relatively few cases of severe disease".
Efficacy Determined After 160 Events:
"In the trials, final efficacy analyses are planned after just 150 to 160 “events,”—that is, a positive indication of symptomatic covid-19, regardless of severity of the illness".
Public health officials disingenuously report the number of trial participants instead of number of events within that group for determination of Covid-19 efficacy.
Observation of 160 individuals with mostly mild symptoms formed the criteria of established Covid-19 vaccine efficacy standards. This is a flat out mockery of scientific safety monitoring.
95% Efficacy Claims Based on Less Than 1% Reduction in Observed Symptoms - Study Used Relative Risk Reduction Instead of Absolute Risk Reduction - three minute minute shows actual data
Pharmaceutical Companies Destroyed Placebo Group, Rendering Future Trial Data Irrelevant with No Comparison Group to Ascertain Benefit and Safety Risk (links to sources included in below summary blog):
Trials did not study for suppression of transmission:
“Our trial will not demonstrate prevention of transmission,” Zaks said, “because in order to do that you have to swab people twice a week for very long periods, and that becomes operationally untenable.” (i.e. this trial doesn't study for main criteria for what public perceives as vaccine benefit, stopping transmission of disease)
In sum, the US gave Emergency Use Authorization for a drug that provided no demonstrable benefit to suppress severe illness or death, stop transmission of disease. All for a Sars CoV2 attributed illness that was not (and is not) a public health emergency, with trial designers unable to find enough participants to monitor for severe outcomes due to mild presentation of illness.
It's fraud and an open scam documented by the data. And, it gets worse because a review of vaccine trial side effect data clearly demonstrates the vaccines induce many of the symptoms they are designed to suppress at FAR greater rates and severity than individuals experience with a positive PCR test diagnosis for Sars CoV2 (virus attributed to cause symptoms of Covid-19).
NO SUBSTANTIVE BENEFIT - SERIOUS RISK:
Original claims of 95% efficacy of Pfizer vaccine to suppress Covid-19 have always been a documented farce. How can a drug that induces side effects (many that mirror the very same symptoms the drugs are purported to suppress) at greater rates than Covid-19 attributed infection be claimed to decrease symptoms at 95%?
"Among all vaccine recipients asked to complete diaries of their symptoms during the 7 days after vaccination, 77.4% reported at least one systemic reaction. The frequency of systemic adverse events was higher in the younger than the older age group (82.8% vs 70.6%). Within each age group, the frequency and severity of systemic adverse events was higher after dose 2 than dose 1. Vomiting and diarrhea were exceptions, and similar between vaccine and placebo groups and regardless of dose. For both age groups, fatigue, headache and new or worsened muscle pain were most common:.
Media & CDC Engaged in Propaganda Campaign to Sell Harm As Benefit:
CDC & media enacted campaign to falsely claim induction of side effects with the same symptoms the Covid-19 vaccines were given EUA to suppress meant the vaccines were WORKING:
"The side effects after the second dose are typically a bit harsher and can include fever, chills, fatigue, and muscle aches. In some instances, people have reported being out of commission for a full 24-hours. But again, this is a sign that the vaccine is doing its job".
The vaccine approved to stop mild side effects (this is what the trials measured) were sold by Dr Fauci as 'doing there job' by inducing the side effects they were EUA to stop.
Business closures were necessitated because the vaccines were doing such a good job:
Covid-19 CAUSE the symptoms drugs are purported to prevent.
Clearly, there is NO benefit to administration of drugs that do not stop transmission of disease and induce the same symptoms they are administered to stop at far greater rate and severity. This is why the media and public health officials attempted to lie to the public for months and state that decreases in cases that occurred due to testing protocol changes were evidence the vaccines 'worked' to stop transmission. They don't stop transmission of disease, and the rise in current case numbers is due to faulty testing methods and unscientific standards for Covid-19 attribution for infection, hospitalization, and deaths.
Explanation for how Covid-19 testing protocol recommendations have driven case rates is fully documented by public health organization evidence and explained in this blog.
Pfizer Approved December 14, 2020, 373 Associated Deaths & Nearly 20,000 injuries in with Vaccine Recorded in Two Weeks:
53 Deaths Halted Swine Flu Vaccination Program in 1976, Over 13,000 deaths now associated with Covid-19 vaccination program:
Pfizer Vaccine Correlated to Deaths in Elderly in Care Hames in First Weeks of Norway Approval:
Norway Documents Pfizer Covid-19 Side Effects Correlate to Elderly Death in Care Homes:
"The Norwegian Medicines Agency announced in a press release that as of Thursday, the Norwegian health registry has received reports of 23 people who died shortly after receiving their first dose of the vaccine.
Of those deaths, 13 have been autopsied and revealed that the common side effects associated with the vaccine may have contributed to more severe reactions among frail, elderly people.
Sigurd Hortemo, chief physician at the Norwegian Medicines Agency, said side effects such as fever and nausea “may have contributed to a fatal outcome in some frail patients.”
Whistleblowers Come Forward, Out Deaths Occurring in Correlation to Covid-19 Vaccine:
NEJM, CDC & Media Misrepresents NEJM Study Finding Majority 82% Miscarriage Rate Before 20 Weeks Post Covid-19 vaccination As Evidence Vaccines Safe in Pregnancy:
127 women before twenty weeks were enrolled in trial and vaccinated before 20 weeks, of which 104 women or 82% lost their pregnancies.
This finding was buried in the data by including women experiencing spontaneous abortion in the first three months with ALL trial outcomes (after 20 weeks loss of pregnancy is classified as still birth and would not apply to women after 20 week term)
84.6% of trial participants were in third trimester when vaccinated.
"Data on pregnancy loss are based on 827 participants in the v-safe pregnancy registry who received an mRNA Covid-19 vaccine (BNT162b2 [Pfizer–BioNTech] or mRNA-1273 [Moderna]) from December 14, 2020, to February 28, 2021, and who reported a completed pregnancy. A total of 700 participants (84.6%) received their first eligible dose in the third trimester. Data on neonatal outcomes are based on 724 live-born infants, including 12 sets of multiples.
‡ A total of 96 of 104 spontaneous abortions (92.3%) occurred before 13 weeks of gestation".
The study lumped the data in with total pregnancy outcomes thus misrepresenting early trimester pregnancy outcomes as the same as women in early pregnancy whom did not receive the vaccine.
This data should have been included SEPARATELY to determine risks for early pregnancy outcomes as goal of study was to determine safety in different terms of pregnancy and spontaneous abortion does not apply to women post 20 weeks.
Fact checkers immediately issued false corrections and ascribed pregnancy loss against the standards used by the research authors and lied to state majority of trial participants were in early trimesters despite the above statement in study in table 4.
CDC Refuses to Correlate Covid-19 Vaccine with Autopsy Evidence of Causality to Deaths:
Drene Keyes went into classic symptoms of anaphylactic shock 20 minutes post Pfizer vaccine and died the same day. Despite treating physician and autopsy evidence documenting anaphylactic reaction as cause of death, public health officials deemed Ms Keyes death occurring from Covid-19 infection on the basis of no evidence what so ever:
Dr Gregory Michaels, died from thrombocytopenia (per autopsy) post vaccination. Despite no underlying health issues or conditions related to development of thrombocytopenia , the CDC did not classify Dr Michaels death as correlated to vaccine due to 'lack of medical certainty:
Global Safety Investigations Launched, Warning Labels Added:
Enter Delta Variant:
The Delta Variant - another public manipulation to rationalize never ending and unnecessary boosters of harmful drugs:
The Delta variant is based on computer modeling genomic sequencing not virus isolation and identification of a mutation. This is the same flawed protocol established to isolate original Sars CoV2 (Covid-19 1.0) with existing sequences with patents that predate 2020.
Full video interview on patent data for Sars CoV2 sequences may be viewed HERE:
Delta variants are NOT diagnosed by individual tests, there is no such test to detect variant or test SPECIFIC to Sars CoV2 at all. All Covid-19 testing picks up dead and live material, and a positive does NOT mean individual is contagious or presenting symptoms due to Sars CoV2 per the CDC own Emergency Use guidelines for RT PCR Testing:
• Detection of viral RNA may not indicate the presence of infectious virus or that 2019-nCoV is the causative agent for clinical symptoms.
• The performance of this test has not been established for monitoring treatment of 2019-nCoV infection.
• The performance of this test has not been established for screening of blood or blood products for the presence of 2019-nCoV.
• This test cannot rule out diseases caused by other bacterial or viral pathogens.
Variant allow false rationale for endless boosters which governments want to make mandatory for function in society through use of vaccine passports.
By Government's Own False Standards, Covid-19 Inoculations Do Not Work:
EUA required 50% effectiveness for Covid-19 vaccines. FDA now seeking full approval for drugs that do not meet EUA standards
Authorities admit vaccines do not work:
"However, vaccination does not prevent reinfection or progression to more serious conditions, including death. Therefore, the secretary stressed the relevance of maintaining preventive measures against the new coronavirus"
Risk Benefit Analysis
High, Widespread Risk/NO Benefit
The public health organization and vaccine data clearly prove it.
This is the reason that the FDA is rushing to approve Pfizer now. The data already reveals Pfizer vaccination is unsafe, unnecessary, and ineffective against its stated goals.
The FDA is moving for expedited approval not only because it will give false authority to mandate harmful drugs onto the public as a means to move forward with vaccine mandates and passport systems.
Pfizer vaccinations will never survive another year and a half safety review scrutiny before significant harmful effects become known to the entirety of the public. Already, mass groups of the injured have formed by the tens of thousands to publicly tell the stories the media is censoring. Soon, that number will swell to millions.
The FDA has no credibility or authority to inform public health policy decisions in the face of bogus approval of unnecessary and harmful drugs. And, no health professional should administer drugs which the evidence clearly demonstrate induce significant health harms with NO correlating benefit. Remember, the liability protection ONLY applies to the pharmaceutical companies the FDA exists to serve, not those charged in implementing the inoculation.
This approval has no real world meaning in anything other than providing false authority to force vaccine policies on the public which could not be implemented under EUA. It is a political move against the public health. The authorization has no scientific credibility or validity.
Decades of pharmaceutical ads selling sickness as health have indoctrinated into the false belief drugs inducing harm is the price of health.