🚨🚨🚨 The FDA Approval is Not What You Think It Is 🚨🚨🚨
🚨 The FDA Approval Facts - Direct from the FDA 🚨
EUA Extension Letter: FDA letter of revision of the August 12th Emergency Use Authorization of the Pfizer Vaccine... ...On August 23, 2021, having concluded that revising this EUA is appropriate to protect the public health or safety under section 564(g)(2) of the Act, FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA....
FDA BLA Approval Letter: BioNTech Manufacturing GmbH BLA Approval... We are issuing Department of Health and Human Services U.S. License No. 2229 to BioNTech Manufacturing GmbH, Mainz, Germany, under the provisions of section 351(a) of the PHS Act controlling the manufacture and sale of biological products. The license authorizes you to introduce or deliver for introduction into interstate commerce, those products for which your company has demonstrated compliance with establishment and product standards. 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
FDA Approves First COVID-19 Vaccine... FDA News: Today, the U.S. Food and Drug Administration approved the first COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty (koe-mir’-na-tee), for the prevention of COVID-19 disease in individuals 16 years of age and older. The vaccine also continues to be available under emergency use authorization (EUA), including for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.
🚨 Experts Explain Why the Letters are Misleading 🚨
GASLIGHTING AMERICA: Did the FDA actually approve a FUTURE covid “vaccine” from BioNTech that does not exist yet?... There appears to be a whole lot of confusion out there about which “vaccine” for the Wuhan coronavirus (Covid-19) was actually “approved” by the U.S. Food and Drug Administration (FDA) on Aug. 23, 2021.
Was the Pfizer vaccine really approved?... More lies, deceit and criminality from the media the cabal and the Pharma companies. THE PFIZER NON VACCINE IS NOT APPROVED AT ALL. Watch to understand what was...
Why would the FDA approve the Pfizer Vaccine without a Formal Advisory Committee Meeting?
FDA Grants Full Approval of Pfizer Vaccine, Critics Blast Agency for Lack of Data, Scientific Debate... According to an article published Aug. 20 in the BMJ, transparency advocates have criticized the FDA decision not to hold a formal advisory committee meeting to discuss Pfizer’s application for full approval — an important mechanism used to scrutinize data. Last year the FDA said it was “committed to use an advisory committee composed of independent experts to ensure deliberations about authorisation or licensure are transparent for the public.”... Data released Friday by the Centers for Disease Control and Prevention (CDC) showed that between Dec. 14, 2020 and Aug. 13, 2021, a total of 326,535 adverse events had been reported to the Vaccine Adverse Events Reporting System (VAERS) attributed to Pfizer’s COVID vaccine, including 9,027 deaths and 56,607 serious injuries.
🚨 Pharma History to Remember 🚨
Justice.Gov: Pfizer $2.3Billion Settlement - Justice Department Announces Largest Health Care Fraud Settlement in Its History...
American pharmaceutical giant Pfizer Inc. and its subsidiary Pharmacia & Upjohn Company Inc. (hereinafter together "Pfizer") have agreed to pay $2.3 billion, the largest health care fraud settlement in the history of the Department of Justice, to resolve criminal and civil liability arising from the illegal promotion of certain pharmaceutical products, the Justice Department announced today.
FDA drugs that were pulled from the market.... FDA-Approved Prescription Drugs Later Pulled from the Markets
Investigational New Drug (IND) Application... Current Federal law requires that a drug be the subject of an approved marketing application before it is transported or distributed across state lines. Because a sponsor will probably want to ship the investigational drug to clinical investigators in many states, it must seek an exemption from that legal requirement.
Past Becomes Present... The FDA has done this before. And they're doing it again.
The list of mistakes that the FDA has made so far with drugs.... VACCINE FDA APPROVED, clinical trials not scheduled to end until 2023 The FDA's track record on 'mistakes' is a long one. In post: a shortlist of the many drugs that made it through 'clinical trials', were given to people for YEARS, and ultimately found to cause SERIOUS HARM/death.
🚨 Don't Forget Vioxx 🚨
When Did Merck Know Vioxx Was Deadly?... Merck should have known Vioxx was deadly years before they pulled the drug from the market, a study of Merck's own data suggests.
Vioxx Killed Half a Million? The Facts Are Grim.... It’s looking more and more likely that the Merck painkiller Vioxx, the blockbuster drug suspected of having caused more than 55,000 deaths from stroke and heart attack before being withdrawn from the market in 2004, actually killed many more people than we previously thought.
Report: Vioxx linked to thousands of deaths... Merck & Co.’s arthritis drug Vioxx may have led to more than 27,000 heart attacks and sudden cardiac deaths before it was pulled from the market last week, the Wall Street Journal reported Wednesday, citing an unreleased study by government regulators.
Vioxx... Vioxx was once a popular drug to treat arthritis. But manufacturer Merck & Co. pulled it from the market in 2004 amid safety concerns.
FDA Approval - Related News
Mandates? Side effects? An end to COVID? What full vaccine approval does & doesn't mean... The Food and Drug Administration's full approval of Pfizer's COVID-19 vaccine could change the landscape in the fight against the virus, leading to more uptake in those waiting on getting the shot and more mandates from businesses and schools.