Search results for: "Operation Warp Speed"

The first COVID-19 vaccine administered in America was to Sandra Lindsey, an ICU nurse, in New York City on December 14, 2020. After months of vaccine development, two companies, Pfizer-BioNTech and Moderna applied to the FDA for Emergency Use Authorization (EUA).  To receive approval, the companies’ data had to be reviewed by the Centers for Disease Control and Prevention (CDC) and its Advisory Committee on Immunization Practices (ACIP), which determined that health care workers and long-term care residents should be the first groups to receive the vaccine. [1, 2, 3, 4] In a press release on December 10, 2020 the FDA assured the public that they would proceed "without sacrificing our rigorous scientific standards for safety and effectiveness."  "The FDA recognizes that transparency and dialogue are critical to building public confidence in COVID-19 vaccines." "The FDA is considered the "gold standard" regulator of medical products. The process that the FDA uses to review is respected worldwide..." On December 10, 2020 The FDA's Center for Biologics Evaluation and Research’s Vaccines and Related Biological Products Advisory Committee (VRBPAC), "made up of independent scientific and public health experts from around the country", met in open session to discuss the request for EUA of..> READ MORE

On December 11, 2020, the US Food and Drug Administration (FDA) granted the first Emergency Use Authorisation (EUA) for a brand new technology product, the Pfizer-BioNTech COVID-19 mRNA vaccine, just 9 months after phase I trials began, and after only 108 days of regulatory safety review. In their press release they stated: "The FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria for issuance of an EUA".  The FDA stated the vaccine "may be effective in preventing COVID-19", then state it is 95% effective in "preventing" COVID-19, that 95% is based on "a 2 month study of a couple hundred people.  That's it!". [3] The day before, on December 10, 2020, the Vaccines and Related Biological Products Advisory Committee (VRBPAC) met to assess the Pfizer-BioNTech COVID-19 Vaccine and prepare a Briefing Document for the FDA. [6] The FDA stated "[t]he vaccine was 95% effective in preventing COVID-19 disease among these clinical trial participants with eight COVID-19 cases in the vaccine group and 162 in the placebo group."  8 plus 162 equals 170 trial participants was all that were used to determined the relative risk of "95% effective", where as the absolute risk (of all 36,523 trial participants)..> READ MORE

On February 27, 2020, independent media, The Highwire, alerted [@1:11:30] the public to the potential dangers of a SARS vaccine, base on a 2012 SARS vaccine study in mice.  Coronovirus vaccines appear to cause “Pathogenic Priming”, a Disease Enhancement otherwise referred to as Antibody Dependent Enhancement (ADE).  What resulted in the animal studies was upon re-infection the mice experienced a cytokine storm followed by death. [1, 2, 3] The paper concluded "Caution in proceeding to application of a SARS-CoV vaccine in humans is indicated." The same effect has been shown in chickens. In addition vasculitis or blood clots were identified in the coronavirus vaccine study in animals. On March 5, 2020, Dr Peter Hotez warned the US government of "the unique potential safety problems of coronavirus vaccines", such as with RSV vaccines in the 1960's where "paradoxical immune enhancement phenomenon" can occur with respiratory virus vaccines, and "we don't entirely understand the basis of it"! They were confronted with the same "immune pathology" problem with coronavirus vaccine tests done on laboratory animals.  The FDA are aware of the problem, these types of vaccines can't be rushed because of the long-term safety implications. [@1:26:30] Yet Operation Warp Speed was officially announced..> READ MORE