Search results for: Biontech

On December 18, 2020 the U.S. Food and Drug Administration (FDA) announced they have "issued an emergency use authorization (EUA) for the second vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). The emergency use authorization allows the Moderna COVID-19 Vaccine to be distributed in the U.S. for use in individuals 18 years of age and older."  The FDA stated the "vaccine was 94.1% effective in preventing COVID-19 disease among these clinical trial participants with 11 cases of COVID-19 in the vaccine group and 185 in the placebo group." This comes the day after the December 17, 2020  VRBPAC meeting where they discussed the EUA of the Moderna COVID-19 Vaccine “for the prevention of COVID-19 in individuals 18 years and older.” This EUA is granted 4 days after the first Pfizer-BioNTech vaccines was administered in the US and 10 days before the WHO declares the virus endemic the vaccines likely not to stop transmission!  

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

In September 2021 the PHMPT sued the FDA for failure to respond to a FOIA request.  The FDA then asked the court to grant them permission to release only 500 pages per month.  On January 6, 2022, 18 months after the FOIA request, US District Judge Mark T. Pittman, Northern District of Texas, ordered the FDA to comply and "produce at least 55,000 pages per month" of the Pfizer documents they relied upon to license their COVID-19 vaccine in USA. Since this time a huge "posse" of collaborating citizens, doctors and lawyers in a coordinated effort to review the Pfizer documents; which are revealing alarming insights into what was known before EUA was granted and shortly into the vaccine rollout! Tracking the Pfizer FOIA documents - HERE

In a press release on January 31, 2022, the FDA announced the approval of the vaccine which under EUA has been known as Moderna COVID-19 Vaccine, but now approved the vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older, under BLA.  This is the second approved COVID-19 vaccine.  Pfizer's Cominarty was granted registration August 2021 yet it is still not available in the USA.

First participants enrolled in Pfizer/BioNTech clinical trial received Omicron-based COVID-19 vaccine candidate as a two-dose primary series and as a booster dose.