Pfizer Approved by the FDA 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.
FDA grants full approval to Pfizer/BioNTech Covid-19 vaccine, opening door to more vaccine mandates... The US Food and Drug Administration on Monday granted full approval to the Pfizer/BioNTech Covid-19 vaccine for people age 16 and older. This is the first coronavirus vaccine approved by the FDA, and is expected to open the door to more vaccine mandates.
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.
Read the Full 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 lettter: 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