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FDA approvals

Information related to approvals by the Federal Drug Administration (FDA) of a vaccine, drug, or medical product.

vaccines
2.4 Nonclinical Overview AZD1222
2.5 Clinical Overview: AZD1222 Marketing Authorisation Application - Primary Analysis (Data Cut-off 07 December 2020)
A cautionary note: Toxicity of polyethylene glycol 200 injected intraperitoneally into mice
Affidavit of LTC. Theresa Long M.D. in Support of a Motion for a Preliminary Injunction Order
An Independent Analysis of the Manufacturing and Quality Issues of the BNT162b BioNTech/Pfizer Quasi-vaccine based on the European Medicines Agency’s Public Assessment Report (EPAR)
Approval letter: Biologics License Application (BLA) Approval for BioNTech (Pfizer) Manufacturing GmbH
BMF Investigation: FDA oversight of clinical trials is “grossly inadequate,” say experts
Cationic compounds used in lipoplexes and polyplexes for gene delivery
CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectivenes
CDC Emails: Our Definition of Vaccine is "Problematic"
CDC Finally Released Its VAERS Safety Monitoring Analyses for COVID Vaccines via FOIA
Compilation of Donald Trump promoting COVID-19 vaccines
Corporate Rap Sheet — Johnson & Johnson
COVID-19 Contracts
COVID-19 vaccine efficacy and effectiveness—the elephant (not) in the room
Covid-19 vaccines and treatments: we must have raw data, now
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
Curing the pandemic of misinformation on COVID-19 mRNA vaccines through real evidence-based medicine - Part 2
Effectiveness of 2, 3, and 4 COVID-19 mRNA Vaccine Doses Among Immunocompetent Adults During Periods when SARS-CoV-2 Omicron BA.1 and BA.2/BA.2.12.1 Sublineages Predominated — VISION Network, 10 States, December 2021–June 2022
Emergency Use Authorization for Vaccines to Prevent COVID-19 - Guidance for Industry
Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) — Emergency Use Authorization (EUA) of the Janssen COVID-19 Vaccine to Prevent Coronavirus Disease 2019 (COVID-19)
Fact Sheet for Recipients and Caregivers - Emergency Use Authorization (EUA) of the Pfizer-Biontech COVID-19 Vaccine to Prevent Coronavirus
FDA Briefing Document - Moderna COVID-19 Vaccine
FDA Briefing Document - Pfizer-BioNTech COVID-19 Vaccine
FDA Takes Key Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for First COVID-19 Vaccine
First case of postmortem study in a patient vaccinated against SARS-CoV-2
Form S-1 Registration Statement Under the Securities Act of 1933: BioNTech SE
Form S-1 Registration Statement Under the Securities Act of 1933: Moderna, Inc.
Functionalized graphene oxide serves as a novel vaccine nano-adjuvant for robust stimulation of cellular immunity
Graphene and graphene oxide as nanomaterials for medicine and biology application
Graphene and the Immune System: A Romance of Many Dimensions
How Bad is My Batch? Batch codes and associated deaths, disabilities and illnesses for Covid 19 Vaccines
Interim position paper: considerations regarding proof of COVID-19 vaccination for international travelers
Intracellular Reverse Transcription of Pfizer BioNTech COVID-19 mRNA Vaccine BNT162b2 In Vitro in Human Liver Cell Line
Johnson & Johnson clinical trial: A Study of Ad26.COV2.S for the Prevention of SARS-CoV-2-Mediated COVID-19 in Adult Participants
Long Term Follow-Up After Administration of Human Gene Therapy Products Guidance for Industry
Moderna clinical trial: A Study to Evaluate Efficacy, Safety, and Immunogenicity of mRNA-1273 Vaccine in Adults Aged 18 Years and Older to Prevent COVID-19
Moderna trial paper: Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine
mRNA Platform: Enabling Drug Discovery & Development
National Childhood Vaccine Injury Act of 1986 (H.R. 5546)
New VAERS analysis reveals hundreds of serious adverse events that the CDC and FDA never told us about
News release: FDA Approves First COVID-19 Vaccine
News release: FDA Takes Additional Action in Fight Against COVID-19 By Issuing Emergency Use Authorization for Second COVID-19 Vaccine
Ninth Amendment to Declaration Under the Public Readiness and Emergency Preparedness (PREP} Act for Medical Countermeasures Against COVID-19
Nobel Laureate Luc Montagnier - Warns Covid Vaccine May Lead to 'Neurodegenerative Illness'
Nonclinical Evaluation Report: BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATY)
OpenVAERS
Outcome Reporting Bias in COVID-19 mRNA Vaccine Clinical Trials
Panel of doctors in Nashville, Tennessee
Pfizer clinical trial: Pfizer-BioNTech COVID-19 BNT162b2 Vaccine Effectiveness Study
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