The FDA Has a History of Rushed Drug Approvals
Two weeks ago, the Pfizer COVID-19 vaccine was reported as the first COVID-19 vaccine to receive full approval from the U.S. Food and Drug Administration (FDA) for individuals aged 16 and older.1 But, for some, questions remain regarding conflicting discrepancies of the wording surrounding the approval.2 While the FDA’s report states that full approval was […]
Johnson & Johnson’s COVID-19 Vaccine Suspended After Blood Disorder Reports
A manufacturing plant in Baltimore, Maryland where two experimental COVID-19 vaccines are manufactured has caused the U.S. Food and Drug Administration (FDA) to delay authorization of the plant’s production lines due to the contamination of 15 million doses of Johnson & Johnson’s (J&J) COVID-19 vaccine.1 Ingredients Used in Two COVID-19 Vaccines “Mixed Up” During Production […]
FDA Opposes COVID-19 Vaccination Dose and Schedule Changes to Vaccinate More People
Only two weeks after the first experimental biologic for SARS-CoV-2 became available, the U.S. was more than 16 millions doses behind Operation Warp Speed’s goal of giving COVID-19 vaccines to 20 million people by the end of 2020.1 Responding to the slow rollout, Operation Warp Speed chief adviser Moncef Slaoui, MD proposed giving half-doses to […]
Patient in Georgia, Health Worker in New York Suffer Anaphylaxis After Getting Pfizer/BioNTech COVID-19 Vaccine
On Dec. 22, 2020, a patient at Decatur Morgan Hospital in Decatur, Alabama suffered a severe allergic reaction called anaphylaxis just minutes after receiving Pfizer/BioNTech’s experimental messenger RNA (mRNA) BNT162b2 vaccine for COVID-19.1 2 3 In a press release, the Alabama Department of Public Health (ADPH) stated the patient, who reportedly had a history of […]
Novartis Manipulated Data in FDA Biologics License Application
On Aug. 6, 2019, the U.S. Food and Drug Administration (FDA) issued a statement saying that Swiss pharmaceutical company Novartis AG submitted a biologics license application (BLA) for the spinal muscular atrophy (SMA) gene therapy Zolgensma (onasemnogene abeparvovec-xioi) with manipulated data and failed to inform regulators until June 28, 2019—more than a month after the […]
