Johnson & Johnson’s COVID-19 Vaccine Suspended After Blood Disorder Reports

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

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

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

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 […]